Protocol Index	

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OP RESEARCH PRO00032923 NCT04935359 ABDELRAHIM	

Types:      Research Oncology Treatment
Synonyms:  MPDAC, GEMZAR, GEMCITABINE, NAB, PACLITAXEL, NIS793 , ABRAXANE

Screening Day -28 to Day -1	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Informed Consent
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Tumor Biopsy Consent Form (Optional)
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Inclusion/Exclusion Criteria
		  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	o IRT Screening (aft4er ICF Signature)  
o IRT Enrollment
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Participation History
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Diagnosis, Stage, Grade and Extent of Cancer
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Demography
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Medical History/Current Medical Conditions
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Smoking and Alcohol History
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	MSI, BRCA1/2, NTRK and other Mutations Status
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	HIV History and Testing where Locally Required
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Prior Antineoplastic Therapy (medications, surgery, radiation)
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Prior/Concomitant Medications (30 Days prior to starting Study Treatment)
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Prior Concomitant Procedures and significant non-drug therapies
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	Physical Examination
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	ECOG or Performance Status (safety run-in)
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	ECOG or Performance Status (Randomized portion)
		  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Calculate calcium corrected for albumin
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Calculate indirect bilirubin
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	EQ-5D-5L, PGIS (ePRO)
		  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	PRO-CTCAE, FACT-GP5 (ePRO)
		  	ONC NURSING COMMUNICATION 38	Interval: --	Occurrences: --	Comments:	PROMIS-29 (ePRO)
		  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	Actigraphy
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	Adverse Events
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Serious Adverse Events
		  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	Health Resource Utilization
		  	ONC NURSING COMMUNICATION 59	Interval: --	Occurrences: --	Comments:	Disposition
			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --			Labs
  	HEPATITIS B VIRUS (HBV), QUANTITATIVE PCR	Interval: --	Occurrences: --		  	HEPATITIS B SURFACE ANTIBODY	Interval: --	Occurrences: --		  	HEPATITIS B SURFACE ANTIGEN	Interval: --	Occurrences: --		  	HEPATITIS B CORE ANTIBODY TOTAL	Interval: --	Occurrences: --		  	HEPATITIS C VIRUS (HCV), QUANTITATIVE PCR	Interval: --	Occurrences: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
  	URIC ACID LEVEL	Interval: --	Occurrences: --			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Labs
  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --		  	T3, FREE	Interval: --	Occurrences: --		  	T4, FREE	Interval: --	Occurrences: --			Labs
  	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --			Labs
  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Only for females of childbearing potential
			Labs
  	CREATININE CLEARANCE, URINE, 24 HOUR	Interval: --	Occurrences: --		  	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --		  	AMYLASE LEVEL	Interval: --	Occurrences: --		  	LIPASE LEVEL	Interval: --	Occurrences: --		  	GGT	Interval: --	Occurrences: --		  	HEMOGLOBIN A1C	Interval: --	Occurrences: --		  	CANCER ANTIGEN 19-9	Interval: --	Occurrences: --		  	TROPONIN	Interval: --	Occurrences: --		  	NT-PROBNP	Interval: --	Occurrences: --		  	NABFERON IFN-B ANTIBODY - ATHENA	Interval: --	Occurrences: --		  	INTERLEUKIN 6	Interval: --	Occurrences: --		  	MISCELLANEOUS REFERRAL TEST	Interval: --	Occurrences: --	Comments:	Interleukin 1
		  	TUMOR NECROSIS FACTOR - ALPHA	Interval: --	Occurrences: --	Comments:	Perform ONLY at HMH and HMCL
			Imaging
☑	CT HEAD W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI
		☐	MRI BRAIN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		☑	CV ECHOCARDIOGRAM RESEARCH ONLY	Interval: --	Occurrences: --		☑	NM BONE SCAN WHOLE BODY	Interval: --	Occurrences: --		☑	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	If Clinically Indicated Localized bone CT scan, MRI or Xray.
			Procedures
  	BIOPSY	Interval: --	Occurrences: --	Comments:	Newly Obtained Tumor Sample or Archival Tumor - Newly obtained tumor: 3-6 passes of a core needle biopsy (note: fine needle biopsies are not acceptable), Archival sample: formalin-fixed paraffin-embedded (FFPE) block (preferred) or at least 15 slides at 5 micrometer thickness and must be freshly cut. Samples collected within 3 months prior to study treatment strongly recommended.
					
Cycle 1	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Line Flush
  	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Use with NIS793		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Do NOT administer with NIS793			Nursing Orders
  	dextrose 5% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open for NIS793		  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.  Do NOT administer with NIS793			Nursing Orders
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	Criteria for Defining Dose-Limiting Toxicities During Safety Run-In: 
A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first cycle (i.e., 28  days or 4 weeks) of the treatment with NIS793 in combination with gemcitabine/nab-paclitaxel  and meets any of the criteria included in Table 6 4. The National Cancer Institute Common Terminology Criteria for Adverse events (NCI CTCAE) version 5 will be used for all grading. The investigator must notify the sponsor immediately of any unexpected CTCAE grade GREATER than or EQUAL to 3 adverse events or laboratory abnormalities (refer to Section 10.1.3 for notification guidelines).
		  	TREATMENT CONDITIONS 3	Interval: --	Occurrences: --	Comments:	Grade 3 toxicity -  
o Cardiac (including valvulopathy): Grade GREATER than or EQUAL to 3 cardiac events. 
o Cutaneous reactions: Grade GREATER than or EQUAL to 3. 
o Gastrointestinal: 
1. Grade 3 nausea and vomiting for GREATER than 3 days despite optimal anti-emetic therapy. 
2. Grade 3 diarrhea for GREATER than 5 days despite optimal antidiarrheal treatment (which could include steroids). 
3. Grade 4 vomiting or diarrhea. 
o Thrombocytopenia: Grade 3 thrombocytopenia with clinically significant bleeding (i.e. life threatening, and invasive intervention indicated) regardless of duration or requirement for transfusion. 
o Renal / Serum Creatinine: Grade GREATER than or EQUAL to 3 serum creatinine. 
o Infusion related reaction: Grade GREATER than or EQUAL to 3 infusion related reaction. 
o Pancreatitis: Grade GREATER than or EQUAL to 3 pancreatitis: Symptomatic serum amylase or lipase elevation, medical intervention required. 
o Peripheral neuropathy. 
o Hemorrhage/ Bleeding.  
o Ocular disorders: Conjunctivitis, blepharitis, vision blurred. 
o Other AEs: 
1. Have not been previously identified for NIS793. 
2. AEs that are known to occur with NIS793.
		  	TREATMENT CONDITIONS 10	Interval: --	Occurrences: --	Comments:	Grade 4 toxicity - 
o Hematological: Grade 4 neutropenia for GREATER than 14 consecutive days, or grade 4 febrile neutropenia. 
o Anemia: Grade 4 anemia. 
o Thrombocytopenia: Grade 4 thrombocytopenia (LESS than25,000/mm3). 
o Hepatobiliary / bilirubin elevation: Grade 4 bilirubin elevation. 
For patients with normal baseline AST, ALT and bilirubin values: 
1. AST or ALT GREATER than 8.0 × ULN; OR 
2. AST or ALT GREATER than 5.0 × ULN for more than 2 weeks; OR 
3. AST or ALT GREATER than 3.0 × ULN combined with total bilirubin GREATER than 2.0 × ULN without evidence of cholestasis. 
For patients with abnormal baseline AST or ALT or abnormal baseline bilirubin value: 
1. ALT or AST GREATER than 3.0 x baseline value; OR 
2. ALT or AST GREATER than 3.0 x baseline (or GREATER than 8.0 x ULN), whichever occurs first, combined with total bilirubin GREATER than 2.0 x baseline and GREATER than 2.0 x ULN without evidence of cholestasis. 
o Infection. 
o Other AEs: 
1. AEs that have not been previously identified for SOC anticancer treatments AEs that are known to occur with NIS793. 
2. Grade 4 AEs that are known to occur with SOC anticancer treatments but cannot be controlled using the recommended product-specific management guidelines (per local prescribing information), or leads to LESS than 50% of planned exposure of study medications. 
3. Other clinically-significant AEs, including a single event or multiple occurrences of the same event that lead to a dosing delay of GREATER than 4 weeks should be considered as DLTs by the Investigators and the sponsor, even if not Grade 3 or higher.
		  	TREATMENT CONDITIONS 11	Interval: --	Occurrences: --	Comments:	The SOC anti-cancer therapy will include combination of gemcitabine and nab-paclitaxel. Events which will NOT be considered as DLT for the purpose of this protocol: Clinically insignificant laboratory values LESS than or EQUAL to grade 2. For electrolyte abnormalities GREATER than or EQUAL to grade 3, the maximum allowable time limit for correction to LESS than or EQUAL to grade 1 is 72 hours.
			Nursing Orders
  	TREATMENT CONDITIONS 12	Interval: --	Occurrences: --	Comments:	Infusion Reaction or Hypersensitivity Reaction - 
o Grade 1-Infusion Reaction or Hypersensitivity Reaction: Decrease infusion rate until recovery from the symptoms. If the infusion reaction happens after the end of infusion (EOI), increase monitoring of vital signs until the participant is symptoms free. Administer subsequent NIS793 infusion at the same rate. 
o Grade 2- Infusion Reaction or Hypersensitivity Reaction: Stop infusion immediately and keep line open. Follow institutional guidelines for the management and follow-up of infusion reaction. Restart infusion at 50% of previous rate under continuous observation. Ensure that there is a minimum observation period of 1 hour prior to restarting the infusion. If the AE recurs at the reinitiated slower rate of infusion, and despite oral pre-medication, permanently discontinue study treatment. 
o Grade 3 or Grade 4- Infusion Reaction or Hypersensitivity Reaction: Stop infusion immediately and keep line open. Follow institutional guidelines for the management and follow-up of infusion reaction. Provide supplemental oxygen, fluids, and other resuscitative measures as needed. Monitor vital signs (e.g. blood pressure, pulse, respiration, and temperature) every 15 ± 5 minutes until resolution.
		  	TREATMENT CONDITIONS 13	Interval: --	Occurrences: --	Comments:	Cytokine Release Syndrome (CRS) - 
o Grade 2: Stop infusion immediately and keep line open. Follow institutional guidelines for the management and follow-up of infusion reaction. Restart infusion at 50% of previous rate under continuous observation. Ensure that there is a minimum observation period of 1 hour prior to restarting the infusion. If the AE recurs at the reinitiated slower rate of infusion, and despite oral pre-medication, permanently discontinue study treatment. 
o Grade 3 or 4: Permanently discontinue study treatment. Follow-up CRS as per institutional guidelines.
		  	TREATMENT CONDITIONS 14	Interval: --	Occurrences: --	Comments:	Ocular (e.g. Conjunctivitis, Blepharitis, blurred vision) - 
o Grade 1: May continue study treatment. Consider ophthalmology consultation. 
o Grade 2: Ophthalmology consultation. Upon resolution to LESS than or EQUAL to Grade 1 consider resuming study treatment in consultation with ophthalmologist. 
o Grade 3: 
1. Interrupt study treatment. 
2. Ophthalmology consultation. 
3. Upon resolution to LESS than or EQUAL to Grade 1 consider resuming study treatment in consultation with ophthalmologist.
o Grade 4:  Permanently discontinue study treatment.
		  	TREATMENT CONDITIONS 15	Interval: --	Occurrences: --	Comments:	Cardiovascular - 
o Grade 2 or greater Myocarditis: Permanently discontinue study treatment. 
o Grade 2 Cardiac Valvulopathy and other Cardiac Toxicity: Interrupt study treatment. Repeat echocardiogram and assess cardiac function. Once resolved to Grade ? 1 or baseline, consider re-administration of treatment, if benefit outweighs the potential risk. 
o Grade 3> Cardiac Valvulopathy and other Cardiac Toxicity: Permanently discontinue study treatment.
		  	TREATMENT CONDITIONS 16	Interval: --	Occurrences: --	Comments:	Isolated AST and/or ALT Elevation - 
o Grade 3 AST or ALT >5.0 - 10.0 x ULN: Interrupt treatment. Repeat liver function tests (LFTs) within 48-72 hours, then monitor LFTs weekly until recovery to grade ?1 or to baseline. Then resume treatment at the same dose interval if resolved in LESS than or EQUAL to 14 days; if resolved in GREATER than 14 days, consider administration Q4W instead of Q2W. 
o Grade 3 AST or ALT >10.0 - 20.0 x ULN: Interrupt treatment. Repeat LFTs within 48-72 hours, then monitor LFTs weekly until recovery to grade LESS than or EQUAL to 1 or to baseline, then increase dosing interval for NIS793 from Q2W to Q4W. 
o Grade 4: AST or ALT (>20 x ULN): Permanently discontinue treatment.
		  	TREATMENT CONDITIONS 17	Interval: --	Occurrences: --	Comments:	With abnormal ALT/AST (up to grade 2 - </= 5.0 x ULN) at baseline - 
o ALT/AST > 2.0 x baseline AND > 5.0 x ULN: Interrupt treatment. Repeat LFTs within 48-72 hours, then monitor LFTs weekly until recovery to baseline; Then resume same dose interval if resolved in LESS than or EQUAL to 14 days; if resolved in GREATER than 14 days, increasing dosing from Q2W to Q4W. 
o ALT/AST > 3.0 x baseline AND >10 x ULN: Interrupt treatment. Repeat LFTs within 48-72 hours, then monitor weekly until resolved to baseline; then increase dosing interval from Q2W to Q4W. 
o AST or ALT >20 x ULN (grade 4): Permanently discontinue treatment.
		  	TREATMENT CONDITIONS 18	Interval: --	Occurrences: --	Comments:	Concomitant elevation of AST and/or ALT and total bilirubin with normal AST/ALT and bilirubin at baseline -
o Grade 2 ALT and/or AST elevation (>3.0 x ULN) with bilirubin > 2.0 x ULN (unless Gilbert's syndrome): Interrupt treatment. Assess if case is drug induced liver injury (DILI). If DILI confirmed, permanently discontinue study treatment. For additional information on follow-up of potential drug induced liver injury cases, refer to Section 6.5.5.1. If no DILI confirmed, interrupt treatment, treat the identified cause according to institutional guidelines. Repeat LFTs within 48-72 hours, then monitor weekly, until enzyme levels resolve to LESS than or EQUAL to grade 1 or baseline.  After recovery, re-administration of study treatment could be considered only if Investigator assesses benefit to outweigh the risk. Any decision regarding re-administration of study drugs and dose regimen should be discussed with the Sponsor.
		  	TREATMENT CONDITIONS 19	Interval: --	Occurrences: --	Comments:	With abnormal ALT/AST at baseline - 
o ALT or AST >3.0 x baseline OR ALT or AST >8.0 x ULN [whichever is lower] combined with total bilirubin >2.0 x baseline AND >2.0 x ULN:  Interrupt treatment. Assess if case is drug induced liver injury (DILI). If DILI confirmed, permanently discontinue study treatment. For additional information on follow-up of potential drug induced liver injury cases, refer to Section 6.5.5.1. If no DILI confirmed, interrupt treatment, treat the identified cause according to institutional guidelines. Repeat LFTs within 48-72 hours, then monitor weekly, until enzyme levels resolve to ?grade 1 or baseline.  After recovery, re-administration of study treatment could be considered only if Investigator assesses benefit to outweigh the risk. Any decision regarding re-administration of study drugs and dose regimen should be discussed with the Sponsor.
		  	TREATMENT CONDITIONS 20	Interval: --	Occurrences: --	Comments:	Isolated total bilirubin elevation - 
o Any elevation > ULN: Fractionate bilirubin, evaluate for cholestatic liver injury (e.g. by testing Alkaline Phosphatase (ALP)) or alternative causes of bilirubin elevation (e.g. disease progression [imaging]). Treat alternative causes according to institutional guidelines. 
o Grade 2 (>1.5 - 3.0 ULN): Repeat LFTs within 48-72 hours, then monitor LFTs weekly until resolution to LESS than or EQUAL to grade 1 or to baseline. If isolated bilirubin remains stable at Grade 2, continue treatment at the same dose regimen. 
o Grade 3 (>3.0 - 10 ULN): Interrupt treatment. Repeat LFTs within 48-72 hours, then monitor LFTs weekly until resolution to LESS than or EQUAL to Grade 1 or to baseline. If resolved in ? 14 days, maintain dose regimen; if not resolved in 14 days, permanently discontinue NIS793. (Please see footnote regarding alternative cause/s of bilirubin elevation). 
o Grade 4 (> 10 x ULN): See footnote*. Otherwise, permanently discontinue study treatment. If alternative cause/s is identified and managed, and bilirubin resolves to ? grade 1 or to baseline, resume treatment at the same dose regimen. *An isolated bilirubin elevation is not typical for DILI. Bilirubin can be elevated either as part of a "Hy's law" constellation with a preceding elevation of ALT/AST, or as part of a cholestatic reaction with simultaneous elevation of other cholestatic parameters (ALP, GGT). Isolated bilirubin can be seen in conjunction with drugs that inhibit bilirubin conjugation or excretion, but both scenarios do not typically represent liver injury. Alternative causes of bilirubin elevation should, therefore, be ruled out before basing dose modification decisions on bilirubin values alone.
		  	TREATMENT CONDITIONS 21	Interval: --	Occurrences: --	Comments:	Asymptomatic amylase and/or lipase elevation - 
o Grade 3, not associated with symptoms or clinical manifestations of pancreatitis: May continue study treatment. If levels do not resolve to LESS than or EQUAL to Grade 2 within LESS than or EQUAL to 14 days after the initial report, interrupt study treatment.  Upon resolution to ? Grade 2, consider resuming study treatment.
		  	TREATMENT CONDITIONS 22	Interval: --	Occurrences: --	Comments:	Renal / Serum Creatinine - 
o Grade 2:  Interrupt Study Treatment. Manage per institutional Practice. Upon resolution to LESS than Grade 1, consider resuming study treatment. 
o Grade 3 or Grade 4: Permanently Discontinue Study Treatment.
		  	TREATMENT CONDITIONS 23	Interval: --	Occurrences: --	Comments:	Hyperthyroidism - 
o Grade 2: Consider Continuing Study Treatment and Management according to institutional practice. 
o Grade 3: Interrupt study treatment. Upon resolution to Grade ? 1 with appropriate management, consider resuming study treatment without dose modification. 
o Grade 4: Must discontinue and manage according to local/institutional guidance.
		  	TREATMENT CONDITIONS 24	Interval: --	Occurrences: --	Comments:	Other Endocrine Disorders - 
o Grade 2 and Grade 3: Interrupt study treatment. Upon resolution to Grade LESS than or EQUAL to 1 with appropriate management, consider resuming study treatment.
		  	TREATMENT CONDITIONS 25	Interval: --	Occurrences: --	Comments:	Dermatology (rash) - 
o Grade 1: Continue study treatment. Consider topical steroids, antihistamines, topical emollients. 
o Grade 2: Consider interrupting study treatment. Topical or oral steroids, antihistamines. If study treatment is held and resolution to LESS than or EQUAL to Grade 1, resume study treatment. 
o Grade 3: Interrupt study treatment. Manage per institutional practice. After resolution to LESS than or EQUAL to Grade 1, consider resuming study treatment after consultation with dermatologist. 
o Grade 4 or Stevens-Johnson syndrome (SJS), or Lyell syndrome/toxic epidermal necrolysis (TEN): Permanently discontinue study treatment and manage according to local/institutional guidance.
		  	TREATMENT CONDITIONS 26	Interval: --	Occurrences: --	Comments:	Neutropenia - 
o Grade 3: Interrupt study treatment until resolved to LESS than or EQUAL to Grade 1 or baseline, then resume study medication. 
o Grade 4: Interrupt study treatment. If resolved in LESS than or EQUAL to 7 days, maintain study treatment.  

Febrile Neutropenia - 
o Grade 3: Interrupt study treatment. Upon resolution of fever and improvement of neutropenia to LESS than or EQUAL to Grade 1 or baseline, resume study treatment. 
o Grade 4: Permanently discontinue study treatment. 

Thrombocytopenia - 
o Grade 3: Interrupt study treatment. Upon resolution to ? Grade 2 or baseline, resume study treatment. For Grade 3 associated with major bleeding, permanently discontinue study treatment. 
o Grade 4: Permanently discontinue study treatment. 

Anemia - 
o Grade 3 or Grade 4: Interrupt study treatment. Upon resolution to LESS than or EQUAL to Grade 2 or baseline within LESS than or EQUAL to 7 days, resume study treatment.
		  	TREATMENT CONDITIONS 27	Interval: --	Occurrences: --	Comments:	Other laboratory adverse events, not specified elsewhere in table and not included in the consensus guidelines - 
o Grade 3 or Grade 4: Interrupt study treatment. Upon resolution to LESS than or EQUAL to Grade 1, resume study treatment without dose modification. Isolated Grade 4 electrolyte abnormalities not associated with clinical sequelae and corrected after appropriate management within 72 hours of their onset do not require discontinuation. In the case of Grade 4 electrolyte imbalances associated with clinical sequelae, or not resolved to LESS than or EQUAL to Grade 1 within 72 hours despite appropriate management, permanently discontinue study treatment. 

Other non-laboratory adverse events, not specified elsewhere in table and not included in the consensus guidelines:
o Grade 2: Consider study treatment interruption. Upon resolution to ? Grade 1, consider resuming study treatment. 
o Grade 3: Interrupt study treatment. Upon resolution to LESS than or EQUAL to Grade 1, resuming study treatment must be discussed with the relevant medical expert. 
o Grade 4: Permanently discontinue study treatment.
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Dose Modifications and Dose Interruption for NIS793: 
No Dose Reductions are allowed for NIS793: Increasing the dosing interval from Q2W to Q4W is allowed under circumstances described in Table 6-5. If NIS793 is interrupted or delayed for GREATER than 8 weeks due to toxicity that is suspected to be related to treatment, study treatment should be permanently discontinued.
			Nursing Orders
  	ONC NURSING COMMUNICATION 60	Interval: --	Occurrences: --	Comments:	Concomitant Medications
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Prior Concomitant Procedures and significant non-drug therapies
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	Physical Examination
		  	ONC NURSING COMMUNICATION 62	Interval: --	Occurrences: --	Comments:	ECOG
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Calculate indirect bilirubin
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	EQ-5D-5L, PGIS (ePRO)
		  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	PRO-CTCAE, FACT-GP5 (ePRO)
		  	ONC NURSING COMMUNICATION 38	Interval: --	Occurrences: --	Comments:	PROMIS-29 (ePRO)
		  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	Actigraphy
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	Adverse Events
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Serious Adverse Events
		  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	Health Resource Utilization
			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
☑	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --	Comments:	As clinically indicated
		☑	T3, FREE	Interval: --	Occurrences: --	Comments:	As clinically indicated
		☑	T4, FREE	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
☑	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated
		☑	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
  	URIC ACID LEVEL	Interval: --	Occurrences: --			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Labs
  	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --			Labs
  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --			Labs
☑	CREATININE CLEARANCE, URINE, 24 HOUR	Interval: --	Occurrences: --		☑	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --		☑	BILIRUBIN DIRECT	Interval: --	Occurrences: --		☑	AMYLASE LEVEL	Interval: --	Occurrences: --		☑	LIPASE LEVEL	Interval: --	Occurrences: --		☑	GGT	Interval: --	Occurrences: --		☑	HEMOGLOBIN A1C	Interval: --	Occurrences: --	Comments:	As clinically indicated
		☑	CANCER ANTIGEN 19-9	Interval: --	Occurrences: --		☑	NABFERON IFN-B ANTIBODY - ATHENA	Interval: --	Occurrences: --	Comments:	Anytime when suspected Cytokine Release Syndrome Occurs
		☑	INTERLEUKIN 6	Interval: --	Occurrences: --	Comments:	Anytime when suspected Cytokine Release Syndrome Occurs
		☑	MISCELLANEOUS REFERRAL TEST	Interval: --	Occurrences: --	Comments:	Interleukin 1 - Anytime when suspected Cytokine Release Syndrome Occurs
		☑	TUMOR NECROSIS FACTOR - ALPHA	Interval: --	Occurrences: --	Comments:	Anytime when suspected Cytokine Release Syndrome Occurs. 
Perform ONLY at HMH and HMCL.
			Imaging
☑	CT HEAD W WO CONTRAST	Interval: --	Occurrences: --	Comments:	As clinically indicated. Or MRI
		☐	MRI BRAIN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	As clinically indicated. Or CT
		☑	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	As clinically indicated  for Tumor Evaluation per RECIST. Or MRI
		☐	MRI CHEST W CONTRAST	Interval: --	Occurrences: --	Comments:	As clinically indicated  for Tumor Evaluation per RECIST. Or CT
		☐	MRI ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	As clinically indicated  for Tumor Evaluation per RECIST. Or CT
		☐	MRI PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	As clinically indicated  for Tumor Evaluation per RECIST. Or CT
		☑	CV ECHOCARDIOGRAM RESEARCH ONLY	Interval: --	Occurrences: --	Comments:	As clinically indicated.
		☑	NM BONE SCAN WHOLE BODY	Interval: --	Occurrences: --	Comments:	As clinically indicated.
		☑	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	If Clinically Indicated Localized bone CT scan, MRI or Xray.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mEq/L; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 28	Interval: --	Occurrences: --	Comments:	o ANC LESS than 1000; 
o Platelets LESS than 100,000; 
o Bilirubin GREATER than 1.6; 
o LFTs GREATER than 10 x ULN.
			Pre-Medications
  	ondansetron (ZOFRAN) IV 8 mg	Dose: 8 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to chemo.			Nursing Orders
  	ONC NURSING COMMUNICATION 68	Interval: --	Occurrences: --	Comments:	Infusion must take place in a facility with appropriate resuscitation equipment available at the bedside, and a physician readily available during the period of drug administration.
		  	ONC NURSING COMMUNICATION 69	Interval: --	Occurrences: --	Comments:	Participants should be closely observed for potential infusion-related reactions including rigors, chills, wheezing, pruritus, flushing, rash, hypotension, hypoxemia, and fever, and vital signs monitored more frequently if clinically indicated, during and for at least 2 hours after the first two NIS793 infusions. The same may apply for subsequent NIS793 infusions if medically indicated. Participants should notify study personnel if symptoms of infusion reaction occur after any NIS793 infusion.
			Chemotherapy
  	INV-NIS793 or placebo (CNIS793B12301 daNIS-2/Pro00032923/Abdelrahim) 2,100 mg in dextrose 5% 100 mL	Dose: 2,100 mg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Protect from light.  Administer intravenously using a 0.2 micron inline filter over 30 minutes.  Flush only with D5W!
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.

	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-NIS793 OR PLACEBO 1050MG/10ML INTRAVENOUS SOLN. (CNIS793B12301 DANIS-2/PRO00032923/ABDELRAHIM)	Medications	2,100 mg	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	80 mL	Yes	Yes			  	NAB-PACLItaxel (ABRAXANE) chemo infusion 125 mg/m2 (Treatment Plan)	Dose: 125 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 3 Hours		  	gemcitabine (GEMZAR) 1,000 mg/m2 in sodium chloride 0.9% 250 mL chemo IVPB	Dose: 1,000 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 3.5 Hours	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	GEMCITABINE 200 MG/5.26 ML (38 MG/ML) INTRAVENOUS SOLUTION	Medications	1,000 mg/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	 	No	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	fexofenadine (ALLEGRA) tablet 180 mg	Dose: 180 mg	Route: oral	PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 8	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Line Flush
  	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Nursing Orders
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Nursing Orders
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	Criteria for Defining Dose-Limiting Toxicities During Safety Run-In: 
A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first cycle (i.e., 28  days or 4 weeks) of the treatment with NIS793 in combination with gemcitabine/nab-paclitaxel  and meets any of the criteria included in Table 6 4. The National Cancer Institute Common Terminology Criteria for Adverse events (NCI CTCAE) version 5 will be used for all grading. The investigator must notify the sponsor immediately of any unexpected CTCAE grade GREATER than or EQUAL to 3 adverse events or laboratory abnormalities (refer to Section 10.1.3 for notification guidelines).
		  	TREATMENT CONDITIONS 3	Interval: --	Occurrences: --	Comments:	Grade 3 toxicity -  
o Cardiac (including valvulopathy): Grade GREATER than or EQUAL to 3 cardiac events. 
o Cutaneous reactions: Grade GREATER than or EQUAL to 3. 
o Gastrointestinal: 
1. Grade 3 nausea and vomiting for GREATER than 3 days despite optimal anti-emetic therapy. 
2. Grade 3 diarrhea for GREATER than 5 days despite optimal antidiarrheal treatment (which could include steroids). 
3. Grade 4 vomiting or diarrhea. 
o Thrombocytopenia: Grade 3 thrombocytopenia with clinically significant bleeding (i.e. life threatening, and invasive intervention indicated) regardless of duration or requirement for transfusion. 
o Renal / Serum Creatinine: Grade GREATER than or EQUAL to 3 serum creatinine. 
o Infusion related reaction: Grade GREATER than or EQUAL to 3 infusion related reaction. 
o Pancreatitis: Grade GREATER than or EQUAL to 3 pancreatitis: Symptomatic serum amylase or lipase elevation, medical intervention required. 
o Peripheral neuropathy. 
o Hemorrhage/ Bleeding.  
o Ocular disorders: Conjunctivitis, blepharitis, vision blurred. 
o Other AEs: 
1. Have not been previously identified for NIS793. 
2. AEs that are known to occur with NIS793.
		  	TREATMENT CONDITIONS 10	Interval: --	Occurrences: --	Comments:	Grade 4 toxicity - 
o Hematological: Grade 4 neutropenia for GREATER than 14 consecutive days, or grade 4 febrile neutropenia. 
o Anemia: Grade 4 anemia. 
o Thrombocytopenia: Grade 4 thrombocytopenia (LESS than25,000/mm3). 
o Hepatobiliary / bilirubin elevation: Grade 4 bilirubin elevation. 
For patients with normal baseline AST, ALT and bilirubin values: 
1. AST or ALT GREATER than 8.0 × ULN; OR 
2. AST or ALT GREATER than 5.0 × ULN for more than 2 weeks; OR 
3. AST or ALT GREATER than 3.0 × ULN combined with total bilirubin GREATER than 2.0 × ULN without evidence of cholestasis. 
For patients with abnormal baseline AST or ALT or abnormal baseline bilirubin value: 
1. ALT or AST GREATER than 3.0 x baseline value; OR 
2. ALT or AST GREATER than 3.0 x baseline (or GREATER than 8.0 x ULN), whichever occurs first, combined with total bilirubin GREATER than 2.0 x baseline and GREATER than 2.0 x ULN without evidence of cholestasis. 
o Infection. 
o Other AEs: 
1. AEs that have not been previously identified for SOC anticancer treatments AEs that are known to occur with NIS793. 
2. Grade 4 AEs that are known to occur with SOC anticancer treatments but cannot be controlled using the recommended product-specific management guidelines (per local prescribing information), or leads to LESS than 50% of planned exposure of study medications. 
3. Other clinically-significant AEs, including a single event or multiple occurrences of the same event that lead to a dosing delay of GREATER than 4 weeks should be considered as DLTs by the Investigators and the sponsor, even if not Grade 3 or higher.
		  	TREATMENT CONDITIONS 11	Interval: --	Occurrences: --	Comments:	The SOC anti-cancer therapy will include combination of gemcitabine and nab-paclitaxel. Events which will NOT be considered as DLT for the purpose of this protocol: Clinically insignificant laboratory values LESS than or EQUAL to grade 2. For electrolyte abnormalities GREATER than or EQUAL to grade 3, the maximum allowable time limit for correction to LESS than or EQUAL to grade 1 is 72 hours.
			Nursing Orders
  	TREATMENT CONDITIONS 12	Interval: --	Occurrences: --	Comments:	Infusion Reaction or Hypersensitivity Reaction - 
o Grade 1-Infusion Reaction or Hypersensitivity Reaction: Decrease infusion rate until recovery from the symptoms. If the infusion reaction happens after the end of infusion (EOI), increase monitoring of vital signs until the participant is symptoms free. Administer subsequent NIS793 infusion at the same rate. 
o Grade 2- Infusion Reaction or Hypersensitivity Reaction: Stop infusion immediately and keep line open. Follow institutional guidelines for the management and follow-up of infusion reaction. Restart infusion at 50% of previous rate under continuous observation. Ensure that there is a minimum observation period of 1 hour prior to restarting the infusion. If the AE recurs at the reinitiated slower rate of infusion, and despite oral pre-medication, permanently discontinue study treatment. 
o Grade 3 or Grade 4- Infusion Reaction or Hypersensitivity Reaction: Stop infusion immediately and keep line open. Follow institutional guidelines for the management and follow-up of infusion reaction. Provide supplemental oxygen, fluids, and other resuscitative measures as needed. Monitor vital signs (e.g. blood pressure, pulse, respiration, and temperature) every 15 ± 5 minutes until resolution.
		  	TREATMENT CONDITIONS 13	Interval: --	Occurrences: --	Comments:	Cytokine Release Syndrome (CRS) - 
o Grade 2: Stop infusion immediately and keep line open. Follow institutional guidelines for the management and follow-up of infusion reaction. Restart infusion at 50% of previous rate under continuous observation. Ensure that there is a minimum observation period of 1 hour prior to restarting the infusion. If the AE recurs at the reinitiated slower rate of infusion, and despite oral pre-medication, permanently discontinue study treatment. 
o Grade 3 or 4: Permanently discontinue study treatment. Follow-up CRS as per institutional guidelines.
		  	TREATMENT CONDITIONS 14	Interval: --	Occurrences: --	Comments:	Ocular (e.g. Conjunctivitis, Blepharitis, blurred vision) - 
o Grade 1: May continue study treatment. Consider ophthalmology consultation. 
o Grade 2: Ophthalmology consultation. Upon resolution to LESS than or EQUAL to Grade 1 consider resuming study treatment in consultation with ophthalmologist. 
o Grade 3: 
1. Interrupt study treatment. 
2. Ophthalmology consultation. 
3. Upon resolution to LESS than or EQUAL to Grade 1 consider resuming study treatment in consultation with ophthalmologist.
o Grade 4:  Permanently discontinue study treatment.
		  	TREATMENT CONDITIONS 15	Interval: --	Occurrences: --	Comments:	Cardiovascular - 
o Grade 2 or greater Myocarditis: Permanently discontinue study treatment. 
o Grade 2 Cardiac Valvulopathy and other Cardiac Toxicity: Interrupt study treatment. Repeat echocardiogram and assess cardiac function. Once resolved to Grade ? 1 or baseline, consider re-administration of treatment, if benefit outweighs the potential risk. 
o Grade 3> Cardiac Valvulopathy and other Cardiac Toxicity: Permanently discontinue study treatment.
		  	TREATMENT CONDITIONS 16	Interval: --	Occurrences: --	Comments:	Isolated AST and/or ALT Elevation - 
o Grade 3 AST or ALT >5.0 - 10.0 x ULN: Interrupt treatment. Repeat liver function tests (LFTs) within 48-72 hours, then monitor LFTs weekly until recovery to grade ?1 or to baseline. Then resume treatment at the same dose interval if resolved in LESS than or EQUAL to 14 days; if resolved in GREATER than 14 days, consider administration Q4W instead of Q2W. 
o Grade 3 AST or ALT >10.0 - 20.0 x ULN: Interrupt treatment. Repeat LFTs within 48-72 hours, then monitor LFTs weekly until recovery to grade LESS than or EQUAL to 1 or to baseline, then increase dosing interval for NIS793 from Q2W to Q4W. 
o Grade 4: AST or ALT (>20 x ULN): Permanently discontinue treatment.
		  	TREATMENT CONDITIONS 17	Interval: --	Occurrences: --	Comments:	With abnormal ALT/AST (up to grade 2 - </= 5.0 x ULN) at baseline - 
o ALT/AST > 2.0 x baseline AND > 5.0 x ULN: Interrupt treatment. Repeat LFTs within 48-72 hours, then monitor LFTs weekly until recovery to baseline; Then resume same dose interval if resolved in LESS than or EQUAL to 14 days; if resolved in GREATER than 14 days, increasing dosing from Q2W to Q4W. 
o ALT/AST > 3.0 x baseline AND >10 x ULN: Interrupt treatment. Repeat LFTs within 48-72 hours, then monitor weekly until resolved to baseline; then increase dosing interval from Q2W to Q4W. 
o AST or ALT >20 x ULN (grade 4): Permanently discontinue treatment.
		  	TREATMENT CONDITIONS 18	Interval: --	Occurrences: --	Comments:	Concomitant elevation of AST and/or ALT and total bilirubin with normal AST/ALT and bilirubin at baseline -
o Grade 2 ALT and/or AST elevation (>3.0 x ULN) with bilirubin > 2.0 x ULN (unless Gilbert's syndrome): Interrupt treatment. Assess if case is drug induced liver injury (DILI). If DILI confirmed, permanently discontinue study treatment. For additional information on follow-up of potential drug induced liver injury cases, refer to Section 6.5.5.1. If no DILI confirmed, interrupt treatment, treat the identified cause according to institutional guidelines. Repeat LFTs within 48-72 hours, then monitor weekly, until enzyme levels resolve to LESS than or EQUAL to grade 1 or baseline.  After recovery, re-administration of study treatment could be considered only if Investigator assesses benefit to outweigh the risk. Any decision regarding re-administration of study drugs and dose regimen should be discussed with the Sponsor.
		  	TREATMENT CONDITIONS 19	Interval: --	Occurrences: --	Comments:	With abnormal ALT/AST at baseline - 
o ALT or AST >3.0 x baseline OR ALT or AST >8.0 x ULN [whichever is lower] combined with total bilirubin >2.0 x baseline AND >2.0 x ULN:  Interrupt treatment. Assess if case is drug induced liver injury (DILI). If DILI confirmed, permanently discontinue study treatment. For additional information on follow-up of potential drug induced liver injury cases, refer to Section 6.5.5.1. If no DILI confirmed, interrupt treatment, treat the identified cause according to institutional guidelines. Repeat LFTs within 48-72 hours, then monitor weekly, until enzyme levels resolve to ?grade 1 or baseline.  After recovery, re-administration of study treatment could be considered only if Investigator assesses benefit to outweigh the risk. Any decision regarding re-administration of study drugs and dose regimen should be discussed with the Sponsor.
		  	TREATMENT CONDITIONS 20	Interval: --	Occurrences: --	Comments:	Isolated total bilirubin elevation - 
o Any elevation > ULN: Fractionate bilirubin, evaluate for cholestatic liver injury (e.g. by testing Alkaline Phosphatase (ALP)) or alternative causes of bilirubin elevation (e.g. disease progression [imaging]). Treat alternative causes according to institutional guidelines. 
o Grade 2 (>1.5 - 3.0 ULN): Repeat LFTs within 48-72 hours, then monitor LFTs weekly until resolution to LESS than or EQUAL to grade 1 or to baseline. If isolated bilirubin remains stable at Grade 2, continue treatment at the same dose regimen. 
o Grade 3 (>3.0 - 10 ULN): Interrupt treatment. Repeat LFTs within 48-72 hours, then monitor LFTs weekly until resolution to LESS than or EQUAL to Grade 1 or to baseline. If resolved in ? 14 days, maintain dose regimen; if not resolved in 14 days, permanently discontinue NIS793. (Please see footnote regarding alternative cause/s of bilirubin elevation). 
o Grade 4 (> 10 x ULN): See footnote*. Otherwise, permanently discontinue study treatment. If alternative cause/s is identified and managed, and bilirubin resolves to ? grade 1 or to baseline, resume treatment at the same dose regimen. *An isolated bilirubin elevation is not typical for DILI. Bilirubin can be elevated either as part of a "Hy's law" constellation with a preceding elevation of ALT/AST, or as part of a cholestatic reaction with simultaneous elevation of other cholestatic parameters (ALP, GGT). Isolated bilirubin can be seen in conjunction with drugs that inhibit bilirubin conjugation or excretion, but both scenarios do not typically represent liver injury. Alternative causes of bilirubin elevation should, therefore, be ruled out before basing dose modification decisions on bilirubin values alone.
		  	TREATMENT CONDITIONS 21	Interval: --	Occurrences: --	Comments:	Asymptomatic amylase and/or lipase elevation - 
o Grade 3, not associated with symptoms or clinical manifestations of pancreatitis: May continue study treatment. If levels do not resolve to LESS than or EQUAL to Grade 2 within LESS than or EQUAL to 14 days after the initial report, interrupt study treatment.  Upon resolution to ? Grade 2, consider resuming study treatment.
		  	TREATMENT CONDITIONS 22	Interval: --	Occurrences: --	Comments:	Renal / Serum Creatinine - 
o Grade 2:  Interrupt Study Treatment. Manage per institutional Practice. Upon resolution to LESS than Grade 1, consider resuming study treatment. 
o Grade 3 or Grade 4: Permanently Discontinue Study Treatment.
		  	TREATMENT CONDITIONS 23	Interval: --	Occurrences: --	Comments:	Hyperthyroidism - 
o Grade 2: Consider Continuing Study Treatment and Management according to institutional practice. 
o Grade 3: Interrupt study treatment. Upon resolution to Grade ? 1 with appropriate management, consider resuming study treatment without dose modification. 
o Grade 4: Must discontinue and manage according to local/institutional guidance.
		  	TREATMENT CONDITIONS 24	Interval: --	Occurrences: --	Comments:	Other Endocrine Disorders - 
o Grade 2 and Grade 3: Interrupt study treatment. Upon resolution to Grade LESS than or EQUAL to 1 with appropriate management, consider resuming study treatment.
		  	TREATMENT CONDITIONS 25	Interval: --	Occurrences: --	Comments:	Dermatology (rash) - 
o Grade 1: Continue study treatment. Consider topical steroids, antihistamines, topical emollients. 
o Grade 2: Consider interrupting study treatment. Topical or oral steroids, antihistamines. If study treatment is held and resolution to LESS than or EQUAL to Grade 1, resume study treatment. 
o Grade 3: Interrupt study treatment. Manage per institutional practice. After resolution to LESS than or EQUAL to Grade 1, consider resuming study treatment after consultation with dermatologist. 
o Grade 4 or Stevens-Johnson syndrome (SJS), or Lyell syndrome/toxic epidermal necrolysis (TEN): Permanently discontinue study treatment and manage according to local/institutional guidance.
		  	TREATMENT CONDITIONS 26	Interval: --	Occurrences: --	Comments:	Neutropenia - 
o Grade 3: Interrupt study treatment until resolved to LESS than or EQUAL to Grade 1 or baseline, then resume study medication. 
o Grade 4: Interrupt study treatment. If resolved in LESS than or EQUAL to 7 days, maintain study treatment.  

Febrile Neutropenia - 
o Grade 3: Interrupt study treatment. Upon resolution of fever and improvement of neutropenia to LESS than or EQUAL to Grade 1 or baseline, resume study treatment. 
o Grade 4: Permanently discontinue study treatment. 

Thrombocytopenia - 
o Grade 3: Interrupt study treatment. Upon resolution to ? Grade 2 or baseline, resume study treatment. For Grade 3 associated with major bleeding, permanently discontinue study treatment. 
o Grade 4: Permanently discontinue study treatment. 

Anemia - 
o Grade 3 or Grade 4: Interrupt study treatment. Upon resolution to LESS than or EQUAL to Grade 2 or baseline within LESS than or EQUAL to 7 days, resume study treatment.
		  	TREATMENT CONDITIONS 27	Interval: --	Occurrences: --	Comments:	Other laboratory adverse events, not specified elsewhere in table and not included in the consensus guidelines - 
o Grade 3 or Grade 4: Interrupt study treatment. Upon resolution to LESS than or EQUAL to Grade 1, resume study treatment without dose modification. Isolated Grade 4 electrolyte abnormalities not associated with clinical sequelae and corrected after appropriate management within 72 hours of their onset do not require discontinuation. In the case of Grade 4 electrolyte imbalances associated with clinical sequelae, or not resolved to LESS than or EQUAL to Grade 1 within 72 hours despite appropriate management, permanently discontinue study treatment. 

Other non-laboratory adverse events, not specified elsewhere in table and not included in the consensus guidelines:
o Grade 2: Consider study treatment interruption. Upon resolution to ? Grade 1, consider resuming study treatment. 
o Grade 3: Interrupt study treatment. Upon resolution to LESS than or EQUAL to Grade 1, resuming study treatment must be discussed with the relevant medical expert. 
o Grade 4: Permanently discontinue study treatment.
			Nursing Orders
  	ONC NURSING COMMUNICATION 60	Interval: --	Occurrences: --	Comments:	Concomitant Medications
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Prior Concomitant Procedures and significant non-drug therapies
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	Physical Examination
		  	ONC NURSING COMMUNICATION 62	Interval: --	Occurrences: --	Comments:	ECOG
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Calculate indirect bilirubin
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	EQ-5D-5L, PGIS (ePRO)
		  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	PRO-CTCAE, FACT-GP5 (ePRO)
		  	ONC NURSING COMMUNICATION 63	Interval: --	Occurrences: --	Comments:	PROMIS-29 (ePRO) - Pain and Fatigue items
		  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	Actigraphy
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	Adverse Events
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Serious Adverse Events
		  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	Health Resource Utilization
			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
☑	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --	Comments:	As clinically indicated
		☑	T3, FREE	Interval: --	Occurrences: --	Comments:	As clinically indicated
		☑	T4, FREE	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
☑	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated
		☑	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
  	URIC ACID LEVEL	Interval: --	Occurrences: --			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Labs
  	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --			Labs
  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
☑	CREATININE CLEARANCE, URINE, 24 HOUR	Interval: --	Occurrences: --		☑	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --		☑	BILIRUBIN DIRECT	Interval: --	Occurrences: --		☑	AMYLASE LEVEL	Interval: --	Occurrences: --		☑	LIPASE LEVEL	Interval: --	Occurrences: --		☑	GGT	Interval: --	Occurrences: --		☑	HEMOGLOBIN A1C	Interval: --	Occurrences: --	Comments:	As clinically indicated
		☑	CANCER ANTIGEN 19-9	Interval: --	Occurrences: --		☑	NABFERON IFN-B ANTIBODY - ATHENA	Interval: --	Occurrences: --	Comments:	Anytime when suspected Cytokine Release Syndrome Occurs
		☑	INTERLEUKIN 6	Interval: --	Occurrences: --	Comments:	Anytime when suspected Cytokine Release Syndrome Occurs
		☑	MISCELLANEOUS REFERRAL TEST	Interval: --	Occurrences: --	Comments:	Interleukin 1 - Anytime when suspected Cytokine Release Syndrome Occurs
		☑	TUMOR NECROSIS FACTOR - ALPHA	Interval: --	Occurrences: --	Comments:	Anytime when suspected Cytokine Release Syndrome Occurs. 
Perform ONLY at HMH and HMCL.
			Imaging
☑	CT HEAD W WO CONTRAST	Interval: --	Occurrences: --	Comments:	As clinically indicated. Or MRI
		☐	MRI BRAIN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	As clinically indicated. Or CT
		☑	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	As clinically indicated  for Tumor Evaluation per RECIST. Or MRI
		☐	MRI CHEST W CONTRAST	Interval: --	Occurrences: --	Comments:	As clinically indicated  for Tumor Evaluation per RECIST. Or CT
		☐	MRI ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	As clinically indicated  for Tumor Evaluation per RECIST. Or CT
		☐	MRI PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	As clinically indicated  for Tumor Evaluation per RECIST. Or CT
		☑	NM BONE SCAN WHOLE BODY	Interval: --	Occurrences: --	Comments:	As clinically indicated.
		☑	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	If Clinically Indicated Localized bone CT scan, MRI or Xray.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mEq/L; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 28	Interval: --	Occurrences: --	Comments:	o ANC LESS than 1000; 
o Platelets LESS than 100,000; 
o Bilirubin GREATER than 1.6; 
o LFTs GREATER than 10 x ULN.
			Pre-Medications
  	ondansetron (ZOFRAN) IV 8 mg	Dose: 8 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to chemo.			Chemotherapy
  	NAB-PACLItaxel (ABRAXANE) chemo infusion 125 mg/m2 (Treatment Plan)	Dose: 125 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes		  	gemcitabine (GEMZAR) 1,000 mg/m2 in sodium chloride 0.9% 250 mL chemo IVPB	Dose: 1,000 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 60 Minutes	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	GEMCITABINE 200 MG/5.26 ML (38 MG/ML) INTRAVENOUS SOLUTION	Medications	1,000 mg/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	 	No	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	fexofenadine (ALLEGRA) tablet 180 mg	Dose: 180 mg	Route: oral	PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 15	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Line Flush
  	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Use with NIS793		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Do NOT administer with NIS793			Nursing Orders
  	dextrose 5% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open for NIS793		  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.  Do NOT administer with NIS793			Nursing Orders
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	Criteria for Defining Dose-Limiting Toxicities During Safety Run-In: 
A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first cycle (i.e., 28  days or 4 weeks) of the treatment with NIS793 in combination with gemcitabine/nab-paclitaxel  and meets any of the criteria included in Table 6 4. The National Cancer Institute Common Terminology Criteria for Adverse events (NCI CTCAE) version 5 will be used for all grading. The investigator must notify the sponsor immediately of any unexpected CTCAE grade GREATER than or EQUAL to 3 adverse events or laboratory abnormalities (refer to Section 10.1.3 for notification guidelines).
		  	TREATMENT CONDITIONS 3	Interval: --	Occurrences: --	Comments:	Grade 3 toxicity -  
o Cardiac (including valvulopathy): Grade GREATER than or EQUAL to 3 cardiac events. 
o Cutaneous reactions: Grade GREATER than or EQUAL to 3. 
o Gastrointestinal: 
1. Grade 3 nausea and vomiting for GREATER than 3 days despite optimal anti-emetic therapy. 
2. Grade 3 diarrhea for GREATER than 5 days despite optimal antidiarrheal treatment (which could include steroids). 
3. Grade 4 vomiting or diarrhea. 
o Thrombocytopenia: Grade 3 thrombocytopenia with clinically significant bleeding (i.e. life threatening, and invasive intervention indicated) regardless of duration or requirement for transfusion. 
o Renal / Serum Creatinine: Grade GREATER than or EQUAL to 3 serum creatinine. 
o Infusion related reaction: Grade GREATER than or EQUAL to 3 infusion related reaction. 
o Pancreatitis: Grade GREATER than or EQUAL to 3 pancreatitis: Symptomatic serum amylase or lipase elevation, medical intervention required. 
o Peripheral neuropathy. 
o Hemorrhage/ Bleeding.  
o Ocular disorders: Conjunctivitis, blepharitis, vision blurred. 
o Other AEs: 
1. Have not been previously identified for NIS793. 
2. AEs that are known to occur with NIS793.
		  	TREATMENT CONDITIONS 10	Interval: --	Occurrences: --	Comments:	Grade 4 toxicity - 
o Hematological: Grade 4 neutropenia for GREATER than 14 consecutive days, or grade 4 febrile neutropenia. 
o Anemia: Grade 4 anemia. 
o Thrombocytopenia: Grade 4 thrombocytopenia (LESS than25,000/mm3). 
o Hepatobiliary / bilirubin elevation: Grade 4 bilirubin elevation. 
For patients with normal baseline AST, ALT and bilirubin values: 
1. AST or ALT GREATER than 8.0 × ULN; OR 
2. AST or ALT GREATER than 5.0 × ULN for more than 2 weeks; OR 
3. AST or ALT GREATER than 3.0 × ULN combined with total bilirubin GREATER than 2.0 × ULN without evidence of cholestasis. 
For patients with abnormal baseline AST or ALT or abnormal baseline bilirubin value: 
1. ALT or AST GREATER than 3.0 x baseline value; OR 
2. ALT or AST GREATER than 3.0 x baseline (or GREATER than 8.0 x ULN), whichever occurs first, combined with total bilirubin GREATER than 2.0 x baseline and GREATER than 2.0 x ULN without evidence of cholestasis. 
o Infection. 
o Other AEs: 
1. AEs that have not been previously identified for SOC anticancer treatments AEs that are known to occur with NIS793. 
2. Grade 4 AEs that are known to occur with SOC anticancer treatments but cannot be controlled using the recommended product-specific management guidelines (per local prescribing information), or leads to LESS than 50% of planned exposure of study medications. 
3. Other clinically-significant AEs, including a single event or multiple occurrences of the same event that lead to a dosing delay of GREATER than 4 weeks should be considered as DLTs by the Investigators and the sponsor, even if not Grade 3 or higher.
		  	TREATMENT CONDITIONS 11	Interval: --	Occurrences: --	Comments:	The SOC anti-cancer therapy will include combination of gemcitabine and nab-paclitaxel. Events which will NOT be considered as DLT for the purpose of this protocol: Clinically insignificant laboratory values LESS than or EQUAL to grade 2. For electrolyte abnormalities GREATER than or EQUAL to grade 3, the maximum allowable time limit for correction to LESS than or EQUAL to grade 1 is 72 hours.
			Nursing Orders
  	TREATMENT CONDITIONS 12	Interval: --	Occurrences: --	Comments:	Infusion Reaction or Hypersensitivity Reaction - 
o Grade 1-Infusion Reaction or Hypersensitivity Reaction: Decrease infusion rate until recovery from the symptoms. If the infusion reaction happens after the end of infusion (EOI), increase monitoring of vital signs until the participant is symptoms free. Administer subsequent NIS793 infusion at the same rate. 
o Grade 2- Infusion Reaction or Hypersensitivity Reaction: Stop infusion immediately and keep line open. Follow institutional guidelines for the management and follow-up of infusion reaction. Restart infusion at 50% of previous rate under continuous observation. Ensure that there is a minimum observation period of 1 hour prior to restarting the infusion. If the AE recurs at the reinitiated slower rate of infusion, and despite oral pre-medication, permanently discontinue study treatment. 
o Grade 3 or Grade 4- Infusion Reaction or Hypersensitivity Reaction: Stop infusion immediately and keep line open. Follow institutional guidelines for the management and follow-up of infusion reaction. Provide supplemental oxygen, fluids, and other resuscitative measures as needed. Monitor vital signs (e.g. blood pressure, pulse, respiration, and temperature) every 15 ± 5 minutes until resolution.
		  	TREATMENT CONDITIONS 13	Interval: --	Occurrences: --	Comments:	Cytokine Release Syndrome (CRS) - 
o Grade 2: Stop infusion immediately and keep line open. Follow institutional guidelines for the management and follow-up of infusion reaction. Restart infusion at 50% of previous rate under continuous observation. Ensure that there is a minimum observation period of 1 hour prior to restarting the infusion. If the AE recurs at the reinitiated slower rate of infusion, and despite oral pre-medication, permanently discontinue study treatment. 
o Grade 3 or 4: Permanently discontinue study treatment. Follow-up CRS as per institutional guidelines.
		  	TREATMENT CONDITIONS 14	Interval: --	Occurrences: --	Comments:	Ocular (e.g. Conjunctivitis, Blepharitis, blurred vision) - 
o Grade 1: May continue study treatment. Consider ophthalmology consultation. 
o Grade 2: Ophthalmology consultation. Upon resolution to LESS than or EQUAL to Grade 1 consider resuming study treatment in consultation with ophthalmologist. 
o Grade 3: 
1. Interrupt study treatment. 
2. Ophthalmology consultation. 
3. Upon resolution to LESS than or EQUAL to Grade 1 consider resuming study treatment in consultation with ophthalmologist.
o Grade 4:  Permanently discontinue study treatment.
		  	TREATMENT CONDITIONS 15	Interval: --	Occurrences: --	Comments:	Cardiovascular - 
o Grade 2 or greater Myocarditis: Permanently discontinue study treatment. 
o Grade 2 Cardiac Valvulopathy and other Cardiac Toxicity: Interrupt study treatment. Repeat echocardiogram and assess cardiac function. Once resolved to Grade ? 1 or baseline, consider re-administration of treatment, if benefit outweighs the potential risk. 
o Grade 3> Cardiac Valvulopathy and other Cardiac Toxicity: Permanently discontinue study treatment.
		  	TREATMENT CONDITIONS 16	Interval: --	Occurrences: --	Comments:	Isolated AST and/or ALT Elevation - 
o Grade 3 AST or ALT >5.0 - 10.0 x ULN: Interrupt treatment. Repeat liver function tests (LFTs) within 48-72 hours, then monitor LFTs weekly until recovery to grade ?1 or to baseline. Then resume treatment at the same dose interval if resolved in LESS than or EQUAL to 14 days; if resolved in GREATER than 14 days, consider administration Q4W instead of Q2W. 
o Grade 3 AST or ALT >10.0 - 20.0 x ULN: Interrupt treatment. Repeat LFTs within 48-72 hours, then monitor LFTs weekly until recovery to grade LESS than or EQUAL to 1 or to baseline, then increase dosing interval for NIS793 from Q2W to Q4W. 
o Grade 4: AST or ALT (>20 x ULN): Permanently discontinue treatment.
		  	TREATMENT CONDITIONS 17	Interval: --	Occurrences: --	Comments:	With abnormal ALT/AST (up to grade 2 - </= 5.0 x ULN) at baseline - 
o ALT/AST > 2.0 x baseline AND > 5.0 x ULN: Interrupt treatment. Repeat LFTs within 48-72 hours, then monitor LFTs weekly until recovery to baseline; Then resume same dose interval if resolved in LESS than or EQUAL to 14 days; if resolved in GREATER than 14 days, increasing dosing from Q2W to Q4W. 
o ALT/AST > 3.0 x baseline AND >10 x ULN: Interrupt treatment. Repeat LFTs within 48-72 hours, then monitor weekly until resolved to baseline; then increase dosing interval from Q2W to Q4W. 
o AST or ALT >20 x ULN (grade 4): Permanently discontinue treatment.
		  	TREATMENT CONDITIONS 18	Interval: --	Occurrences: --	Comments:	Concomitant elevation of AST and/or ALT and total bilirubin with normal AST/ALT and bilirubin at baseline -
o Grade 2 ALT and/or AST elevation (>3.0 x ULN) with bilirubin > 2.0 x ULN (unless Gilbert's syndrome): Interrupt treatment. Assess if case is drug induced liver injury (DILI). If DILI confirmed, permanently discontinue study treatment. For additional information on follow-up of potential drug induced liver injury cases, refer to Section 6.5.5.1. If no DILI confirmed, interrupt treatment, treat the identified cause according to institutional guidelines. Repeat LFTs within 48-72 hours, then monitor weekly, until enzyme levels resolve to LESS than or EQUAL to grade 1 or baseline.  After recovery, re-administration of study treatment could be considered only if Investigator assesses benefit to outweigh the risk. Any decision regarding re-administration of study drugs and dose regimen should be discussed with the Sponsor.
		  	TREATMENT CONDITIONS 19	Interval: --	Occurrences: --	Comments:	With abnormal ALT/AST at baseline - 
o ALT or AST >3.0 x baseline OR ALT or AST >8.0 x ULN [whichever is lower] combined with total bilirubin >2.0 x baseline AND >2.0 x ULN:  Interrupt treatment. Assess if case is drug induced liver injury (DILI). If DILI confirmed, permanently discontinue study treatment. For additional information on follow-up of potential drug induced liver injury cases, refer to Section 6.5.5.1. If no DILI confirmed, interrupt treatment, treat the identified cause according to institutional guidelines. Repeat LFTs within 48-72 hours, then monitor weekly, until enzyme levels resolve to ?grade 1 or baseline.  After recovery, re-administration of study treatment could be considered only if Investigator assesses benefit to outweigh the risk. Any decision regarding re-administration of study drugs and dose regimen should be discussed with the Sponsor.
		  	TREATMENT CONDITIONS 20	Interval: --	Occurrences: --	Comments:	Isolated total bilirubin elevation - 
o Any elevation > ULN: Fractionate bilirubin, evaluate for cholestatic liver injury (e.g. by testing Alkaline Phosphatase (ALP)) or alternative causes of bilirubin elevation (e.g. disease progression [imaging]). Treat alternative causes according to institutional guidelines. 
o Grade 2 (>1.5 - 3.0 ULN): Repeat LFTs within 48-72 hours, then monitor LFTs weekly until resolution to LESS than or EQUAL to grade 1 or to baseline. If isolated bilirubin remains stable at Grade 2, continue treatment at the same dose regimen. 
o Grade 3 (>3.0 - 10 ULN): Interrupt treatment. Repeat LFTs within 48-72 hours, then monitor LFTs weekly until resolution to LESS than or EQUAL to Grade 1 or to baseline. If resolved in ? 14 days, maintain dose regimen; if not resolved in 14 days, permanently discontinue NIS793. (Please see footnote regarding alternative cause/s of bilirubin elevation). 
o Grade 4 (> 10 x ULN): See footnote*. Otherwise, permanently discontinue study treatment. If alternative cause/s is identified and managed, and bilirubin resolves to ? grade 1 or to baseline, resume treatment at the same dose regimen. *An isolated bilirubin elevation is not typical for DILI. Bilirubin can be elevated either as part of a "Hy's law" constellation with a preceding elevation of ALT/AST, or as part of a cholestatic reaction with simultaneous elevation of other cholestatic parameters (ALP, GGT). Isolated bilirubin can be seen in conjunction with drugs that inhibit bilirubin conjugation or excretion, but both scenarios do not typically represent liver injury. Alternative causes of bilirubin elevation should, therefore, be ruled out before basing dose modification decisions on bilirubin values alone.
		  	TREATMENT CONDITIONS 21	Interval: --	Occurrences: --	Comments:	Asymptomatic amylase and/or lipase elevation - 
o Grade 3, not associated with symptoms or clinical manifestations of pancreatitis: May continue study treatment. If levels do not resolve to LESS than or EQUAL to Grade 2 within LESS than or EQUAL to 14 days after the initial report, interrupt study treatment.  Upon resolution to ? Grade 2, consider resuming study treatment.
		  	TREATMENT CONDITIONS 22	Interval: --	Occurrences: --	Comments:	Renal / Serum Creatinine - 
o Grade 2:  Interrupt Study Treatment. Manage per institutional Practice. Upon resolution to LESS than Grade 1, consider resuming study treatment. 
o Grade 3 or Grade 4: Permanently Discontinue Study Treatment.
		  	TREATMENT CONDITIONS 23	Interval: --	Occurrences: --	Comments:	Hyperthyroidism - 
o Grade 2: Consider Continuing Study Treatment and Management according to institutional practice. 
o Grade 3: Interrupt study treatment. Upon resolution to Grade ? 1 with appropriate management, consider resuming study treatment without dose modification. 
o Grade 4: Must discontinue and manage according to local/institutional guidance.
		  	TREATMENT CONDITIONS 24	Interval: --	Occurrences: --	Comments:	Other Endocrine Disorders - 
o Grade 2 and Grade 3: Interrupt study treatment. Upon resolution to Grade LESS than or EQUAL to 1 with appropriate management, consider resuming study treatment.
		  	TREATMENT CONDITIONS 25	Interval: --	Occurrences: --	Comments:	Dermatology (rash) - 
o Grade 1: Continue study treatment. Consider topical steroids, antihistamines, topical emollients. 
o Grade 2: Consider interrupting study treatment. Topical or oral steroids, antihistamines. If study treatment is held and resolution to LESS than or EQUAL to Grade 1, resume study treatment. 
o Grade 3: Interrupt study treatment. Manage per institutional practice. After resolution to LESS than or EQUAL to Grade 1, consider resuming study treatment after consultation with dermatologist. 
o Grade 4 or Stevens-Johnson syndrome (SJS), or Lyell syndrome/toxic epidermal necrolysis (TEN): Permanently discontinue study treatment and manage according to local/institutional guidance.
		  	TREATMENT CONDITIONS 26	Interval: --	Occurrences: --	Comments:	Neutropenia - 
o Grade 3: Interrupt study treatment until resolved to LESS than or EQUAL to Grade 1 or baseline, then resume study medication. 
o Grade 4: Interrupt study treatment. If resolved in LESS than or EQUAL to 7 days, maintain study treatment.  

Febrile Neutropenia - 
o Grade 3: Interrupt study treatment. Upon resolution of fever and improvement of neutropenia to LESS than or EQUAL to Grade 1 or baseline, resume study treatment. 
o Grade 4: Permanently discontinue study treatment. 

Thrombocytopenia - 
o Grade 3: Interrupt study treatment. Upon resolution to ? Grade 2 or baseline, resume study treatment. For Grade 3 associated with major bleeding, permanently discontinue study treatment. 
o Grade 4: Permanently discontinue study treatment. 

Anemia - 
o Grade 3 or Grade 4: Interrupt study treatment. Upon resolution to LESS than or EQUAL to Grade 2 or baseline within LESS than or EQUAL to 7 days, resume study treatment.
		  	TREATMENT CONDITIONS 27	Interval: --	Occurrences: --	Comments:	Other laboratory adverse events, not specified elsewhere in table and not included in the consensus guidelines - 
o Grade 3 or Grade 4: Interrupt study treatment. Upon resolution to LESS than or EQUAL to Grade 1, resume study treatment without dose modification. Isolated Grade 4 electrolyte abnormalities not associated with clinical sequelae and corrected after appropriate management within 72 hours of their onset do not require discontinuation. In the case of Grade 4 electrolyte imbalances associated with clinical sequelae, or not resolved to LESS than or EQUAL to Grade 1 within 72 hours despite appropriate management, permanently discontinue study treatment. 

Other non-laboratory adverse events, not specified elsewhere in table and not included in the consensus guidelines:
o Grade 2: Consider study treatment interruption. Upon resolution to ? Grade 1, consider resuming study treatment. 
o Grade 3: Interrupt study treatment. Upon resolution to LESS than or EQUAL to Grade 1, resuming study treatment must be discussed with the relevant medical expert. 
o Grade 4: Permanently discontinue study treatment.
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Dose Modifications and Dose Interruption for NIS793: 
No Dose Reductions are allowed for NIS793: Increasing the dosing interval from Q2W to Q4W is allowed under circumstances described in Table 6-5. If NIS793 is interrupted or delayed for GREATER than 8 weeks due to toxicity that is suspected to be related to treatment, study treatment should be permanently discontinued.
			Nursing Orders
  	ONC NURSING COMMUNICATION 60	Interval: --	Occurrences: --	Comments:	Concomitant Medications
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Prior Concomitant Procedures and significant non-drug therapies
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	Physical Examination
		  	ONC NURSING COMMUNICATION 62	Interval: --	Occurrences: --	Comments:	ECOG
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Calculate indirect bilirubin
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	EQ-5D-5L, PGIS (ePRO)
		  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	PRO-CTCAE, FACT-GP5 (ePRO)
		  	ONC NURSING COMMUNICATION 63	Interval: --	Occurrences: --	Comments:	PROMIS-29 (ePRO) - Pain and Fatigue items
		  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	Actigraphy
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	Adverse Events
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Serious Adverse Events
		  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	Health Resource Utilization
			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
☑	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --	Comments:	As clinically indicated
		☑	T3, FREE	Interval: --	Occurrences: --	Comments:	As clinically indicated
		☑	T4, FREE	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
☑	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated
		☑	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
  	URIC ACID LEVEL	Interval: --	Occurrences: --			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Labs
  	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --			Labs
  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
☑	CREATININE CLEARANCE, URINE, 24 HOUR	Interval: --	Occurrences: --		☑	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --		☑	BILIRUBIN DIRECT	Interval: --	Occurrences: --		☑	AMYLASE LEVEL	Interval: --	Occurrences: --		☑	LIPASE LEVEL	Interval: --	Occurrences: --		☑	GGT	Interval: --	Occurrences: --		☑	HEMOGLOBIN A1C	Interval: --	Occurrences: --	Comments:	As clinically indicated
		☑	CANCER ANTIGEN 19-9	Interval: --	Occurrences: --		☑	NABFERON IFN-B ANTIBODY - ATHENA	Interval: --	Occurrences: --	Comments:	Anytime when suspected Cytokine Release Syndrome Occurs
		☑	INTERLEUKIN 6	Interval: --	Occurrences: --	Comments:	Anytime when suspected Cytokine Release Syndrome Occurs
		☑	MISCELLANEOUS REFERRAL TEST	Interval: --	Occurrences: --	Comments:	Interleukin 1 - Anytime when suspected Cytokine Release Syndrome Occurs
		☑	TUMOR NECROSIS FACTOR - ALPHA	Interval: --	Occurrences: --	Comments:	Anytime when suspected Cytokine Release Syndrome Occurs. 
Perform ONLY at HMH and HMCL.
			Imaging
☑	CT HEAD W WO CONTRAST	Interval: --	Occurrences: --	Comments:	As clinically indicated. Or MRI
		☐	MRI BRAIN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	As clinically indicated. Or CT
		☑	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	As clinically indicated  for Tumor Evaluation per RECIST. Or MRI
		☐	MRI CHEST W CONTRAST	Interval: --	Occurrences: --	Comments:	As clinically indicated  for Tumor Evaluation per RECIST. Or CT
		☐	MRI ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	As clinically indicated  for Tumor Evaluation per RECIST. Or CT
		☐	MRI PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	As clinically indicated  for Tumor Evaluation per RECIST. Or CT
		☑	NM BONE SCAN WHOLE BODY	Interval: --	Occurrences: --	Comments:	As clinically indicated.
		☑	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	If Clinically Indicated Localized bone CT scan, MRI or Xray.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mEq/L; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 28	Interval: --	Occurrences: --	Comments:	o ANC LESS than 1000; 
o Platelets LESS than 100,000; 
o Bilirubin GREATER than 1.6; 
o LFTs GREATER than 10 x ULN.
			Pre-Medications
  	ondansetron (ZOFRAN) IV 8 mg	Dose: 8 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to chemo.			Nursing Orders
  	ONC NURSING COMMUNICATION 68	Interval: --	Occurrences: --	Comments:	Infusion must take place in a facility with appropriate resuscitation equipment available at the bedside, and a physician readily available during the period of drug administration.
		  	ONC NURSING COMMUNICATION 69	Interval: --	Occurrences: --	Comments:	Participants should be closely observed for potential infusion-related reactions including rigors, chills, wheezing, pruritus, flushing, rash, hypotension, hypoxemia, and fever, and vital signs monitored more frequently if clinically indicated, during and for at least 2 hours after the first two NIS793 infusions. The same may apply for subsequent NIS793 infusions if medically indicated. Participants should notify study personnel if symptoms of infusion reaction occur after any NIS793 infusion.
			Chemotherapy
  	INV-NIS793 or placebo (CNIS793B12301 daNIS-2/Pro00032923/Abdelrahim) 2,100 mg in dextrose 5% 100 mL	Dose: 2,100 mg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Protect from light.  Administer intravenously using a 0.2 micron inline filter over 30 minutes.  Flush only with D5W!
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.

	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-NIS793 OR PLACEBO 1050MG/10ML INTRAVENOUS SOLN. (CNIS793B12301 DANIS-2/PRO00032923/ABDELRAHIM)	Medications	2,100 mg	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	80 mL	Yes	Yes			  	NAB-PACLItaxel (ABRAXANE) chemo infusion 125 mg/m2 (Treatment Plan)	Dose: 125 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 3 Hours		  	gemcitabine (GEMZAR) 1,000 mg/m2 in sodium chloride 0.9% 250 mL chemo IVPB	Dose: 1,000 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 3.5 Hours	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	GEMCITABINE 200 MG/5.26 ML (38 MG/ML) INTRAVENOUS SOLUTION	Medications	1,000 mg/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	 	No	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	fexofenadine (ALLEGRA) tablet 180 mg	Dose: 180 mg	Route: oral	PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 2	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Line Flush
  	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Use with NIS793		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Do NOT administer with NIS793			Nursing Orders
  	dextrose 5% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open for NIS793		  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.  Do NOT administer with NIS793			Nursing Orders
  	TREATMENT CONDITIONS 12	Interval: --	Occurrences: --	Comments:	Infusion Reaction or Hypersensitivity Reaction - 
o Grade 1-Infusion Reaction or Hypersensitivity Reaction: Decrease infusion rate until recovery from the symptoms. If the infusion reaction happens after the end of infusion (EOI), increase monitoring of vital signs until the participant is symptoms free. Administer subsequent NIS793 infusion at the same rate. 
o Grade 2- Infusion Reaction or Hypersensitivity Reaction: Stop infusion immediately and keep line open. Follow institutional guidelines for the management and follow-up of infusion reaction. Restart infusion at 50% of previous rate under continuous observation. Ensure that there is a minimum observation period of 1 hour prior to restarting the infusion. If the AE recurs at the reinitiated slower rate of infusion, and despite oral pre-medication, permanently discontinue study treatment. 
o Grade 3 or Grade 4- Infusion Reaction or Hypersensitivity Reaction: Stop infusion immediately and keep line open. Follow institutional guidelines for the management and follow-up of infusion reaction. Provide supplemental oxygen, fluids, and other resuscitative measures as needed. Monitor vital signs (e.g. blood pressure, pulse, respiration, and temperature) every 15 ± 5 minutes until resolution.
		  	TREATMENT CONDITIONS 13	Interval: --	Occurrences: --	Comments:	Cytokine Release Syndrome (CRS) - 
o Grade 2: Stop infusion immediately and keep line open. Follow institutional guidelines for the management and follow-up of infusion reaction. Restart infusion at 50% of previous rate under continuous observation. Ensure that there is a minimum observation period of 1 hour prior to restarting the infusion. If the AE recurs at the reinitiated slower rate of infusion, and despite oral pre-medication, permanently discontinue study treatment. 
o Grade 3 or 4: Permanently discontinue study treatment. Follow-up CRS as per institutional guidelines.
		  	TREATMENT CONDITIONS 14	Interval: --	Occurrences: --	Comments:	Ocular (e.g. Conjunctivitis, Blepharitis, blurred vision) - 
o Grade 1: May continue study treatment. Consider ophthalmology consultation. 
o Grade 2: Ophthalmology consultation. Upon resolution to LESS than or EQUAL to Grade 1 consider resuming study treatment in consultation with ophthalmologist. 
o Grade 3: 
1. Interrupt study treatment. 
2. Ophthalmology consultation. 
3. Upon resolution to LESS than or EQUAL to Grade 1 consider resuming study treatment in consultation with ophthalmologist.
o Grade 4:  Permanently discontinue study treatment.
		  	TREATMENT CONDITIONS 15	Interval: --	Occurrences: --	Comments:	Cardiovascular - 
o Grade 2 or greater Myocarditis: Permanently discontinue study treatment. 
o Grade 2 Cardiac Valvulopathy and other Cardiac Toxicity: Interrupt study treatment. Repeat echocardiogram and assess cardiac function. Once resolved to Grade ? 1 or baseline, consider re-administration of treatment, if benefit outweighs the potential risk. 
o Grade 3> Cardiac Valvulopathy and other Cardiac Toxicity: Permanently discontinue study treatment.
		  	TREATMENT CONDITIONS 16	Interval: --	Occurrences: --	Comments:	Isolated AST and/or ALT Elevation - 
o Grade 3 AST or ALT >5.0 - 10.0 x ULN: Interrupt treatment. Repeat liver function tests (LFTs) within 48-72 hours, then monitor LFTs weekly until recovery to grade ?1 or to baseline. Then resume treatment at the same dose interval if resolved in LESS than or EQUAL to 14 days; if resolved in GREATER than 14 days, consider administration Q4W instead of Q2W. 
o Grade 3 AST or ALT >10.0 - 20.0 x ULN: Interrupt treatment. Repeat LFTs within 48-72 hours, then monitor LFTs weekly until recovery to grade LESS than or EQUAL to 1 or to baseline, then increase dosing interval for NIS793 from Q2W to Q4W. 
o Grade 4: AST or ALT (>20 x ULN): Permanently discontinue treatment.
		  	TREATMENT CONDITIONS 17	Interval: --	Occurrences: --	Comments:	With abnormal ALT/AST (up to grade 2 - </= 5.0 x ULN) at baseline - 
o ALT/AST > 2.0 x baseline AND > 5.0 x ULN: Interrupt treatment. Repeat LFTs within 48-72 hours, then monitor LFTs weekly until recovery to baseline; Then resume same dose interval if resolved in LESS than or EQUAL to 14 days; if resolved in GREATER than 14 days, increasing dosing from Q2W to Q4W. 
o ALT/AST > 3.0 x baseline AND >10 x ULN: Interrupt treatment. Repeat LFTs within 48-72 hours, then monitor weekly until resolved to baseline; then increase dosing interval from Q2W to Q4W. 
o AST or ALT >20 x ULN (grade 4): Permanently discontinue treatment.
		  	TREATMENT CONDITIONS 18	Interval: --	Occurrences: --	Comments:	Concomitant elevation of AST and/or ALT and total bilirubin with normal AST/ALT and bilirubin at baseline -
o Grade 2 ALT and/or AST elevation (>3.0 x ULN) with bilirubin > 2.0 x ULN (unless Gilbert's syndrome): Interrupt treatment. Assess if case is drug induced liver injury (DILI). If DILI confirmed, permanently discontinue study treatment. For additional information on follow-up of potential drug induced liver injury cases, refer to Section 6.5.5.1. If no DILI confirmed, interrupt treatment, treat the identified cause according to institutional guidelines. Repeat LFTs within 48-72 hours, then monitor weekly, until enzyme levels resolve to LESS than or EQUAL to grade 1 or baseline.  After recovery, re-administration of study treatment could be considered only if Investigator assesses benefit to outweigh the risk. Any decision regarding re-administration of study drugs and dose regimen should be discussed with the Sponsor.
		  	TREATMENT CONDITIONS 19	Interval: --	Occurrences: --	Comments:	With abnormal ALT/AST at baseline - 
o ALT or AST >3.0 x baseline OR ALT or AST >8.0 x ULN [whichever is lower] combined with total bilirubin >2.0 x baseline AND >2.0 x ULN:  Interrupt treatment. Assess if case is drug induced liver injury (DILI). If DILI confirmed, permanently discontinue study treatment. For additional information on follow-up of potential drug induced liver injury cases, refer to Section 6.5.5.1. If no DILI confirmed, interrupt treatment, treat the identified cause according to institutional guidelines. Repeat LFTs within 48-72 hours, then monitor weekly, until enzyme levels resolve to ?grade 1 or baseline.  After recovery, re-administration of study treatment could be considered only if Investigator assesses benefit to outweigh the risk. Any decision regarding re-administration of study drugs and dose regimen should be discussed with the Sponsor.
		  	TREATMENT CONDITIONS 20	Interval: --	Occurrences: --	Comments:	Isolated total bilirubin elevation - 
o Any elevation > ULN: Fractionate bilirubin, evaluate for cholestatic liver injury (e.g. by testing Alkaline Phosphatase (ALP)) or alternative causes of bilirubin elevation (e.g. disease progression [imaging]). Treat alternative causes according to institutional guidelines. 
o Grade 2 (>1.5 - 3.0 ULN): Repeat LFTs within 48-72 hours, then monitor LFTs weekly until resolution to LESS than or EQUAL to grade 1 or to baseline. If isolated bilirubin remains stable at Grade 2, continue treatment at the same dose regimen. 
o Grade 3 (>3.0 - 10 ULN): Interrupt treatment. Repeat LFTs within 48-72 hours, then monitor LFTs weekly until resolution to LESS than or EQUAL to Grade 1 or to baseline. If resolved in ? 14 days, maintain dose regimen; if not resolved in 14 days, permanently discontinue NIS793. (Please see footnote regarding alternative cause/s of bilirubin elevation). 
o Grade 4 (> 10 x ULN): See footnote*. Otherwise, permanently discontinue study treatment. If alternative cause/s is identified and managed, and bilirubin resolves to ? grade 1 or to baseline, resume treatment at the same dose regimen. *An isolated bilirubin elevation is not typical for DILI. Bilirubin can be elevated either as part of a "Hy's law" constellation with a preceding elevation of ALT/AST, or as part of a cholestatic reaction with simultaneous elevation of other cholestatic parameters (ALP, GGT). Isolated bilirubin can be seen in conjunction with drugs that inhibit bilirubin conjugation or excretion, but both scenarios do not typically represent liver injury. Alternative causes of bilirubin elevation should, therefore, be ruled out before basing dose modification decisions on bilirubin values alone.
		  	TREATMENT CONDITIONS 21	Interval: --	Occurrences: --	Comments:	Asymptomatic amylase and/or lipase elevation - 
o Grade 3, not associated with symptoms or clinical manifestations of pancreatitis: May continue study treatment. If levels do not resolve to LESS than or EQUAL to Grade 2 within LESS than or EQUAL to 14 days after the initial report, interrupt study treatment.  Upon resolution to ? Grade 2, consider resuming study treatment.
		  	TREATMENT CONDITIONS 22	Interval: --	Occurrences: --	Comments:	Renal / Serum Creatinine - 
o Grade 2:  Interrupt Study Treatment. Manage per institutional Practice. Upon resolution to LESS than Grade 1, consider resuming study treatment. 
o Grade 3 or Grade 4: Permanently Discontinue Study Treatment.
		  	TREATMENT CONDITIONS 23	Interval: --	Occurrences: --	Comments:	Hyperthyroidism - 
o Grade 2: Consider Continuing Study Treatment and Management according to institutional practice. 
o Grade 3: Interrupt study treatment. Upon resolution to Grade ? 1 with appropriate management, consider resuming study treatment without dose modification. 
o Grade 4: Must discontinue and manage according to local/institutional guidance.
		  	TREATMENT CONDITIONS 24	Interval: --	Occurrences: --	Comments:	Other Endocrine Disorders - 
o Grade 2 and Grade 3: Interrupt study treatment. Upon resolution to Grade LESS than or EQUAL to 1 with appropriate management, consider resuming study treatment.
		  	TREATMENT CONDITIONS 25	Interval: --	Occurrences: --	Comments:	Dermatology (rash) - 
o Grade 1: Continue study treatment. Consider topical steroids, antihistamines, topical emollients. 
o Grade 2: Consider interrupting study treatment. Topical or oral steroids, antihistamines. If study treatment is held and resolution to LESS than or EQUAL to Grade 1, resume study treatment. 
o Grade 3: Interrupt study treatment. Manage per institutional practice. After resolution to LESS than or EQUAL to Grade 1, consider resuming study treatment after consultation with dermatologist. 
o Grade 4 or Stevens-Johnson syndrome (SJS), or Lyell syndrome/toxic epidermal necrolysis (TEN): Permanently discontinue study treatment and manage according to local/institutional guidance.
		  	TREATMENT CONDITIONS 26	Interval: --	Occurrences: --	Comments:	Neutropenia - 
o Grade 3: Interrupt study treatment until resolved to LESS than or EQUAL to Grade 1 or baseline, then resume study medication. 
o Grade 4: Interrupt study treatment. If resolved in LESS than or EQUAL to 7 days, maintain study treatment.  

Febrile Neutropenia - 
o Grade 3: Interrupt study treatment. Upon resolution of fever and improvement of neutropenia to LESS than or EQUAL to Grade 1 or baseline, resume study treatment. 
o Grade 4: Permanently discontinue study treatment. 

Thrombocytopenia - 
o Grade 3: Interrupt study treatment. Upon resolution to ? Grade 2 or baseline, resume study treatment. For Grade 3 associated with major bleeding, permanently discontinue study treatment. 
o Grade 4: Permanently discontinue study treatment. 

Anemia - 
o Grade 3 or Grade 4: Interrupt study treatment. Upon resolution to LESS than or EQUAL to Grade 2 or baseline within LESS than or EQUAL to 7 days, resume study treatment.
		  	TREATMENT CONDITIONS 27	Interval: --	Occurrences: --	Comments:	Other laboratory adverse events, not specified elsewhere in table and not included in the consensus guidelines - 
o Grade 3 or Grade 4: Interrupt study treatment. Upon resolution to LESS than or EQUAL to Grade 1, resume study treatment without dose modification. Isolated Grade 4 electrolyte abnormalities not associated with clinical sequelae and corrected after appropriate management within 72 hours of their onset do not require discontinuation. In the case of Grade 4 electrolyte imbalances associated with clinical sequelae, or not resolved to LESS than or EQUAL to Grade 1 within 72 hours despite appropriate management, permanently discontinue study treatment. 

Other non-laboratory adverse events, not specified elsewhere in table and not included in the consensus guidelines:
o Grade 2: Consider study treatment interruption. Upon resolution to ? Grade 1, consider resuming study treatment. 
o Grade 3: Interrupt study treatment. Upon resolution to LESS than or EQUAL to Grade 1, resuming study treatment must be discussed with the relevant medical expert. 
o Grade 4: Permanently discontinue study treatment.
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Dose Modifications and Dose Interruption for NIS793: 
No Dose Reductions are allowed for NIS793: Increasing the dosing interval from Q2W to Q4W is allowed under circumstances described in Table 6-5. If NIS793 is interrupted or delayed for GREATER than 8 weeks due to toxicity that is suspected to be related to treatment, study treatment should be permanently discontinued.
			Nursing Orders
  	ONC NURSING COMMUNICATION 60	Interval: --	Occurrences: --	Comments:	Concomitant Medications
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Prior Concomitant Procedures and significant non-drug therapies
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	Physical Examination
		  	ONC NURSING COMMUNICATION 62	Interval: --	Occurrences: --	Comments:	ECOG
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Calculate indirect bilirubin
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	EQ-5D-5L, PGIS (ePRO)
		  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	PRO-CTCAE, FACT-GP5 (ePRO)
		  	ONC NURSING COMMUNICATION 63	Interval: --	Occurrences: --	Comments:	PROMIS-29 (ePRO) - Pain and Fatigue items
		  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	Actigraphy
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	Adverse Events
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Serious Adverse Events
		  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	Health Resource Utilization
			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
☑	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --	Comments:	As clinically indicated
		☑	T3, FREE	Interval: --	Occurrences: --	Comments:	As clinically indicated
		☑	T4, FREE	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
☑	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated
		☑	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
  	URIC ACID LEVEL	Interval: --	Occurrences: --			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Labs
  	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --			Labs
  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --			Labs
☑	CREATININE CLEARANCE, URINE, 24 HOUR	Interval: --	Occurrences: --		☑	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --		☑	BILIRUBIN DIRECT	Interval: --	Occurrences: --		☑	AMYLASE LEVEL	Interval: --	Occurrences: --		☑	LIPASE LEVEL	Interval: --	Occurrences: --		☑	GGT	Interval: --	Occurrences: --		☑	HEMOGLOBIN A1C	Interval: --	Occurrences: --	Comments:	As clinically indicated
		☑	NABFERON IFN-B ANTIBODY - ATHENA	Interval: --	Occurrences: --	Comments:	Anytime when suspected Cytokine Release Syndrome Occurs
		☑	INTERLEUKIN 6	Interval: --	Occurrences: --	Comments:	Anytime when suspected Cytokine Release Syndrome Occurs
		☑	MISCELLANEOUS REFERRAL TEST	Interval: --	Occurrences: --	Comments:	Interleukin 1 - Anytime when suspected Cytokine Release Syndrome Occurs
		☑	TUMOR NECROSIS FACTOR - ALPHA	Interval: --	Occurrences: --	Comments:	Anytime when suspected Cytokine Release Syndrome Occurs. 
Perform ONLY at HMH and HMCL.
			Imaging
☑	CT HEAD W WO CONTRAST	Interval: --	Occurrences: --	Comments:	As clinically indicated. Or MRI
		☐	MRI BRAIN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	As clinically indicated. Or CT
		☑	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	As clinically indicated  for Tumor Evaluation per RECIST. Or MRI
		☐	MRI CHEST W CONTRAST	Interval: --	Occurrences: --	Comments:	As clinically indicated  for Tumor Evaluation per RECIST. Or CT
		☐	MRI ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	As clinically indicated  for Tumor Evaluation per RECIST. Or CT
		☐	MRI PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	As clinically indicated  for Tumor Evaluation per RECIST. Or CT
		☑	CV ECHOCARDIOGRAM RESEARCH ONLY	Interval: --	Occurrences: --	Comments:	As clinically indicated.
		☑	NM BONE SCAN WHOLE BODY	Interval: --	Occurrences: --	Comments:	As clinically indicated.
		☑	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	If Clinically Indicated Localized bone CT scan, MRI or Xray.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mEq/L; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 28	Interval: --	Occurrences: --	Comments:	o ANC LESS than 1000; 
o Platelets LESS than 100,000; 
o Bilirubin GREATER than 1.6; 
o LFTs GREATER than 10 x ULN.
			Pre-Medications
  	ondansetron (ZOFRAN) IV 8 mg	Dose: 8 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to chemo.			Nursing Orders
  	ONC NURSING COMMUNICATION 68	Interval: --	Occurrences: --	Comments:	Infusion must take place in a facility with appropriate resuscitation equipment available at the bedside, and a physician readily available during the period of drug administration.
		  	ONC NURSING COMMUNICATION 69	Interval: --	Occurrences: --	Comments:	Participants should be closely observed for potential infusion-related reactions including rigors, chills, wheezing, pruritus, flushing, rash, hypotension, hypoxemia, and fever, and vital signs monitored more frequently if clinically indicated, during and for at least 2 hours after the first two NIS793 infusions. The same may apply for subsequent NIS793 infusions if medically indicated. Participants should notify study personnel if symptoms of infusion reaction occur after any NIS793 infusion.
			Chemotherapy
  	INV-NIS793 or placebo (CNIS793B12301 daNIS-2/Pro00032923/Abdelrahim) 2,100 mg in dextrose 5% 100 mL	Dose: 2,100 mg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Protect from light.  Administer intravenously using a 0.2 micron inline filter over 30 minutes.  Flush only with D5W!
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.

	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-NIS793 OR PLACEBO 1050MG/10ML INTRAVENOUS SOLN. (CNIS793B12301 DANIS-2/PRO00032923/ABDELRAHIM)	Medications	2,100 mg	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	80 mL	Yes	Yes			  	NAB-PACLItaxel (ABRAXANE) chemo infusion 125 mg/m2 (Treatment Plan)	Dose: 125 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 3 Hours		  	gemcitabine (GEMZAR) 1,000 mg/m2 in sodium chloride 0.9% 250 mL chemo IVPB	Dose: 1,000 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 3.5 Hours	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	GEMCITABINE 200 MG/5.26 ML (38 MG/ML) INTRAVENOUS SOLUTION	Medications	1,000 mg/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	 	No	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	fexofenadine (ALLEGRA) tablet 180 mg	Dose: 180 mg	Route: oral	PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 8	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Line Flush
  	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Nursing Orders
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Nursing Orders
  	TREATMENT CONDITIONS 12	Interval: --	Occurrences: --	Comments:	Infusion Reaction or Hypersensitivity Reaction - 
o Grade 1-Infusion Reaction or Hypersensitivity Reaction: Decrease infusion rate until recovery from the symptoms. If the infusion reaction happens after the end of infusion (EOI), increase monitoring of vital signs until the participant is symptoms free. Administer subsequent NIS793 infusion at the same rate. 
o Grade 2- Infusion Reaction or Hypersensitivity Reaction: Stop infusion immediately and keep line open. Follow institutional guidelines for the management and follow-up of infusion reaction. Restart infusion at 50% of previous rate under continuous observation. Ensure that there is a minimum observation period of 1 hour prior to restarting the infusion. If the AE recurs at the reinitiated slower rate of infusion, and despite oral pre-medication, permanently discontinue study treatment. 
o Grade 3 or Grade 4- Infusion Reaction or Hypersensitivity Reaction: Stop infusion immediately and keep line open. Follow institutional guidelines for the management and follow-up of infusion reaction. Provide supplemental oxygen, fluids, and other resuscitative measures as needed. Monitor vital signs (e.g. blood pressure, pulse, respiration, and temperature) every 15 ± 5 minutes until resolution.
		  	TREATMENT CONDITIONS 13	Interval: --	Occurrences: --	Comments:	Cytokine Release Syndrome (CRS) - 
o Grade 2: Stop infusion immediately and keep line open. Follow institutional guidelines for the management and follow-up of infusion reaction. Restart infusion at 50% of previous rate under continuous observation. Ensure that there is a minimum observation period of 1 hour prior to restarting the infusion. If the AE recurs at the reinitiated slower rate of infusion, and despite oral pre-medication, permanently discontinue study treatment. 
o Grade 3 or 4: Permanently discontinue study treatment. Follow-up CRS as per institutional guidelines.
		  	TREATMENT CONDITIONS 14	Interval: --	Occurrences: --	Comments:	Ocular (e.g. Conjunctivitis, Blepharitis, blurred vision) - 
o Grade 1: May continue study treatment. Consider ophthalmology consultation. 
o Grade 2: Ophthalmology consultation. Upon resolution to LESS than or EQUAL to Grade 1 consider resuming study treatment in consultation with ophthalmologist. 
o Grade 3: 
1. Interrupt study treatment. 
2. Ophthalmology consultation. 
3. Upon resolution to LESS than or EQUAL to Grade 1 consider resuming study treatment in consultation with ophthalmologist.
o Grade 4:  Permanently discontinue study treatment.
		  	TREATMENT CONDITIONS 15	Interval: --	Occurrences: --	Comments:	Cardiovascular - 
o Grade 2 or greater Myocarditis: Permanently discontinue study treatment. 
o Grade 2 Cardiac Valvulopathy and other Cardiac Toxicity: Interrupt study treatment. Repeat echocardiogram and assess cardiac function. Once resolved to Grade ? 1 or baseline, consider re-administration of treatment, if benefit outweighs the potential risk. 
o Grade 3> Cardiac Valvulopathy and other Cardiac Toxicity: Permanently discontinue study treatment.
		  	TREATMENT CONDITIONS 16	Interval: --	Occurrences: --	Comments:	Isolated AST and/or ALT Elevation - 
o Grade 3 AST or ALT >5.0 - 10.0 x ULN: Interrupt treatment. Repeat liver function tests (LFTs) within 48-72 hours, then monitor LFTs weekly until recovery to grade ?1 or to baseline. Then resume treatment at the same dose interval if resolved in LESS than or EQUAL to 14 days; if resolved in GREATER than 14 days, consider administration Q4W instead of Q2W. 
o Grade 3 AST or ALT >10.0 - 20.0 x ULN: Interrupt treatment. Repeat LFTs within 48-72 hours, then monitor LFTs weekly until recovery to grade LESS than or EQUAL to 1 or to baseline, then increase dosing interval for NIS793 from Q2W to Q4W. 
o Grade 4: AST or ALT (>20 x ULN): Permanently discontinue treatment.
		  	TREATMENT CONDITIONS 17	Interval: --	Occurrences: --	Comments:	With abnormal ALT/AST (up to grade 2 - </= 5.0 x ULN) at baseline - 
o ALT/AST > 2.0 x baseline AND > 5.0 x ULN: Interrupt treatment. Repeat LFTs within 48-72 hours, then monitor LFTs weekly until recovery to baseline; Then resume same dose interval if resolved in LESS than or EQUAL to 14 days; if resolved in GREATER than 14 days, increasing dosing from Q2W to Q4W. 
o ALT/AST > 3.0 x baseline AND >10 x ULN: Interrupt treatment. Repeat LFTs within 48-72 hours, then monitor weekly until resolved to baseline; then increase dosing interval from Q2W to Q4W. 
o AST or ALT >20 x ULN (grade 4): Permanently discontinue treatment.
		  	TREATMENT CONDITIONS 18	Interval: --	Occurrences: --	Comments:	Concomitant elevation of AST and/or ALT and total bilirubin with normal AST/ALT and bilirubin at baseline -
o Grade 2 ALT and/or AST elevation (>3.0 x ULN) with bilirubin > 2.0 x ULN (unless Gilbert's syndrome): Interrupt treatment. Assess if case is drug induced liver injury (DILI). If DILI confirmed, permanently discontinue study treatment. For additional information on follow-up of potential drug induced liver injury cases, refer to Section 6.5.5.1. If no DILI confirmed, interrupt treatment, treat the identified cause according to institutional guidelines. Repeat LFTs within 48-72 hours, then monitor weekly, until enzyme levels resolve to LESS than or EQUAL to grade 1 or baseline.  After recovery, re-administration of study treatment could be considered only if Investigator assesses benefit to outweigh the risk. Any decision regarding re-administration of study drugs and dose regimen should be discussed with the Sponsor.
		  	TREATMENT CONDITIONS 19	Interval: --	Occurrences: --	Comments:	With abnormal ALT/AST at baseline - 
o ALT or AST >3.0 x baseline OR ALT or AST >8.0 x ULN [whichever is lower] combined with total bilirubin >2.0 x baseline AND >2.0 x ULN:  Interrupt treatment. Assess if case is drug induced liver injury (DILI). If DILI confirmed, permanently discontinue study treatment. For additional information on follow-up of potential drug induced liver injury cases, refer to Section 6.5.5.1. If no DILI confirmed, interrupt treatment, treat the identified cause according to institutional guidelines. Repeat LFTs within 48-72 hours, then monitor weekly, until enzyme levels resolve to ?grade 1 or baseline.  After recovery, re-administration of study treatment could be considered only if Investigator assesses benefit to outweigh the risk. Any decision regarding re-administration of study drugs and dose regimen should be discussed with the Sponsor.
		  	TREATMENT CONDITIONS 20	Interval: --	Occurrences: --	Comments:	Isolated total bilirubin elevation - 
o Any elevation > ULN: Fractionate bilirubin, evaluate for cholestatic liver injury (e.g. by testing Alkaline Phosphatase (ALP)) or alternative causes of bilirubin elevation (e.g. disease progression [imaging]). Treat alternative causes according to institutional guidelines. 
o Grade 2 (>1.5 - 3.0 ULN): Repeat LFTs within 48-72 hours, then monitor LFTs weekly until resolution to LESS than or EQUAL to grade 1 or to baseline. If isolated bilirubin remains stable at Grade 2, continue treatment at the same dose regimen. 
o Grade 3 (>3.0 - 10 ULN): Interrupt treatment. Repeat LFTs within 48-72 hours, then monitor LFTs weekly until resolution to LESS than or EQUAL to Grade 1 or to baseline. If resolved in ? 14 days, maintain dose regimen; if not resolved in 14 days, permanently discontinue NIS793. (Please see footnote regarding alternative cause/s of bilirubin elevation). 
o Grade 4 (> 10 x ULN): See footnote*. Otherwise, permanently discontinue study treatment. If alternative cause/s is identified and managed, and bilirubin resolves to ? grade 1 or to baseline, resume treatment at the same dose regimen. *An isolated bilirubin elevation is not typical for DILI. Bilirubin can be elevated either as part of a "Hy's law" constellation with a preceding elevation of ALT/AST, or as part of a cholestatic reaction with simultaneous elevation of other cholestatic parameters (ALP, GGT). Isolated bilirubin can be seen in conjunction with drugs that inhibit bilirubin conjugation or excretion, but both scenarios do not typically represent liver injury. Alternative causes of bilirubin elevation should, therefore, be ruled out before basing dose modification decisions on bilirubin values alone.
		  	TREATMENT CONDITIONS 21	Interval: --	Occurrences: --	Comments:	Asymptomatic amylase and/or lipase elevation - 
o Grade 3, not associated with symptoms or clinical manifestations of pancreatitis: May continue study treatment. If levels do not resolve to LESS than or EQUAL to Grade 2 within LESS than or EQUAL to 14 days after the initial report, interrupt study treatment.  Upon resolution to ? Grade 2, consider resuming study treatment.
		  	TREATMENT CONDITIONS 22	Interval: --	Occurrences: --	Comments:	Renal / Serum Creatinine - 
o Grade 2:  Interrupt Study Treatment. Manage per institutional Practice. Upon resolution to LESS than Grade 1, consider resuming study treatment. 
o Grade 3 or Grade 4: Permanently Discontinue Study Treatment.
		  	TREATMENT CONDITIONS 23	Interval: --	Occurrences: --	Comments:	Hyperthyroidism - 
o Grade 2: Consider Continuing Study Treatment and Management according to institutional practice. 
o Grade 3: Interrupt study treatment. Upon resolution to Grade ? 1 with appropriate management, consider resuming study treatment without dose modification. 
o Grade 4: Must discontinue and manage according to local/institutional guidance.
		  	TREATMENT CONDITIONS 24	Interval: --	Occurrences: --	Comments:	Other Endocrine Disorders - 
o Grade 2 and Grade 3: Interrupt study treatment. Upon resolution to Grade LESS than or EQUAL to 1 with appropriate management, consider resuming study treatment.
		  	TREATMENT CONDITIONS 25	Interval: --	Occurrences: --	Comments:	Dermatology (rash) - 
o Grade 1: Continue study treatment. Consider topical steroids, antihistamines, topical emollients. 
o Grade 2: Consider interrupting study treatment. Topical or oral steroids, antihistamines. If study treatment is held and resolution to LESS than or EQUAL to Grade 1, resume study treatment. 
o Grade 3: Interrupt study treatment. Manage per institutional practice. After resolution to LESS than or EQUAL to Grade 1, consider resuming study treatment after consultation with dermatologist. 
o Grade 4 or Stevens-Johnson syndrome (SJS), or Lyell syndrome/toxic epidermal necrolysis (TEN): Permanently discontinue study treatment and manage according to local/institutional guidance.
		  	TREATMENT CONDITIONS 26	Interval: --	Occurrences: --	Comments:	Neutropenia - 
o Grade 3: Interrupt study treatment until resolved to LESS than or EQUAL to Grade 1 or baseline, then resume study medication. 
o Grade 4: Interrupt study treatment. If resolved in LESS than or EQUAL to 7 days, maintain study treatment.  

Febrile Neutropenia - 
o Grade 3: Interrupt study treatment. Upon resolution of fever and improvement of neutropenia to LESS than or EQUAL to Grade 1 or baseline, resume study treatment. 
o Grade 4: Permanently discontinue study treatment. 

Thrombocytopenia - 
o Grade 3: Interrupt study treatment. Upon resolution to ? Grade 2 or baseline, resume study treatment. For Grade 3 associated with major bleeding, permanently discontinue study treatment. 
o Grade 4: Permanently discontinue study treatment. 

Anemia - 
o Grade 3 or Grade 4: Interrupt study treatment. Upon resolution to LESS than or EQUAL to Grade 2 or baseline within LESS than or EQUAL to 7 days, resume study treatment.
		  	TREATMENT CONDITIONS 27	Interval: --	Occurrences: --	Comments:	Other laboratory adverse events, not specified elsewhere in table and not included in the consensus guidelines - 
o Grade 3 or Grade 4: Interrupt study treatment. Upon resolution to LESS than or EQUAL to Grade 1, resume study treatment without dose modification. Isolated Grade 4 electrolyte abnormalities not associated with clinical sequelae and corrected after appropriate management within 72 hours of their onset do not require discontinuation. In the case of Grade 4 electrolyte imbalances associated with clinical sequelae, or not resolved to LESS than or EQUAL to Grade 1 within 72 hours despite appropriate management, permanently discontinue study treatment. 

Other non-laboratory adverse events, not specified elsewhere in table and not included in the consensus guidelines:
o Grade 2: Consider study treatment interruption. Upon resolution to ? Grade 1, consider resuming study treatment. 
o Grade 3: Interrupt study treatment. Upon resolution to LESS than or EQUAL to Grade 1, resuming study treatment must be discussed with the relevant medical expert. 
o Grade 4: Permanently discontinue study treatment.
			Nursing Orders
  	ONC NURSING COMMUNICATION 60	Interval: --	Occurrences: --	Comments:	Concomitant Medications
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Prior Concomitant Procedures and significant non-drug therapies
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	Physical Examination
		  	ONC NURSING COMMUNICATION 62	Interval: --	Occurrences: --	Comments:	ECOG
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Calculate indirect bilirubin
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	EQ-5D-5L, PGIS (ePRO)
		  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	PRO-CTCAE, FACT-GP5 (ePRO)
		  	ONC NURSING COMMUNICATION 63	Interval: --	Occurrences: --	Comments:	PROMIS-29 (ePRO) - Pain and Fatigue items
		  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	Actigraphy
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	Adverse Events
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Serious Adverse Events
		  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	Health Resource Utilization
			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
☑	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --	Comments:	As clinically indicated
		☑	T3, FREE	Interval: --	Occurrences: --	Comments:	As clinically indicated
		☑	T4, FREE	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
☑	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated
		☑	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
  	URIC ACID LEVEL	Interval: --	Occurrences: --			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Labs
  	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --			Labs
  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
☑	CREATININE CLEARANCE, URINE, 24 HOUR	Interval: --	Occurrences: --		☑	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --		☑	BILIRUBIN DIRECT	Interval: --	Occurrences: --		☑	AMYLASE LEVEL	Interval: --	Occurrences: --		☑	LIPASE LEVEL	Interval: --	Occurrences: --		☑	GGT	Interval: --	Occurrences: --		☑	HEMOGLOBIN A1C	Interval: --	Occurrences: --	Comments:	As clinically indicated
		☑	CANCER ANTIGEN 19-9	Interval: --	Occurrences: --		☑	NABFERON IFN-B ANTIBODY - ATHENA	Interval: --	Occurrences: --	Comments:	Anytime when suspected Cytokine Release Syndrome Occurs
		☑	INTERLEUKIN 6	Interval: --	Occurrences: --	Comments:	Anytime when suspected Cytokine Release Syndrome Occurs
		☑	MISCELLANEOUS REFERRAL TEST	Interval: --	Occurrences: --	Comments:	Interleukin 1 - Anytime when suspected Cytokine Release Syndrome Occurs
		☑	TUMOR NECROSIS FACTOR - ALPHA	Interval: --	Occurrences: --	Comments:	Anytime when suspected Cytokine Release Syndrome Occurs. 
Perform ONLY at HMH and HMCL.
			Imaging
☑	CT HEAD W WO CONTRAST	Interval: --	Occurrences: --	Comments:	As clinically indicated. Or MRI
		☐	MRI BRAIN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	As clinically indicated. Or CT
		☑	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	As clinically indicated  for Tumor Evaluation per RECIST. Or MRI
		☐	MRI CHEST W CONTRAST	Interval: --	Occurrences: --	Comments:	As clinically indicated  for Tumor Evaluation per RECIST. Or CT
		☐	MRI ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	As clinically indicated  for Tumor Evaluation per RECIST. Or CT
		☐	MRI PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	As clinically indicated  for Tumor Evaluation per RECIST. Or CT
		☑	NM BONE SCAN WHOLE BODY	Interval: --	Occurrences: --	Comments:	As clinically indicated.
		☑	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	If Clinically Indicated Localized bone CT scan, MRI or Xray.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mEq/L; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 28	Interval: --	Occurrences: --	Comments:	o ANC LESS than 1000; 
o Platelets LESS than 100,000; 
o Bilirubin GREATER than 1.6; 
o LFTs GREATER than 10 x ULN.
			Pre-Medications
  	ondansetron (ZOFRAN) IV 8 mg	Dose: 8 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to chemo.			Chemotherapy
  	NAB-PACLItaxel (ABRAXANE) chemo infusion 125 mg/m2 (Treatment Plan)	Dose: 125 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes		  	gemcitabine (GEMZAR) 1,000 mg/m2 in sodium chloride 0.9% 250 mL chemo IVPB	Dose: 1,000 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 60 Minutes	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	GEMCITABINE 200 MG/5.26 ML (38 MG/ML) INTRAVENOUS SOLUTION	Medications	1,000 mg/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	 	No	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	fexofenadine (ALLEGRA) tablet 180 mg	Dose: 180 mg	Route: oral	PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 15	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Line Flush
  	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Use with NIS793		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Do NOT administer with NIS793			Nursing Orders
  	dextrose 5% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open for NIS793		  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.  Do NOT administer with NIS793			Nursing Orders
  	TREATMENT CONDITIONS 12	Interval: --	Occurrences: --	Comments:	Infusion Reaction or Hypersensitivity Reaction - 
o Grade 1-Infusion Reaction or Hypersensitivity Reaction: Decrease infusion rate until recovery from the symptoms. If the infusion reaction happens after the end of infusion (EOI), increase monitoring of vital signs until the participant is symptoms free. Administer subsequent NIS793 infusion at the same rate. 
o Grade 2- Infusion Reaction or Hypersensitivity Reaction: Stop infusion immediately and keep line open. Follow institutional guidelines for the management and follow-up of infusion reaction. Restart infusion at 50% of previous rate under continuous observation. Ensure that there is a minimum observation period of 1 hour prior to restarting the infusion. If the AE recurs at the reinitiated slower rate of infusion, and despite oral pre-medication, permanently discontinue study treatment. 
o Grade 3 or Grade 4- Infusion Reaction or Hypersensitivity Reaction: Stop infusion immediately and keep line open. Follow institutional guidelines for the management and follow-up of infusion reaction. Provide supplemental oxygen, fluids, and other resuscitative measures as needed. Monitor vital signs (e.g. blood pressure, pulse, respiration, and temperature) every 15 ± 5 minutes until resolution.
		  	TREATMENT CONDITIONS 13	Interval: --	Occurrences: --	Comments:	Cytokine Release Syndrome (CRS) - 
o Grade 2: Stop infusion immediately and keep line open. Follow institutional guidelines for the management and follow-up of infusion reaction. Restart infusion at 50% of previous rate under continuous observation. Ensure that there is a minimum observation period of 1 hour prior to restarting the infusion. If the AE recurs at the reinitiated slower rate of infusion, and despite oral pre-medication, permanently discontinue study treatment. 
o Grade 3 or 4: Permanently discontinue study treatment. Follow-up CRS as per institutional guidelines.
		  	TREATMENT CONDITIONS 14	Interval: --	Occurrences: --	Comments:	Ocular (e.g. Conjunctivitis, Blepharitis, blurred vision) - 
o Grade 1: May continue study treatment. Consider ophthalmology consultation. 
o Grade 2: Ophthalmology consultation. Upon resolution to LESS than or EQUAL to Grade 1 consider resuming study treatment in consultation with ophthalmologist. 
o Grade 3: 
1. Interrupt study treatment. 
2. Ophthalmology consultation. 
3. Upon resolution to LESS than or EQUAL to Grade 1 consider resuming study treatment in consultation with ophthalmologist.
o Grade 4:  Permanently discontinue study treatment.
		  	TREATMENT CONDITIONS 15	Interval: --	Occurrences: --	Comments:	Cardiovascular - 
o Grade 2 or greater Myocarditis: Permanently discontinue study treatment. 
o Grade 2 Cardiac Valvulopathy and other Cardiac Toxicity: Interrupt study treatment. Repeat echocardiogram and assess cardiac function. Once resolved to Grade ? 1 or baseline, consider re-administration of treatment, if benefit outweighs the potential risk. 
o Grade 3> Cardiac Valvulopathy and other Cardiac Toxicity: Permanently discontinue study treatment.
		  	TREATMENT CONDITIONS 16	Interval: --	Occurrences: --	Comments:	Isolated AST and/or ALT Elevation - 
o Grade 3 AST or ALT >5.0 - 10.0 x ULN: Interrupt treatment. Repeat liver function tests (LFTs) within 48-72 hours, then monitor LFTs weekly until recovery to grade ?1 or to baseline. Then resume treatment at the same dose interval if resolved in LESS than or EQUAL to 14 days; if resolved in GREATER than 14 days, consider administration Q4W instead of Q2W. 
o Grade 3 AST or ALT >10.0 - 20.0 x ULN: Interrupt treatment. Repeat LFTs within 48-72 hours, then monitor LFTs weekly until recovery to grade LESS than or EQUAL to 1 or to baseline, then increase dosing interval for NIS793 from Q2W to Q4W. 
o Grade 4: AST or ALT (>20 x ULN): Permanently discontinue treatment.
		  	TREATMENT CONDITIONS 17	Interval: --	Occurrences: --	Comments:	With abnormal ALT/AST (up to grade 2 - </= 5.0 x ULN) at baseline - 
o ALT/AST > 2.0 x baseline AND > 5.0 x ULN: Interrupt treatment. Repeat LFTs within 48-72 hours, then monitor LFTs weekly until recovery to baseline; Then resume same dose interval if resolved in LESS than or EQUAL to 14 days; if resolved in GREATER than 14 days, increasing dosing from Q2W to Q4W. 
o ALT/AST > 3.0 x baseline AND >10 x ULN: Interrupt treatment. Repeat LFTs within 48-72 hours, then monitor weekly until resolved to baseline; then increase dosing interval from Q2W to Q4W. 
o AST or ALT >20 x ULN (grade 4): Permanently discontinue treatment.
		  	TREATMENT CONDITIONS 18	Interval: --	Occurrences: --	Comments:	Concomitant elevation of AST and/or ALT and total bilirubin with normal AST/ALT and bilirubin at baseline -
o Grade 2 ALT and/or AST elevation (>3.0 x ULN) with bilirubin > 2.0 x ULN (unless Gilbert's syndrome): Interrupt treatment. Assess if case is drug induced liver injury (DILI). If DILI confirmed, permanently discontinue study treatment. For additional information on follow-up of potential drug induced liver injury cases, refer to Section 6.5.5.1. If no DILI confirmed, interrupt treatment, treat the identified cause according to institutional guidelines. Repeat LFTs within 48-72 hours, then monitor weekly, until enzyme levels resolve to LESS than or EQUAL to grade 1 or baseline.  After recovery, re-administration of study treatment could be considered only if Investigator assesses benefit to outweigh the risk. Any decision regarding re-administration of study drugs and dose regimen should be discussed with the Sponsor.
		  	TREATMENT CONDITIONS 19	Interval: --	Occurrences: --	Comments:	With abnormal ALT/AST at baseline - 
o ALT or AST >3.0 x baseline OR ALT or AST >8.0 x ULN [whichever is lower] combined with total bilirubin >2.0 x baseline AND >2.0 x ULN:  Interrupt treatment. Assess if case is drug induced liver injury (DILI). If DILI confirmed, permanently discontinue study treatment. For additional information on follow-up of potential drug induced liver injury cases, refer to Section 6.5.5.1. If no DILI confirmed, interrupt treatment, treat the identified cause according to institutional guidelines. Repeat LFTs within 48-72 hours, then monitor weekly, until enzyme levels resolve to ?grade 1 or baseline.  After recovery, re-administration of study treatment could be considered only if Investigator assesses benefit to outweigh the risk. Any decision regarding re-administration of study drugs and dose regimen should be discussed with the Sponsor.
		  	TREATMENT CONDITIONS 20	Interval: --	Occurrences: --	Comments:	Isolated total bilirubin elevation - 
o Any elevation > ULN: Fractionate bilirubin, evaluate for cholestatic liver injury (e.g. by testing Alkaline Phosphatase (ALP)) or alternative causes of bilirubin elevation (e.g. disease progression [imaging]). Treat alternative causes according to institutional guidelines. 
o Grade 2 (>1.5 - 3.0 ULN): Repeat LFTs within 48-72 hours, then monitor LFTs weekly until resolution to LESS than or EQUAL to grade 1 or to baseline. If isolated bilirubin remains stable at Grade 2, continue treatment at the same dose regimen. 
o Grade 3 (>3.0 - 10 ULN): Interrupt treatment. Repeat LFTs within 48-72 hours, then monitor LFTs weekly until resolution to LESS than or EQUAL to Grade 1 or to baseline. If resolved in ? 14 days, maintain dose regimen; if not resolved in 14 days, permanently discontinue NIS793. (Please see footnote regarding alternative cause/s of bilirubin elevation). 
o Grade 4 (> 10 x ULN): See footnote*. Otherwise, permanently discontinue study treatment. If alternative cause/s is identified and managed, and bilirubin resolves to ? grade 1 or to baseline, resume treatment at the same dose regimen. *An isolated bilirubin elevation is not typical for DILI. Bilirubin can be elevated either as part of a "Hy's law" constellation with a preceding elevation of ALT/AST, or as part of a cholestatic reaction with simultaneous elevation of other cholestatic parameters (ALP, GGT). Isolated bilirubin can be seen in conjunction with drugs that inhibit bilirubin conjugation or excretion, but both scenarios do not typically represent liver injury. Alternative causes of bilirubin elevation should, therefore, be ruled out before basing dose modification decisions on bilirubin values alone.
		  	TREATMENT CONDITIONS 21	Interval: --	Occurrences: --	Comments:	Asymptomatic amylase and/or lipase elevation - 
o Grade 3, not associated with symptoms or clinical manifestations of pancreatitis: May continue study treatment. If levels do not resolve to LESS than or EQUAL to Grade 2 within LESS than or EQUAL to 14 days after the initial report, interrupt study treatment.  Upon resolution to ? Grade 2, consider resuming study treatment.
		  	TREATMENT CONDITIONS 22	Interval: --	Occurrences: --	Comments:	Renal / Serum Creatinine - 
o Grade 2:  Interrupt Study Treatment. Manage per institutional Practice. Upon resolution to LESS than Grade 1, consider resuming study treatment. 
o Grade 3 or Grade 4: Permanently Discontinue Study Treatment.
		  	TREATMENT CONDITIONS 23	Interval: --	Occurrences: --	Comments:	Hyperthyroidism - 
o Grade 2: Consider Continuing Study Treatment and Management according to institutional practice. 
o Grade 3: Interrupt study treatment. Upon resolution to Grade ? 1 with appropriate management, consider resuming study treatment without dose modification. 
o Grade 4: Must discontinue and manage according to local/institutional guidance.
		  	TREATMENT CONDITIONS 24	Interval: --	Occurrences: --	Comments:	Other Endocrine Disorders - 
o Grade 2 and Grade 3: Interrupt study treatment. Upon resolution to Grade LESS than or EQUAL to 1 with appropriate management, consider resuming study treatment.
		  	TREATMENT CONDITIONS 25	Interval: --	Occurrences: --	Comments:	Dermatology (rash) - 
o Grade 1: Continue study treatment. Consider topical steroids, antihistamines, topical emollients. 
o Grade 2: Consider interrupting study treatment. Topical or oral steroids, antihistamines. If study treatment is held and resolution to LESS than or EQUAL to Grade 1, resume study treatment. 
o Grade 3: Interrupt study treatment. Manage per institutional practice. After resolution to LESS than or EQUAL to Grade 1, consider resuming study treatment after consultation with dermatologist. 
o Grade 4 or Stevens-Johnson syndrome (SJS), or Lyell syndrome/toxic epidermal necrolysis (TEN): Permanently discontinue study treatment and manage according to local/institutional guidance.
		  	TREATMENT CONDITIONS 26	Interval: --	Occurrences: --	Comments:	Neutropenia - 
o Grade 3: Interrupt study treatment until resolved to LESS than or EQUAL to Grade 1 or baseline, then resume study medication. 
o Grade 4: Interrupt study treatment. If resolved in LESS than or EQUAL to 7 days, maintain study treatment.  

Febrile Neutropenia - 
o Grade 3: Interrupt study treatment. Upon resolution of fever and improvement of neutropenia to LESS than or EQUAL to Grade 1 or baseline, resume study treatment. 
o Grade 4: Permanently discontinue study treatment. 

Thrombocytopenia - 
o Grade 3: Interrupt study treatment. Upon resolution to ? Grade 2 or baseline, resume study treatment. For Grade 3 associated with major bleeding, permanently discontinue study treatment. 
o Grade 4: Permanently discontinue study treatment. 

Anemia - 
o Grade 3 or Grade 4: Interrupt study treatment. Upon resolution to LESS than or EQUAL to Grade 2 or baseline within LESS than or EQUAL to 7 days, resume study treatment.
		  	TREATMENT CONDITIONS 27	Interval: --	Occurrences: --	Comments:	Other laboratory adverse events, not specified elsewhere in table and not included in the consensus guidelines - 
o Grade 3 or Grade 4: Interrupt study treatment. Upon resolution to LESS than or EQUAL to Grade 1, resume study treatment without dose modification. Isolated Grade 4 electrolyte abnormalities not associated with clinical sequelae and corrected after appropriate management within 72 hours of their onset do not require discontinuation. In the case of Grade 4 electrolyte imbalances associated with clinical sequelae, or not resolved to LESS than or EQUAL to Grade 1 within 72 hours despite appropriate management, permanently discontinue study treatment. 

Other non-laboratory adverse events, not specified elsewhere in table and not included in the consensus guidelines:
o Grade 2: Consider study treatment interruption. Upon resolution to ? Grade 1, consider resuming study treatment. 
o Grade 3: Interrupt study treatment. Upon resolution to LESS than or EQUAL to Grade 1, resuming study treatment must be discussed with the relevant medical expert. 
o Grade 4: Permanently discontinue study treatment.
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Dose Modifications and Dose Interruption for NIS793: 
No Dose Reductions are allowed for NIS793: Increasing the dosing interval from Q2W to Q4W is allowed under circumstances described in Table 6-5. If NIS793 is interrupted or delayed for GREATER than 8 weeks due to toxicity that is suspected to be related to treatment, study treatment should be permanently discontinued.
			Nursing Orders
  	ONC NURSING COMMUNICATION 60	Interval: --	Occurrences: --	Comments:	Concomitant Medications
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Prior Concomitant Procedures and significant non-drug therapies
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	Physical Examination
		  	ONC NURSING COMMUNICATION 62	Interval: --	Occurrences: --	Comments:	ECOG
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Calculate indirect bilirubin
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	EQ-5D-5L, PGIS (ePRO)
		  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	PRO-CTCAE, FACT-GP5 (ePRO)
		  	ONC NURSING COMMUNICATION 63	Interval: --	Occurrences: --	Comments:	PROMIS-29 (ePRO) - Pain and Fatigue items
		  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	Actigraphy
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	Adverse Events
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Serious Adverse Events
		  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	Health Resource Utilization
			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
☑	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --	Comments:	As clinically indicated
		☑	T3, FREE	Interval: --	Occurrences: --	Comments:	As clinically indicated
		☑	T4, FREE	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
☑	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated
		☑	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
  	URIC ACID LEVEL	Interval: --	Occurrences: --			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Labs
  	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --			Labs
  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
☑	CREATININE CLEARANCE, URINE, 24 HOUR	Interval: --	Occurrences: --		☑	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --		☑	BILIRUBIN DIRECT	Interval: --	Occurrences: --		☑	AMYLASE LEVEL	Interval: --	Occurrences: --		☑	LIPASE LEVEL	Interval: --	Occurrences: --		☑	GGT	Interval: --	Occurrences: --		☑	HEMOGLOBIN A1C	Interval: --	Occurrences: --	Comments:	As clinically indicated
		☑	CANCER ANTIGEN 19-9	Interval: --	Occurrences: --		☑	NABFERON IFN-B ANTIBODY - ATHENA	Interval: --	Occurrences: --	Comments:	Anytime when suspected Cytokine Release Syndrome Occurs
		☑	INTERLEUKIN 6	Interval: --	Occurrences: --	Comments:	Anytime when suspected Cytokine Release Syndrome Occurs
		☑	MISCELLANEOUS REFERRAL TEST	Interval: --	Occurrences: --	Comments:	Interleukin 1 - Anytime when suspected Cytokine Release Syndrome Occurs
		☑	TUMOR NECROSIS FACTOR - ALPHA	Interval: --	Occurrences: --	Comments:	Anytime when suspected Cytokine Release Syndrome Occurs. 
Perform ONLY at HMH and HMCL.
			Imaging
☑	CT HEAD W WO CONTRAST	Interval: --	Occurrences: --	Comments:	As clinically indicated. Or MRI
		☐	MRI BRAIN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	As clinically indicated. Or CT
		☑	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	As clinically indicated  for Tumor Evaluation per RECIST. Or MRI
		☐	MRI CHEST W CONTRAST	Interval: --	Occurrences: --	Comments:	As clinically indicated  for Tumor Evaluation per RECIST. Or CT
		☐	MRI ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	As clinically indicated  for Tumor Evaluation per RECIST. Or CT
		☐	MRI PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	As clinically indicated  for Tumor Evaluation per RECIST. Or CT
		☑	NM BONE SCAN WHOLE BODY	Interval: --	Occurrences: --	Comments:	As clinically indicated.
		☑	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	If Clinically Indicated Localized bone CT scan, MRI or Xray.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mEq/L; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 28	Interval: --	Occurrences: --	Comments:	o ANC LESS than 1000; 
o Platelets LESS than 100,000; 
o Bilirubin GREATER than 1.6; 
o LFTs GREATER than 10 x ULN.
			Pre-Medications
  	ondansetron (ZOFRAN) IV 8 mg	Dose: 8 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to chemo.			Nursing Orders
  	ONC NURSING COMMUNICATION 68	Interval: --	Occurrences: --	Comments:	Infusion must take place in a facility with appropriate resuscitation equipment available at the bedside, and a physician readily available during the period of drug administration.
		  	ONC NURSING COMMUNICATION 69	Interval: --	Occurrences: --	Comments:	Participants should be closely observed for potential infusion-related reactions including rigors, chills, wheezing, pruritus, flushing, rash, hypotension, hypoxemia, and fever, and vital signs monitored more frequently if clinically indicated, during and for at least 2 hours after the first two NIS793 infusions. The same may apply for subsequent NIS793 infusions if medically indicated. Participants should notify study personnel if symptoms of infusion reaction occur after any NIS793 infusion.
			Chemotherapy
  	INV-NIS793 or placebo (CNIS793B12301 daNIS-2/Pro00032923/Abdelrahim) 2,100 mg in dextrose 5% 100 mL	Dose: 2,100 mg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Protect from light.  Administer intravenously using a 0.2 micron inline filter over 30 minutes.  Flush only with D5W!
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.

	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-NIS793 OR PLACEBO 1050MG/10ML INTRAVENOUS SOLN. (CNIS793B12301 DANIS-2/PRO00032923/ABDELRAHIM)	Medications	2,100 mg	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	80 mL	Yes	Yes			  	NAB-PACLItaxel (ABRAXANE) chemo infusion 125 mg/m2 (Treatment Plan)	Dose: 125 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 3 Hours		  	gemcitabine (GEMZAR) 1,000 mg/m2 in sodium chloride 0.9% 250 mL chemo IVPB	Dose: 1,000 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 3.5 Hours	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	GEMCITABINE 200 MG/5.26 ML (38 MG/ML) INTRAVENOUS SOLUTION	Medications	1,000 mg/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	 	No	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	fexofenadine (ALLEGRA) tablet 180 mg	Dose: 180 mg	Route: oral	PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 3	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Line Flush
  	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Use with NIS793		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Do NOT administer with NIS793			Nursing Orders
  	dextrose 5% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open for NIS793		  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.  Do NOT administer with NIS793			Nursing Orders
  	TREATMENT CONDITIONS 12	Interval: --	Occurrences: --	Comments:	Infusion Reaction or Hypersensitivity Reaction - 
o Grade 1-Infusion Reaction or Hypersensitivity Reaction: Decrease infusion rate until recovery from the symptoms. If the infusion reaction happens after the end of infusion (EOI), increase monitoring of vital signs until the participant is symptoms free. Administer subsequent NIS793 infusion at the same rate. 
o Grade 2- Infusion Reaction or Hypersensitivity Reaction: Stop infusion immediately and keep line open. Follow institutional guidelines for the management and follow-up of infusion reaction. Restart infusion at 50% of previous rate under continuous observation. Ensure that there is a minimum observation period of 1 hour prior to restarting the infusion. If the AE recurs at the reinitiated slower rate of infusion, and despite oral pre-medication, permanently discontinue study treatment. 
o Grade 3 or Grade 4- Infusion Reaction or Hypersensitivity Reaction: Stop infusion immediately and keep line open. Follow institutional guidelines for the management and follow-up of infusion reaction. Provide supplemental oxygen, fluids, and other resuscitative measures as needed. Monitor vital signs (e.g. blood pressure, pulse, respiration, and temperature) every 15 ± 5 minutes until resolution.
		  	TREATMENT CONDITIONS 13	Interval: --	Occurrences: --	Comments:	Cytokine Release Syndrome (CRS) - 
o Grade 2: Stop infusion immediately and keep line open. Follow institutional guidelines for the management and follow-up of infusion reaction. Restart infusion at 50% of previous rate under continuous observation. Ensure that there is a minimum observation period of 1 hour prior to restarting the infusion. If the AE recurs at the reinitiated slower rate of infusion, and despite oral pre-medication, permanently discontinue study treatment. 
o Grade 3 or 4: Permanently discontinue study treatment. Follow-up CRS as per institutional guidelines.
		  	TREATMENT CONDITIONS 14	Interval: --	Occurrences: --	Comments:	Ocular (e.g. Conjunctivitis, Blepharitis, blurred vision) - 
o Grade 1: May continue study treatment. Consider ophthalmology consultation. 
o Grade 2: Ophthalmology consultation. Upon resolution to LESS than or EQUAL to Grade 1 consider resuming study treatment in consultation with ophthalmologist. 
o Grade 3: 
1. Interrupt study treatment. 
2. Ophthalmology consultation. 
3. Upon resolution to LESS than or EQUAL to Grade 1 consider resuming study treatment in consultation with ophthalmologist.
o Grade 4:  Permanently discontinue study treatment.
		  	TREATMENT CONDITIONS 15	Interval: --	Occurrences: --	Comments:	Cardiovascular - 
o Grade 2 or greater Myocarditis: Permanently discontinue study treatment. 
o Grade 2 Cardiac Valvulopathy and other Cardiac Toxicity: Interrupt study treatment. Repeat echocardiogram and assess cardiac function. Once resolved to Grade ? 1 or baseline, consider re-administration of treatment, if benefit outweighs the potential risk. 
o Grade 3> Cardiac Valvulopathy and other Cardiac Toxicity: Permanently discontinue study treatment.
		  	TREATMENT CONDITIONS 16	Interval: --	Occurrences: --	Comments:	Isolated AST and/or ALT Elevation - 
o Grade 3 AST or ALT >5.0 - 10.0 x ULN: Interrupt treatment. Repeat liver function tests (LFTs) within 48-72 hours, then monitor LFTs weekly until recovery to grade ?1 or to baseline. Then resume treatment at the same dose interval if resolved in LESS than or EQUAL to 14 days; if resolved in GREATER than 14 days, consider administration Q4W instead of Q2W. 
o Grade 3 AST or ALT >10.0 - 20.0 x ULN: Interrupt treatment. Repeat LFTs within 48-72 hours, then monitor LFTs weekly until recovery to grade LESS than or EQUAL to 1 or to baseline, then increase dosing interval for NIS793 from Q2W to Q4W. 
o Grade 4: AST or ALT (>20 x ULN): Permanently discontinue treatment.
		  	TREATMENT CONDITIONS 17	Interval: --	Occurrences: --	Comments:	With abnormal ALT/AST (up to grade 2 - </= 5.0 x ULN) at baseline - 
o ALT/AST > 2.0 x baseline AND > 5.0 x ULN: Interrupt treatment. Repeat LFTs within 48-72 hours, then monitor LFTs weekly until recovery to baseline; Then resume same dose interval if resolved in LESS than or EQUAL to 14 days; if resolved in GREATER than 14 days, increasing dosing from Q2W to Q4W. 
o ALT/AST > 3.0 x baseline AND >10 x ULN: Interrupt treatment. Repeat LFTs within 48-72 hours, then monitor weekly until resolved to baseline; then increase dosing interval from Q2W to Q4W. 
o AST or ALT >20 x ULN (grade 4): Permanently discontinue treatment.
		  	TREATMENT CONDITIONS 18	Interval: --	Occurrences: --	Comments:	Concomitant elevation of AST and/or ALT and total bilirubin with normal AST/ALT and bilirubin at baseline -
o Grade 2 ALT and/or AST elevation (>3.0 x ULN) with bilirubin > 2.0 x ULN (unless Gilbert's syndrome): Interrupt treatment. Assess if case is drug induced liver injury (DILI). If DILI confirmed, permanently discontinue study treatment. For additional information on follow-up of potential drug induced liver injury cases, refer to Section 6.5.5.1. If no DILI confirmed, interrupt treatment, treat the identified cause according to institutional guidelines. Repeat LFTs within 48-72 hours, then monitor weekly, until enzyme levels resolve to LESS than or EQUAL to grade 1 or baseline.  After recovery, re-administration of study treatment could be considered only if Investigator assesses benefit to outweigh the risk. Any decision regarding re-administration of study drugs and dose regimen should be discussed with the Sponsor.
		  	TREATMENT CONDITIONS 19	Interval: --	Occurrences: --	Comments:	With abnormal ALT/AST at baseline - 
o ALT or AST >3.0 x baseline OR ALT or AST >8.0 x ULN [whichever is lower] combined with total bilirubin >2.0 x baseline AND >2.0 x ULN:  Interrupt treatment. Assess if case is drug induced liver injury (DILI). If DILI confirmed, permanently discontinue study treatment. For additional information on follow-up of potential drug induced liver injury cases, refer to Section 6.5.5.1. If no DILI confirmed, interrupt treatment, treat the identified cause according to institutional guidelines. Repeat LFTs within 48-72 hours, then monitor weekly, until enzyme levels resolve to ?grade 1 or baseline.  After recovery, re-administration of study treatment could be considered only if Investigator assesses benefit to outweigh the risk. Any decision regarding re-administration of study drugs and dose regimen should be discussed with the Sponsor.
		  	TREATMENT CONDITIONS 20	Interval: --	Occurrences: --	Comments:	Isolated total bilirubin elevation - 
o Any elevation > ULN: Fractionate bilirubin, evaluate for cholestatic liver injury (e.g. by testing Alkaline Phosphatase (ALP)) or alternative causes of bilirubin elevation (e.g. disease progression [imaging]). Treat alternative causes according to institutional guidelines. 
o Grade 2 (>1.5 - 3.0 ULN): Repeat LFTs within 48-72 hours, then monitor LFTs weekly until resolution to LESS than or EQUAL to grade 1 or to baseline. If isolated bilirubin remains stable at Grade 2, continue treatment at the same dose regimen. 
o Grade 3 (>3.0 - 10 ULN): Interrupt treatment. Repeat LFTs within 48-72 hours, then monitor LFTs weekly until resolution to LESS than or EQUAL to Grade 1 or to baseline. If resolved in ? 14 days, maintain dose regimen; if not resolved in 14 days, permanently discontinue NIS793. (Please see footnote regarding alternative cause/s of bilirubin elevation). 
o Grade 4 (> 10 x ULN): See footnote*. Otherwise, permanently discontinue study treatment. If alternative cause/s is identified and managed, and bilirubin resolves to ? grade 1 or to baseline, resume treatment at the same dose regimen. *An isolated bilirubin elevation is not typical for DILI. Bilirubin can be elevated either as part of a "Hy's law" constellation with a preceding elevation of ALT/AST, or as part of a cholestatic reaction with simultaneous elevation of other cholestatic parameters (ALP, GGT). Isolated bilirubin can be seen in conjunction with drugs that inhibit bilirubin conjugation or excretion, but both scenarios do not typically represent liver injury. Alternative causes of bilirubin elevation should, therefore, be ruled out before basing dose modification decisions on bilirubin values alone.
		  	TREATMENT CONDITIONS 21	Interval: --	Occurrences: --	Comments:	Asymptomatic amylase and/or lipase elevation - 
o Grade 3, not associated with symptoms or clinical manifestations of pancreatitis: May continue study treatment. If levels do not resolve to LESS than or EQUAL to Grade 2 within LESS than or EQUAL to 14 days after the initial report, interrupt study treatment.  Upon resolution to ? Grade 2, consider resuming study treatment.
		  	TREATMENT CONDITIONS 22	Interval: --	Occurrences: --	Comments:	Renal / Serum Creatinine - 
o Grade 2:  Interrupt Study Treatment. Manage per institutional Practice. Upon resolution to LESS than Grade 1, consider resuming study treatment. 
o Grade 3 or Grade 4: Permanently Discontinue Study Treatment.
		  	TREATMENT CONDITIONS 23	Interval: --	Occurrences: --	Comments:	Hyperthyroidism - 
o Grade 2: Consider Continuing Study Treatment and Management according to institutional practice. 
o Grade 3: Interrupt study treatment. Upon resolution to Grade ? 1 with appropriate management, consider resuming study treatment without dose modification. 
o Grade 4: Must discontinue and manage according to local/institutional guidance.
		  	TREATMENT CONDITIONS 24	Interval: --	Occurrences: --	Comments:	Other Endocrine Disorders - 
o Grade 2 and Grade 3: Interrupt study treatment. Upon resolution to Grade LESS than or EQUAL to 1 with appropriate management, consider resuming study treatment.
		  	TREATMENT CONDITIONS 25	Interval: --	Occurrences: --	Comments:	Dermatology (rash) - 
o Grade 1: Continue study treatment. Consider topical steroids, antihistamines, topical emollients. 
o Grade 2: Consider interrupting study treatment. Topical or oral steroids, antihistamines. If study treatment is held and resolution to LESS than or EQUAL to Grade 1, resume study treatment. 
o Grade 3: Interrupt study treatment. Manage per institutional practice. After resolution to LESS than or EQUAL to Grade 1, consider resuming study treatment after consultation with dermatologist. 
o Grade 4 or Stevens-Johnson syndrome (SJS), or Lyell syndrome/toxic epidermal necrolysis (TEN): Permanently discontinue study treatment and manage according to local/institutional guidance.
		  	TREATMENT CONDITIONS 26	Interval: --	Occurrences: --	Comments:	Neutropenia - 
o Grade 3: Interrupt study treatment until resolved to LESS than or EQUAL to Grade 1 or baseline, then resume study medication. 
o Grade 4: Interrupt study treatment. If resolved in LESS than or EQUAL to 7 days, maintain study treatment.  

Febrile Neutropenia - 
o Grade 3: Interrupt study treatment. Upon resolution of fever and improvement of neutropenia to LESS than or EQUAL to Grade 1 or baseline, resume study treatment. 
o Grade 4: Permanently discontinue study treatment. 

Thrombocytopenia - 
o Grade 3: Interrupt study treatment. Upon resolution to ? Grade 2 or baseline, resume study treatment. For Grade 3 associated with major bleeding, permanently discontinue study treatment. 
o Grade 4: Permanently discontinue study treatment. 

Anemia - 
o Grade 3 or Grade 4: Interrupt study treatment. Upon resolution to LESS than or EQUAL to Grade 2 or baseline within LESS than or EQUAL to 7 days, resume study treatment.
		  	TREATMENT CONDITIONS 27	Interval: --	Occurrences: --	Comments:	Other laboratory adverse events, not specified elsewhere in table and not included in the consensus guidelines - 
o Grade 3 or Grade 4: Interrupt study treatment. Upon resolution to LESS than or EQUAL to Grade 1, resume study treatment without dose modification. Isolated Grade 4 electrolyte abnormalities not associated with clinical sequelae and corrected after appropriate management within 72 hours of their onset do not require discontinuation. In the case of Grade 4 electrolyte imbalances associated with clinical sequelae, or not resolved to LESS than or EQUAL to Grade 1 within 72 hours despite appropriate management, permanently discontinue study treatment. 

Other non-laboratory adverse events, not specified elsewhere in table and not included in the consensus guidelines:
o Grade 2: Consider study treatment interruption. Upon resolution to ? Grade 1, consider resuming study treatment. 
o Grade 3: Interrupt study treatment. Upon resolution to LESS than or EQUAL to Grade 1, resuming study treatment must be discussed with the relevant medical expert. 
o Grade 4: Permanently discontinue study treatment.
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Dose Modifications and Dose Interruption for NIS793: 
No Dose Reductions are allowed for NIS793: Increasing the dosing interval from Q2W to Q4W is allowed under circumstances described in Table 6-5. If NIS793 is interrupted or delayed for GREATER than 8 weeks due to toxicity that is suspected to be related to treatment, study treatment should be permanently discontinued.
			Nursing Orders
  	ONC NURSING COMMUNICATION 60	Interval: --	Occurrences: --	Comments:	Concomitant Medications
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Prior Concomitant Procedures and significant non-drug therapies
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	Physical Examination
		  	ONC NURSING COMMUNICATION 62	Interval: --	Occurrences: --	Comments:	ECOG
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Calculate indirect bilirubin
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	EQ-5D-5L, PGIS (ePRO)
		  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	PRO-CTCAE, FACT-GP5 (ePRO)
		  	ONC NURSING COMMUNICATION 63	Interval: --	Occurrences: --	Comments:	PROMIS-29 (ePRO) - Pain and Fatigue items
		  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	Actigraphy
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	Adverse Events
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Serious Adverse Events
		  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	Health Resource Utilization
			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
☑	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --	Comments:	As clinically indicated
		☑	T3, FREE	Interval: --	Occurrences: --	Comments:	As clinically indicated
		☑	T4, FREE	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
☑	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated
		☑	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
  	URIC ACID LEVEL	Interval: --	Occurrences: --			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Labs
  	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --			Labs
  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --			Labs
☑	CREATININE CLEARANCE, URINE, 24 HOUR	Interval: --	Occurrences: --		☑	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --		☑	BILIRUBIN DIRECT	Interval: --	Occurrences: --		☑	AMYLASE LEVEL	Interval: --	Occurrences: --		☑	LIPASE LEVEL	Interval: --	Occurrences: --		☑	GGT	Interval: --	Occurrences: --		☑	HEMOGLOBIN A1C	Interval: --	Occurrences: --	Comments:	As clinically indicated
		☑	CANCER ANTIGEN 19-9	Interval: --	Occurrences: --		☑	TROPONIN	Interval: --	Occurrences: --	Comments:	As clinically indicated
		☑	NT-PROBNP	Interval: --	Occurrences: --	Comments:	As clinically indicated
		☑	NABFERON IFN-B ANTIBODY - ATHENA	Interval: --	Occurrences: --	Comments:	Anytime when suspected Cytokine Release Syndrome Occurs
		☑	INTERLEUKIN 6	Interval: --	Occurrences: --	Comments:	Anytime when suspected Cytokine Release Syndrome Occurs
		☑	MISCELLANEOUS REFERRAL TEST	Interval: --	Occurrences: --	Comments:	Interleukin 1 - Anytime when suspected Cytokine Release Syndrome Occurs
		☑	TUMOR NECROSIS FACTOR - ALPHA	Interval: --	Occurrences: --	Comments:	Anytime when suspected Cytokine Release Syndrome Occurs. 
Perform ONLY at HMH and HMCL.
			Imaging
☑	CT HEAD W WO CONTRAST	Interval: --	Occurrences: --	Comments:	As clinically indicated. Or MRI
		☐	MRI BRAIN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	As clinically indicated. Or CT
		☑	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	As clinically indicated  for Tumor Evaluation per RECIST. Or MRI
		☐	MRI CHEST W CONTRAST	Interval: --	Occurrences: --	Comments:	As clinically indicated  for Tumor Evaluation per RECIST. Or CT
		☐	MRI ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	As clinically indicated  for Tumor Evaluation per RECIST. Or CT
		☐	MRI PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	As clinically indicated  for Tumor Evaluation per RECIST. Or CT
		☑	NM BONE SCAN WHOLE BODY	Interval: --	Occurrences: --	Comments:	As clinically indicated.
		☑	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	If Clinically Indicated Localized bone CT scan, MRI or Xray.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Nursing Orders
  	TREATMENT CONDITIONS 28	Interval: --	Occurrences: --	Comments:	o ANC LESS than 1000; 
o Platelets LESS than 100,000; 
o Bilirubin GREATER than 1.6; 
o LFTs GREATER than 10 x ULN.
			Pre-Medications
  	ondansetron (ZOFRAN) IV 8 mg	Dose: 8 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to chemo.			Nursing Orders
  	ONC NURSING COMMUNICATION 68	Interval: --	Occurrences: --	Comments:	Infusion must take place in a facility with appropriate resuscitation equipment available at the bedside, and a physician readily available during the period of drug administration.
		  	ONC NURSING COMMUNICATION 69	Interval: --	Occurrences: --	Comments:	Participants should be closely observed for potential infusion-related reactions including rigors, chills, wheezing, pruritus, flushing, rash, hypotension, hypoxemia, and fever, and vital signs monitored more frequently if clinically indicated, during and for at least 2 hours after the first two NIS793 infusions. The same may apply for subsequent NIS793 infusions if medically indicated. Participants should notify study personnel if symptoms of infusion reaction occur after any NIS793 infusion.
			Chemotherapy
  	INV-NIS793 or placebo (CNIS793B12301 daNIS-2/Pro00032923/Abdelrahim) 2,100 mg in dextrose 5% 100 mL	Dose: 2,100 mg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Protect from light.  Administer intravenously using a 0.2 micron inline filter over 30 minutes.  Flush only with D5W!
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.

	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-NIS793 OR PLACEBO 1050MG/10ML INTRAVENOUS SOLN. (CNIS793B12301 DANIS-2/PRO00032923/ABDELRAHIM)	Medications	2,100 mg	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	80 mL	Yes	Yes			  	NAB-PACLItaxel (ABRAXANE) chemo infusion 125 mg/m2 (Treatment Plan)	Dose: 125 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 3 Hours		  	gemcitabine (GEMZAR) 1,000 mg/m2 in sodium chloride 0.9% 250 mL chemo IVPB	Dose: 1,000 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 3.5 Hours	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	GEMCITABINE 200 MG/5.26 ML (38 MG/ML) INTRAVENOUS SOLUTION	Medications	1,000 mg/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	 	No	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	fexofenadine (ALLEGRA) tablet 180 mg	Dose: 180 mg	Route: oral	PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 8	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Line Flush
  	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Nursing Orders
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Nursing Orders
  	TREATMENT CONDITIONS 12	Interval: --	Occurrences: --	Comments:	Infusion Reaction or Hypersensitivity Reaction - 
o Grade 1-Infusion Reaction or Hypersensitivity Reaction: Decrease infusion rate until recovery from the symptoms. If the infusion reaction happens after the end of infusion (EOI), increase monitoring of vital signs until the participant is symptoms free. Administer subsequent NIS793 infusion at the same rate. 
o Grade 2- Infusion Reaction or Hypersensitivity Reaction: Stop infusion immediately and keep line open. Follow institutional guidelines for the management and follow-up of infusion reaction. Restart infusion at 50% of previous rate under continuous observation. Ensure that there is a minimum observation period of 1 hour prior to restarting the infusion. If the AE recurs at the reinitiated slower rate of infusion, and despite oral pre-medication, permanently discontinue study treatment. 
o Grade 3 or Grade 4- Infusion Reaction or Hypersensitivity Reaction: Stop infusion immediately and keep line open. Follow institutional guidelines for the management and follow-up of infusion reaction. Provide supplemental oxygen, fluids, and other resuscitative measures as needed. Monitor vital signs (e.g. blood pressure, pulse, respiration, and temperature) every 15 ± 5 minutes until resolution.
		  	TREATMENT CONDITIONS 13	Interval: --	Occurrences: --	Comments:	Cytokine Release Syndrome (CRS) - 
o Grade 2: Stop infusion immediately and keep line open. Follow institutional guidelines for the management and follow-up of infusion reaction. Restart infusion at 50% of previous rate under continuous observation. Ensure that there is a minimum observation period of 1 hour prior to restarting the infusion. If the AE recurs at the reinitiated slower rate of infusion, and despite oral pre-medication, permanently discontinue study treatment. 
o Grade 3 or 4: Permanently discontinue study treatment. Follow-up CRS as per institutional guidelines.
		  	TREATMENT CONDITIONS 14	Interval: --	Occurrences: --	Comments:	Ocular (e.g. Conjunctivitis, Blepharitis, blurred vision) - 
o Grade 1: May continue study treatment. Consider ophthalmology consultation. 
o Grade 2: Ophthalmology consultation. Upon resolution to LESS than or EQUAL to Grade 1 consider resuming study treatment in consultation with ophthalmologist. 
o Grade 3: 
1. Interrupt study treatment. 
2. Ophthalmology consultation. 
3. Upon resolution to LESS than or EQUAL to Grade 1 consider resuming study treatment in consultation with ophthalmologist.
o Grade 4:  Permanently discontinue study treatment.
		  	TREATMENT CONDITIONS 15	Interval: --	Occurrences: --	Comments:	Cardiovascular - 
o Grade 2 or greater Myocarditis: Permanently discontinue study treatment. 
o Grade 2 Cardiac Valvulopathy and other Cardiac Toxicity: Interrupt study treatment. Repeat echocardiogram and assess cardiac function. Once resolved to Grade ? 1 or baseline, consider re-administration of treatment, if benefit outweighs the potential risk. 
o Grade 3> Cardiac Valvulopathy and other Cardiac Toxicity: Permanently discontinue study treatment.
		  	TREATMENT CONDITIONS 16	Interval: --	Occurrences: --	Comments:	Isolated AST and/or ALT Elevation - 
o Grade 3 AST or ALT >5.0 - 10.0 x ULN: Interrupt treatment. Repeat liver function tests (LFTs) within 48-72 hours, then monitor LFTs weekly until recovery to grade ?1 or to baseline. Then resume treatment at the same dose interval if resolved in LESS than or EQUAL to 14 days; if resolved in GREATER than 14 days, consider administration Q4W instead of Q2W. 
o Grade 3 AST or ALT >10.0 - 20.0 x ULN: Interrupt treatment. Repeat LFTs within 48-72 hours, then monitor LFTs weekly until recovery to grade LESS than or EQUAL to 1 or to baseline, then increase dosing interval for NIS793 from Q2W to Q4W. 
o Grade 4: AST or ALT (>20 x ULN): Permanently discontinue treatment.
		  	TREATMENT CONDITIONS 17	Interval: --	Occurrences: --	Comments:	With abnormal ALT/AST (up to grade 2 - </= 5.0 x ULN) at baseline - 
o ALT/AST > 2.0 x baseline AND > 5.0 x ULN: Interrupt treatment. Repeat LFTs within 48-72 hours, then monitor LFTs weekly until recovery to baseline; Then resume same dose interval if resolved in LESS than or EQUAL to 14 days; if resolved in GREATER than 14 days, increasing dosing from Q2W to Q4W. 
o ALT/AST > 3.0 x baseline AND >10 x ULN: Interrupt treatment. Repeat LFTs within 48-72 hours, then monitor weekly until resolved to baseline; then increase dosing interval from Q2W to Q4W. 
o AST or ALT >20 x ULN (grade 4): Permanently discontinue treatment.
		  	TREATMENT CONDITIONS 18	Interval: --	Occurrences: --	Comments:	Concomitant elevation of AST and/or ALT and total bilirubin with normal AST/ALT and bilirubin at baseline -
o Grade 2 ALT and/or AST elevation (>3.0 x ULN) with bilirubin > 2.0 x ULN (unless Gilbert's syndrome): Interrupt treatment. Assess if case is drug induced liver injury (DILI). If DILI confirmed, permanently discontinue study treatment. For additional information on follow-up of potential drug induced liver injury cases, refer to Section 6.5.5.1. If no DILI confirmed, interrupt treatment, treat the identified cause according to institutional guidelines. Repeat LFTs within 48-72 hours, then monitor weekly, until enzyme levels resolve to LESS than or EQUAL to grade 1 or baseline.  After recovery, re-administration of study treatment could be considered only if Investigator assesses benefit to outweigh the risk. Any decision regarding re-administration of study drugs and dose regimen should be discussed with the Sponsor.
		  	TREATMENT CONDITIONS 19	Interval: --	Occurrences: --	Comments:	With abnormal ALT/AST at baseline - 
o ALT or AST >3.0 x baseline OR ALT or AST >8.0 x ULN [whichever is lower] combined with total bilirubin >2.0 x baseline AND >2.0 x ULN:  Interrupt treatment. Assess if case is drug induced liver injury (DILI). If DILI confirmed, permanently discontinue study treatment. For additional information on follow-up of potential drug induced liver injury cases, refer to Section 6.5.5.1. If no DILI confirmed, interrupt treatment, treat the identified cause according to institutional guidelines. Repeat LFTs within 48-72 hours, then monitor weekly, until enzyme levels resolve to ?grade 1 or baseline.  After recovery, re-administration of study treatment could be considered only if Investigator assesses benefit to outweigh the risk. Any decision regarding re-administration of study drugs and dose regimen should be discussed with the Sponsor.
		  	TREATMENT CONDITIONS 20	Interval: --	Occurrences: --	Comments:	Isolated total bilirubin elevation - 
o Any elevation > ULN: Fractionate bilirubin, evaluate for cholestatic liver injury (e.g. by testing Alkaline Phosphatase (ALP)) or alternative causes of bilirubin elevation (e.g. disease progression [imaging]). Treat alternative causes according to institutional guidelines. 
o Grade 2 (>1.5 - 3.0 ULN): Repeat LFTs within 48-72 hours, then monitor LFTs weekly until resolution to LESS than or EQUAL to grade 1 or to baseline. If isolated bilirubin remains stable at Grade 2, continue treatment at the same dose regimen. 
o Grade 3 (>3.0 - 10 ULN): Interrupt treatment. Repeat LFTs within 48-72 hours, then monitor LFTs weekly until resolution to LESS than or EQUAL to Grade 1 or to baseline. If resolved in ? 14 days, maintain dose regimen; if not resolved in 14 days, permanently discontinue NIS793. (Please see footnote regarding alternative cause/s of bilirubin elevation). 
o Grade 4 (> 10 x ULN): See footnote*. Otherwise, permanently discontinue study treatment. If alternative cause/s is identified and managed, and bilirubin resolves to ? grade 1 or to baseline, resume treatment at the same dose regimen. *An isolated bilirubin elevation is not typical for DILI. Bilirubin can be elevated either as part of a "Hy's law" constellation with a preceding elevation of ALT/AST, or as part of a cholestatic reaction with simultaneous elevation of other cholestatic parameters (ALP, GGT). Isolated bilirubin can be seen in conjunction with drugs that inhibit bilirubin conjugation or excretion, but both scenarios do not typically represent liver injury. Alternative causes of bilirubin elevation should, therefore, be ruled out before basing dose modification decisions on bilirubin values alone.
		  	TREATMENT CONDITIONS 21	Interval: --	Occurrences: --	Comments:	Asymptomatic amylase and/or lipase elevation - 
o Grade 3, not associated with symptoms or clinical manifestations of pancreatitis: May continue study treatment. If levels do not resolve to LESS than or EQUAL to Grade 2 within LESS than or EQUAL to 14 days after the initial report, interrupt study treatment.  Upon resolution to ? Grade 2, consider resuming study treatment.
		  	TREATMENT CONDITIONS 22	Interval: --	Occurrences: --	Comments:	Renal / Serum Creatinine - 
o Grade 2:  Interrupt Study Treatment. Manage per institutional Practice. Upon resolution to LESS than Grade 1, consider resuming study treatment. 
o Grade 3 or Grade 4: Permanently Discontinue Study Treatment.
		  	TREATMENT CONDITIONS 23	Interval: --	Occurrences: --	Comments:	Hyperthyroidism - 
o Grade 2: Consider Continuing Study Treatment and Management according to institutional practice. 
o Grade 3: Interrupt study treatment. Upon resolution to Grade ? 1 with appropriate management, consider resuming study treatment without dose modification. 
o Grade 4: Must discontinue and manage according to local/institutional guidance.
		  	TREATMENT CONDITIONS 24	Interval: --	Occurrences: --	Comments:	Other Endocrine Disorders - 
o Grade 2 and Grade 3: Interrupt study treatment. Upon resolution to Grade LESS than or EQUAL to 1 with appropriate management, consider resuming study treatment.
		  	TREATMENT CONDITIONS 25	Interval: --	Occurrences: --	Comments:	Dermatology (rash) - 
o Grade 1: Continue study treatment. Consider topical steroids, antihistamines, topical emollients. 
o Grade 2: Consider interrupting study treatment. Topical or oral steroids, antihistamines. If study treatment is held and resolution to LESS than or EQUAL to Grade 1, resume study treatment. 
o Grade 3: Interrupt study treatment. Manage per institutional practice. After resolution to LESS than or EQUAL to Grade 1, consider resuming study treatment after consultation with dermatologist. 
o Grade 4 or Stevens-Johnson syndrome (SJS), or Lyell syndrome/toxic epidermal necrolysis (TEN): Permanently discontinue study treatment and manage according to local/institutional guidance.
		  	TREATMENT CONDITIONS 26	Interval: --	Occurrences: --	Comments:	Neutropenia - 
o Grade 3: Interrupt study treatment until resolved to LESS than or EQUAL to Grade 1 or baseline, then resume study medication. 
o Grade 4: Interrupt study treatment. If resolved in LESS than or EQUAL to 7 days, maintain study treatment.  

Febrile Neutropenia - 
o Grade 3: Interrupt study treatment. Upon resolution of fever and improvement of neutropenia to LESS than or EQUAL to Grade 1 or baseline, resume study treatment. 
o Grade 4: Permanently discontinue study treatment. 

Thrombocytopenia - 
o Grade 3: Interrupt study treatment. Upon resolution to ? Grade 2 or baseline, resume study treatment. For Grade 3 associated with major bleeding, permanently discontinue study treatment. 
o Grade 4: Permanently discontinue study treatment. 

Anemia - 
o Grade 3 or Grade 4: Interrupt study treatment. Upon resolution to LESS than or EQUAL to Grade 2 or baseline within LESS than or EQUAL to 7 days, resume study treatment.
		  	TREATMENT CONDITIONS 27	Interval: --	Occurrences: --	Comments:	Other laboratory adverse events, not specified elsewhere in table and not included in the consensus guidelines - 
o Grade 3 or Grade 4: Interrupt study treatment. Upon resolution to LESS than or EQUAL to Grade 1, resume study treatment without dose modification. Isolated Grade 4 electrolyte abnormalities not associated with clinical sequelae and corrected after appropriate management within 72 hours of their onset do not require discontinuation. In the case of Grade 4 electrolyte imbalances associated with clinical sequelae, or not resolved to LESS than or EQUAL to Grade 1 within 72 hours despite appropriate management, permanently discontinue study treatment. 

Other non-laboratory adverse events, not specified elsewhere in table and not included in the consensus guidelines:
o Grade 2: Consider study treatment interruption. Upon resolution to ? Grade 1, consider resuming study treatment. 
o Grade 3: Interrupt study treatment. Upon resolution to LESS than or EQUAL to Grade 1, resuming study treatment must be discussed with the relevant medical expert. 
o Grade 4: Permanently discontinue study treatment.
			Nursing Orders
  	ONC NURSING COMMUNICATION 60	Interval: --	Occurrences: --	Comments:	Concomitant Medications
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Prior Concomitant Procedures and significant non-drug therapies
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Calculate indirect bilirubin
		  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	PRO-CTCAE, FACT-GP5 (ePRO)
		  	ONC NURSING COMMUNICATION 63	Interval: --	Occurrences: --	Comments:	PROMIS-29 (ePRO) - Pain and Fatigue items
		  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	Actigraphy
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	Adverse Events
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Serious Adverse Events
		  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	Health Resource Utilization
			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
☑	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --	Comments:	As clinically indicated
		☑	T3, FREE	Interval: --	Occurrences: --	Comments:	As clinically indicated
		☑	T4, FREE	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
☑	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated
		☑	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
  	URIC ACID LEVEL	Interval: --	Occurrences: --			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Labs
  	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --			Labs
  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
☑	CREATININE CLEARANCE, URINE, 24 HOUR	Interval: --	Occurrences: --		☑	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --		☑	BILIRUBIN DIRECT	Interval: --	Occurrences: --		☑	AMYLASE LEVEL	Interval: --	Occurrences: --		☑	LIPASE LEVEL	Interval: --	Occurrences: --		☑	GGT	Interval: --	Occurrences: --		☑	HEMOGLOBIN A1C	Interval: --	Occurrences: --	Comments:	As clinically indicated
		☑	NABFERON IFN-B ANTIBODY - ATHENA	Interval: --	Occurrences: --	Comments:	Anytime when suspected Cytokine Release Syndrome Occurs
		☑	INTERLEUKIN 6	Interval: --	Occurrences: --	Comments:	Anytime when suspected Cytokine Release Syndrome Occurs
		☑	MISCELLANEOUS REFERRAL TEST	Interval: --	Occurrences: --	Comments:	Interleukin 1 - Anytime when suspected Cytokine Release Syndrome Occurs
		☑	TUMOR NECROSIS FACTOR - ALPHA	Interval: --	Occurrences: --	Comments:	Anytime when suspected Cytokine Release Syndrome Occurs. 
Perform ONLY at HMH and HMCL.
			Imaging
☑	CT HEAD W WO CONTRAST	Interval: --	Occurrences: --	Comments:	As clinically indicated. Or MRI
		☐	MRI BRAIN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	As clinically indicated. Or CT
		☑	CV ECHOCARDIOGRAM RESEARCH ONLY	Interval: --	Occurrences: --	Comments:	As clinically indicated.
		☑	NM BONE SCAN WHOLE BODY	Interval: --	Occurrences: --	Comments:	As clinically indicated.
		☑	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	If Clinically Indicated Localized bone CT scan, MRI or Xray.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mEq/L; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 28	Interval: --	Occurrences: --	Comments:	o ANC LESS than 1000; 
o Platelets LESS than 100,000; 
o Bilirubin GREATER than 1.6; 
o LFTs GREATER than 10 x ULN.
			Pre-Medications
  	ondansetron (ZOFRAN) IV 8 mg	Dose: 8 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to chemo.			Chemotherapy
  	NAB-PACLItaxel (ABRAXANE) chemo infusion 125 mg/m2 (Treatment Plan)	Dose: 125 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes		  	gemcitabine (GEMZAR) 1,000 mg/m2 in sodium chloride 0.9% 250 mL chemo IVPB	Dose: 1,000 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 60 Minutes	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	GEMCITABINE 200 MG/5.26 ML (38 MG/ML) INTRAVENOUS SOLUTION	Medications	1,000 mg/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	 	No	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	fexofenadine (ALLEGRA) tablet 180 mg	Dose: 180 mg	Route: oral	PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 15	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Line Flush
  	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Use with NIS793		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Do NOT administer with NIS793			Nursing Orders
  	dextrose 5% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open for NIS793		  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.  Do NOT administer with NIS793			Nursing Orders
  	TREATMENT CONDITIONS 12	Interval: --	Occurrences: --	Comments:	Infusion Reaction or Hypersensitivity Reaction - 
o Grade 1-Infusion Reaction or Hypersensitivity Reaction: Decrease infusion rate until recovery from the symptoms. If the infusion reaction happens after the end of infusion (EOI), increase monitoring of vital signs until the participant is symptoms free. Administer subsequent NIS793 infusion at the same rate. 
o Grade 2- Infusion Reaction or Hypersensitivity Reaction: Stop infusion immediately and keep line open. Follow institutional guidelines for the management and follow-up of infusion reaction. Restart infusion at 50% of previous rate under continuous observation. Ensure that there is a minimum observation period of 1 hour prior to restarting the infusion. If the AE recurs at the reinitiated slower rate of infusion, and despite oral pre-medication, permanently discontinue study treatment. 
o Grade 3 or Grade 4- Infusion Reaction or Hypersensitivity Reaction: Stop infusion immediately and keep line open. Follow institutional guidelines for the management and follow-up of infusion reaction. Provide supplemental oxygen, fluids, and other resuscitative measures as needed. Monitor vital signs (e.g. blood pressure, pulse, respiration, and temperature) every 15 ± 5 minutes until resolution.
		  	TREATMENT CONDITIONS 13	Interval: --	Occurrences: --	Comments:	Cytokine Release Syndrome (CRS) - 
o Grade 2: Stop infusion immediately and keep line open. Follow institutional guidelines for the management and follow-up of infusion reaction. Restart infusion at 50% of previous rate under continuous observation. Ensure that there is a minimum observation period of 1 hour prior to restarting the infusion. If the AE recurs at the reinitiated slower rate of infusion, and despite oral pre-medication, permanently discontinue study treatment. 
o Grade 3 or 4: Permanently discontinue study treatment. Follow-up CRS as per institutional guidelines.
		  	TREATMENT CONDITIONS 14	Interval: --	Occurrences: --	Comments:	Ocular (e.g. Conjunctivitis, Blepharitis, blurred vision) - 
o Grade 1: May continue study treatment. Consider ophthalmology consultation. 
o Grade 2: Ophthalmology consultation. Upon resolution to LESS than or EQUAL to Grade 1 consider resuming study treatment in consultation with ophthalmologist. 
o Grade 3: 
1. Interrupt study treatment. 
2. Ophthalmology consultation. 
3. Upon resolution to LESS than or EQUAL to Grade 1 consider resuming study treatment in consultation with ophthalmologist.
o Grade 4:  Permanently discontinue study treatment.
		  	TREATMENT CONDITIONS 15	Interval: --	Occurrences: --	Comments:	Cardiovascular - 
o Grade 2 or greater Myocarditis: Permanently discontinue study treatment. 
o Grade 2 Cardiac Valvulopathy and other Cardiac Toxicity: Interrupt study treatment. Repeat echocardiogram and assess cardiac function. Once resolved to Grade ? 1 or baseline, consider re-administration of treatment, if benefit outweighs the potential risk. 
o Grade 3> Cardiac Valvulopathy and other Cardiac Toxicity: Permanently discontinue study treatment.
		  	TREATMENT CONDITIONS 16	Interval: --	Occurrences: --	Comments:	Isolated AST and/or ALT Elevation - 
o Grade 3 AST or ALT >5.0 - 10.0 x ULN: Interrupt treatment. Repeat liver function tests (LFTs) within 48-72 hours, then monitor LFTs weekly until recovery to grade ?1 or to baseline. Then resume treatment at the same dose interval if resolved in LESS than or EQUAL to 14 days; if resolved in GREATER than 14 days, consider administration Q4W instead of Q2W. 
o Grade 3 AST or ALT >10.0 - 20.0 x ULN: Interrupt treatment. Repeat LFTs within 48-72 hours, then monitor LFTs weekly until recovery to grade LESS than or EQUAL to 1 or to baseline, then increase dosing interval for NIS793 from Q2W to Q4W. 
o Grade 4: AST or ALT (>20 x ULN): Permanently discontinue treatment.
		  	TREATMENT CONDITIONS 17	Interval: --	Occurrences: --	Comments:	With abnormal ALT/AST (up to grade 2 - </= 5.0 x ULN) at baseline - 
o ALT/AST > 2.0 x baseline AND > 5.0 x ULN: Interrupt treatment. Repeat LFTs within 48-72 hours, then monitor LFTs weekly until recovery to baseline; Then resume same dose interval if resolved in LESS than or EQUAL to 14 days; if resolved in GREATER than 14 days, increasing dosing from Q2W to Q4W. 
o ALT/AST > 3.0 x baseline AND >10 x ULN: Interrupt treatment. Repeat LFTs within 48-72 hours, then monitor weekly until resolved to baseline; then increase dosing interval from Q2W to Q4W. 
o AST or ALT >20 x ULN (grade 4): Permanently discontinue treatment.
		  	TREATMENT CONDITIONS 18	Interval: --	Occurrences: --	Comments:	Concomitant elevation of AST and/or ALT and total bilirubin with normal AST/ALT and bilirubin at baseline -
o Grade 2 ALT and/or AST elevation (>3.0 x ULN) with bilirubin > 2.0 x ULN (unless Gilbert's syndrome): Interrupt treatment. Assess if case is drug induced liver injury (DILI). If DILI confirmed, permanently discontinue study treatment. For additional information on follow-up of potential drug induced liver injury cases, refer to Section 6.5.5.1. If no DILI confirmed, interrupt treatment, treat the identified cause according to institutional guidelines. Repeat LFTs within 48-72 hours, then monitor weekly, until enzyme levels resolve to LESS than or EQUAL to grade 1 or baseline.  After recovery, re-administration of study treatment could be considered only if Investigator assesses benefit to outweigh the risk. Any decision regarding re-administration of study drugs and dose regimen should be discussed with the Sponsor.
		  	TREATMENT CONDITIONS 19	Interval: --	Occurrences: --	Comments:	With abnormal ALT/AST at baseline - 
o ALT or AST >3.0 x baseline OR ALT or AST >8.0 x ULN [whichever is lower] combined with total bilirubin >2.0 x baseline AND >2.0 x ULN:  Interrupt treatment. Assess if case is drug induced liver injury (DILI). If DILI confirmed, permanently discontinue study treatment. For additional information on follow-up of potential drug induced liver injury cases, refer to Section 6.5.5.1. If no DILI confirmed, interrupt treatment, treat the identified cause according to institutional guidelines. Repeat LFTs within 48-72 hours, then monitor weekly, until enzyme levels resolve to ?grade 1 or baseline.  After recovery, re-administration of study treatment could be considered only if Investigator assesses benefit to outweigh the risk. Any decision regarding re-administration of study drugs and dose regimen should be discussed with the Sponsor.
		  	TREATMENT CONDITIONS 20	Interval: --	Occurrences: --	Comments:	Isolated total bilirubin elevation - 
o Any elevation > ULN: Fractionate bilirubin, evaluate for cholestatic liver injury (e.g. by testing Alkaline Phosphatase (ALP)) or alternative causes of bilirubin elevation (e.g. disease progression [imaging]). Treat alternative causes according to institutional guidelines. 
o Grade 2 (>1.5 - 3.0 ULN): Repeat LFTs within 48-72 hours, then monitor LFTs weekly until resolution to LESS than or EQUAL to grade 1 or to baseline. If isolated bilirubin remains stable at Grade 2, continue treatment at the same dose regimen. 
o Grade 3 (>3.0 - 10 ULN): Interrupt treatment. Repeat LFTs within 48-72 hours, then monitor LFTs weekly until resolution to LESS than or EQUAL to Grade 1 or to baseline. If resolved in ? 14 days, maintain dose regimen; if not resolved in 14 days, permanently discontinue NIS793. (Please see footnote regarding alternative cause/s of bilirubin elevation). 
o Grade 4 (> 10 x ULN): See footnote*. Otherwise, permanently discontinue study treatment. If alternative cause/s is identified and managed, and bilirubin resolves to ? grade 1 or to baseline, resume treatment at the same dose regimen. *An isolated bilirubin elevation is not typical for DILI. Bilirubin can be elevated either as part of a "Hy's law" constellation with a preceding elevation of ALT/AST, or as part of a cholestatic reaction with simultaneous elevation of other cholestatic parameters (ALP, GGT). Isolated bilirubin can be seen in conjunction with drugs that inhibit bilirubin conjugation or excretion, but both scenarios do not typically represent liver injury. Alternative causes of bilirubin elevation should, therefore, be ruled out before basing dose modification decisions on bilirubin values alone.
		  	TREATMENT CONDITIONS 21	Interval: --	Occurrences: --	Comments:	Asymptomatic amylase and/or lipase elevation - 
o Grade 3, not associated with symptoms or clinical manifestations of pancreatitis: May continue study treatment. If levels do not resolve to LESS than or EQUAL to Grade 2 within LESS than or EQUAL to 14 days after the initial report, interrupt study treatment.  Upon resolution to ? Grade 2, consider resuming study treatment.
		  	TREATMENT CONDITIONS 22	Interval: --	Occurrences: --	Comments:	Renal / Serum Creatinine - 
o Grade 2:  Interrupt Study Treatment. Manage per institutional Practice. Upon resolution to LESS than Grade 1, consider resuming study treatment. 
o Grade 3 or Grade 4: Permanently Discontinue Study Treatment.
		  	TREATMENT CONDITIONS 23	Interval: --	Occurrences: --	Comments:	Hyperthyroidism - 
o Grade 2: Consider Continuing Study Treatment and Management according to institutional practice. 
o Grade 3: Interrupt study treatment. Upon resolution to Grade ? 1 with appropriate management, consider resuming study treatment without dose modification. 
o Grade 4: Must discontinue and manage according to local/institutional guidance.
		  	TREATMENT CONDITIONS 24	Interval: --	Occurrences: --	Comments:	Other Endocrine Disorders - 
o Grade 2 and Grade 3: Interrupt study treatment. Upon resolution to Grade LESS than or EQUAL to 1 with appropriate management, consider resuming study treatment.
		  	TREATMENT CONDITIONS 25	Interval: --	Occurrences: --	Comments:	Dermatology (rash) - 
o Grade 1: Continue study treatment. Consider topical steroids, antihistamines, topical emollients. 
o Grade 2: Consider interrupting study treatment. Topical or oral steroids, antihistamines. If study treatment is held and resolution to LESS than or EQUAL to Grade 1, resume study treatment. 
o Grade 3: Interrupt study treatment. Manage per institutional practice. After resolution to LESS than or EQUAL to Grade 1, consider resuming study treatment after consultation with dermatologist. 
o Grade 4 or Stevens-Johnson syndrome (SJS), or Lyell syndrome/toxic epidermal necrolysis (TEN): Permanently discontinue study treatment and manage according to local/institutional guidance.
		  	TREATMENT CONDITIONS 26	Interval: --	Occurrences: --	Comments:	Neutropenia - 
o Grade 3: Interrupt study treatment until resolved to LESS than or EQUAL to Grade 1 or baseline, then resume study medication. 
o Grade 4: Interrupt study treatment. If resolved in LESS than or EQUAL to 7 days, maintain study treatment.  

Febrile Neutropenia - 
o Grade 3: Interrupt study treatment. Upon resolution of fever and improvement of neutropenia to LESS than or EQUAL to Grade 1 or baseline, resume study treatment. 
o Grade 4: Permanently discontinue study treatment. 

Thrombocytopenia - 
o Grade 3: Interrupt study treatment. Upon resolution to ? Grade 2 or baseline, resume study treatment. For Grade 3 associated with major bleeding, permanently discontinue study treatment. 
o Grade 4: Permanently discontinue study treatment. 

Anemia - 
o Grade 3 or Grade 4: Interrupt study treatment. Upon resolution to LESS than or EQUAL to Grade 2 or baseline within LESS than or EQUAL to 7 days, resume study treatment.
		  	TREATMENT CONDITIONS 27	Interval: --	Occurrences: --	Comments:	Other laboratory adverse events, not specified elsewhere in table and not included in the consensus guidelines - 
o Grade 3 or Grade 4: Interrupt study treatment. Upon resolution to LESS than or EQUAL to Grade 1, resume study treatment without dose modification. Isolated Grade 4 electrolyte abnormalities not associated with clinical sequelae and corrected after appropriate management within 72 hours of their onset do not require discontinuation. In the case of Grade 4 electrolyte imbalances associated with clinical sequelae, or not resolved to LESS than or EQUAL to Grade 1 within 72 hours despite appropriate management, permanently discontinue study treatment. 

Other non-laboratory adverse events, not specified elsewhere in table and not included in the consensus guidelines:
o Grade 2: Consider study treatment interruption. Upon resolution to ? Grade 1, consider resuming study treatment. 
o Grade 3: Interrupt study treatment. Upon resolution to LESS than or EQUAL to Grade 1, resuming study treatment must be discussed with the relevant medical expert. 
o Grade 4: Permanently discontinue study treatment.
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Dose Modifications and Dose Interruption for NIS793: 
No Dose Reductions are allowed for NIS793: Increasing the dosing interval from Q2W to Q4W is allowed under circumstances described in Table 6-5. If NIS793 is interrupted or delayed for GREATER than 8 weeks due to toxicity that is suspected to be related to treatment, study treatment should be permanently discontinued.
			Nursing Orders
  	ONC NURSING COMMUNICATION 60	Interval: --	Occurrences: --	Comments:	Concomitant Medications
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Prior Concomitant Procedures and significant non-drug therapies
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	Physical Examination
		  	ONC NURSING COMMUNICATION 62	Interval: --	Occurrences: --	Comments:	ECOG
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Calculate indirect bilirubin
		  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	PRO-CTCAE, FACT-GP5 (ePRO)
		  	ONC NURSING COMMUNICATION 63	Interval: --	Occurrences: --	Comments:	PROMIS-29 (ePRO) - Pain and Fatigue items
		  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	Actigraphy
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	Adverse Events
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Serious Adverse Events
		  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	Health Resource Utilization
			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
☑	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --	Comments:	As clinically indicated
		☑	T3, FREE	Interval: --	Occurrences: --	Comments:	As clinically indicated
		☑	T4, FREE	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
☑	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated
		☑	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
  	URIC ACID LEVEL	Interval: --	Occurrences: --			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Labs
  	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --			Labs
  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
☑	CREATININE CLEARANCE, URINE, 24 HOUR	Interval: --	Occurrences: --		☑	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --		☑	BILIRUBIN DIRECT	Interval: --	Occurrences: --		☑	AMYLASE LEVEL	Interval: --	Occurrences: --		☑	LIPASE LEVEL	Interval: --	Occurrences: --		☑	GGT	Interval: --	Occurrences: --		☑	HEMOGLOBIN A1C	Interval: --	Occurrences: --	Comments:	As clinically indicated
		☑	NABFERON IFN-B ANTIBODY - ATHENA	Interval: --	Occurrences: --	Comments:	Anytime when suspected Cytokine Release Syndrome Occurs
		☑	INTERLEUKIN 6	Interval: --	Occurrences: --	Comments:	Anytime when suspected Cytokine Release Syndrome Occurs
		☑	MISCELLANEOUS REFERRAL TEST	Interval: --	Occurrences: --	Comments:	Interleukin 1 - Anytime when suspected Cytokine Release Syndrome Occurs
		☑	TUMOR NECROSIS FACTOR - ALPHA	Interval: --	Occurrences: --	Comments:	Anytime when suspected Cytokine Release Syndrome Occurs. 
Perform ONLY at HMH and HMCL.
			Imaging
☑	CT HEAD W WO CONTRAST	Interval: --	Occurrences: --	Comments:	As clinically indicated. Or MRI
		☐	MRI BRAIN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	As clinically indicated. Or CT
		☑	CV ECHOCARDIOGRAM RESEARCH ONLY	Interval: --	Occurrences: --	Comments:	As clinically indicated.
		☑	NM BONE SCAN WHOLE BODY	Interval: --	Occurrences: --	Comments:	As clinically indicated.
		☑	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	If Clinically Indicated Localized bone CT scan, MRI or Xray.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mEq/L; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 28	Interval: --	Occurrences: --	Comments:	o ANC LESS than 1000; 
o Platelets LESS than 100,000; 
o Bilirubin GREATER than 1.6; 
o LFTs GREATER than 10 x ULN.
			Pre-Medications
  	ondansetron (ZOFRAN) IV 8 mg	Dose: 8 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to chemo.			Nursing Orders
  	ONC NURSING COMMUNICATION 68	Interval: --	Occurrences: --	Comments:	Infusion must take place in a facility with appropriate resuscitation equipment available at the bedside, and a physician readily available during the period of drug administration.
		  	ONC NURSING COMMUNICATION 69	Interval: --	Occurrences: --	Comments:	Participants should be closely observed for potential infusion-related reactions including rigors, chills, wheezing, pruritus, flushing, rash, hypotension, hypoxemia, and fever, and vital signs monitored more frequently if clinically indicated, during and for at least 2 hours after the first two NIS793 infusions. The same may apply for subsequent NIS793 infusions if medically indicated. Participants should notify study personnel if symptoms of infusion reaction occur after any NIS793 infusion.
			Chemotherapy
  	INV-NIS793 or placebo (CNIS793B12301 daNIS-2/Pro00032923/Abdelrahim) 2,100 mg in dextrose 5% 100 mL	Dose: 2,100 mg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Protect from light.  Administer intravenously using a 0.2 micron inline filter over 30 minutes.  Flush only with D5W!
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.

	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-NIS793 OR PLACEBO 1050MG/10ML INTRAVENOUS SOLN. (CNIS793B12301 DANIS-2/PRO00032923/ABDELRAHIM)	Medications	2,100 mg	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	80 mL	Yes	Yes			  	NAB-PACLItaxel (ABRAXANE) chemo infusion 125 mg/m2 (Treatment Plan)	Dose: 125 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 3 Hours		  	gemcitabine (GEMZAR) 1,000 mg/m2 in sodium chloride 0.9% 250 mL chemo IVPB	Dose: 1,000 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 3.5 Hours	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	GEMCITABINE 200 MG/5.26 ML (38 MG/ML) INTRAVENOUS SOLUTION	Medications	1,000 mg/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	 	No	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	fexofenadine (ALLEGRA) tablet 180 mg	Dose: 180 mg	Route: oral	PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 4	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Line Flush
  	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Use with NIS793		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Do NOT administer with NIS793			Nursing Orders
  	dextrose 5% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open for NIS793		  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.  Do NOT administer with NIS793			Nursing Orders
  	TREATMENT CONDITIONS 12	Interval: --	Occurrences: --	Comments:	Infusion Reaction or Hypersensitivity Reaction - 
o Grade 1-Infusion Reaction or Hypersensitivity Reaction: Decrease infusion rate until recovery from the symptoms. If the infusion reaction happens after the end of infusion (EOI), increase monitoring of vital signs until the participant is symptoms free. Administer subsequent NIS793 infusion at the same rate. 
o Grade 2- Infusion Reaction or Hypersensitivity Reaction: Stop infusion immediately and keep line open. Follow institutional guidelines for the management and follow-up of infusion reaction. Restart infusion at 50% of previous rate under continuous observation. Ensure that there is a minimum observation period of 1 hour prior to restarting the infusion. If the AE recurs at the reinitiated slower rate of infusion, and despite oral pre-medication, permanently discontinue study treatment. 
o Grade 3 or Grade 4- Infusion Reaction or Hypersensitivity Reaction: Stop infusion immediately and keep line open. Follow institutional guidelines for the management and follow-up of infusion reaction. Provide supplemental oxygen, fluids, and other resuscitative measures as needed. Monitor vital signs (e.g. blood pressure, pulse, respiration, and temperature) every 15 ± 5 minutes until resolution.
		  	TREATMENT CONDITIONS 13	Interval: --	Occurrences: --	Comments:	Cytokine Release Syndrome (CRS) - 
o Grade 2: Stop infusion immediately and keep line open. Follow institutional guidelines for the management and follow-up of infusion reaction. Restart infusion at 50% of previous rate under continuous observation. Ensure that there is a minimum observation period of 1 hour prior to restarting the infusion. If the AE recurs at the reinitiated slower rate of infusion, and despite oral pre-medication, permanently discontinue study treatment. 
o Grade 3 or 4: Permanently discontinue study treatment. Follow-up CRS as per institutional guidelines.
		  	TREATMENT CONDITIONS 14	Interval: --	Occurrences: --	Comments:	Ocular (e.g. Conjunctivitis, Blepharitis, blurred vision) - 
o Grade 1: May continue study treatment. Consider ophthalmology consultation. 
o Grade 2: Ophthalmology consultation. Upon resolution to LESS than or EQUAL to Grade 1 consider resuming study treatment in consultation with ophthalmologist. 
o Grade 3: 
1. Interrupt study treatment. 
2. Ophthalmology consultation. 
3. Upon resolution to LESS than or EQUAL to Grade 1 consider resuming study treatment in consultation with ophthalmologist.
o Grade 4:  Permanently discontinue study treatment.
		  	TREATMENT CONDITIONS 15	Interval: --	Occurrences: --	Comments:	Cardiovascular - 
o Grade 2 or greater Myocarditis: Permanently discontinue study treatment. 
o Grade 2 Cardiac Valvulopathy and other Cardiac Toxicity: Interrupt study treatment. Repeat echocardiogram and assess cardiac function. Once resolved to Grade ? 1 or baseline, consider re-administration of treatment, if benefit outweighs the potential risk. 
o Grade 3> Cardiac Valvulopathy and other Cardiac Toxicity: Permanently discontinue study treatment.
		  	TREATMENT CONDITIONS 16	Interval: --	Occurrences: --	Comments:	Isolated AST and/or ALT Elevation - 
o Grade 3 AST or ALT >5.0 - 10.0 x ULN: Interrupt treatment. Repeat liver function tests (LFTs) within 48-72 hours, then monitor LFTs weekly until recovery to grade ?1 or to baseline. Then resume treatment at the same dose interval if resolved in LESS than or EQUAL to 14 days; if resolved in GREATER than 14 days, consider administration Q4W instead of Q2W. 
o Grade 3 AST or ALT >10.0 - 20.0 x ULN: Interrupt treatment. Repeat LFTs within 48-72 hours, then monitor LFTs weekly until recovery to grade LESS than or EQUAL to 1 or to baseline, then increase dosing interval for NIS793 from Q2W to Q4W. 
o Grade 4: AST or ALT (>20 x ULN): Permanently discontinue treatment.
		  	TREATMENT CONDITIONS 17	Interval: --	Occurrences: --	Comments:	With abnormal ALT/AST (up to grade 2 - </= 5.0 x ULN) at baseline - 
o ALT/AST > 2.0 x baseline AND > 5.0 x ULN: Interrupt treatment. Repeat LFTs within 48-72 hours, then monitor LFTs weekly until recovery to baseline; Then resume same dose interval if resolved in LESS than or EQUAL to 14 days; if resolved in GREATER than 14 days, increasing dosing from Q2W to Q4W. 
o ALT/AST > 3.0 x baseline AND >10 x ULN: Interrupt treatment. Repeat LFTs within 48-72 hours, then monitor weekly until resolved to baseline; then increase dosing interval from Q2W to Q4W. 
o AST or ALT >20 x ULN (grade 4): Permanently discontinue treatment.
		  	TREATMENT CONDITIONS 18	Interval: --	Occurrences: --	Comments:	Concomitant elevation of AST and/or ALT and total bilirubin with normal AST/ALT and bilirubin at baseline -
o Grade 2 ALT and/or AST elevation (>3.0 x ULN) with bilirubin > 2.0 x ULN (unless Gilbert's syndrome): Interrupt treatment. Assess if case is drug induced liver injury (DILI). If DILI confirmed, permanently discontinue study treatment. For additional information on follow-up of potential drug induced liver injury cases, refer to Section 6.5.5.1. If no DILI confirmed, interrupt treatment, treat the identified cause according to institutional guidelines. Repeat LFTs within 48-72 hours, then monitor weekly, until enzyme levels resolve to LESS than or EQUAL to grade 1 or baseline.  After recovery, re-administration of study treatment could be considered only if Investigator assesses benefit to outweigh the risk. Any decision regarding re-administration of study drugs and dose regimen should be discussed with the Sponsor.
		  	TREATMENT CONDITIONS 19	Interval: --	Occurrences: --	Comments:	With abnormal ALT/AST at baseline - 
o ALT or AST >3.0 x baseline OR ALT or AST >8.0 x ULN [whichever is lower] combined with total bilirubin >2.0 x baseline AND >2.0 x ULN:  Interrupt treatment. Assess if case is drug induced liver injury (DILI). If DILI confirmed, permanently discontinue study treatment. For additional information on follow-up of potential drug induced liver injury cases, refer to Section 6.5.5.1. If no DILI confirmed, interrupt treatment, treat the identified cause according to institutional guidelines. Repeat LFTs within 48-72 hours, then monitor weekly, until enzyme levels resolve to ?grade 1 or baseline.  After recovery, re-administration of study treatment could be considered only if Investigator assesses benefit to outweigh the risk. Any decision regarding re-administration of study drugs and dose regimen should be discussed with the Sponsor.
		  	TREATMENT CONDITIONS 20	Interval: --	Occurrences: --	Comments:	Isolated total bilirubin elevation - 
o Any elevation > ULN: Fractionate bilirubin, evaluate for cholestatic liver injury (e.g. by testing Alkaline Phosphatase (ALP)) or alternative causes of bilirubin elevation (e.g. disease progression [imaging]). Treat alternative causes according to institutional guidelines. 
o Grade 2 (>1.5 - 3.0 ULN): Repeat LFTs within 48-72 hours, then monitor LFTs weekly until resolution to LESS than or EQUAL to grade 1 or to baseline. If isolated bilirubin remains stable at Grade 2, continue treatment at the same dose regimen. 
o Grade 3 (>3.0 - 10 ULN): Interrupt treatment. Repeat LFTs within 48-72 hours, then monitor LFTs weekly until resolution to LESS than or EQUAL to Grade 1 or to baseline. If resolved in ? 14 days, maintain dose regimen; if not resolved in 14 days, permanently discontinue NIS793. (Please see footnote regarding alternative cause/s of bilirubin elevation). 
o Grade 4 (> 10 x ULN): See footnote*. Otherwise, permanently discontinue study treatment. If alternative cause/s is identified and managed, and bilirubin resolves to ? grade 1 or to baseline, resume treatment at the same dose regimen. *An isolated bilirubin elevation is not typical for DILI. Bilirubin can be elevated either as part of a "Hy's law" constellation with a preceding elevation of ALT/AST, or as part of a cholestatic reaction with simultaneous elevation of other cholestatic parameters (ALP, GGT). Isolated bilirubin can be seen in conjunction with drugs that inhibit bilirubin conjugation or excretion, but both scenarios do not typically represent liver injury. Alternative causes of bilirubin elevation should, therefore, be ruled out before basing dose modification decisions on bilirubin values alone.
		  	TREATMENT CONDITIONS 21	Interval: --	Occurrences: --	Comments:	Asymptomatic amylase and/or lipase elevation - 
o Grade 3, not associated with symptoms or clinical manifestations of pancreatitis: May continue study treatment. If levels do not resolve to LESS than or EQUAL to Grade 2 within LESS than or EQUAL to 14 days after the initial report, interrupt study treatment.  Upon resolution to ? Grade 2, consider resuming study treatment.
		  	TREATMENT CONDITIONS 22	Interval: --	Occurrences: --	Comments:	Renal / Serum Creatinine - 
o Grade 2:  Interrupt Study Treatment. Manage per institutional Practice. Upon resolution to LESS than Grade 1, consider resuming study treatment. 
o Grade 3 or Grade 4: Permanently Discontinue Study Treatment.
		  	TREATMENT CONDITIONS 23	Interval: --	Occurrences: --	Comments:	Hyperthyroidism - 
o Grade 2: Consider Continuing Study Treatment and Management according to institutional practice. 
o Grade 3: Interrupt study treatment. Upon resolution to Grade ? 1 with appropriate management, consider resuming study treatment without dose modification. 
o Grade 4: Must discontinue and manage according to local/institutional guidance.
		  	TREATMENT CONDITIONS 24	Interval: --	Occurrences: --	Comments:	Other Endocrine Disorders - 
o Grade 2 and Grade 3: Interrupt study treatment. Upon resolution to Grade LESS than or EQUAL to 1 with appropriate management, consider resuming study treatment.
		  	TREATMENT CONDITIONS 25	Interval: --	Occurrences: --	Comments:	Dermatology (rash) - 
o Grade 1: Continue study treatment. Consider topical steroids, antihistamines, topical emollients. 
o Grade 2: Consider interrupting study treatment. Topical or oral steroids, antihistamines. If study treatment is held and resolution to LESS than or EQUAL to Grade 1, resume study treatment. 
o Grade 3: Interrupt study treatment. Manage per institutional practice. After resolution to LESS than or EQUAL to Grade 1, consider resuming study treatment after consultation with dermatologist. 
o Grade 4 or Stevens-Johnson syndrome (SJS), or Lyell syndrome/toxic epidermal necrolysis (TEN): Permanently discontinue study treatment and manage according to local/institutional guidance.
		  	TREATMENT CONDITIONS 26	Interval: --	Occurrences: --	Comments:	Neutropenia - 
o Grade 3: Interrupt study treatment until resolved to LESS than or EQUAL to Grade 1 or baseline, then resume study medication. 
o Grade 4: Interrupt study treatment. If resolved in LESS than or EQUAL to 7 days, maintain study treatment.  

Febrile Neutropenia - 
o Grade 3: Interrupt study treatment. Upon resolution of fever and improvement of neutropenia to LESS than or EQUAL to Grade 1 or baseline, resume study treatment. 
o Grade 4: Permanently discontinue study treatment. 

Thrombocytopenia - 
o Grade 3: Interrupt study treatment. Upon resolution to ? Grade 2 or baseline, resume study treatment. For Grade 3 associated with major bleeding, permanently discontinue study treatment. 
o Grade 4: Permanently discontinue study treatment. 

Anemia - 
o Grade 3 or Grade 4: Interrupt study treatment. Upon resolution to LESS than or EQUAL to Grade 2 or baseline within LESS than or EQUAL to 7 days, resume study treatment.
		  	TREATMENT CONDITIONS 27	Interval: --	Occurrences: --	Comments:	Other laboratory adverse events, not specified elsewhere in table and not included in the consensus guidelines - 
o Grade 3 or Grade 4: Interrupt study treatment. Upon resolution to LESS than or EQUAL to Grade 1, resume study treatment without dose modification. Isolated Grade 4 electrolyte abnormalities not associated with clinical sequelae and corrected after appropriate management within 72 hours of their onset do not require discontinuation. In the case of Grade 4 electrolyte imbalances associated with clinical sequelae, or not resolved to LESS than or EQUAL to Grade 1 within 72 hours despite appropriate management, permanently discontinue study treatment. 

Other non-laboratory adverse events, not specified elsewhere in table and not included in the consensus guidelines:
o Grade 2: Consider study treatment interruption. Upon resolution to ? Grade 1, consider resuming study treatment. 
o Grade 3: Interrupt study treatment. Upon resolution to LESS than or EQUAL to Grade 1, resuming study treatment must be discussed with the relevant medical expert. 
o Grade 4: Permanently discontinue study treatment.
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Dose Modifications and Dose Interruption for NIS793: 
No Dose Reductions are allowed for NIS793: Increasing the dosing interval from Q2W to Q4W is allowed under circumstances described in Table 6-5. If NIS793 is interrupted or delayed for GREATER than 8 weeks due to toxicity that is suspected to be related to treatment, study treatment should be permanently discontinued.
			Nursing Orders
  	ONC NURSING COMMUNICATION 60	Interval: --	Occurrences: --	Comments:	Concomitant Medications
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Prior Concomitant Procedures and significant non-drug therapies
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	Physical Examination
		  	ONC NURSING COMMUNICATION 62	Interval: --	Occurrences: --	Comments:	ECOG
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Calculate indirect bilirubin
		  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	PRO-CTCAE, FACT-GP5 (ePRO)
		  	ONC NURSING COMMUNICATION 63	Interval: --	Occurrences: --	Comments:	PROMIS-29 (ePRO) - Pain and Fatigue items
		  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	Actigraphy
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	Adverse Events
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Serious Adverse Events
		  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	Health Resource Utilization
			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
☑	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --	Comments:	As clinically indicated
		☑	T3, FREE	Interval: --	Occurrences: --	Comments:	As clinically indicated
		☑	T4, FREE	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
☑	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated
		☑	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
  	URIC ACID LEVEL	Interval: --	Occurrences: --			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Labs
  	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --			Labs
  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --			Labs
☑	CREATININE CLEARANCE, URINE, 24 HOUR	Interval: --	Occurrences: --		☑	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --		☑	BILIRUBIN DIRECT	Interval: --	Occurrences: --		☑	AMYLASE LEVEL	Interval: --	Occurrences: --		☑	LIPASE LEVEL	Interval: --	Occurrences: --		☑	GGT	Interval: --	Occurrences: --		☑	HEMOGLOBIN A1C	Interval: --	Occurrences: --	Comments:	As clinically indicated
		☑	NABFERON IFN-B ANTIBODY - ATHENA	Interval: --	Occurrences: --	Comments:	Anytime when suspected Cytokine Release Syndrome Occurs
		☑	INTERLEUKIN 6	Interval: --	Occurrences: --	Comments:	Anytime when suspected Cytokine Release Syndrome Occurs
		☑	MISCELLANEOUS REFERRAL TEST	Interval: --	Occurrences: --	Comments:	Interleukin 1 - Anytime when suspected Cytokine Release Syndrome Occurs
		☑	TUMOR NECROSIS FACTOR - ALPHA	Interval: --	Occurrences: --	Comments:	Anytime when suspected Cytokine Release Syndrome Occurs. 
Perform ONLY at HMH and HMCL.
			Imaging
☑	CT HEAD W WO CONTRAST	Interval: --	Occurrences: --	Comments:	As clinically indicated. Or MRI
		☐	MRI BRAIN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	As clinically indicated. Or CT
		☑	CV ECHOCARDIOGRAM RESEARCH ONLY	Interval: --	Occurrences: --	Comments:	As clinically indicated.
		☑	NM BONE SCAN WHOLE BODY	Interval: --	Occurrences: --	Comments:	As clinically indicated.
		☑	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	If Clinically Indicated Localized bone CT scan, MRI or Xray.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mEq/L; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 28	Interval: --	Occurrences: --	Comments:	o ANC LESS than 1000; 
o Platelets LESS than 100,000; 
o Bilirubin GREATER than 1.6; 
o LFTs GREATER than 10 x ULN.
			Pre-Medications
  	ondansetron (ZOFRAN) IV 8 mg	Dose: 8 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to chemo.			Nursing Orders
  	ONC NURSING COMMUNICATION 68	Interval: --	Occurrences: --	Comments:	Infusion must take place in a facility with appropriate resuscitation equipment available at the bedside, and a physician readily available during the period of drug administration.
		  	ONC NURSING COMMUNICATION 69	Interval: --	Occurrences: --	Comments:	Participants should be closely observed for potential infusion-related reactions including rigors, chills, wheezing, pruritus, flushing, rash, hypotension, hypoxemia, and fever, and vital signs monitored more frequently if clinically indicated, during and for at least 2 hours after the first two NIS793 infusions. The same may apply for subsequent NIS793 infusions if medically indicated. Participants should notify study personnel if symptoms of infusion reaction occur after any NIS793 infusion.
			Chemotherapy
  	INV-NIS793 or placebo (CNIS793B12301 daNIS-2/Pro00032923/Abdelrahim) 2,100 mg in dextrose 5% 100 mL	Dose: 2,100 mg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Protect from light.  Administer intravenously using a 0.2 micron inline filter over 30 minutes.  Flush only with D5W!
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.

	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-NIS793 OR PLACEBO 1050MG/10ML INTRAVENOUS SOLN. (CNIS793B12301 DANIS-2/PRO00032923/ABDELRAHIM)	Medications	2,100 mg	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	80 mL	Yes	Yes			  	NAB-PACLItaxel (ABRAXANE) chemo infusion 125 mg/m2 (Treatment Plan)	Dose: 125 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 3 Hours		  	gemcitabine (GEMZAR) 1,000 mg/m2 in sodium chloride 0.9% 250 mL chemo IVPB	Dose: 1,000 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 3.5 Hours	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	GEMCITABINE 200 MG/5.26 ML (38 MG/ML) INTRAVENOUS SOLUTION	Medications	1,000 mg/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	 	No	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	fexofenadine (ALLEGRA) tablet 180 mg	Dose: 180 mg	Route: oral	PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 8	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Line Flush
  	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Nursing Orders
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Nursing Orders
  	TREATMENT CONDITIONS 12	Interval: --	Occurrences: --	Comments:	Infusion Reaction or Hypersensitivity Reaction - 
o Grade 1-Infusion Reaction or Hypersensitivity Reaction: Decrease infusion rate until recovery from the symptoms. If the infusion reaction happens after the end of infusion (EOI), increase monitoring of vital signs until the participant is symptoms free. Administer subsequent NIS793 infusion at the same rate. 
o Grade 2- Infusion Reaction or Hypersensitivity Reaction: Stop infusion immediately and keep line open. Follow institutional guidelines for the management and follow-up of infusion reaction. Restart infusion at 50% of previous rate under continuous observation. Ensure that there is a minimum observation period of 1 hour prior to restarting the infusion. If the AE recurs at the reinitiated slower rate of infusion, and despite oral pre-medication, permanently discontinue study treatment. 
o Grade 3 or Grade 4- Infusion Reaction or Hypersensitivity Reaction: Stop infusion immediately and keep line open. Follow institutional guidelines for the management and follow-up of infusion reaction. Provide supplemental oxygen, fluids, and other resuscitative measures as needed. Monitor vital signs (e.g. blood pressure, pulse, respiration, and temperature) every 15 ± 5 minutes until resolution.
		  	TREATMENT CONDITIONS 13	Interval: --	Occurrences: --	Comments:	Cytokine Release Syndrome (CRS) - 
o Grade 2: Stop infusion immediately and keep line open. Follow institutional guidelines for the management and follow-up of infusion reaction. Restart infusion at 50% of previous rate under continuous observation. Ensure that there is a minimum observation period of 1 hour prior to restarting the infusion. If the AE recurs at the reinitiated slower rate of infusion, and despite oral pre-medication, permanently discontinue study treatment. 
o Grade 3 or 4: Permanently discontinue study treatment. Follow-up CRS as per institutional guidelines.
		  	TREATMENT CONDITIONS 14	Interval: --	Occurrences: --	Comments:	Ocular (e.g. Conjunctivitis, Blepharitis, blurred vision) - 
o Grade 1: May continue study treatment. Consider ophthalmology consultation. 
o Grade 2: Ophthalmology consultation. Upon resolution to LESS than or EQUAL to Grade 1 consider resuming study treatment in consultation with ophthalmologist. 
o Grade 3: 
1. Interrupt study treatment. 
2. Ophthalmology consultation. 
3. Upon resolution to LESS than or EQUAL to Grade 1 consider resuming study treatment in consultation with ophthalmologist.
o Grade 4:  Permanently discontinue study treatment.
		  	TREATMENT CONDITIONS 15	Interval: --	Occurrences: --	Comments:	Cardiovascular - 
o Grade 2 or greater Myocarditis: Permanently discontinue study treatment. 
o Grade 2 Cardiac Valvulopathy and other Cardiac Toxicity: Interrupt study treatment. Repeat echocardiogram and assess cardiac function. Once resolved to Grade ? 1 or baseline, consider re-administration of treatment, if benefit outweighs the potential risk. 
o Grade 3> Cardiac Valvulopathy and other Cardiac Toxicity: Permanently discontinue study treatment.
		  	TREATMENT CONDITIONS 16	Interval: --	Occurrences: --	Comments:	Isolated AST and/or ALT Elevation - 
o Grade 3 AST or ALT >5.0 - 10.0 x ULN: Interrupt treatment. Repeat liver function tests (LFTs) within 48-72 hours, then monitor LFTs weekly until recovery to grade ?1 or to baseline. Then resume treatment at the same dose interval if resolved in LESS than or EQUAL to 14 days; if resolved in GREATER than 14 days, consider administration Q4W instead of Q2W. 
o Grade 3 AST or ALT >10.0 - 20.0 x ULN: Interrupt treatment. Repeat LFTs within 48-72 hours, then monitor LFTs weekly until recovery to grade LESS than or EQUAL to 1 or to baseline, then increase dosing interval for NIS793 from Q2W to Q4W. 
o Grade 4: AST or ALT (>20 x ULN): Permanently discontinue treatment.
		  	TREATMENT CONDITIONS 17	Interval: --	Occurrences: --	Comments:	With abnormal ALT/AST (up to grade 2 - </= 5.0 x ULN) at baseline - 
o ALT/AST > 2.0 x baseline AND > 5.0 x ULN: Interrupt treatment. Repeat LFTs within 48-72 hours, then monitor LFTs weekly until recovery to baseline; Then resume same dose interval if resolved in LESS than or EQUAL to 14 days; if resolved in GREATER than 14 days, increasing dosing from Q2W to Q4W. 
o ALT/AST > 3.0 x baseline AND >10 x ULN: Interrupt treatment. Repeat LFTs within 48-72 hours, then monitor weekly until resolved to baseline; then increase dosing interval from Q2W to Q4W. 
o AST or ALT >20 x ULN (grade 4): Permanently discontinue treatment.
		  	TREATMENT CONDITIONS 18	Interval: --	Occurrences: --	Comments:	Concomitant elevation of AST and/or ALT and total bilirubin with normal AST/ALT and bilirubin at baseline -
o Grade 2 ALT and/or AST elevation (>3.0 x ULN) with bilirubin > 2.0 x ULN (unless Gilbert's syndrome): Interrupt treatment. Assess if case is drug induced liver injury (DILI). If DILI confirmed, permanently discontinue study treatment. For additional information on follow-up of potential drug induced liver injury cases, refer to Section 6.5.5.1. If no DILI confirmed, interrupt treatment, treat the identified cause according to institutional guidelines. Repeat LFTs within 48-72 hours, then monitor weekly, until enzyme levels resolve to LESS than or EQUAL to grade 1 or baseline.  After recovery, re-administration of study treatment could be considered only if Investigator assesses benefit to outweigh the risk. Any decision regarding re-administration of study drugs and dose regimen should be discussed with the Sponsor.
		  	TREATMENT CONDITIONS 19	Interval: --	Occurrences: --	Comments:	With abnormal ALT/AST at baseline - 
o ALT or AST >3.0 x baseline OR ALT or AST >8.0 x ULN [whichever is lower] combined with total bilirubin >2.0 x baseline AND >2.0 x ULN:  Interrupt treatment. Assess if case is drug induced liver injury (DILI). If DILI confirmed, permanently discontinue study treatment. For additional information on follow-up of potential drug induced liver injury cases, refer to Section 6.5.5.1. If no DILI confirmed, interrupt treatment, treat the identified cause according to institutional guidelines. Repeat LFTs within 48-72 hours, then monitor weekly, until enzyme levels resolve to ?grade 1 or baseline.  After recovery, re-administration of study treatment could be considered only if Investigator assesses benefit to outweigh the risk. Any decision regarding re-administration of study drugs and dose regimen should be discussed with the Sponsor.
		  	TREATMENT CONDITIONS 20	Interval: --	Occurrences: --	Comments:	Isolated total bilirubin elevation - 
o Any elevation > ULN: Fractionate bilirubin, evaluate for cholestatic liver injury (e.g. by testing Alkaline Phosphatase (ALP)) or alternative causes of bilirubin elevation (e.g. disease progression [imaging]). Treat alternative causes according to institutional guidelines. 
o Grade 2 (>1.5 - 3.0 ULN): Repeat LFTs within 48-72 hours, then monitor LFTs weekly until resolution to LESS than or EQUAL to grade 1 or to baseline. If isolated bilirubin remains stable at Grade 2, continue treatment at the same dose regimen. 
o Grade 3 (>3.0 - 10 ULN): Interrupt treatment. Repeat LFTs within 48-72 hours, then monitor LFTs weekly until resolution to LESS than or EQUAL to Grade 1 or to baseline. If resolved in ? 14 days, maintain dose regimen; if not resolved in 14 days, permanently discontinue NIS793. (Please see footnote regarding alternative cause/s of bilirubin elevation). 
o Grade 4 (> 10 x ULN): See footnote*. Otherwise, permanently discontinue study treatment. If alternative cause/s is identified and managed, and bilirubin resolves to ? grade 1 or to baseline, resume treatment at the same dose regimen. *An isolated bilirubin elevation is not typical for DILI. Bilirubin can be elevated either as part of a "Hy's law" constellation with a preceding elevation of ALT/AST, or as part of a cholestatic reaction with simultaneous elevation of other cholestatic parameters (ALP, GGT). Isolated bilirubin can be seen in conjunction with drugs that inhibit bilirubin conjugation or excretion, but both scenarios do not typically represent liver injury. Alternative causes of bilirubin elevation should, therefore, be ruled out before basing dose modification decisions on bilirubin values alone.
		  	TREATMENT CONDITIONS 21	Interval: --	Occurrences: --	Comments:	Asymptomatic amylase and/or lipase elevation - 
o Grade 3, not associated with symptoms or clinical manifestations of pancreatitis: May continue study treatment. If levels do not resolve to LESS than or EQUAL to Grade 2 within LESS than or EQUAL to 14 days after the initial report, interrupt study treatment.  Upon resolution to ? Grade 2, consider resuming study treatment.
		  	TREATMENT CONDITIONS 22	Interval: --	Occurrences: --	Comments:	Renal / Serum Creatinine - 
o Grade 2:  Interrupt Study Treatment. Manage per institutional Practice. Upon resolution to LESS than Grade 1, consider resuming study treatment. 
o Grade 3 or Grade 4: Permanently Discontinue Study Treatment.
		  	TREATMENT CONDITIONS 23	Interval: --	Occurrences: --	Comments:	Hyperthyroidism - 
o Grade 2: Consider Continuing Study Treatment and Management according to institutional practice. 
o Grade 3: Interrupt study treatment. Upon resolution to Grade ? 1 with appropriate management, consider resuming study treatment without dose modification. 
o Grade 4: Must discontinue and manage according to local/institutional guidance.
		  	TREATMENT CONDITIONS 24	Interval: --	Occurrences: --	Comments:	Other Endocrine Disorders - 
o Grade 2 and Grade 3: Interrupt study treatment. Upon resolution to Grade LESS than or EQUAL to 1 with appropriate management, consider resuming study treatment.
		  	TREATMENT CONDITIONS 25	Interval: --	Occurrences: --	Comments:	Dermatology (rash) - 
o Grade 1: Continue study treatment. Consider topical steroids, antihistamines, topical emollients. 
o Grade 2: Consider interrupting study treatment. Topical or oral steroids, antihistamines. If study treatment is held and resolution to LESS than or EQUAL to Grade 1, resume study treatment. 
o Grade 3: Interrupt study treatment. Manage per institutional practice. After resolution to LESS than or EQUAL to Grade 1, consider resuming study treatment after consultation with dermatologist. 
o Grade 4 or Stevens-Johnson syndrome (SJS), or Lyell syndrome/toxic epidermal necrolysis (TEN): Permanently discontinue study treatment and manage according to local/institutional guidance.
		  	TREATMENT CONDITIONS 26	Interval: --	Occurrences: --	Comments:	Neutropenia - 
o Grade 3: Interrupt study treatment until resolved to LESS than or EQUAL to Grade 1 or baseline, then resume study medication. 
o Grade 4: Interrupt study treatment. If resolved in LESS than or EQUAL to 7 days, maintain study treatment.  

Febrile Neutropenia - 
o Grade 3: Interrupt study treatment. Upon resolution of fever and improvement of neutropenia to LESS than or EQUAL to Grade 1 or baseline, resume study treatment. 
o Grade 4: Permanently discontinue study treatment. 

Thrombocytopenia - 
o Grade 3: Interrupt study treatment. Upon resolution to ? Grade 2 or baseline, resume study treatment. For Grade 3 associated with major bleeding, permanently discontinue study treatment. 
o Grade 4: Permanently discontinue study treatment. 

Anemia - 
o Grade 3 or Grade 4: Interrupt study treatment. Upon resolution to LESS than or EQUAL to Grade 2 or baseline within LESS than or EQUAL to 7 days, resume study treatment.
		  	TREATMENT CONDITIONS 27	Interval: --	Occurrences: --	Comments:	Other laboratory adverse events, not specified elsewhere in table and not included in the consensus guidelines - 
o Grade 3 or Grade 4: Interrupt study treatment. Upon resolution to LESS than or EQUAL to Grade 1, resume study treatment without dose modification. Isolated Grade 4 electrolyte abnormalities not associated with clinical sequelae and corrected after appropriate management within 72 hours of their onset do not require discontinuation. In the case of Grade 4 electrolyte imbalances associated with clinical sequelae, or not resolved to LESS than or EQUAL to Grade 1 within 72 hours despite appropriate management, permanently discontinue study treatment. 

Other non-laboratory adverse events, not specified elsewhere in table and not included in the consensus guidelines:
o Grade 2: Consider study treatment interruption. Upon resolution to ? Grade 1, consider resuming study treatment. 
o Grade 3: Interrupt study treatment. Upon resolution to LESS than or EQUAL to Grade 1, resuming study treatment must be discussed with the relevant medical expert. 
o Grade 4: Permanently discontinue study treatment.
			Nursing Orders
  	ONC NURSING COMMUNICATION 60	Interval: --	Occurrences: --	Comments:	Concomitant Medications
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Prior Concomitant Procedures and significant non-drug therapies
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Calculate indirect bilirubin
		  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	PRO-CTCAE, FACT-GP5 (ePRO)
		  	ONC NURSING COMMUNICATION 63	Interval: --	Occurrences: --	Comments:	PROMIS-29 (ePRO) - Pain and Fatigue items
		  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	Actigraphy
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	Adverse Events
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Serious Adverse Events
		  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	Health Resource Utilization
			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
☑	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --	Comments:	As clinically indicated
		☑	T3, FREE	Interval: --	Occurrences: --	Comments:	As clinically indicated
		☑	T4, FREE	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
☑	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated
		☑	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
  	URIC ACID LEVEL	Interval: --	Occurrences: --			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Labs
  	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --			Labs
  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
☑	CREATININE CLEARANCE, URINE, 24 HOUR	Interval: --	Occurrences: --		☑	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --		☑	BILIRUBIN DIRECT	Interval: --	Occurrences: --		☑	AMYLASE LEVEL	Interval: --	Occurrences: --		☑	LIPASE LEVEL	Interval: --	Occurrences: --		☑	GGT	Interval: --	Occurrences: --		☑	HEMOGLOBIN A1C	Interval: --	Occurrences: --	Comments:	As clinically indicated
		☑	NABFERON IFN-B ANTIBODY - ATHENA	Interval: --	Occurrences: --	Comments:	Anytime when suspected Cytokine Release Syndrome Occurs
		☑	INTERLEUKIN 6	Interval: --	Occurrences: --	Comments:	Anytime when suspected Cytokine Release Syndrome Occurs
		☑	MISCELLANEOUS REFERRAL TEST	Interval: --	Occurrences: --	Comments:	Interleukin 1 - Anytime when suspected Cytokine Release Syndrome Occurs
		☑	TUMOR NECROSIS FACTOR - ALPHA	Interval: --	Occurrences: --	Comments:	Anytime when suspected Cytokine Release Syndrome Occurs. 
Perform ONLY at HMH and HMCL.
			Imaging
☑	CT HEAD W WO CONTRAST	Interval: --	Occurrences: --	Comments:	As clinically indicated. Or MRI
		☐	MRI BRAIN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	As clinically indicated. Or CT
		☑	CV ECHOCARDIOGRAM RESEARCH ONLY	Interval: --	Occurrences: --	Comments:	As clinically indicated.
		☑	NM BONE SCAN WHOLE BODY	Interval: --	Occurrences: --	Comments:	As clinically indicated.
		☑	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	If Clinically Indicated Localized bone CT scan, MRI or Xray.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mEq/L; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 28	Interval: --	Occurrences: --	Comments:	o ANC LESS than 1000; 
o Platelets LESS than 100,000; 
o Bilirubin GREATER than 1.6; 
o LFTs GREATER than 10 x ULN.
			Pre-Medications
  	ondansetron (ZOFRAN) IV 8 mg	Dose: 8 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to chemo.			Chemotherapy
  	NAB-PACLItaxel (ABRAXANE) chemo infusion 125 mg/m2 (Treatment Plan)	Dose: 125 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes		  	gemcitabine (GEMZAR) 1,000 mg/m2 in sodium chloride 0.9% 250 mL chemo IVPB	Dose: 1,000 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 60 Minutes	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	GEMCITABINE 200 MG/5.26 ML (38 MG/ML) INTRAVENOUS SOLUTION	Medications	1,000 mg/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	 	No	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	fexofenadine (ALLEGRA) tablet 180 mg	Dose: 180 mg	Route: oral	PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 15	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Line Flush
  	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Use with NIS793		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Do NOT administer with NIS793			Nursing Orders
  	dextrose 5% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open for NIS793		  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.  Do NOT administer with NIS793			Nursing Orders
  	TREATMENT CONDITIONS 12	Interval: --	Occurrences: --	Comments:	Infusion Reaction or Hypersensitivity Reaction - 
o Grade 1-Infusion Reaction or Hypersensitivity Reaction: Decrease infusion rate until recovery from the symptoms. If the infusion reaction happens after the end of infusion (EOI), increase monitoring of vital signs until the participant is symptoms free. Administer subsequent NIS793 infusion at the same rate. 
o Grade 2- Infusion Reaction or Hypersensitivity Reaction: Stop infusion immediately and keep line open. Follow institutional guidelines for the management and follow-up of infusion reaction. Restart infusion at 50% of previous rate under continuous observation. Ensure that there is a minimum observation period of 1 hour prior to restarting the infusion. If the AE recurs at the reinitiated slower rate of infusion, and despite oral pre-medication, permanently discontinue study treatment. 
o Grade 3 or Grade 4- Infusion Reaction or Hypersensitivity Reaction: Stop infusion immediately and keep line open. Follow institutional guidelines for the management and follow-up of infusion reaction. Provide supplemental oxygen, fluids, and other resuscitative measures as needed. Monitor vital signs (e.g. blood pressure, pulse, respiration, and temperature) every 15 ± 5 minutes until resolution.
		  	TREATMENT CONDITIONS 13	Interval: --	Occurrences: --	Comments:	Cytokine Release Syndrome (CRS) - 
o Grade 2: Stop infusion immediately and keep line open. Follow institutional guidelines for the management and follow-up of infusion reaction. Restart infusion at 50% of previous rate under continuous observation. Ensure that there is a minimum observation period of 1 hour prior to restarting the infusion. If the AE recurs at the reinitiated slower rate of infusion, and despite oral pre-medication, permanently discontinue study treatment. 
o Grade 3 or 4: Permanently discontinue study treatment. Follow-up CRS as per institutional guidelines.
		  	TREATMENT CONDITIONS 14	Interval: --	Occurrences: --	Comments:	Ocular (e.g. Conjunctivitis, Blepharitis, blurred vision) - 
o Grade 1: May continue study treatment. Consider ophthalmology consultation. 
o Grade 2: Ophthalmology consultation. Upon resolution to LESS than or EQUAL to Grade 1 consider resuming study treatment in consultation with ophthalmologist. 
o Grade 3: 
1. Interrupt study treatment. 
2. Ophthalmology consultation. 
3. Upon resolution to LESS than or EQUAL to Grade 1 consider resuming study treatment in consultation with ophthalmologist.
o Grade 4:  Permanently discontinue study treatment.
		  	TREATMENT CONDITIONS 15	Interval: --	Occurrences: --	Comments:	Cardiovascular - 
o Grade 2 or greater Myocarditis: Permanently discontinue study treatment. 
o Grade 2 Cardiac Valvulopathy and other Cardiac Toxicity: Interrupt study treatment. Repeat echocardiogram and assess cardiac function. Once resolved to Grade ? 1 or baseline, consider re-administration of treatment, if benefit outweighs the potential risk. 
o Grade 3> Cardiac Valvulopathy and other Cardiac Toxicity: Permanently discontinue study treatment.
		  	TREATMENT CONDITIONS 16	Interval: --	Occurrences: --	Comments:	Isolated AST and/or ALT Elevation - 
o Grade 3 AST or ALT >5.0 - 10.0 x ULN: Interrupt treatment. Repeat liver function tests (LFTs) within 48-72 hours, then monitor LFTs weekly until recovery to grade ?1 or to baseline. Then resume treatment at the same dose interval if resolved in LESS than or EQUAL to 14 days; if resolved in GREATER than 14 days, consider administration Q4W instead of Q2W. 
o Grade 3 AST or ALT >10.0 - 20.0 x ULN: Interrupt treatment. Repeat LFTs within 48-72 hours, then monitor LFTs weekly until recovery to grade LESS than or EQUAL to 1 or to baseline, then increase dosing interval for NIS793 from Q2W to Q4W. 
o Grade 4: AST or ALT (>20 x ULN): Permanently discontinue treatment.
		  	TREATMENT CONDITIONS 17	Interval: --	Occurrences: --	Comments:	With abnormal ALT/AST (up to grade 2 - </= 5.0 x ULN) at baseline - 
o ALT/AST > 2.0 x baseline AND > 5.0 x ULN: Interrupt treatment. Repeat LFTs within 48-72 hours, then monitor LFTs weekly until recovery to baseline; Then resume same dose interval if resolved in LESS than or EQUAL to 14 days; if resolved in GREATER than 14 days, increasing dosing from Q2W to Q4W. 
o ALT/AST > 3.0 x baseline AND >10 x ULN: Interrupt treatment. Repeat LFTs within 48-72 hours, then monitor weekly until resolved to baseline; then increase dosing interval from Q2W to Q4W. 
o AST or ALT >20 x ULN (grade 4): Permanently discontinue treatment.
		  	TREATMENT CONDITIONS 18	Interval: --	Occurrences: --	Comments:	Concomitant elevation of AST and/or ALT and total bilirubin with normal AST/ALT and bilirubin at baseline -
o Grade 2 ALT and/or AST elevation (>3.0 x ULN) with bilirubin > 2.0 x ULN (unless Gilbert's syndrome): Interrupt treatment. Assess if case is drug induced liver injury (DILI). If DILI confirmed, permanently discontinue study treatment. For additional information on follow-up of potential drug induced liver injury cases, refer to Section 6.5.5.1. If no DILI confirmed, interrupt treatment, treat the identified cause according to institutional guidelines. Repeat LFTs within 48-72 hours, then monitor weekly, until enzyme levels resolve to LESS than or EQUAL to grade 1 or baseline.  After recovery, re-administration of study treatment could be considered only if Investigator assesses benefit to outweigh the risk. Any decision regarding re-administration of study drugs and dose regimen should be discussed with the Sponsor.
		  	TREATMENT CONDITIONS 19	Interval: --	Occurrences: --	Comments:	With abnormal ALT/AST at baseline - 
o ALT or AST >3.0 x baseline OR ALT or AST >8.0 x ULN [whichever is lower] combined with total bilirubin >2.0 x baseline AND >2.0 x ULN:  Interrupt treatment. Assess if case is drug induced liver injury (DILI). If DILI confirmed, permanently discontinue study treatment. For additional information on follow-up of potential drug induced liver injury cases, refer to Section 6.5.5.1. If no DILI confirmed, interrupt treatment, treat the identified cause according to institutional guidelines. Repeat LFTs within 48-72 hours, then monitor weekly, until enzyme levels resolve to ?grade 1 or baseline.  After recovery, re-administration of study treatment could be considered only if Investigator assesses benefit to outweigh the risk. Any decision regarding re-administration of study drugs and dose regimen should be discussed with the Sponsor.
		  	TREATMENT CONDITIONS 20	Interval: --	Occurrences: --	Comments:	Isolated total bilirubin elevation - 
o Any elevation > ULN: Fractionate bilirubin, evaluate for cholestatic liver injury (e.g. by testing Alkaline Phosphatase (ALP)) or alternative causes of bilirubin elevation (e.g. disease progression [imaging]). Treat alternative causes according to institutional guidelines. 
o Grade 2 (>1.5 - 3.0 ULN): Repeat LFTs within 48-72 hours, then monitor LFTs weekly until resolution to LESS than or EQUAL to grade 1 or to baseline. If isolated bilirubin remains stable at Grade 2, continue treatment at the same dose regimen. 
o Grade 3 (>3.0 - 10 ULN): Interrupt treatment. Repeat LFTs within 48-72 hours, then monitor LFTs weekly until resolution to LESS than or EQUAL to Grade 1 or to baseline. If resolved in ? 14 days, maintain dose regimen; if not resolved in 14 days, permanently discontinue NIS793. (Please see footnote regarding alternative cause/s of bilirubin elevation). 
o Grade 4 (> 10 x ULN): See footnote*. Otherwise, permanently discontinue study treatment. If alternative cause/s is identified and managed, and bilirubin resolves to ? grade 1 or to baseline, resume treatment at the same dose regimen. *An isolated bilirubin elevation is not typical for DILI. Bilirubin can be elevated either as part of a "Hy's law" constellation with a preceding elevation of ALT/AST, or as part of a cholestatic reaction with simultaneous elevation of other cholestatic parameters (ALP, GGT). Isolated bilirubin can be seen in conjunction with drugs that inhibit bilirubin conjugation or excretion, but both scenarios do not typically represent liver injury. Alternative causes of bilirubin elevation should, therefore, be ruled out before basing dose modification decisions on bilirubin values alone.
		  	TREATMENT CONDITIONS 21	Interval: --	Occurrences: --	Comments:	Asymptomatic amylase and/or lipase elevation - 
o Grade 3, not associated with symptoms or clinical manifestations of pancreatitis: May continue study treatment. If levels do not resolve to LESS than or EQUAL to Grade 2 within LESS than or EQUAL to 14 days after the initial report, interrupt study treatment.  Upon resolution to ? Grade 2, consider resuming study treatment.
		  	TREATMENT CONDITIONS 22	Interval: --	Occurrences: --	Comments:	Renal / Serum Creatinine - 
o Grade 2:  Interrupt Study Treatment. Manage per institutional Practice. Upon resolution to LESS than Grade 1, consider resuming study treatment. 
o Grade 3 or Grade 4: Permanently Discontinue Study Treatment.
		  	TREATMENT CONDITIONS 23	Interval: --	Occurrences: --	Comments:	Hyperthyroidism - 
o Grade 2: Consider Continuing Study Treatment and Management according to institutional practice. 
o Grade 3: Interrupt study treatment. Upon resolution to Grade ? 1 with appropriate management, consider resuming study treatment without dose modification. 
o Grade 4: Must discontinue and manage according to local/institutional guidance.
		  	TREATMENT CONDITIONS 24	Interval: --	Occurrences: --	Comments:	Other Endocrine Disorders - 
o Grade 2 and Grade 3: Interrupt study treatment. Upon resolution to Grade LESS than or EQUAL to 1 with appropriate management, consider resuming study treatment.
		  	TREATMENT CONDITIONS 25	Interval: --	Occurrences: --	Comments:	Dermatology (rash) - 
o Grade 1: Continue study treatment. Consider topical steroids, antihistamines, topical emollients. 
o Grade 2: Consider interrupting study treatment. Topical or oral steroids, antihistamines. If study treatment is held and resolution to LESS than or EQUAL to Grade 1, resume study treatment. 
o Grade 3: Interrupt study treatment. Manage per institutional practice. After resolution to LESS than or EQUAL to Grade 1, consider resuming study treatment after consultation with dermatologist. 
o Grade 4 or Stevens-Johnson syndrome (SJS), or Lyell syndrome/toxic epidermal necrolysis (TEN): Permanently discontinue study treatment and manage according to local/institutional guidance.
		  	TREATMENT CONDITIONS 26	Interval: --	Occurrences: --	Comments:	Neutropenia - 
o Grade 3: Interrupt study treatment until resolved to LESS than or EQUAL to Grade 1 or baseline, then resume study medication. 
o Grade 4: Interrupt study treatment. If resolved in LESS than or EQUAL to 7 days, maintain study treatment.  

Febrile Neutropenia - 
o Grade 3: Interrupt study treatment. Upon resolution of fever and improvement of neutropenia to LESS than or EQUAL to Grade 1 or baseline, resume study treatment. 
o Grade 4: Permanently discontinue study treatment. 

Thrombocytopenia - 
o Grade 3: Interrupt study treatment. Upon resolution to ? Grade 2 or baseline, resume study treatment. For Grade 3 associated with major bleeding, permanently discontinue study treatment. 
o Grade 4: Permanently discontinue study treatment. 

Anemia - 
o Grade 3 or Grade 4: Interrupt study treatment. Upon resolution to LESS than or EQUAL to Grade 2 or baseline within LESS than or EQUAL to 7 days, resume study treatment.
		  	TREATMENT CONDITIONS 27	Interval: --	Occurrences: --	Comments:	Other laboratory adverse events, not specified elsewhere in table and not included in the consensus guidelines - 
o Grade 3 or Grade 4: Interrupt study treatment. Upon resolution to LESS than or EQUAL to Grade 1, resume study treatment without dose modification. Isolated Grade 4 electrolyte abnormalities not associated with clinical sequelae and corrected after appropriate management within 72 hours of their onset do not require discontinuation. In the case of Grade 4 electrolyte imbalances associated with clinical sequelae, or not resolved to LESS than or EQUAL to Grade 1 within 72 hours despite appropriate management, permanently discontinue study treatment. 

Other non-laboratory adverse events, not specified elsewhere in table and not included in the consensus guidelines:
o Grade 2: Consider study treatment interruption. Upon resolution to ? Grade 1, consider resuming study treatment. 
o Grade 3: Interrupt study treatment. Upon resolution to LESS than or EQUAL to Grade 1, resuming study treatment must be discussed with the relevant medical expert. 
o Grade 4: Permanently discontinue study treatment.
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Dose Modifications and Dose Interruption for NIS793: 
No Dose Reductions are allowed for NIS793: Increasing the dosing interval from Q2W to Q4W is allowed under circumstances described in Table 6-5. If NIS793 is interrupted or delayed for GREATER than 8 weeks due to toxicity that is suspected to be related to treatment, study treatment should be permanently discontinued.
			Nursing Orders
  	ONC NURSING COMMUNICATION 60	Interval: --	Occurrences: --	Comments:	Concomitant Medications
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Prior Concomitant Procedures and significant non-drug therapies
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	Physical Examination
		  	ONC NURSING COMMUNICATION 62	Interval: --	Occurrences: --	Comments:	ECOG
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Calculate indirect bilirubin
		  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	PRO-CTCAE, FACT-GP5 (ePRO)
		  	ONC NURSING COMMUNICATION 63	Interval: --	Occurrences: --	Comments:	PROMIS-29 (ePRO) - Pain and Fatigue items
		  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	Actigraphy
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	Adverse Events
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Serious Adverse Events
		  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	Health Resource Utilization
			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
☑	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --	Comments:	As clinically indicated
		☑	T3, FREE	Interval: --	Occurrences: --	Comments:	As clinically indicated
		☑	T4, FREE	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
☑	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated
		☑	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
  	URIC ACID LEVEL	Interval: --	Occurrences: --			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Labs
  	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --			Labs
  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
☑	CREATININE CLEARANCE, URINE, 24 HOUR	Interval: --	Occurrences: --		☑	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --		☑	BILIRUBIN DIRECT	Interval: --	Occurrences: --		☑	AMYLASE LEVEL	Interval: --	Occurrences: --		☑	LIPASE LEVEL	Interval: --	Occurrences: --		☑	GGT	Interval: --	Occurrences: --		☑	HEMOGLOBIN A1C	Interval: --	Occurrences: --	Comments:	As clinically indicated
		☑	NABFERON IFN-B ANTIBODY - ATHENA	Interval: --	Occurrences: --	Comments:	Anytime when suspected Cytokine Release Syndrome Occurs
		☑	INTERLEUKIN 6	Interval: --	Occurrences: --	Comments:	Anytime when suspected Cytokine Release Syndrome Occurs
		☑	MISCELLANEOUS REFERRAL TEST	Interval: --	Occurrences: --	Comments:	Interleukin 1 - Anytime when suspected Cytokine Release Syndrome Occurs
		☑	TUMOR NECROSIS FACTOR - ALPHA	Interval: --	Occurrences: --	Comments:	Anytime when suspected Cytokine Release Syndrome Occurs. 
Perform ONLY at HMH and HMCL.
			Imaging
☑	CT HEAD W WO CONTRAST	Interval: --	Occurrences: --	Comments:	As clinically indicated. Or MRI
		☐	MRI BRAIN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	As clinically indicated. Or CT
		☑	CV ECHOCARDIOGRAM RESEARCH ONLY	Interval: --	Occurrences: --	Comments:	As clinically indicated.
		☑	NM BONE SCAN WHOLE BODY	Interval: --	Occurrences: --	Comments:	As clinically indicated.
		☑	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	If Clinically Indicated Localized bone CT scan, MRI or Xray.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mEq/L; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 28	Interval: --	Occurrences: --	Comments:	o ANC LESS than 1000; 
o Platelets LESS than 100,000; 
o Bilirubin GREATER than 1.6; 
o LFTs GREATER than 10 x ULN.
			Pre-Medications
  	ondansetron (ZOFRAN) IV 8 mg	Dose: 8 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to chemo.			Nursing Orders
  	ONC NURSING COMMUNICATION 68	Interval: --	Occurrences: --	Comments:	Infusion must take place in a facility with appropriate resuscitation equipment available at the bedside, and a physician readily available during the period of drug administration.
		  	ONC NURSING COMMUNICATION 69	Interval: --	Occurrences: --	Comments:	Participants should be closely observed for potential infusion-related reactions including rigors, chills, wheezing, pruritus, flushing, rash, hypotension, hypoxemia, and fever, and vital signs monitored more frequently if clinically indicated, during and for at least 2 hours after the first two NIS793 infusions. The same may apply for subsequent NIS793 infusions if medically indicated. Participants should notify study personnel if symptoms of infusion reaction occur after any NIS793 infusion.
			Chemotherapy
  	INV-NIS793 or placebo (CNIS793B12301 daNIS-2/Pro00032923/Abdelrahim) 2,100 mg in dextrose 5% 100 mL	Dose: 2,100 mg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Protect from light.  Administer intravenously using a 0.2 micron inline filter over 30 minutes.  Flush only with D5W!
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.

	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-NIS793 OR PLACEBO 1050MG/10ML INTRAVENOUS SOLN. (CNIS793B12301 DANIS-2/PRO00032923/ABDELRAHIM)	Medications	2,100 mg	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	80 mL	Yes	Yes			  	NAB-PACLItaxel (ABRAXANE) chemo infusion 125 mg/m2 (Treatment Plan)	Dose: 125 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 3 Hours		  	gemcitabine (GEMZAR) 1,000 mg/m2 in sodium chloride 0.9% 250 mL chemo IVPB	Dose: 1,000 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 3.5 Hours	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	GEMCITABINE 200 MG/5.26 ML (38 MG/ML) INTRAVENOUS SOLUTION	Medications	1,000 mg/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	 	No	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	fexofenadine (ALLEGRA) tablet 180 mg	Dose: 180 mg	Route: oral	PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 5	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Line Flush
  	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Use with NIS793		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Do NOT administer with NIS793			Nursing Orders
  	dextrose 5% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open for NIS793		  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.  Do NOT administer with NIS793			Nursing Orders
  	TREATMENT CONDITIONS 12	Interval: --	Occurrences: --	Comments:	Infusion Reaction or Hypersensitivity Reaction - 
o Grade 1-Infusion Reaction or Hypersensitivity Reaction: Decrease infusion rate until recovery from the symptoms. If the infusion reaction happens after the end of infusion (EOI), increase monitoring of vital signs until the participant is symptoms free. Administer subsequent NIS793 infusion at the same rate. 
o Grade 2- Infusion Reaction or Hypersensitivity Reaction: Stop infusion immediately and keep line open. Follow institutional guidelines for the management and follow-up of infusion reaction. Restart infusion at 50% of previous rate under continuous observation. Ensure that there is a minimum observation period of 1 hour prior to restarting the infusion. If the AE recurs at the reinitiated slower rate of infusion, and despite oral pre-medication, permanently discontinue study treatment. 
o Grade 3 or Grade 4- Infusion Reaction or Hypersensitivity Reaction: Stop infusion immediately and keep line open. Follow institutional guidelines for the management and follow-up of infusion reaction. Provide supplemental oxygen, fluids, and other resuscitative measures as needed. Monitor vital signs (e.g. blood pressure, pulse, respiration, and temperature) every 15 ± 5 minutes until resolution.
		  	TREATMENT CONDITIONS 13	Interval: --	Occurrences: --	Comments:	Cytokine Release Syndrome (CRS) - 
o Grade 2: Stop infusion immediately and keep line open. Follow institutional guidelines for the management and follow-up of infusion reaction. Restart infusion at 50% of previous rate under continuous observation. Ensure that there is a minimum observation period of 1 hour prior to restarting the infusion. If the AE recurs at the reinitiated slower rate of infusion, and despite oral pre-medication, permanently discontinue study treatment. 
o Grade 3 or 4: Permanently discontinue study treatment. Follow-up CRS as per institutional guidelines.
		  	TREATMENT CONDITIONS 14	Interval: --	Occurrences: --	Comments:	Ocular (e.g. Conjunctivitis, Blepharitis, blurred vision) - 
o Grade 1: May continue study treatment. Consider ophthalmology consultation. 
o Grade 2: Ophthalmology consultation. Upon resolution to LESS than or EQUAL to Grade 1 consider resuming study treatment in consultation with ophthalmologist. 
o Grade 3: 
1. Interrupt study treatment. 
2. Ophthalmology consultation. 
3. Upon resolution to LESS than or EQUAL to Grade 1 consider resuming study treatment in consultation with ophthalmologist.
o Grade 4:  Permanently discontinue study treatment.
		  	TREATMENT CONDITIONS 15	Interval: --	Occurrences: --	Comments:	Cardiovascular - 
o Grade 2 or greater Myocarditis: Permanently discontinue study treatment. 
o Grade 2 Cardiac Valvulopathy and other Cardiac Toxicity: Interrupt study treatment. Repeat echocardiogram and assess cardiac function. Once resolved to Grade ? 1 or baseline, consider re-administration of treatment, if benefit outweighs the potential risk. 
o Grade 3> Cardiac Valvulopathy and other Cardiac Toxicity: Permanently discontinue study treatment.
		  	TREATMENT CONDITIONS 16	Interval: --	Occurrences: --	Comments:	Isolated AST and/or ALT Elevation - 
o Grade 3 AST or ALT >5.0 - 10.0 x ULN: Interrupt treatment. Repeat liver function tests (LFTs) within 48-72 hours, then monitor LFTs weekly until recovery to grade ?1 or to baseline. Then resume treatment at the same dose interval if resolved in LESS than or EQUAL to 14 days; if resolved in GREATER than 14 days, consider administration Q4W instead of Q2W. 
o Grade 3 AST or ALT >10.0 - 20.0 x ULN: Interrupt treatment. Repeat LFTs within 48-72 hours, then monitor LFTs weekly until recovery to grade LESS than or EQUAL to 1 or to baseline, then increase dosing interval for NIS793 from Q2W to Q4W. 
o Grade 4: AST or ALT (>20 x ULN): Permanently discontinue treatment.
		  	TREATMENT CONDITIONS 17	Interval: --	Occurrences: --	Comments:	With abnormal ALT/AST (up to grade 2 - </= 5.0 x ULN) at baseline - 
o ALT/AST > 2.0 x baseline AND > 5.0 x ULN: Interrupt treatment. Repeat LFTs within 48-72 hours, then monitor LFTs weekly until recovery to baseline; Then resume same dose interval if resolved in LESS than or EQUAL to 14 days; if resolved in GREATER than 14 days, increasing dosing from Q2W to Q4W. 
o ALT/AST > 3.0 x baseline AND >10 x ULN: Interrupt treatment. Repeat LFTs within 48-72 hours, then monitor weekly until resolved to baseline; then increase dosing interval from Q2W to Q4W. 
o AST or ALT >20 x ULN (grade 4): Permanently discontinue treatment.
		  	TREATMENT CONDITIONS 18	Interval: --	Occurrences: --	Comments:	Concomitant elevation of AST and/or ALT and total bilirubin with normal AST/ALT and bilirubin at baseline -
o Grade 2 ALT and/or AST elevation (>3.0 x ULN) with bilirubin > 2.0 x ULN (unless Gilbert's syndrome): Interrupt treatment. Assess if case is drug induced liver injury (DILI). If DILI confirmed, permanently discontinue study treatment. For additional information on follow-up of potential drug induced liver injury cases, refer to Section 6.5.5.1. If no DILI confirmed, interrupt treatment, treat the identified cause according to institutional guidelines. Repeat LFTs within 48-72 hours, then monitor weekly, until enzyme levels resolve to LESS than or EQUAL to grade 1 or baseline.  After recovery, re-administration of study treatment could be considered only if Investigator assesses benefit to outweigh the risk. Any decision regarding re-administration of study drugs and dose regimen should be discussed with the Sponsor.
		  	TREATMENT CONDITIONS 19	Interval: --	Occurrences: --	Comments:	With abnormal ALT/AST at baseline - 
o ALT or AST >3.0 x baseline OR ALT or AST >8.0 x ULN [whichever is lower] combined with total bilirubin >2.0 x baseline AND >2.0 x ULN:  Interrupt treatment. Assess if case is drug induced liver injury (DILI). If DILI confirmed, permanently discontinue study treatment. For additional information on follow-up of potential drug induced liver injury cases, refer to Section 6.5.5.1. If no DILI confirmed, interrupt treatment, treat the identified cause according to institutional guidelines. Repeat LFTs within 48-72 hours, then monitor weekly, until enzyme levels resolve to ?grade 1 or baseline.  After recovery, re-administration of study treatment could be considered only if Investigator assesses benefit to outweigh the risk. Any decision regarding re-administration of study drugs and dose regimen should be discussed with the Sponsor.
		  	TREATMENT CONDITIONS 20	Interval: --	Occurrences: --	Comments:	Isolated total bilirubin elevation - 
o Any elevation > ULN: Fractionate bilirubin, evaluate for cholestatic liver injury (e.g. by testing Alkaline Phosphatase (ALP)) or alternative causes of bilirubin elevation (e.g. disease progression [imaging]). Treat alternative causes according to institutional guidelines. 
o Grade 2 (>1.5 - 3.0 ULN): Repeat LFTs within 48-72 hours, then monitor LFTs weekly until resolution to LESS than or EQUAL to grade 1 or to baseline. If isolated bilirubin remains stable at Grade 2, continue treatment at the same dose regimen. 
o Grade 3 (>3.0 - 10 ULN): Interrupt treatment. Repeat LFTs within 48-72 hours, then monitor LFTs weekly until resolution to LESS than or EQUAL to Grade 1 or to baseline. If resolved in ? 14 days, maintain dose regimen; if not resolved in 14 days, permanently discontinue NIS793. (Please see footnote regarding alternative cause/s of bilirubin elevation). 
o Grade 4 (> 10 x ULN): See footnote*. Otherwise, permanently discontinue study treatment. If alternative cause/s is identified and managed, and bilirubin resolves to ? grade 1 or to baseline, resume treatment at the same dose regimen. *An isolated bilirubin elevation is not typical for DILI. Bilirubin can be elevated either as part of a "Hy's law" constellation with a preceding elevation of ALT/AST, or as part of a cholestatic reaction with simultaneous elevation of other cholestatic parameters (ALP, GGT). Isolated bilirubin can be seen in conjunction with drugs that inhibit bilirubin conjugation or excretion, but both scenarios do not typically represent liver injury. Alternative causes of bilirubin elevation should, therefore, be ruled out before basing dose modification decisions on bilirubin values alone.
		  	TREATMENT CONDITIONS 21	Interval: --	Occurrences: --	Comments:	Asymptomatic amylase and/or lipase elevation - 
o Grade 3, not associated with symptoms or clinical manifestations of pancreatitis: May continue study treatment. If levels do not resolve to LESS than or EQUAL to Grade 2 within LESS than or EQUAL to 14 days after the initial report, interrupt study treatment.  Upon resolution to ? Grade 2, consider resuming study treatment.
		  	TREATMENT CONDITIONS 22	Interval: --	Occurrences: --	Comments:	Renal / Serum Creatinine - 
o Grade 2:  Interrupt Study Treatment. Manage per institutional Practice. Upon resolution to LESS than Grade 1, consider resuming study treatment. 
o Grade 3 or Grade 4: Permanently Discontinue Study Treatment.
		  	TREATMENT CONDITIONS 23	Interval: --	Occurrences: --	Comments:	Hyperthyroidism - 
o Grade 2: Consider Continuing Study Treatment and Management according to institutional practice. 
o Grade 3: Interrupt study treatment. Upon resolution to Grade ? 1 with appropriate management, consider resuming study treatment without dose modification. 
o Grade 4: Must discontinue and manage according to local/institutional guidance.
		  	TREATMENT CONDITIONS 24	Interval: --	Occurrences: --	Comments:	Other Endocrine Disorders - 
o Grade 2 and Grade 3: Interrupt study treatment. Upon resolution to Grade LESS than or EQUAL to 1 with appropriate management, consider resuming study treatment.
		  	TREATMENT CONDITIONS 25	Interval: --	Occurrences: --	Comments:	Dermatology (rash) - 
o Grade 1: Continue study treatment. Consider topical steroids, antihistamines, topical emollients. 
o Grade 2: Consider interrupting study treatment. Topical or oral steroids, antihistamines. If study treatment is held and resolution to LESS than or EQUAL to Grade 1, resume study treatment. 
o Grade 3: Interrupt study treatment. Manage per institutional practice. After resolution to LESS than or EQUAL to Grade 1, consider resuming study treatment after consultation with dermatologist. 
o Grade 4 or Stevens-Johnson syndrome (SJS), or Lyell syndrome/toxic epidermal necrolysis (TEN): Permanently discontinue study treatment and manage according to local/institutional guidance.
		  	TREATMENT CONDITIONS 26	Interval: --	Occurrences: --	Comments:	Neutropenia - 
o Grade 3: Interrupt study treatment until resolved to LESS than or EQUAL to Grade 1 or baseline, then resume study medication. 
o Grade 4: Interrupt study treatment. If resolved in LESS than or EQUAL to 7 days, maintain study treatment.  

Febrile Neutropenia - 
o Grade 3: Interrupt study treatment. Upon resolution of fever and improvement of neutropenia to LESS than or EQUAL to Grade 1 or baseline, resume study treatment. 
o Grade 4: Permanently discontinue study treatment. 

Thrombocytopenia - 
o Grade 3: Interrupt study treatment. Upon resolution to ? Grade 2 or baseline, resume study treatment. For Grade 3 associated with major bleeding, permanently discontinue study treatment. 
o Grade 4: Permanently discontinue study treatment. 

Anemia - 
o Grade 3 or Grade 4: Interrupt study treatment. Upon resolution to LESS than or EQUAL to Grade 2 or baseline within LESS than or EQUAL to 7 days, resume study treatment.
		  	TREATMENT CONDITIONS 27	Interval: --	Occurrences: --	Comments:	Other laboratory adverse events, not specified elsewhere in table and not included in the consensus guidelines - 
o Grade 3 or Grade 4: Interrupt study treatment. Upon resolution to LESS than or EQUAL to Grade 1, resume study treatment without dose modification. Isolated Grade 4 electrolyte abnormalities not associated with clinical sequelae and corrected after appropriate management within 72 hours of their onset do not require discontinuation. In the case of Grade 4 electrolyte imbalances associated with clinical sequelae, or not resolved to LESS than or EQUAL to Grade 1 within 72 hours despite appropriate management, permanently discontinue study treatment. 

Other non-laboratory adverse events, not specified elsewhere in table and not included in the consensus guidelines:
o Grade 2: Consider study treatment interruption. Upon resolution to ? Grade 1, consider resuming study treatment. 
o Grade 3: Interrupt study treatment. Upon resolution to LESS than or EQUAL to Grade 1, resuming study treatment must be discussed with the relevant medical expert. 
o Grade 4: Permanently discontinue study treatment.
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Dose Modifications and Dose Interruption for NIS793: 
No Dose Reductions are allowed for NIS793: Increasing the dosing interval from Q2W to Q4W is allowed under circumstances described in Table 6-5. If NIS793 is interrupted or delayed for GREATER than 8 weeks due to toxicity that is suspected to be related to treatment, study treatment should be permanently discontinued.
			Nursing Orders
  	ONC NURSING COMMUNICATION 60	Interval: --	Occurrences: --	Comments:	Concomitant Medications
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Prior Concomitant Procedures and significant non-drug therapies
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	Physical Examination
		  	ONC NURSING COMMUNICATION 62	Interval: --	Occurrences: --	Comments:	ECOG
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Calculate indirect bilirubin
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	EQ-5D-5L, PGIS (ePRO)
		  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	PRO-CTCAE, FACT-GP5 (ePRO)
		  	ONC NURSING COMMUNICATION 38	Interval: --	Occurrences: --	Comments:	PROMIS-29 (ePRO)
		  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	Actigraphy
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	Adverse Events
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Serious Adverse Events
		  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	Health Resource Utilization
			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
☑	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --	Comments:	As clinically indicated
		☑	T3, FREE	Interval: --	Occurrences: --	Comments:	As clinically indicated
		☑	T4, FREE	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
☑	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated
		☑	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
  	URIC ACID LEVEL	Interval: --	Occurrences: --			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Labs
  	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --			Labs
  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --			Labs
☑	CREATININE CLEARANCE, URINE, 24 HOUR	Interval: --	Occurrences: --		☑	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --		☑	BILIRUBIN DIRECT	Interval: --	Occurrences: --		☑	AMYLASE LEVEL	Interval: --	Occurrences: --		☑	LIPASE LEVEL	Interval: --	Occurrences: --		☑	GGT	Interval: --	Occurrences: --		☑	HEMOGLOBIN A1C	Interval: --	Occurrences: --	Comments:	As clinically indicated
		☑	CANCER ANTIGEN 19-9	Interval: --	Occurrences: --		☑	NABFERON IFN-B ANTIBODY - ATHENA	Interval: --	Occurrences: --	Comments:	Anytime when suspected Cytokine Release Syndrome Occurs
		☑	INTERLEUKIN 6	Interval: --	Occurrences: --	Comments:	Anytime when suspected Cytokine Release Syndrome Occurs
		☑	MISCELLANEOUS REFERRAL TEST	Interval: --	Occurrences: --	Comments:	Interleukin 1 - Anytime when suspected Cytokine Release Syndrome Occurs
		☑	TUMOR NECROSIS FACTOR - ALPHA	Interval: --	Occurrences: --	Comments:	Anytime when suspected Cytokine Release Syndrome Occurs. 
Perform ONLY at HMH and HMCL.
			Imaging
☑	CT HEAD W WO CONTRAST	Interval: --	Occurrences: --	Comments:	As clinically indicated. Or MRI
		☐	MRI BRAIN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	As clinically indicated. Or CT
		☑	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	As clinically indicated  for Tumor Evaluation per RECIST. Or MRI
		☐	MRI CHEST W CONTRAST	Interval: --	Occurrences: --	Comments:	As clinically indicated  for Tumor Evaluation per RECIST. Or CT
		☐	MRI ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	As clinically indicated  for Tumor Evaluation per RECIST. Or CT
		☐	MRI PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	As clinically indicated  for Tumor Evaluation per RECIST. Or CT
		☑	CV ECHOCARDIOGRAM RESEARCH ONLY	Interval: --	Occurrences: --	Comments:	As clinically indicated.
		☑	NM BONE SCAN WHOLE BODY	Interval: --	Occurrences: --	Comments:	As clinically indicated.
		☑	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	If Clinically Indicated Localized bone CT scan, MRI or Xray.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mEq/L; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 28	Interval: --	Occurrences: --	Comments:	o ANC LESS than 1000; 
o Platelets LESS than 100,000; 
o Bilirubin GREATER than 1.6; 
o LFTs GREATER than 10 x ULN.
			Pre-Medications
  	ondansetron (ZOFRAN) IV 8 mg	Dose: 8 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to chemo.			Nursing Orders
  	ONC NURSING COMMUNICATION 68	Interval: --	Occurrences: --	Comments:	Infusion must take place in a facility with appropriate resuscitation equipment available at the bedside, and a physician readily available during the period of drug administration.
		  	ONC NURSING COMMUNICATION 69	Interval: --	Occurrences: --	Comments:	Participants should be closely observed for potential infusion-related reactions including rigors, chills, wheezing, pruritus, flushing, rash, hypotension, hypoxemia, and fever, and vital signs monitored more frequently if clinically indicated, during and for at least 2 hours after the first two NIS793 infusions. The same may apply for subsequent NIS793 infusions if medically indicated. Participants should notify study personnel if symptoms of infusion reaction occur after any NIS793 infusion.
			Chemotherapy
  	INV-NIS793 or placebo (CNIS793B12301 daNIS-2/Pro00032923/Abdelrahim) 2,100 mg in dextrose 5% 100 mL	Dose: 2,100 mg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Protect from light.  Administer intravenously using a 0.2 micron inline filter over 30 minutes.  Flush only with D5W!
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.

	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-NIS793 OR PLACEBO 1050MG/10ML INTRAVENOUS SOLN. (CNIS793B12301 DANIS-2/PRO00032923/ABDELRAHIM)	Medications	2,100 mg	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	80 mL	Yes	Yes			  	NAB-PACLItaxel (ABRAXANE) chemo infusion 125 mg/m2 (Treatment Plan)	Dose: 125 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 3 Hours		  	gemcitabine (GEMZAR) 1,000 mg/m2 in sodium chloride 0.9% 250 mL chemo IVPB	Dose: 1,000 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 3.5 Hours	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	GEMCITABINE 200 MG/5.26 ML (38 MG/ML) INTRAVENOUS SOLUTION	Medications	1,000 mg/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	 	No	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	fexofenadine (ALLEGRA) tablet 180 mg	Dose: 180 mg	Route: oral	PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 8	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Line Flush
  	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Nursing Orders
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Nursing Orders
  	TREATMENT CONDITIONS 12	Interval: --	Occurrences: --	Comments:	Infusion Reaction or Hypersensitivity Reaction - 
o Grade 1-Infusion Reaction or Hypersensitivity Reaction: Decrease infusion rate until recovery from the symptoms. If the infusion reaction happens after the end of infusion (EOI), increase monitoring of vital signs until the participant is symptoms free. Administer subsequent NIS793 infusion at the same rate. 
o Grade 2- Infusion Reaction or Hypersensitivity Reaction: Stop infusion immediately and keep line open. Follow institutional guidelines for the management and follow-up of infusion reaction. Restart infusion at 50% of previous rate under continuous observation. Ensure that there is a minimum observation period of 1 hour prior to restarting the infusion. If the AE recurs at the reinitiated slower rate of infusion, and despite oral pre-medication, permanently discontinue study treatment. 
o Grade 3 or Grade 4- Infusion Reaction or Hypersensitivity Reaction: Stop infusion immediately and keep line open. Follow institutional guidelines for the management and follow-up of infusion reaction. Provide supplemental oxygen, fluids, and other resuscitative measures as needed. Monitor vital signs (e.g. blood pressure, pulse, respiration, and temperature) every 15 ± 5 minutes until resolution.
		  	TREATMENT CONDITIONS 13	Interval: --	Occurrences: --	Comments:	Cytokine Release Syndrome (CRS) - 
o Grade 2: Stop infusion immediately and keep line open. Follow institutional guidelines for the management and follow-up of infusion reaction. Restart infusion at 50% of previous rate under continuous observation. Ensure that there is a minimum observation period of 1 hour prior to restarting the infusion. If the AE recurs at the reinitiated slower rate of infusion, and despite oral pre-medication, permanently discontinue study treatment. 
o Grade 3 or 4: Permanently discontinue study treatment. Follow-up CRS as per institutional guidelines.
		  	TREATMENT CONDITIONS 14	Interval: --	Occurrences: --	Comments:	Ocular (e.g. Conjunctivitis, Blepharitis, blurred vision) - 
o Grade 1: May continue study treatment. Consider ophthalmology consultation. 
o Grade 2: Ophthalmology consultation. Upon resolution to LESS than or EQUAL to Grade 1 consider resuming study treatment in consultation with ophthalmologist. 
o Grade 3: 
1. Interrupt study treatment. 
2. Ophthalmology consultation. 
3. Upon resolution to LESS than or EQUAL to Grade 1 consider resuming study treatment in consultation with ophthalmologist.
o Grade 4:  Permanently discontinue study treatment.
		  	TREATMENT CONDITIONS 15	Interval: --	Occurrences: --	Comments:	Cardiovascular - 
o Grade 2 or greater Myocarditis: Permanently discontinue study treatment. 
o Grade 2 Cardiac Valvulopathy and other Cardiac Toxicity: Interrupt study treatment. Repeat echocardiogram and assess cardiac function. Once resolved to Grade ? 1 or baseline, consider re-administration of treatment, if benefit outweighs the potential risk. 
o Grade 3> Cardiac Valvulopathy and other Cardiac Toxicity: Permanently discontinue study treatment.
		  	TREATMENT CONDITIONS 16	Interval: --	Occurrences: --	Comments:	Isolated AST and/or ALT Elevation - 
o Grade 3 AST or ALT >5.0 - 10.0 x ULN: Interrupt treatment. Repeat liver function tests (LFTs) within 48-72 hours, then monitor LFTs weekly until recovery to grade ?1 or to baseline. Then resume treatment at the same dose interval if resolved in LESS than or EQUAL to 14 days; if resolved in GREATER than 14 days, consider administration Q4W instead of Q2W. 
o Grade 3 AST or ALT >10.0 - 20.0 x ULN: Interrupt treatment. Repeat LFTs within 48-72 hours, then monitor LFTs weekly until recovery to grade LESS than or EQUAL to 1 or to baseline, then increase dosing interval for NIS793 from Q2W to Q4W. 
o Grade 4: AST or ALT (>20 x ULN): Permanently discontinue treatment.
		  	TREATMENT CONDITIONS 17	Interval: --	Occurrences: --	Comments:	With abnormal ALT/AST (up to grade 2 - </= 5.0 x ULN) at baseline - 
o ALT/AST > 2.0 x baseline AND > 5.0 x ULN: Interrupt treatment. Repeat LFTs within 48-72 hours, then monitor LFTs weekly until recovery to baseline; Then resume same dose interval if resolved in LESS than or EQUAL to 14 days; if resolved in GREATER than 14 days, increasing dosing from Q2W to Q4W. 
o ALT/AST > 3.0 x baseline AND >10 x ULN: Interrupt treatment. Repeat LFTs within 48-72 hours, then monitor weekly until resolved to baseline; then increase dosing interval from Q2W to Q4W. 
o AST or ALT >20 x ULN (grade 4): Permanently discontinue treatment.
		  	TREATMENT CONDITIONS 18	Interval: --	Occurrences: --	Comments:	Concomitant elevation of AST and/or ALT and total bilirubin with normal AST/ALT and bilirubin at baseline -
o Grade 2 ALT and/or AST elevation (>3.0 x ULN) with bilirubin > 2.0 x ULN (unless Gilbert's syndrome): Interrupt treatment. Assess if case is drug induced liver injury (DILI). If DILI confirmed, permanently discontinue study treatment. For additional information on follow-up of potential drug induced liver injury cases, refer to Section 6.5.5.1. If no DILI confirmed, interrupt treatment, treat the identified cause according to institutional guidelines. Repeat LFTs within 48-72 hours, then monitor weekly, until enzyme levels resolve to LESS than or EQUAL to grade 1 or baseline.  After recovery, re-administration of study treatment could be considered only if Investigator assesses benefit to outweigh the risk. Any decision regarding re-administration of study drugs and dose regimen should be discussed with the Sponsor.
		  	TREATMENT CONDITIONS 19	Interval: --	Occurrences: --	Comments:	With abnormal ALT/AST at baseline - 
o ALT or AST >3.0 x baseline OR ALT or AST >8.0 x ULN [whichever is lower] combined with total bilirubin >2.0 x baseline AND >2.0 x ULN:  Interrupt treatment. Assess if case is drug induced liver injury (DILI). If DILI confirmed, permanently discontinue study treatment. For additional information on follow-up of potential drug induced liver injury cases, refer to Section 6.5.5.1. If no DILI confirmed, interrupt treatment, treat the identified cause according to institutional guidelines. Repeat LFTs within 48-72 hours, then monitor weekly, until enzyme levels resolve to ?grade 1 or baseline.  After recovery, re-administration of study treatment could be considered only if Investigator assesses benefit to outweigh the risk. Any decision regarding re-administration of study drugs and dose regimen should be discussed with the Sponsor.
		  	TREATMENT CONDITIONS 20	Interval: --	Occurrences: --	Comments:	Isolated total bilirubin elevation - 
o Any elevation > ULN: Fractionate bilirubin, evaluate for cholestatic liver injury (e.g. by testing Alkaline Phosphatase (ALP)) or alternative causes of bilirubin elevation (e.g. disease progression [imaging]). Treat alternative causes according to institutional guidelines. 
o Grade 2 (>1.5 - 3.0 ULN): Repeat LFTs within 48-72 hours, then monitor LFTs weekly until resolution to LESS than or EQUAL to grade 1 or to baseline. If isolated bilirubin remains stable at Grade 2, continue treatment at the same dose regimen. 
o Grade 3 (>3.0 - 10 ULN): Interrupt treatment. Repeat LFTs within 48-72 hours, then monitor LFTs weekly until resolution to LESS than or EQUAL to Grade 1 or to baseline. If resolved in ? 14 days, maintain dose regimen; if not resolved in 14 days, permanently discontinue NIS793. (Please see footnote regarding alternative cause/s of bilirubin elevation). 
o Grade 4 (> 10 x ULN): See footnote*. Otherwise, permanently discontinue study treatment. If alternative cause/s is identified and managed, and bilirubin resolves to ? grade 1 or to baseline, resume treatment at the same dose regimen. *An isolated bilirubin elevation is not typical for DILI. Bilirubin can be elevated either as part of a "Hy's law" constellation with a preceding elevation of ALT/AST, or as part of a cholestatic reaction with simultaneous elevation of other cholestatic parameters (ALP, GGT). Isolated bilirubin can be seen in conjunction with drugs that inhibit bilirubin conjugation or excretion, but both scenarios do not typically represent liver injury. Alternative causes of bilirubin elevation should, therefore, be ruled out before basing dose modification decisions on bilirubin values alone.
		  	TREATMENT CONDITIONS 21	Interval: --	Occurrences: --	Comments:	Asymptomatic amylase and/or lipase elevation - 
o Grade 3, not associated with symptoms or clinical manifestations of pancreatitis: May continue study treatment. If levels do not resolve to LESS than or EQUAL to Grade 2 within LESS than or EQUAL to 14 days after the initial report, interrupt study treatment.  Upon resolution to ? Grade 2, consider resuming study treatment.
		  	TREATMENT CONDITIONS 22	Interval: --	Occurrences: --	Comments:	Renal / Serum Creatinine - 
o Grade 2:  Interrupt Study Treatment. Manage per institutional Practice. Upon resolution to LESS than Grade 1, consider resuming study treatment. 
o Grade 3 or Grade 4: Permanently Discontinue Study Treatment.
		  	TREATMENT CONDITIONS 23	Interval: --	Occurrences: --	Comments:	Hyperthyroidism - 
o Grade 2: Consider Continuing Study Treatment and Management according to institutional practice. 
o Grade 3: Interrupt study treatment. Upon resolution to Grade ? 1 with appropriate management, consider resuming study treatment without dose modification. 
o Grade 4: Must discontinue and manage according to local/institutional guidance.
		  	TREATMENT CONDITIONS 24	Interval: --	Occurrences: --	Comments:	Other Endocrine Disorders - 
o Grade 2 and Grade 3: Interrupt study treatment. Upon resolution to Grade LESS than or EQUAL to 1 with appropriate management, consider resuming study treatment.
		  	TREATMENT CONDITIONS 25	Interval: --	Occurrences: --	Comments:	Dermatology (rash) - 
o Grade 1: Continue study treatment. Consider topical steroids, antihistamines, topical emollients. 
o Grade 2: Consider interrupting study treatment. Topical or oral steroids, antihistamines. If study treatment is held and resolution to LESS than or EQUAL to Grade 1, resume study treatment. 
o Grade 3: Interrupt study treatment. Manage per institutional practice. After resolution to LESS than or EQUAL to Grade 1, consider resuming study treatment after consultation with dermatologist. 
o Grade 4 or Stevens-Johnson syndrome (SJS), or Lyell syndrome/toxic epidermal necrolysis (TEN): Permanently discontinue study treatment and manage according to local/institutional guidance.
		  	TREATMENT CONDITIONS 26	Interval: --	Occurrences: --	Comments:	Neutropenia - 
o Grade 3: Interrupt study treatment until resolved to LESS than or EQUAL to Grade 1 or baseline, then resume study medication. 
o Grade 4: Interrupt study treatment. If resolved in LESS than or EQUAL to 7 days, maintain study treatment.  

Febrile Neutropenia - 
o Grade 3: Interrupt study treatment. Upon resolution of fever and improvement of neutropenia to LESS than or EQUAL to Grade 1 or baseline, resume study treatment. 
o Grade 4: Permanently discontinue study treatment. 

Thrombocytopenia - 
o Grade 3: Interrupt study treatment. Upon resolution to ? Grade 2 or baseline, resume study treatment. For Grade 3 associated with major bleeding, permanently discontinue study treatment. 
o Grade 4: Permanently discontinue study treatment. 

Anemia - 
o Grade 3 or Grade 4: Interrupt study treatment. Upon resolution to LESS than or EQUAL to Grade 2 or baseline within LESS than or EQUAL to 7 days, resume study treatment.
		  	TREATMENT CONDITIONS 27	Interval: --	Occurrences: --	Comments:	Other laboratory adverse events, not specified elsewhere in table and not included in the consensus guidelines - 
o Grade 3 or Grade 4: Interrupt study treatment. Upon resolution to LESS than or EQUAL to Grade 1, resume study treatment without dose modification. Isolated Grade 4 electrolyte abnormalities not associated with clinical sequelae and corrected after appropriate management within 72 hours of their onset do not require discontinuation. In the case of Grade 4 electrolyte imbalances associated with clinical sequelae, or not resolved to LESS than or EQUAL to Grade 1 within 72 hours despite appropriate management, permanently discontinue study treatment. 

Other non-laboratory adverse events, not specified elsewhere in table and not included in the consensus guidelines:
o Grade 2: Consider study treatment interruption. Upon resolution to ? Grade 1, consider resuming study treatment. 
o Grade 3: Interrupt study treatment. Upon resolution to LESS than or EQUAL to Grade 1, resuming study treatment must be discussed with the relevant medical expert. 
o Grade 4: Permanently discontinue study treatment.
			Nursing Orders
  	ONC NURSING COMMUNICATION 60	Interval: --	Occurrences: --	Comments:	Concomitant Medications
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Prior Concomitant Procedures and significant non-drug therapies
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Calculate indirect bilirubin
		  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	Actigraphy
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	Adverse Events
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Serious Adverse Events
		  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	Health Resource Utilization
			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
☑	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --	Comments:	As clinically indicated
		☑	T3, FREE	Interval: --	Occurrences: --	Comments:	As clinically indicated
		☑	T4, FREE	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
☑	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated
		☑	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
  	URIC ACID LEVEL	Interval: --	Occurrences: --			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Labs
  	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --			Labs
  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
☑	CREATININE CLEARANCE, URINE, 24 HOUR	Interval: --	Occurrences: --		☑	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --		☑	BILIRUBIN DIRECT	Interval: --	Occurrences: --		☑	AMYLASE LEVEL	Interval: --	Occurrences: --		☑	LIPASE LEVEL	Interval: --	Occurrences: --		☑	GGT	Interval: --	Occurrences: --		☑	HEMOGLOBIN A1C	Interval: --	Occurrences: --	Comments:	As clinically indicated
		☑	NABFERON IFN-B ANTIBODY - ATHENA	Interval: --	Occurrences: --	Comments:	Anytime when suspected Cytokine Release Syndrome Occurs
		☑	INTERLEUKIN 6	Interval: --	Occurrences: --	Comments:	Anytime when suspected Cytokine Release Syndrome Occurs
		☑	MISCELLANEOUS REFERRAL TEST	Interval: --	Occurrences: --	Comments:	Interleukin 1 - Anytime when suspected Cytokine Release Syndrome Occurs
		☑	TUMOR NECROSIS FACTOR - ALPHA	Interval: --	Occurrences: --	Comments:	Anytime when suspected Cytokine Release Syndrome Occurs. 
Perform ONLY at HMH and HMCL.
			Imaging
☑	CT HEAD W WO CONTRAST	Interval: --	Occurrences: --	Comments:	As clinically indicated. Or MRI
		☐	MRI BRAIN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	As clinically indicated. Or CT
		☑	CV ECHOCARDIOGRAM RESEARCH ONLY	Interval: --	Occurrences: --	Comments:	As clinically indicated.
		☑	NM BONE SCAN WHOLE BODY	Interval: --	Occurrences: --	Comments:	As clinically indicated.
		☑	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	If Clinically Indicated Localized bone CT scan, MRI or Xray.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mEq/L; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 28	Interval: --	Occurrences: --	Comments:	o ANC LESS than 1000; 
o Platelets LESS than 100,000; 
o Bilirubin GREATER than 1.6; 
o LFTs GREATER than 10 x ULN.
			Pre-Medications
  	ondansetron (ZOFRAN) IV 8 mg	Dose: 8 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to chemo.			Chemotherapy
  	NAB-PACLItaxel (ABRAXANE) chemo infusion 125 mg/m2 (Treatment Plan)	Dose: 125 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes		  	gemcitabine (GEMZAR) 1,000 mg/m2 in sodium chloride 0.9% 250 mL chemo IVPB	Dose: 1,000 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 60 Minutes	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	GEMCITABINE 200 MG/5.26 ML (38 MG/ML) INTRAVENOUS SOLUTION	Medications	1,000 mg/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	 	No	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	fexofenadine (ALLEGRA) tablet 180 mg	Dose: 180 mg	Route: oral	PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 15	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Line Flush
  	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Use with NIS793		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Do NOT administer with NIS793			Nursing Orders
  	dextrose 5% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open for NIS793		  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.  Do NOT administer with NIS793			Nursing Orders
  	TREATMENT CONDITIONS 12	Interval: --	Occurrences: --	Comments:	Infusion Reaction or Hypersensitivity Reaction - 
o Grade 1-Infusion Reaction or Hypersensitivity Reaction: Decrease infusion rate until recovery from the symptoms. If the infusion reaction happens after the end of infusion (EOI), increase monitoring of vital signs until the participant is symptoms free. Administer subsequent NIS793 infusion at the same rate. 
o Grade 2- Infusion Reaction or Hypersensitivity Reaction: Stop infusion immediately and keep line open. Follow institutional guidelines for the management and follow-up of infusion reaction. Restart infusion at 50% of previous rate under continuous observation. Ensure that there is a minimum observation period of 1 hour prior to restarting the infusion. If the AE recurs at the reinitiated slower rate of infusion, and despite oral pre-medication, permanently discontinue study treatment. 
o Grade 3 or Grade 4- Infusion Reaction or Hypersensitivity Reaction: Stop infusion immediately and keep line open. Follow institutional guidelines for the management and follow-up of infusion reaction. Provide supplemental oxygen, fluids, and other resuscitative measures as needed. Monitor vital signs (e.g. blood pressure, pulse, respiration, and temperature) every 15 ± 5 minutes until resolution.
		  	TREATMENT CONDITIONS 13	Interval: --	Occurrences: --	Comments:	Cytokine Release Syndrome (CRS) - 
o Grade 2: Stop infusion immediately and keep line open. Follow institutional guidelines for the management and follow-up of infusion reaction. Restart infusion at 50% of previous rate under continuous observation. Ensure that there is a minimum observation period of 1 hour prior to restarting the infusion. If the AE recurs at the reinitiated slower rate of infusion, and despite oral pre-medication, permanently discontinue study treatment. 
o Grade 3 or 4: Permanently discontinue study treatment. Follow-up CRS as per institutional guidelines.
		  	TREATMENT CONDITIONS 14	Interval: --	Occurrences: --	Comments:	Ocular (e.g. Conjunctivitis, Blepharitis, blurred vision) - 
o Grade 1: May continue study treatment. Consider ophthalmology consultation. 
o Grade 2: Ophthalmology consultation. Upon resolution to LESS than or EQUAL to Grade 1 consider resuming study treatment in consultation with ophthalmologist. 
o Grade 3: 
1. Interrupt study treatment. 
2. Ophthalmology consultation. 
3. Upon resolution to LESS than or EQUAL to Grade 1 consider resuming study treatment in consultation with ophthalmologist.
o Grade 4:  Permanently discontinue study treatment.
		  	TREATMENT CONDITIONS 15	Interval: --	Occurrences: --	Comments:	Cardiovascular - 
o Grade 2 or greater Myocarditis: Permanently discontinue study treatment. 
o Grade 2 Cardiac Valvulopathy and other Cardiac Toxicity: Interrupt study treatment. Repeat echocardiogram and assess cardiac function. Once resolved to Grade ? 1 or baseline, consider re-administration of treatment, if benefit outweighs the potential risk. 
o Grade 3> Cardiac Valvulopathy and other Cardiac Toxicity: Permanently discontinue study treatment.
		  	TREATMENT CONDITIONS 16	Interval: --	Occurrences: --	Comments:	Isolated AST and/or ALT Elevation - 
o Grade 3 AST or ALT >5.0 - 10.0 x ULN: Interrupt treatment. Repeat liver function tests (LFTs) within 48-72 hours, then monitor LFTs weekly until recovery to grade ?1 or to baseline. Then resume treatment at the same dose interval if resolved in LESS than or EQUAL to 14 days; if resolved in GREATER than 14 days, consider administration Q4W instead of Q2W. 
o Grade 3 AST or ALT >10.0 - 20.0 x ULN: Interrupt treatment. Repeat LFTs within 48-72 hours, then monitor LFTs weekly until recovery to grade LESS than or EQUAL to 1 or to baseline, then increase dosing interval for NIS793 from Q2W to Q4W. 
o Grade 4: AST or ALT (>20 x ULN): Permanently discontinue treatment.
		  	TREATMENT CONDITIONS 17	Interval: --	Occurrences: --	Comments:	With abnormal ALT/AST (up to grade 2 - </= 5.0 x ULN) at baseline - 
o ALT/AST > 2.0 x baseline AND > 5.0 x ULN: Interrupt treatment. Repeat LFTs within 48-72 hours, then monitor LFTs weekly until recovery to baseline; Then resume same dose interval if resolved in LESS than or EQUAL to 14 days; if resolved in GREATER than 14 days, increasing dosing from Q2W to Q4W. 
o ALT/AST > 3.0 x baseline AND >10 x ULN: Interrupt treatment. Repeat LFTs within 48-72 hours, then monitor weekly until resolved to baseline; then increase dosing interval from Q2W to Q4W. 
o AST or ALT >20 x ULN (grade 4): Permanently discontinue treatment.
		  	TREATMENT CONDITIONS 18	Interval: --	Occurrences: --	Comments:	Concomitant elevation of AST and/or ALT and total bilirubin with normal AST/ALT and bilirubin at baseline -
o Grade 2 ALT and/or AST elevation (>3.0 x ULN) with bilirubin > 2.0 x ULN (unless Gilbert's syndrome): Interrupt treatment. Assess if case is drug induced liver injury (DILI). If DILI confirmed, permanently discontinue study treatment. For additional information on follow-up of potential drug induced liver injury cases, refer to Section 6.5.5.1. If no DILI confirmed, interrupt treatment, treat the identified cause according to institutional guidelines. Repeat LFTs within 48-72 hours, then monitor weekly, until enzyme levels resolve to LESS than or EQUAL to grade 1 or baseline.  After recovery, re-administration of study treatment could be considered only if Investigator assesses benefit to outweigh the risk. Any decision regarding re-administration of study drugs and dose regimen should be discussed with the Sponsor.
		  	TREATMENT CONDITIONS 19	Interval: --	Occurrences: --	Comments:	With abnormal ALT/AST at baseline - 
o ALT or AST >3.0 x baseline OR ALT or AST >8.0 x ULN [whichever is lower] combined with total bilirubin >2.0 x baseline AND >2.0 x ULN:  Interrupt treatment. Assess if case is drug induced liver injury (DILI). If DILI confirmed, permanently discontinue study treatment. For additional information on follow-up of potential drug induced liver injury cases, refer to Section 6.5.5.1. If no DILI confirmed, interrupt treatment, treat the identified cause according to institutional guidelines. Repeat LFTs within 48-72 hours, then monitor weekly, until enzyme levels resolve to ?grade 1 or baseline.  After recovery, re-administration of study treatment could be considered only if Investigator assesses benefit to outweigh the risk. Any decision regarding re-administration of study drugs and dose regimen should be discussed with the Sponsor.
		  	TREATMENT CONDITIONS 20	Interval: --	Occurrences: --	Comments:	Isolated total bilirubin elevation - 
o Any elevation > ULN: Fractionate bilirubin, evaluate for cholestatic liver injury (e.g. by testing Alkaline Phosphatase (ALP)) or alternative causes of bilirubin elevation (e.g. disease progression [imaging]). Treat alternative causes according to institutional guidelines. 
o Grade 2 (>1.5 - 3.0 ULN): Repeat LFTs within 48-72 hours, then monitor LFTs weekly until resolution to LESS than or EQUAL to grade 1 or to baseline. If isolated bilirubin remains stable at Grade 2, continue treatment at the same dose regimen. 
o Grade 3 (>3.0 - 10 ULN): Interrupt treatment. Repeat LFTs within 48-72 hours, then monitor LFTs weekly until resolution to LESS than or EQUAL to Grade 1 or to baseline. If resolved in ? 14 days, maintain dose regimen; if not resolved in 14 days, permanently discontinue NIS793. (Please see footnote regarding alternative cause/s of bilirubin elevation). 
o Grade 4 (> 10 x ULN): See footnote*. Otherwise, permanently discontinue study treatment. If alternative cause/s is identified and managed, and bilirubin resolves to ? grade 1 or to baseline, resume treatment at the same dose regimen. *An isolated bilirubin elevation is not typical for DILI. Bilirubin can be elevated either as part of a "Hy's law" constellation with a preceding elevation of ALT/AST, or as part of a cholestatic reaction with simultaneous elevation of other cholestatic parameters (ALP, GGT). Isolated bilirubin can be seen in conjunction with drugs that inhibit bilirubin conjugation or excretion, but both scenarios do not typically represent liver injury. Alternative causes of bilirubin elevation should, therefore, be ruled out before basing dose modification decisions on bilirubin values alone.
		  	TREATMENT CONDITIONS 21	Interval: --	Occurrences: --	Comments:	Asymptomatic amylase and/or lipase elevation - 
o Grade 3, not associated with symptoms or clinical manifestations of pancreatitis: May continue study treatment. If levels do not resolve to LESS than or EQUAL to Grade 2 within LESS than or EQUAL to 14 days after the initial report, interrupt study treatment.  Upon resolution to ? Grade 2, consider resuming study treatment.
		  	TREATMENT CONDITIONS 22	Interval: --	Occurrences: --	Comments:	Renal / Serum Creatinine - 
o Grade 2:  Interrupt Study Treatment. Manage per institutional Practice. Upon resolution to LESS than Grade 1, consider resuming study treatment. 
o Grade 3 or Grade 4: Permanently Discontinue Study Treatment.
		  	TREATMENT CONDITIONS 23	Interval: --	Occurrences: --	Comments:	Hyperthyroidism - 
o Grade 2: Consider Continuing Study Treatment and Management according to institutional practice. 
o Grade 3: Interrupt study treatment. Upon resolution to Grade ? 1 with appropriate management, consider resuming study treatment without dose modification. 
o Grade 4: Must discontinue and manage according to local/institutional guidance.
		  	TREATMENT CONDITIONS 24	Interval: --	Occurrences: --	Comments:	Other Endocrine Disorders - 
o Grade 2 and Grade 3: Interrupt study treatment. Upon resolution to Grade LESS than or EQUAL to 1 with appropriate management, consider resuming study treatment.
		  	TREATMENT CONDITIONS 25	Interval: --	Occurrences: --	Comments:	Dermatology (rash) - 
o Grade 1: Continue study treatment. Consider topical steroids, antihistamines, topical emollients. 
o Grade 2: Consider interrupting study treatment. Topical or oral steroids, antihistamines. If study treatment is held and resolution to LESS than or EQUAL to Grade 1, resume study treatment. 
o Grade 3: Interrupt study treatment. Manage per institutional practice. After resolution to LESS than or EQUAL to Grade 1, consider resuming study treatment after consultation with dermatologist. 
o Grade 4 or Stevens-Johnson syndrome (SJS), or Lyell syndrome/toxic epidermal necrolysis (TEN): Permanently discontinue study treatment and manage according to local/institutional guidance.
		  	TREATMENT CONDITIONS 26	Interval: --	Occurrences: --	Comments:	Neutropenia - 
o Grade 3: Interrupt study treatment until resolved to LESS than or EQUAL to Grade 1 or baseline, then resume study medication. 
o Grade 4: Interrupt study treatment. If resolved in LESS than or EQUAL to 7 days, maintain study treatment.  

Febrile Neutropenia - 
o Grade 3: Interrupt study treatment. Upon resolution of fever and improvement of neutropenia to LESS than or EQUAL to Grade 1 or baseline, resume study treatment. 
o Grade 4: Permanently discontinue study treatment. 

Thrombocytopenia - 
o Grade 3: Interrupt study treatment. Upon resolution to ? Grade 2 or baseline, resume study treatment. For Grade 3 associated with major bleeding, permanently discontinue study treatment. 
o Grade 4: Permanently discontinue study treatment. 

Anemia - 
o Grade 3 or Grade 4: Interrupt study treatment. Upon resolution to LESS than or EQUAL to Grade 2 or baseline within LESS than or EQUAL to 7 days, resume study treatment.
		  	TREATMENT CONDITIONS 27	Interval: --	Occurrences: --	Comments:	Other laboratory adverse events, not specified elsewhere in table and not included in the consensus guidelines - 
o Grade 3 or Grade 4: Interrupt study treatment. Upon resolution to LESS than or EQUAL to Grade 1, resume study treatment without dose modification. Isolated Grade 4 electrolyte abnormalities not associated with clinical sequelae and corrected after appropriate management within 72 hours of their onset do not require discontinuation. In the case of Grade 4 electrolyte imbalances associated with clinical sequelae, or not resolved to LESS than or EQUAL to Grade 1 within 72 hours despite appropriate management, permanently discontinue study treatment. 

Other non-laboratory adverse events, not specified elsewhere in table and not included in the consensus guidelines:
o Grade 2: Consider study treatment interruption. Upon resolution to ? Grade 1, consider resuming study treatment. 
o Grade 3: Interrupt study treatment. Upon resolution to LESS than or EQUAL to Grade 1, resuming study treatment must be discussed with the relevant medical expert. 
o Grade 4: Permanently discontinue study treatment.
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Dose Modifications and Dose Interruption for NIS793: 
No Dose Reductions are allowed for NIS793: Increasing the dosing interval from Q2W to Q4W is allowed under circumstances described in Table 6-5. If NIS793 is interrupted or delayed for GREATER than 8 weeks due to toxicity that is suspected to be related to treatment, study treatment should be permanently discontinued.
			Nursing Orders
  	ONC NURSING COMMUNICATION 60	Interval: --	Occurrences: --	Comments:	Concomitant Medications
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Prior Concomitant Procedures and significant non-drug therapies
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	Physical Examination
		  	ONC NURSING COMMUNICATION 62	Interval: --	Occurrences: --	Comments:	ECOG
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Calculate indirect bilirubin
		  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	Actigraphy
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	Adverse Events
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Serious Adverse Events
		  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	Health Resource Utilization
			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
☑	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --	Comments:	As clinically indicated
		☑	T3, FREE	Interval: --	Occurrences: --	Comments:	As clinically indicated
		☑	T4, FREE	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
☑	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated
		☑	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
  	URIC ACID LEVEL	Interval: --	Occurrences: --			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Labs
  	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --			Labs
  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
☑	CREATININE CLEARANCE, URINE, 24 HOUR	Interval: --	Occurrences: --		☑	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --		☑	BILIRUBIN DIRECT	Interval: --	Occurrences: --		☑	AMYLASE LEVEL	Interval: --	Occurrences: --		☑	LIPASE LEVEL	Interval: --	Occurrences: --		☑	GGT	Interval: --	Occurrences: --		☑	HEMOGLOBIN A1C	Interval: --	Occurrences: --	Comments:	As clinically indicated
		☑	NABFERON IFN-B ANTIBODY - ATHENA	Interval: --	Occurrences: --	Comments:	Anytime when suspected Cytokine Release Syndrome Occurs
		☑	INTERLEUKIN 6	Interval: --	Occurrences: --	Comments:	Anytime when suspected Cytokine Release Syndrome Occurs
		☑	MISCELLANEOUS REFERRAL TEST	Interval: --	Occurrences: --	Comments:	Interleukin 1 - Anytime when suspected Cytokine Release Syndrome Occurs
		☑	TUMOR NECROSIS FACTOR - ALPHA	Interval: --	Occurrences: --	Comments:	Anytime when suspected Cytokine Release Syndrome Occurs. 
Perform ONLY at HMH and HMCL.
			Imaging
☑	CT HEAD W WO CONTRAST	Interval: --	Occurrences: --	Comments:	As clinically indicated. Or MRI
		☐	MRI BRAIN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	As clinically indicated. Or CT
		☑	CV ECHOCARDIOGRAM RESEARCH ONLY	Interval: --	Occurrences: --	Comments:	As clinically indicated.
		☑	NM BONE SCAN WHOLE BODY	Interval: --	Occurrences: --	Comments:	As clinically indicated.
		☑	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	If Clinically Indicated Localized bone CT scan, MRI or Xray.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mEq/L; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 28	Interval: --	Occurrences: --	Comments:	o ANC LESS than 1000; 
o Platelets LESS than 100,000; 
o Bilirubin GREATER than 1.6; 
o LFTs GREATER than 10 x ULN.
			Pre-Medications
  	ondansetron (ZOFRAN) IV 8 mg	Dose: 8 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to chemo.			Nursing Orders
  	ONC NURSING COMMUNICATION 68	Interval: --	Occurrences: --	Comments:	Infusion must take place in a facility with appropriate resuscitation equipment available at the bedside, and a physician readily available during the period of drug administration.
		  	ONC NURSING COMMUNICATION 69	Interval: --	Occurrences: --	Comments:	Participants should be closely observed for potential infusion-related reactions including rigors, chills, wheezing, pruritus, flushing, rash, hypotension, hypoxemia, and fever, and vital signs monitored more frequently if clinically indicated, during and for at least 2 hours after the first two NIS793 infusions. The same may apply for subsequent NIS793 infusions if medically indicated. Participants should notify study personnel if symptoms of infusion reaction occur after any NIS793 infusion.
			Chemotherapy
  	INV-NIS793 or placebo (CNIS793B12301 daNIS-2/Pro00032923/Abdelrahim) 2,100 mg in dextrose 5% 100 mL	Dose: 2,100 mg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Protect from light.  Administer intravenously using a 0.2 micron inline filter over 30 minutes.  Flush only with D5W!
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.

	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-NIS793 OR PLACEBO 1050MG/10ML INTRAVENOUS SOLN. (CNIS793B12301 DANIS-2/PRO00032923/ABDELRAHIM)	Medications	2,100 mg	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	80 mL	Yes	Yes			  	NAB-PACLItaxel (ABRAXANE) chemo infusion 125 mg/m2 (Treatment Plan)	Dose: 125 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 3 Hours		  	gemcitabine (GEMZAR) 1,000 mg/m2 in sodium chloride 0.9% 250 mL chemo IVPB	Dose: 1,000 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 3.5 Hours	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	GEMCITABINE 200 MG/5.26 ML (38 MG/ML) INTRAVENOUS SOLUTION	Medications	1,000 mg/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	 	No	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	fexofenadine (ALLEGRA) tablet 180 mg	Dose: 180 mg	Route: oral	PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 6	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Line Flush
  	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Use with NIS793		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Do NOT administer with NIS793			Nursing Orders
  	dextrose 5% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open for NIS793		  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.  Do NOT administer with NIS793			Nursing Orders
  	TREATMENT CONDITIONS 12	Interval: --	Occurrences: --	Comments:	Infusion Reaction or Hypersensitivity Reaction - 
o Grade 1-Infusion Reaction or Hypersensitivity Reaction: Decrease infusion rate until recovery from the symptoms. If the infusion reaction happens after the end of infusion (EOI), increase monitoring of vital signs until the participant is symptoms free. Administer subsequent NIS793 infusion at the same rate. 
o Grade 2- Infusion Reaction or Hypersensitivity Reaction: Stop infusion immediately and keep line open. Follow institutional guidelines for the management and follow-up of infusion reaction. Restart infusion at 50% of previous rate under continuous observation. Ensure that there is a minimum observation period of 1 hour prior to restarting the infusion. If the AE recurs at the reinitiated slower rate of infusion, and despite oral pre-medication, permanently discontinue study treatment. 
o Grade 3 or Grade 4- Infusion Reaction or Hypersensitivity Reaction: Stop infusion immediately and keep line open. Follow institutional guidelines for the management and follow-up of infusion reaction. Provide supplemental oxygen, fluids, and other resuscitative measures as needed. Monitor vital signs (e.g. blood pressure, pulse, respiration, and temperature) every 15 ± 5 minutes until resolution.
		  	TREATMENT CONDITIONS 13	Interval: --	Occurrences: --	Comments:	Cytokine Release Syndrome (CRS) - 
o Grade 2: Stop infusion immediately and keep line open. Follow institutional guidelines for the management and follow-up of infusion reaction. Restart infusion at 50% of previous rate under continuous observation. Ensure that there is a minimum observation period of 1 hour prior to restarting the infusion. If the AE recurs at the reinitiated slower rate of infusion, and despite oral pre-medication, permanently discontinue study treatment. 
o Grade 3 or 4: Permanently discontinue study treatment. Follow-up CRS as per institutional guidelines.
		  	TREATMENT CONDITIONS 14	Interval: --	Occurrences: --	Comments:	Ocular (e.g. Conjunctivitis, Blepharitis, blurred vision) - 
o Grade 1: May continue study treatment. Consider ophthalmology consultation. 
o Grade 2: Ophthalmology consultation. Upon resolution to LESS than or EQUAL to Grade 1 consider resuming study treatment in consultation with ophthalmologist. 
o Grade 3: 
1. Interrupt study treatment. 
2. Ophthalmology consultation. 
3. Upon resolution to LESS than or EQUAL to Grade 1 consider resuming study treatment in consultation with ophthalmologist.
o Grade 4:  Permanently discontinue study treatment.
		  	TREATMENT CONDITIONS 15	Interval: --	Occurrences: --	Comments:	Cardiovascular - 
o Grade 2 or greater Myocarditis: Permanently discontinue study treatment. 
o Grade 2 Cardiac Valvulopathy and other Cardiac Toxicity: Interrupt study treatment. Repeat echocardiogram and assess cardiac function. Once resolved to Grade ? 1 or baseline, consider re-administration of treatment, if benefit outweighs the potential risk. 
o Grade 3> Cardiac Valvulopathy and other Cardiac Toxicity: Permanently discontinue study treatment.
		  	TREATMENT CONDITIONS 16	Interval: --	Occurrences: --	Comments:	Isolated AST and/or ALT Elevation - 
o Grade 3 AST or ALT >5.0 - 10.0 x ULN: Interrupt treatment. Repeat liver function tests (LFTs) within 48-72 hours, then monitor LFTs weekly until recovery to grade ?1 or to baseline. Then resume treatment at the same dose interval if resolved in LESS than or EQUAL to 14 days; if resolved in GREATER than 14 days, consider administration Q4W instead of Q2W. 
o Grade 3 AST or ALT >10.0 - 20.0 x ULN: Interrupt treatment. Repeat LFTs within 48-72 hours, then monitor LFTs weekly until recovery to grade LESS than or EQUAL to 1 or to baseline, then increase dosing interval for NIS793 from Q2W to Q4W. 
o Grade 4: AST or ALT (>20 x ULN): Permanently discontinue treatment.
		  	TREATMENT CONDITIONS 17	Interval: --	Occurrences: --	Comments:	With abnormal ALT/AST (up to grade 2 - </= 5.0 x ULN) at baseline - 
o ALT/AST > 2.0 x baseline AND > 5.0 x ULN: Interrupt treatment. Repeat LFTs within 48-72 hours, then monitor LFTs weekly until recovery to baseline; Then resume same dose interval if resolved in LESS than or EQUAL to 14 days; if resolved in GREATER than 14 days, increasing dosing from Q2W to Q4W. 
o ALT/AST > 3.0 x baseline AND >10 x ULN: Interrupt treatment. Repeat LFTs within 48-72 hours, then monitor weekly until resolved to baseline; then increase dosing interval from Q2W to Q4W. 
o AST or ALT >20 x ULN (grade 4): Permanently discontinue treatment.
		  	TREATMENT CONDITIONS 18	Interval: --	Occurrences: --	Comments:	Concomitant elevation of AST and/or ALT and total bilirubin with normal AST/ALT and bilirubin at baseline -
o Grade 2 ALT and/or AST elevation (>3.0 x ULN) with bilirubin > 2.0 x ULN (unless Gilbert's syndrome): Interrupt treatment. Assess if case is drug induced liver injury (DILI). If DILI confirmed, permanently discontinue study treatment. For additional information on follow-up of potential drug induced liver injury cases, refer to Section 6.5.5.1. If no DILI confirmed, interrupt treatment, treat the identified cause according to institutional guidelines. Repeat LFTs within 48-72 hours, then monitor weekly, until enzyme levels resolve to LESS than or EQUAL to grade 1 or baseline.  After recovery, re-administration of study treatment could be considered only if Investigator assesses benefit to outweigh the risk. Any decision regarding re-administration of study drugs and dose regimen should be discussed with the Sponsor.
		  	TREATMENT CONDITIONS 19	Interval: --	Occurrences: --	Comments:	With abnormal ALT/AST at baseline - 
o ALT or AST >3.0 x baseline OR ALT or AST >8.0 x ULN [whichever is lower] combined with total bilirubin >2.0 x baseline AND >2.0 x ULN:  Interrupt treatment. Assess if case is drug induced liver injury (DILI). If DILI confirmed, permanently discontinue study treatment. For additional information on follow-up of potential drug induced liver injury cases, refer to Section 6.5.5.1. If no DILI confirmed, interrupt treatment, treat the identified cause according to institutional guidelines. Repeat LFTs within 48-72 hours, then monitor weekly, until enzyme levels resolve to ?grade 1 or baseline.  After recovery, re-administration of study treatment could be considered only if Investigator assesses benefit to outweigh the risk. Any decision regarding re-administration of study drugs and dose regimen should be discussed with the Sponsor.
		  	TREATMENT CONDITIONS 20	Interval: --	Occurrences: --	Comments:	Isolated total bilirubin elevation - 
o Any elevation > ULN: Fractionate bilirubin, evaluate for cholestatic liver injury (e.g. by testing Alkaline Phosphatase (ALP)) or alternative causes of bilirubin elevation (e.g. disease progression [imaging]). Treat alternative causes according to institutional guidelines. 
o Grade 2 (>1.5 - 3.0 ULN): Repeat LFTs within 48-72 hours, then monitor LFTs weekly until resolution to LESS than or EQUAL to grade 1 or to baseline. If isolated bilirubin remains stable at Grade 2, continue treatment at the same dose regimen. 
o Grade 3 (>3.0 - 10 ULN): Interrupt treatment. Repeat LFTs within 48-72 hours, then monitor LFTs weekly until resolution to LESS than or EQUAL to Grade 1 or to baseline. If resolved in ? 14 days, maintain dose regimen; if not resolved in 14 days, permanently discontinue NIS793. (Please see footnote regarding alternative cause/s of bilirubin elevation). 
o Grade 4 (> 10 x ULN): See footnote*. Otherwise, permanently discontinue study treatment. If alternative cause/s is identified and managed, and bilirubin resolves to ? grade 1 or to baseline, resume treatment at the same dose regimen. *An isolated bilirubin elevation is not typical for DILI. Bilirubin can be elevated either as part of a "Hy's law" constellation with a preceding elevation of ALT/AST, or as part of a cholestatic reaction with simultaneous elevation of other cholestatic parameters (ALP, GGT). Isolated bilirubin can be seen in conjunction with drugs that inhibit bilirubin conjugation or excretion, but both scenarios do not typically represent liver injury. Alternative causes of bilirubin elevation should, therefore, be ruled out before basing dose modification decisions on bilirubin values alone.
		  	TREATMENT CONDITIONS 21	Interval: --	Occurrences: --	Comments:	Asymptomatic amylase and/or lipase elevation - 
o Grade 3, not associated with symptoms or clinical manifestations of pancreatitis: May continue study treatment. If levels do not resolve to LESS than or EQUAL to Grade 2 within LESS than or EQUAL to 14 days after the initial report, interrupt study treatment.  Upon resolution to ? Grade 2, consider resuming study treatment.
		  	TREATMENT CONDITIONS 22	Interval: --	Occurrences: --	Comments:	Renal / Serum Creatinine - 
o Grade 2:  Interrupt Study Treatment. Manage per institutional Practice. Upon resolution to LESS than Grade 1, consider resuming study treatment. 
o Grade 3 or Grade 4: Permanently Discontinue Study Treatment.
		  	TREATMENT CONDITIONS 23	Interval: --	Occurrences: --	Comments:	Hyperthyroidism - 
o Grade 2: Consider Continuing Study Treatment and Management according to institutional practice. 
o Grade 3: Interrupt study treatment. Upon resolution to Grade ? 1 with appropriate management, consider resuming study treatment without dose modification. 
o Grade 4: Must discontinue and manage according to local/institutional guidance.
		  	TREATMENT CONDITIONS 24	Interval: --	Occurrences: --	Comments:	Other Endocrine Disorders - 
o Grade 2 and Grade 3: Interrupt study treatment. Upon resolution to Grade LESS than or EQUAL to 1 with appropriate management, consider resuming study treatment.
		  	TREATMENT CONDITIONS 25	Interval: --	Occurrences: --	Comments:	Dermatology (rash) - 
o Grade 1: Continue study treatment. Consider topical steroids, antihistamines, topical emollients. 
o Grade 2: Consider interrupting study treatment. Topical or oral steroids, antihistamines. If study treatment is held and resolution to LESS than or EQUAL to Grade 1, resume study treatment. 
o Grade 3: Interrupt study treatment. Manage per institutional practice. After resolution to LESS than or EQUAL to Grade 1, consider resuming study treatment after consultation with dermatologist. 
o Grade 4 or Stevens-Johnson syndrome (SJS), or Lyell syndrome/toxic epidermal necrolysis (TEN): Permanently discontinue study treatment and manage according to local/institutional guidance.
		  	TREATMENT CONDITIONS 26	Interval: --	Occurrences: --	Comments:	Neutropenia - 
o Grade 3: Interrupt study treatment until resolved to LESS than or EQUAL to Grade 1 or baseline, then resume study medication. 
o Grade 4: Interrupt study treatment. If resolved in LESS than or EQUAL to 7 days, maintain study treatment.  

Febrile Neutropenia - 
o Grade 3: Interrupt study treatment. Upon resolution of fever and improvement of neutropenia to LESS than or EQUAL to Grade 1 or baseline, resume study treatment. 
o Grade 4: Permanently discontinue study treatment. 

Thrombocytopenia - 
o Grade 3: Interrupt study treatment. Upon resolution to ? Grade 2 or baseline, resume study treatment. For Grade 3 associated with major bleeding, permanently discontinue study treatment. 
o Grade 4: Permanently discontinue study treatment. 

Anemia - 
o Grade 3 or Grade 4: Interrupt study treatment. Upon resolution to LESS than or EQUAL to Grade 2 or baseline within LESS than or EQUAL to 7 days, resume study treatment.
		  	TREATMENT CONDITIONS 27	Interval: --	Occurrences: --	Comments:	Other laboratory adverse events, not specified elsewhere in table and not included in the consensus guidelines - 
o Grade 3 or Grade 4: Interrupt study treatment. Upon resolution to LESS than or EQUAL to Grade 1, resume study treatment without dose modification. Isolated Grade 4 electrolyte abnormalities not associated with clinical sequelae and corrected after appropriate management within 72 hours of their onset do not require discontinuation. In the case of Grade 4 electrolyte imbalances associated with clinical sequelae, or not resolved to LESS than or EQUAL to Grade 1 within 72 hours despite appropriate management, permanently discontinue study treatment. 

Other non-laboratory adverse events, not specified elsewhere in table and not included in the consensus guidelines:
o Grade 2: Consider study treatment interruption. Upon resolution to ? Grade 1, consider resuming study treatment. 
o Grade 3: Interrupt study treatment. Upon resolution to LESS than or EQUAL to Grade 1, resuming study treatment must be discussed with the relevant medical expert. 
o Grade 4: Permanently discontinue study treatment.
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Dose Modifications and Dose Interruption for NIS793: 
No Dose Reductions are allowed for NIS793: Increasing the dosing interval from Q2W to Q4W is allowed under circumstances described in Table 6-5. If NIS793 is interrupted or delayed for GREATER than 8 weeks due to toxicity that is suspected to be related to treatment, study treatment should be permanently discontinued.
			Nursing Orders
  	ONC NURSING COMMUNICATION 60	Interval: --	Occurrences: --	Comments:	Concomitant Medications
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Prior Concomitant Procedures and significant non-drug therapies
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	Physical Examination
		  	ONC NURSING COMMUNICATION 62	Interval: --	Occurrences: --	Comments:	ECOG
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Calculate indirect bilirubin
		  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	PRO-CTCAE, FACT-GP5 (ePRO)
		  	ONC NURSING COMMUNICATION 38	Interval: --	Occurrences: --	Comments:	PROMIS-29 (ePRO)
		  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	Actigraphy
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	Adverse Events
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Serious Adverse Events
		  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	Health Resource Utilization
			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
☑	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --	Comments:	As clinically indicated
		☑	T3, FREE	Interval: --	Occurrences: --	Comments:	As clinically indicated
		☑	T4, FREE	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
☑	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated
		☑	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
  	URIC ACID LEVEL	Interval: --	Occurrences: --			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Labs
  	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --			Labs
  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --			Labs
☑	CREATININE CLEARANCE, URINE, 24 HOUR	Interval: --	Occurrences: --		☑	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --		☑	BILIRUBIN DIRECT	Interval: --	Occurrences: --		☑	AMYLASE LEVEL	Interval: --	Occurrences: --		☑	LIPASE LEVEL	Interval: --	Occurrences: --		☑	GGT	Interval: --	Occurrences: --		☑	HEMOGLOBIN A1C	Interval: --	Occurrences: --	Comments:	As clinically indicated
		☑	NABFERON IFN-B ANTIBODY - ATHENA	Interval: --	Occurrences: --	Comments:	Anytime when suspected Cytokine Release Syndrome Occurs
		☑	INTERLEUKIN 6	Interval: --	Occurrences: --	Comments:	Anytime when suspected Cytokine Release Syndrome Occurs
		☑	MISCELLANEOUS REFERRAL TEST	Interval: --	Occurrences: --	Comments:	Interleukin 1 - Anytime when suspected Cytokine Release Syndrome Occurs
		☑	TUMOR NECROSIS FACTOR - ALPHA	Interval: --	Occurrences: --	Comments:	Anytime when suspected Cytokine Release Syndrome Occurs. 
Perform ONLY at HMH and HMCL.
			Imaging
☑	CT HEAD W WO CONTRAST	Interval: --	Occurrences: --	Comments:	As clinically indicated. Or MRI
		☐	MRI BRAIN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	As clinically indicated. Or CT
		☑	CV ECHOCARDIOGRAM RESEARCH ONLY	Interval: --	Occurrences: --	Comments:	As clinically indicated.
		☑	NM BONE SCAN WHOLE BODY	Interval: --	Occurrences: --	Comments:	As clinically indicated.
		☑	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	If Clinically Indicated Localized bone CT scan, MRI or Xray.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mEq/L; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 28	Interval: --	Occurrences: --	Comments:	o ANC LESS than 1000; 
o Platelets LESS than 100,000; 
o Bilirubin GREATER than 1.6; 
o LFTs GREATER than 10 x ULN.
			Pre-Medications
  	ondansetron (ZOFRAN) IV 8 mg	Dose: 8 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to chemo.			Nursing Orders
  	ONC NURSING COMMUNICATION 68	Interval: --	Occurrences: --	Comments:	Infusion must take place in a facility with appropriate resuscitation equipment available at the bedside, and a physician readily available during the period of drug administration.
		  	ONC NURSING COMMUNICATION 69	Interval: --	Occurrences: --	Comments:	Participants should be closely observed for potential infusion-related reactions including rigors, chills, wheezing, pruritus, flushing, rash, hypotension, hypoxemia, and fever, and vital signs monitored more frequently if clinically indicated, during and for at least 2 hours after the first two NIS793 infusions. The same may apply for subsequent NIS793 infusions if medically indicated. Participants should notify study personnel if symptoms of infusion reaction occur after any NIS793 infusion.
			Chemotherapy
  	INV-NIS793 or placebo (CNIS793B12301 daNIS-2/Pro00032923/Abdelrahim) 2,100 mg in dextrose 5% 100 mL	Dose: 2,100 mg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Protect from light.  Administer intravenously using a 0.2 micron inline filter over 30 minutes.  Flush only with D5W!
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.

	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-NIS793 OR PLACEBO 1050MG/10ML INTRAVENOUS SOLN. (CNIS793B12301 DANIS-2/PRO00032923/ABDELRAHIM)	Medications	2,100 mg	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	80 mL	Yes	Yes			  	NAB-PACLItaxel (ABRAXANE) chemo infusion 125 mg/m2 (Treatment Plan)	Dose: 125 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 3 Hours		  	gemcitabine (GEMZAR) 1,000 mg/m2 in sodium chloride 0.9% 250 mL chemo IVPB	Dose: 1,000 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 3.5 Hours	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	GEMCITABINE 200 MG/5.26 ML (38 MG/ML) INTRAVENOUS SOLUTION	Medications	1,000 mg/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	 	No	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	fexofenadine (ALLEGRA) tablet 180 mg	Dose: 180 mg	Route: oral	PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 8	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Line Flush
  	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Nursing Orders
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Nursing Orders
  	TREATMENT CONDITIONS 12	Interval: --	Occurrences: --	Comments:	Infusion Reaction or Hypersensitivity Reaction - 
o Grade 1-Infusion Reaction or Hypersensitivity Reaction: Decrease infusion rate until recovery from the symptoms. If the infusion reaction happens after the end of infusion (EOI), increase monitoring of vital signs until the participant is symptoms free. Administer subsequent NIS793 infusion at the same rate. 
o Grade 2- Infusion Reaction or Hypersensitivity Reaction: Stop infusion immediately and keep line open. Follow institutional guidelines for the management and follow-up of infusion reaction. Restart infusion at 50% of previous rate under continuous observation. Ensure that there is a minimum observation period of 1 hour prior to restarting the infusion. If the AE recurs at the reinitiated slower rate of infusion, and despite oral pre-medication, permanently discontinue study treatment. 
o Grade 3 or Grade 4- Infusion Reaction or Hypersensitivity Reaction: Stop infusion immediately and keep line open. Follow institutional guidelines for the management and follow-up of infusion reaction. Provide supplemental oxygen, fluids, and other resuscitative measures as needed. Monitor vital signs (e.g. blood pressure, pulse, respiration, and temperature) every 15 ± 5 minutes until resolution.
		  	TREATMENT CONDITIONS 13	Interval: --	Occurrences: --	Comments:	Cytokine Release Syndrome (CRS) - 
o Grade 2: Stop infusion immediately and keep line open. Follow institutional guidelines for the management and follow-up of infusion reaction. Restart infusion at 50% of previous rate under continuous observation. Ensure that there is a minimum observation period of 1 hour prior to restarting the infusion. If the AE recurs at the reinitiated slower rate of infusion, and despite oral pre-medication, permanently discontinue study treatment. 
o Grade 3 or 4: Permanently discontinue study treatment. Follow-up CRS as per institutional guidelines.
		  	TREATMENT CONDITIONS 14	Interval: --	Occurrences: --	Comments:	Ocular (e.g. Conjunctivitis, Blepharitis, blurred vision) - 
o Grade 1: May continue study treatment. Consider ophthalmology consultation. 
o Grade 2: Ophthalmology consultation. Upon resolution to LESS than or EQUAL to Grade 1 consider resuming study treatment in consultation with ophthalmologist. 
o Grade 3: 
1. Interrupt study treatment. 
2. Ophthalmology consultation. 
3. Upon resolution to LESS than or EQUAL to Grade 1 consider resuming study treatment in consultation with ophthalmologist.
o Grade 4:  Permanently discontinue study treatment.
		  	TREATMENT CONDITIONS 15	Interval: --	Occurrences: --	Comments:	Cardiovascular - 
o Grade 2 or greater Myocarditis: Permanently discontinue study treatment. 
o Grade 2 Cardiac Valvulopathy and other Cardiac Toxicity: Interrupt study treatment. Repeat echocardiogram and assess cardiac function. Once resolved to Grade ? 1 or baseline, consider re-administration of treatment, if benefit outweighs the potential risk. 
o Grade 3> Cardiac Valvulopathy and other Cardiac Toxicity: Permanently discontinue study treatment.
		  	TREATMENT CONDITIONS 16	Interval: --	Occurrences: --	Comments:	Isolated AST and/or ALT Elevation - 
o Grade 3 AST or ALT >5.0 - 10.0 x ULN: Interrupt treatment. Repeat liver function tests (LFTs) within 48-72 hours, then monitor LFTs weekly until recovery to grade ?1 or to baseline. Then resume treatment at the same dose interval if resolved in LESS than or EQUAL to 14 days; if resolved in GREATER than 14 days, consider administration Q4W instead of Q2W. 
o Grade 3 AST or ALT >10.0 - 20.0 x ULN: Interrupt treatment. Repeat LFTs within 48-72 hours, then monitor LFTs weekly until recovery to grade LESS than or EQUAL to 1 or to baseline, then increase dosing interval for NIS793 from Q2W to Q4W. 
o Grade 4: AST or ALT (>20 x ULN): Permanently discontinue treatment.
		  	TREATMENT CONDITIONS 17	Interval: --	Occurrences: --	Comments:	With abnormal ALT/AST (up to grade 2 - </= 5.0 x ULN) at baseline - 
o ALT/AST > 2.0 x baseline AND > 5.0 x ULN: Interrupt treatment. Repeat LFTs within 48-72 hours, then monitor LFTs weekly until recovery to baseline; Then resume same dose interval if resolved in LESS than or EQUAL to 14 days; if resolved in GREATER than 14 days, increasing dosing from Q2W to Q4W. 
o ALT/AST > 3.0 x baseline AND >10 x ULN: Interrupt treatment. Repeat LFTs within 48-72 hours, then monitor weekly until resolved to baseline; then increase dosing interval from Q2W to Q4W. 
o AST or ALT >20 x ULN (grade 4): Permanently discontinue treatment.
		  	TREATMENT CONDITIONS 18	Interval: --	Occurrences: --	Comments:	Concomitant elevation of AST and/or ALT and total bilirubin with normal AST/ALT and bilirubin at baseline -
o Grade 2 ALT and/or AST elevation (>3.0 x ULN) with bilirubin > 2.0 x ULN (unless Gilbert's syndrome): Interrupt treatment. Assess if case is drug induced liver injury (DILI). If DILI confirmed, permanently discontinue study treatment. For additional information on follow-up of potential drug induced liver injury cases, refer to Section 6.5.5.1. If no DILI confirmed, interrupt treatment, treat the identified cause according to institutional guidelines. Repeat LFTs within 48-72 hours, then monitor weekly, until enzyme levels resolve to LESS than or EQUAL to grade 1 or baseline.  After recovery, re-administration of study treatment could be considered only if Investigator assesses benefit to outweigh the risk. Any decision regarding re-administration of study drugs and dose regimen should be discussed with the Sponsor.
		  	TREATMENT CONDITIONS 19	Interval: --	Occurrences: --	Comments:	With abnormal ALT/AST at baseline - 
o ALT or AST >3.0 x baseline OR ALT or AST >8.0 x ULN [whichever is lower] combined with total bilirubin >2.0 x baseline AND >2.0 x ULN:  Interrupt treatment. Assess if case is drug induced liver injury (DILI). If DILI confirmed, permanently discontinue study treatment. For additional information on follow-up of potential drug induced liver injury cases, refer to Section 6.5.5.1. If no DILI confirmed, interrupt treatment, treat the identified cause according to institutional guidelines. Repeat LFTs within 48-72 hours, then monitor weekly, until enzyme levels resolve to ?grade 1 or baseline.  After recovery, re-administration of study treatment could be considered only if Investigator assesses benefit to outweigh the risk. Any decision regarding re-administration of study drugs and dose regimen should be discussed with the Sponsor.
		  	TREATMENT CONDITIONS 20	Interval: --	Occurrences: --	Comments:	Isolated total bilirubin elevation - 
o Any elevation > ULN: Fractionate bilirubin, evaluate for cholestatic liver injury (e.g. by testing Alkaline Phosphatase (ALP)) or alternative causes of bilirubin elevation (e.g. disease progression [imaging]). Treat alternative causes according to institutional guidelines. 
o Grade 2 (>1.5 - 3.0 ULN): Repeat LFTs within 48-72 hours, then monitor LFTs weekly until resolution to LESS than or EQUAL to grade 1 or to baseline. If isolated bilirubin remains stable at Grade 2, continue treatment at the same dose regimen. 
o Grade 3 (>3.0 - 10 ULN): Interrupt treatment. Repeat LFTs within 48-72 hours, then monitor LFTs weekly until resolution to LESS than or EQUAL to Grade 1 or to baseline. If resolved in ? 14 days, maintain dose regimen; if not resolved in 14 days, permanently discontinue NIS793. (Please see footnote regarding alternative cause/s of bilirubin elevation). 
o Grade 4 (> 10 x ULN): See footnote*. Otherwise, permanently discontinue study treatment. If alternative cause/s is identified and managed, and bilirubin resolves to ? grade 1 or to baseline, resume treatment at the same dose regimen. *An isolated bilirubin elevation is not typical for DILI. Bilirubin can be elevated either as part of a "Hy's law" constellation with a preceding elevation of ALT/AST, or as part of a cholestatic reaction with simultaneous elevation of other cholestatic parameters (ALP, GGT). Isolated bilirubin can be seen in conjunction with drugs that inhibit bilirubin conjugation or excretion, but both scenarios do not typically represent liver injury. Alternative causes of bilirubin elevation should, therefore, be ruled out before basing dose modification decisions on bilirubin values alone.
		  	TREATMENT CONDITIONS 21	Interval: --	Occurrences: --	Comments:	Asymptomatic amylase and/or lipase elevation - 
o Grade 3, not associated with symptoms or clinical manifestations of pancreatitis: May continue study treatment. If levels do not resolve to LESS than or EQUAL to Grade 2 within LESS than or EQUAL to 14 days after the initial report, interrupt study treatment.  Upon resolution to ? Grade 2, consider resuming study treatment.
		  	TREATMENT CONDITIONS 22	Interval: --	Occurrences: --	Comments:	Renal / Serum Creatinine - 
o Grade 2:  Interrupt Study Treatment. Manage per institutional Practice. Upon resolution to LESS than Grade 1, consider resuming study treatment. 
o Grade 3 or Grade 4: Permanently Discontinue Study Treatment.
		  	TREATMENT CONDITIONS 23	Interval: --	Occurrences: --	Comments:	Hyperthyroidism - 
o Grade 2: Consider Continuing Study Treatment and Management according to institutional practice. 
o Grade 3: Interrupt study treatment. Upon resolution to Grade ? 1 with appropriate management, consider resuming study treatment without dose modification. 
o Grade 4: Must discontinue and manage according to local/institutional guidance.
		  	TREATMENT CONDITIONS 24	Interval: --	Occurrences: --	Comments:	Other Endocrine Disorders - 
o Grade 2 and Grade 3: Interrupt study treatment. Upon resolution to Grade LESS than or EQUAL to 1 with appropriate management, consider resuming study treatment.
		  	TREATMENT CONDITIONS 25	Interval: --	Occurrences: --	Comments:	Dermatology (rash) - 
o Grade 1: Continue study treatment. Consider topical steroids, antihistamines, topical emollients. 
o Grade 2: Consider interrupting study treatment. Topical or oral steroids, antihistamines. If study treatment is held and resolution to LESS than or EQUAL to Grade 1, resume study treatment. 
o Grade 3: Interrupt study treatment. Manage per institutional practice. After resolution to LESS than or EQUAL to Grade 1, consider resuming study treatment after consultation with dermatologist. 
o Grade 4 or Stevens-Johnson syndrome (SJS), or Lyell syndrome/toxic epidermal necrolysis (TEN): Permanently discontinue study treatment and manage according to local/institutional guidance.
		  	TREATMENT CONDITIONS 26	Interval: --	Occurrences: --	Comments:	Neutropenia - 
o Grade 3: Interrupt study treatment until resolved to LESS than or EQUAL to Grade 1 or baseline, then resume study medication. 
o Grade 4: Interrupt study treatment. If resolved in LESS than or EQUAL to 7 days, maintain study treatment.  

Febrile Neutropenia - 
o Grade 3: Interrupt study treatment. Upon resolution of fever and improvement of neutropenia to LESS than or EQUAL to Grade 1 or baseline, resume study treatment. 
o Grade 4: Permanently discontinue study treatment. 

Thrombocytopenia - 
o Grade 3: Interrupt study treatment. Upon resolution to ? Grade 2 or baseline, resume study treatment. For Grade 3 associated with major bleeding, permanently discontinue study treatment. 
o Grade 4: Permanently discontinue study treatment. 

Anemia - 
o Grade 3 or Grade 4: Interrupt study treatment. Upon resolution to LESS than or EQUAL to Grade 2 or baseline within LESS than or EQUAL to 7 days, resume study treatment.
		  	TREATMENT CONDITIONS 27	Interval: --	Occurrences: --	Comments:	Other laboratory adverse events, not specified elsewhere in table and not included in the consensus guidelines - 
o Grade 3 or Grade 4: Interrupt study treatment. Upon resolution to LESS than or EQUAL to Grade 1, resume study treatment without dose modification. Isolated Grade 4 electrolyte abnormalities not associated with clinical sequelae and corrected after appropriate management within 72 hours of their onset do not require discontinuation. In the case of Grade 4 electrolyte imbalances associated with clinical sequelae, or not resolved to LESS than or EQUAL to Grade 1 within 72 hours despite appropriate management, permanently discontinue study treatment. 

Other non-laboratory adverse events, not specified elsewhere in table and not included in the consensus guidelines:
o Grade 2: Consider study treatment interruption. Upon resolution to ? Grade 1, consider resuming study treatment. 
o Grade 3: Interrupt study treatment. Upon resolution to LESS than or EQUAL to Grade 1, resuming study treatment must be discussed with the relevant medical expert. 
o Grade 4: Permanently discontinue study treatment.
			Nursing Orders
  	ONC NURSING COMMUNICATION 60	Interval: --	Occurrences: --	Comments:	Concomitant Medications
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Prior Concomitant Procedures and significant non-drug therapies
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Calculate indirect bilirubin
		  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	Actigraphy
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	Adverse Events
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Serious Adverse Events
		  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	Health Resource Utilization
			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
☑	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --	Comments:	As clinically indicated
		☑	T3, FREE	Interval: --	Occurrences: --	Comments:	As clinically indicated
		☑	T4, FREE	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
☑	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated
		☑	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
  	URIC ACID LEVEL	Interval: --	Occurrences: --			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Labs
  	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --			Labs
  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
☑	CREATININE CLEARANCE, URINE, 24 HOUR	Interval: --	Occurrences: --		☑	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --		☑	BILIRUBIN DIRECT	Interval: --	Occurrences: --		☑	AMYLASE LEVEL	Interval: --	Occurrences: --		☑	LIPASE LEVEL	Interval: --	Occurrences: --		☑	GGT	Interval: --	Occurrences: --		☑	HEMOGLOBIN A1C	Interval: --	Occurrences: --	Comments:	As clinically indicated
		☑	NABFERON IFN-B ANTIBODY - ATHENA	Interval: --	Occurrences: --	Comments:	Anytime when suspected Cytokine Release Syndrome Occurs
		☑	INTERLEUKIN 6	Interval: --	Occurrences: --	Comments:	Anytime when suspected Cytokine Release Syndrome Occurs
		☑	MISCELLANEOUS REFERRAL TEST	Interval: --	Occurrences: --	Comments:	Interleukin 1 - Anytime when suspected Cytokine Release Syndrome Occurs
		☑	TUMOR NECROSIS FACTOR - ALPHA	Interval: --	Occurrences: --	Comments:	Anytime when suspected Cytokine Release Syndrome Occurs. 
Perform ONLY at HMH and HMCL.
			Imaging
☑	CT HEAD W WO CONTRAST	Interval: --	Occurrences: --	Comments:	As clinically indicated. Or MRI
		☐	MRI BRAIN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	As clinically indicated. Or CT
		☑	CV ECHOCARDIOGRAM RESEARCH ONLY	Interval: --	Occurrences: --	Comments:	As clinically indicated.
		☑	NM BONE SCAN WHOLE BODY	Interval: --	Occurrences: --	Comments:	As clinically indicated.
		☑	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	If Clinically Indicated Localized bone CT scan, MRI or Xray.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mEq/L; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 28	Interval: --	Occurrences: --	Comments:	o ANC LESS than 1000; 
o Platelets LESS than 100,000; 
o Bilirubin GREATER than 1.6; 
o LFTs GREATER than 10 x ULN.
			Pre-Medications
  	ondansetron (ZOFRAN) IV 8 mg	Dose: 8 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to chemo.			Chemotherapy
  	NAB-PACLItaxel (ABRAXANE) chemo infusion 125 mg/m2 (Treatment Plan)	Dose: 125 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes		  	gemcitabine (GEMZAR) 1,000 mg/m2 in sodium chloride 0.9% 250 mL chemo IVPB	Dose: 1,000 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 60 Minutes	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	GEMCITABINE 200 MG/5.26 ML (38 MG/ML) INTRAVENOUS SOLUTION	Medications	1,000 mg/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	 	No	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	fexofenadine (ALLEGRA) tablet 180 mg	Dose: 180 mg	Route: oral	PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 15	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Line Flush
  	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Use with NIS793		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Do NOT administer with NIS793			Nursing Orders
  	dextrose 5% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open for NIS793		  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.  Do NOT administer with NIS793			Nursing Orders
  	TREATMENT CONDITIONS 12	Interval: --	Occurrences: --	Comments:	Infusion Reaction or Hypersensitivity Reaction - 
o Grade 1-Infusion Reaction or Hypersensitivity Reaction: Decrease infusion rate until recovery from the symptoms. If the infusion reaction happens after the end of infusion (EOI), increase monitoring of vital signs until the participant is symptoms free. Administer subsequent NIS793 infusion at the same rate. 
o Grade 2- Infusion Reaction or Hypersensitivity Reaction: Stop infusion immediately and keep line open. Follow institutional guidelines for the management and follow-up of infusion reaction. Restart infusion at 50% of previous rate under continuous observation. Ensure that there is a minimum observation period of 1 hour prior to restarting the infusion. If the AE recurs at the reinitiated slower rate of infusion, and despite oral pre-medication, permanently discontinue study treatment. 
o Grade 3 or Grade 4- Infusion Reaction or Hypersensitivity Reaction: Stop infusion immediately and keep line open. Follow institutional guidelines for the management and follow-up of infusion reaction. Provide supplemental oxygen, fluids, and other resuscitative measures as needed. Monitor vital signs (e.g. blood pressure, pulse, respiration, and temperature) every 15 ± 5 minutes until resolution.
		  	TREATMENT CONDITIONS 13	Interval: --	Occurrences: --	Comments:	Cytokine Release Syndrome (CRS) - 
o Grade 2: Stop infusion immediately and keep line open. Follow institutional guidelines for the management and follow-up of infusion reaction. Restart infusion at 50% of previous rate under continuous observation. Ensure that there is a minimum observation period of 1 hour prior to restarting the infusion. If the AE recurs at the reinitiated slower rate of infusion, and despite oral pre-medication, permanently discontinue study treatment. 
o Grade 3 or 4: Permanently discontinue study treatment. Follow-up CRS as per institutional guidelines.
		  	TREATMENT CONDITIONS 14	Interval: --	Occurrences: --	Comments:	Ocular (e.g. Conjunctivitis, Blepharitis, blurred vision) - 
o Grade 1: May continue study treatment. Consider ophthalmology consultation. 
o Grade 2: Ophthalmology consultation. Upon resolution to LESS than or EQUAL to Grade 1 consider resuming study treatment in consultation with ophthalmologist. 
o Grade 3: 
1. Interrupt study treatment. 
2. Ophthalmology consultation. 
3. Upon resolution to LESS than or EQUAL to Grade 1 consider resuming study treatment in consultation with ophthalmologist.
o Grade 4:  Permanently discontinue study treatment.
		  	TREATMENT CONDITIONS 15	Interval: --	Occurrences: --	Comments:	Cardiovascular - 
o Grade 2 or greater Myocarditis: Permanently discontinue study treatment. 
o Grade 2 Cardiac Valvulopathy and other Cardiac Toxicity: Interrupt study treatment. Repeat echocardiogram and assess cardiac function. Once resolved to Grade ? 1 or baseline, consider re-administration of treatment, if benefit outweighs the potential risk. 
o Grade 3> Cardiac Valvulopathy and other Cardiac Toxicity: Permanently discontinue study treatment.
		  	TREATMENT CONDITIONS 16	Interval: --	Occurrences: --	Comments:	Isolated AST and/or ALT Elevation - 
o Grade 3 AST or ALT >5.0 - 10.0 x ULN: Interrupt treatment. Repeat liver function tests (LFTs) within 48-72 hours, then monitor LFTs weekly until recovery to grade ?1 or to baseline. Then resume treatment at the same dose interval if resolved in LESS than or EQUAL to 14 days; if resolved in GREATER than 14 days, consider administration Q4W instead of Q2W. 
o Grade 3 AST or ALT >10.0 - 20.0 x ULN: Interrupt treatment. Repeat LFTs within 48-72 hours, then monitor LFTs weekly until recovery to grade LESS than or EQUAL to 1 or to baseline, then increase dosing interval for NIS793 from Q2W to Q4W. 
o Grade 4: AST or ALT (>20 x ULN): Permanently discontinue treatment.
		  	TREATMENT CONDITIONS 17	Interval: --	Occurrences: --	Comments:	With abnormal ALT/AST (up to grade 2 - </= 5.0 x ULN) at baseline - 
o ALT/AST > 2.0 x baseline AND > 5.0 x ULN: Interrupt treatment. Repeat LFTs within 48-72 hours, then monitor LFTs weekly until recovery to baseline; Then resume same dose interval if resolved in LESS than or EQUAL to 14 days; if resolved in GREATER than 14 days, increasing dosing from Q2W to Q4W. 
o ALT/AST > 3.0 x baseline AND >10 x ULN: Interrupt treatment. Repeat LFTs within 48-72 hours, then monitor weekly until resolved to baseline; then increase dosing interval from Q2W to Q4W. 
o AST or ALT >20 x ULN (grade 4): Permanently discontinue treatment.
		  	TREATMENT CONDITIONS 18	Interval: --	Occurrences: --	Comments:	Concomitant elevation of AST and/or ALT and total bilirubin with normal AST/ALT and bilirubin at baseline -
o Grade 2 ALT and/or AST elevation (>3.0 x ULN) with bilirubin > 2.0 x ULN (unless Gilbert's syndrome): Interrupt treatment. Assess if case is drug induced liver injury (DILI). If DILI confirmed, permanently discontinue study treatment. For additional information on follow-up of potential drug induced liver injury cases, refer to Section 6.5.5.1. If no DILI confirmed, interrupt treatment, treat the identified cause according to institutional guidelines. Repeat LFTs within 48-72 hours, then monitor weekly, until enzyme levels resolve to LESS than or EQUAL to grade 1 or baseline.  After recovery, re-administration of study treatment could be considered only if Investigator assesses benefit to outweigh the risk. Any decision regarding re-administration of study drugs and dose regimen should be discussed with the Sponsor.
		  	TREATMENT CONDITIONS 19	Interval: --	Occurrences: --	Comments:	With abnormal ALT/AST at baseline - 
o ALT or AST >3.0 x baseline OR ALT or AST >8.0 x ULN [whichever is lower] combined with total bilirubin >2.0 x baseline AND >2.0 x ULN:  Interrupt treatment. Assess if case is drug induced liver injury (DILI). If DILI confirmed, permanently discontinue study treatment. For additional information on follow-up of potential drug induced liver injury cases, refer to Section 6.5.5.1. If no DILI confirmed, interrupt treatment, treat the identified cause according to institutional guidelines. Repeat LFTs within 48-72 hours, then monitor weekly, until enzyme levels resolve to ?grade 1 or baseline.  After recovery, re-administration of study treatment could be considered only if Investigator assesses benefit to outweigh the risk. Any decision regarding re-administration of study drugs and dose regimen should be discussed with the Sponsor.
		  	TREATMENT CONDITIONS 20	Interval: --	Occurrences: --	Comments:	Isolated total bilirubin elevation - 
o Any elevation > ULN: Fractionate bilirubin, evaluate for cholestatic liver injury (e.g. by testing Alkaline Phosphatase (ALP)) or alternative causes of bilirubin elevation (e.g. disease progression [imaging]). Treat alternative causes according to institutional guidelines. 
o Grade 2 (>1.5 - 3.0 ULN): Repeat LFTs within 48-72 hours, then monitor LFTs weekly until resolution to LESS than or EQUAL to grade 1 or to baseline. If isolated bilirubin remains stable at Grade 2, continue treatment at the same dose regimen. 
o Grade 3 (>3.0 - 10 ULN): Interrupt treatment. Repeat LFTs within 48-72 hours, then monitor LFTs weekly until resolution to LESS than or EQUAL to Grade 1 or to baseline. If resolved in ? 14 days, maintain dose regimen; if not resolved in 14 days, permanently discontinue NIS793. (Please see footnote regarding alternative cause/s of bilirubin elevation). 
o Grade 4 (> 10 x ULN): See footnote*. Otherwise, permanently discontinue study treatment. If alternative cause/s is identified and managed, and bilirubin resolves to ? grade 1 or to baseline, resume treatment at the same dose regimen. *An isolated bilirubin elevation is not typical for DILI. Bilirubin can be elevated either as part of a "Hy's law" constellation with a preceding elevation of ALT/AST, or as part of a cholestatic reaction with simultaneous elevation of other cholestatic parameters (ALP, GGT). Isolated bilirubin can be seen in conjunction with drugs that inhibit bilirubin conjugation or excretion, but both scenarios do not typically represent liver injury. Alternative causes of bilirubin elevation should, therefore, be ruled out before basing dose modification decisions on bilirubin values alone.
		  	TREATMENT CONDITIONS 21	Interval: --	Occurrences: --	Comments:	Asymptomatic amylase and/or lipase elevation - 
o Grade 3, not associated with symptoms or clinical manifestations of pancreatitis: May continue study treatment. If levels do not resolve to LESS than or EQUAL to Grade 2 within LESS than or EQUAL to 14 days after the initial report, interrupt study treatment.  Upon resolution to ? Grade 2, consider resuming study treatment.
		  	TREATMENT CONDITIONS 22	Interval: --	Occurrences: --	Comments:	Renal / Serum Creatinine - 
o Grade 2:  Interrupt Study Treatment. Manage per institutional Practice. Upon resolution to LESS than Grade 1, consider resuming study treatment. 
o Grade 3 or Grade 4: Permanently Discontinue Study Treatment.
		  	TREATMENT CONDITIONS 23	Interval: --	Occurrences: --	Comments:	Hyperthyroidism - 
o Grade 2: Consider Continuing Study Treatment and Management according to institutional practice. 
o Grade 3: Interrupt study treatment. Upon resolution to Grade ? 1 with appropriate management, consider resuming study treatment without dose modification. 
o Grade 4: Must discontinue and manage according to local/institutional guidance.
		  	TREATMENT CONDITIONS 24	Interval: --	Occurrences: --	Comments:	Other Endocrine Disorders - 
o Grade 2 and Grade 3: Interrupt study treatment. Upon resolution to Grade LESS than or EQUAL to 1 with appropriate management, consider resuming study treatment.
		  	TREATMENT CONDITIONS 25	Interval: --	Occurrences: --	Comments:	Dermatology (rash) - 
o Grade 1: Continue study treatment. Consider topical steroids, antihistamines, topical emollients. 
o Grade 2: Consider interrupting study treatment. Topical or oral steroids, antihistamines. If study treatment is held and resolution to LESS than or EQUAL to Grade 1, resume study treatment. 
o Grade 3: Interrupt study treatment. Manage per institutional practice. After resolution to LESS than or EQUAL to Grade 1, consider resuming study treatment after consultation with dermatologist. 
o Grade 4 or Stevens-Johnson syndrome (SJS), or Lyell syndrome/toxic epidermal necrolysis (TEN): Permanently discontinue study treatment and manage according to local/institutional guidance.
		  	TREATMENT CONDITIONS 26	Interval: --	Occurrences: --	Comments:	Neutropenia - 
o Grade 3: Interrupt study treatment until resolved to LESS than or EQUAL to Grade 1 or baseline, then resume study medication. 
o Grade 4: Interrupt study treatment. If resolved in LESS than or EQUAL to 7 days, maintain study treatment.  

Febrile Neutropenia - 
o Grade 3: Interrupt study treatment. Upon resolution of fever and improvement of neutropenia to LESS than or EQUAL to Grade 1 or baseline, resume study treatment. 
o Grade 4: Permanently discontinue study treatment. 

Thrombocytopenia - 
o Grade 3: Interrupt study treatment. Upon resolution to ? Grade 2 or baseline, resume study treatment. For Grade 3 associated with major bleeding, permanently discontinue study treatment. 
o Grade 4: Permanently discontinue study treatment. 

Anemia - 
o Grade 3 or Grade 4: Interrupt study treatment. Upon resolution to LESS than or EQUAL to Grade 2 or baseline within LESS than or EQUAL to 7 days, resume study treatment.
		  	TREATMENT CONDITIONS 27	Interval: --	Occurrences: --	Comments:	Other laboratory adverse events, not specified elsewhere in table and not included in the consensus guidelines - 
o Grade 3 or Grade 4: Interrupt study treatment. Upon resolution to LESS than or EQUAL to Grade 1, resume study treatment without dose modification. Isolated Grade 4 electrolyte abnormalities not associated with clinical sequelae and corrected after appropriate management within 72 hours of their onset do not require discontinuation. In the case of Grade 4 electrolyte imbalances associated with clinical sequelae, or not resolved to LESS than or EQUAL to Grade 1 within 72 hours despite appropriate management, permanently discontinue study treatment. 

Other non-laboratory adverse events, not specified elsewhere in table and not included in the consensus guidelines:
o Grade 2: Consider study treatment interruption. Upon resolution to ? Grade 1, consider resuming study treatment. 
o Grade 3: Interrupt study treatment. Upon resolution to LESS than or EQUAL to Grade 1, resuming study treatment must be discussed with the relevant medical expert. 
o Grade 4: Permanently discontinue study treatment.
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Dose Modifications and Dose Interruption for NIS793: 
No Dose Reductions are allowed for NIS793: Increasing the dosing interval from Q2W to Q4W is allowed under circumstances described in Table 6-5. If NIS793 is interrupted or delayed for GREATER than 8 weeks due to toxicity that is suspected to be related to treatment, study treatment should be permanently discontinued.
			Nursing Orders
  	ONC NURSING COMMUNICATION 60	Interval: --	Occurrences: --	Comments:	Concomitant Medications
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Prior Concomitant Procedures and significant non-drug therapies
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	Physical Examination
		  	ONC NURSING COMMUNICATION 62	Interval: --	Occurrences: --	Comments:	ECOG
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Calculate indirect bilirubin
		  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	Actigraphy
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	Adverse Events
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Serious Adverse Events
		  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	Health Resource Utilization
			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
☑	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --	Comments:	As clinically indicated
		☑	T3, FREE	Interval: --	Occurrences: --	Comments:	As clinically indicated
		☑	T4, FREE	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
☑	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated
		☑	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
  	URIC ACID LEVEL	Interval: --	Occurrences: --			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Labs
  	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --			Labs
  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
☑	CREATININE CLEARANCE, URINE, 24 HOUR	Interval: --	Occurrences: --		☑	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --		☑	BILIRUBIN DIRECT	Interval: --	Occurrences: --		☑	AMYLASE LEVEL	Interval: --	Occurrences: --		☑	LIPASE LEVEL	Interval: --	Occurrences: --		☑	GGT	Interval: --	Occurrences: --		☑	HEMOGLOBIN A1C	Interval: --	Occurrences: --	Comments:	As clinically indicated
		☑	NABFERON IFN-B ANTIBODY - ATHENA	Interval: --	Occurrences: --	Comments:	Anytime when suspected Cytokine Release Syndrome Occurs
		☑	INTERLEUKIN 6	Interval: --	Occurrences: --	Comments:	Anytime when suspected Cytokine Release Syndrome Occurs
		☑	MISCELLANEOUS REFERRAL TEST	Interval: --	Occurrences: --	Comments:	Interleukin 1 - Anytime when suspected Cytokine Release Syndrome Occurs
		☑	TUMOR NECROSIS FACTOR - ALPHA	Interval: --	Occurrences: --	Comments:	Anytime when suspected Cytokine Release Syndrome Occurs. 
Perform ONLY at HMH and HMCL.
			Imaging
☑	CT HEAD W WO CONTRAST	Interval: --	Occurrences: --	Comments:	As clinically indicated. Or MRI
		☐	MRI BRAIN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	As clinically indicated. Or CT
		☑	CV ECHOCARDIOGRAM RESEARCH ONLY	Interval: --	Occurrences: --	Comments:	As clinically indicated.
		☑	NM BONE SCAN WHOLE BODY	Interval: --	Occurrences: --	Comments:	As clinically indicated.
		☑	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	If Clinically Indicated Localized bone CT scan, MRI or Xray.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mEq/L; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 28	Interval: --	Occurrences: --	Comments:	o ANC LESS than 1000; 
o Platelets LESS than 100,000; 
o Bilirubin GREATER than 1.6; 
o LFTs GREATER than 10 x ULN.
			Pre-Medications
  	ondansetron (ZOFRAN) IV 8 mg	Dose: 8 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to chemo.			Nursing Orders
  	ONC NURSING COMMUNICATION 68	Interval: --	Occurrences: --	Comments:	Infusion must take place in a facility with appropriate resuscitation equipment available at the bedside, and a physician readily available during the period of drug administration.
		  	ONC NURSING COMMUNICATION 69	Interval: --	Occurrences: --	Comments:	Participants should be closely observed for potential infusion-related reactions including rigors, chills, wheezing, pruritus, flushing, rash, hypotension, hypoxemia, and fever, and vital signs monitored more frequently if clinically indicated, during and for at least 2 hours after the first two NIS793 infusions. The same may apply for subsequent NIS793 infusions if medically indicated. Participants should notify study personnel if symptoms of infusion reaction occur after any NIS793 infusion.
			Chemotherapy
  	INV-NIS793 or placebo (CNIS793B12301 daNIS-2/Pro00032923/Abdelrahim) 2,100 mg in dextrose 5% 100 mL	Dose: 2,100 mg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Protect from light.  Administer intravenously using a 0.2 micron inline filter over 30 minutes.  Flush only with D5W!
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.

	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-NIS793 OR PLACEBO 1050MG/10ML INTRAVENOUS SOLN. (CNIS793B12301 DANIS-2/PRO00032923/ABDELRAHIM)	Medications	2,100 mg	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	80 mL	Yes	Yes			  	NAB-PACLItaxel (ABRAXANE) chemo infusion 125 mg/m2 (Treatment Plan)	Dose: 125 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 3 Hours		  	gemcitabine (GEMZAR) 1,000 mg/m2 in sodium chloride 0.9% 250 mL chemo IVPB	Dose: 1,000 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 3.5 Hours	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	GEMCITABINE 200 MG/5.26 ML (38 MG/ML) INTRAVENOUS SOLUTION	Medications	1,000 mg/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	 	No	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	fexofenadine (ALLEGRA) tablet 180 mg	Dose: 180 mg	Route: oral	PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
End of Treatment	Repeat 1 time	Cycle length: 32 days	Day 1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 60	Interval: --	Occurrences: --	Comments:	Concomitant Medications
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Prior Concomitant Procedures and significant non-drug therapies
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	Physical Examination
		  	ONC NURSING COMMUNICATION 62	Interval: --	Occurrences: --	Comments:	ECOG
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Calculate indirect bilirubin
		  	ONC NURSING COMMUNICATION 64	Interval: --	Occurrences: --	Comments:	PGIC (ePRO)
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	EQ-5D-5L, PGIS (ePRO)
		  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	PRO-CTCAE, FACT-GP5 (ePRO)
		  	ONC NURSING COMMUNICATION 38	Interval: --	Occurrences: --	Comments:	PROMIS-29 (ePRO)
		  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	Actigraphy
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	Adverse Events
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Serious Adverse Events
		  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	Health Resource Utilization
		  	ONC NURSING COMMUNICATION 59	Interval: --	Occurrences: --	Comments:	Disposition
		  	ONC NURSING COMMUNICATION 65	Interval: --	Occurrences: --	Comments:	Antineoplastic therapies since discontinuation of study treatment
		  	ONC NURSING COMMUNICATION 66	Interval: --	Occurrences: --	Comments:	IRT Discontinuation
			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
  	URIC ACID LEVEL	Interval: --	Occurrences: --			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Labs
  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --		  	T3, FREE	Interval: --	Occurrences: --		  	T4, FREE	Interval: --	Occurrences: --			Labs
  	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --			Labs
  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Only for females of childbearing potential
			Labs
  	CREATININE CLEARANCE, URINE, 24 HOUR	Interval: --	Occurrences: --		  	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --		  	AMYLASE LEVEL	Interval: --	Occurrences: --		  	LIPASE LEVEL	Interval: --	Occurrences: --		  	GGT	Interval: --	Occurrences: --		  	HEMOGLOBIN A1C	Interval: --	Occurrences: --		  	CANCER ANTIGEN 19-9	Interval: --	Occurrences: --		  	NABFERON IFN-B ANTIBODY - ATHENA	Interval: --	Occurrences: --		  	INTERLEUKIN 6	Interval: --	Occurrences: --		  	MISCELLANEOUS REFERRAL TEST	Interval: --	Occurrences: --	Comments:	Interleukin 1
		  	TUMOR NECROSIS FACTOR - ALPHA	Interval: --	Occurrences: --	Comments:	Perform ONLY at HMH and HMCL
			Imaging
☑	CT HEAD W WO CONTRAST	Interval: --	Occurrences: --	Comments:	As clinically indicated. Or MRI
		☐	MRI BRAIN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	As clinically indicated. Or CT
		☑	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	As clinically indicated  for Tumor Evaluation per RECIST. Or MRI
		☐	MRI CHEST W CONTRAST	Interval: --	Occurrences: --	Comments:	As clinically indicated  for Tumor Evaluation per RECIST. Or CT
		☐	MRI ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	As clinically indicated  for Tumor Evaluation per RECIST. Or CT
		☐	MRI PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	As clinically indicated  for Tumor Evaluation per RECIST. Or CT
		☑	CV ECHOCARDIOGRAM RESEARCH ONLY	Interval: --	Occurrences: --	Comments:	As clinically indicated.
		☑	NM BONE SCAN WHOLE BODY	Interval: --	Occurrences: --	Comments:	As clinically indicated.
		☑	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	If Clinically Indicated Localized bone CT scan, MRI or Xray.
			Procedures
  	BIOPSY	Interval: --	Occurrences: --	Comments:	Newly Obtained Tumor Sample or Archival Tumor - Newly obtained tumor: 3-6 passes of a core needle biopsy (note: fine needle biopsies are not acceptable), Archival sample: formalin-fixed paraffin-embedded (FFPE) block (preferred) or at least 15 slides at 5 micrometer thickness and must be freshly cut. Samples collected within 3 months prior to study treatment strongly recommended.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --					
Safety Follow Up	Repeat 1 time	Cycle length: 120 days	At 30 Days	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 60	Interval: --	Occurrences: --	Comments:	Concomitant Medications
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Prior Concomitant Procedures and significant non-drug therapies
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	Physical Examination
		  	ONC NURSING COMMUNICATION 62	Interval: --	Occurrences: --	Comments:	ECOG
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Calculate indirect bilirubin
		  	ONC NURSING COMMUNICATION 64	Interval: --	Occurrences: --	Comments:	PGIC (ePRO)
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	EQ-5D-5L, PGIS (ePRO)
		  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	PRO-CTCAE, FACT-GP5 (ePRO)
		  	ONC NURSING COMMUNICATION 38	Interval: --	Occurrences: --	Comments:	PROMIS-29 (ePRO)
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	Adverse Events
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Serious Adverse Events
		  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	Health Resource Utilization
		  	ONC NURSING COMMUNICATION 65	Interval: --	Occurrences: --	Comments:	Antineoplastic therapies since discontinuation of study treatment
			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
☑	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --	Comments:	As clinically indicated
		☑	T3, FREE	Interval: --	Occurrences: --	Comments:	As clinically indicated
		☑	T4, FREE	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
☑	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated
		☑	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
  	URIC ACID LEVEL	Interval: --	Occurrences: --			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Labs
  	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --			Labs
  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Only for females of childbearing potential
			Labs
☑	CREATININE CLEARANCE, URINE, 24 HOUR	Interval: --	Occurrences: --		☑	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --		☑	BILIRUBIN DIRECT	Interval: --	Occurrences: --		☑	AMYLASE LEVEL	Interval: --	Occurrences: --		☑	LIPASE LEVEL	Interval: --	Occurrences: --		☑	GGT	Interval: --	Occurrences: --		☑	HEMOGLOBIN A1C	Interval: --	Occurrences: --	Comments:	As clinically indicated
		☑	TROPONIN	Interval: --	Occurrences: --	Comments:	As clinically indicated
		☑	NT-PROBNP	Interval: --	Occurrences: --	Comments:	As clinically indicated
		☑	NABFERON IFN-B ANTIBODY - ATHENA	Interval: --	Occurrences: --	Comments:	Anytime when suspected Cytokine Release Syndrome Occurs
		☑	INTERLEUKIN 6	Interval: --	Occurrences: --	Comments:	Anytime when suspected Cytokine Release Syndrome Occurs
		☑	MISCELLANEOUS REFERRAL TEST	Interval: --	Occurrences: --	Comments:	Interleukin 1. 
Anytime when suspected Cytokine Release Syndrome Occurs.
		☑	TUMOR NECROSIS FACTOR - ALPHA	Interval: --	Occurrences: --	Comments:	Perform ONLY at HMH and HMCL. 
Anytime when suspected Cytokine Release Syndrome Occurs.
			Imaging
  	CV ECHOCARDIOGRAM RESEARCH ONLY	Interval: --	Occurrences: --	Comments:	As clinically indicated.
				At 60 Days	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 60	Interval: --	Occurrences: --	Comments:	Concomitant Medications
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Prior Concomitant Procedures and significant non-drug therapies
		  	ONC NURSING COMMUNICATION 64	Interval: --	Occurrences: --	Comments:	PGIC (ePRO)
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	EQ-5D-5L, PGIS (ePRO)
		  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	PRO-CTCAE, FACT-GP5 (ePRO)
		  	ONC NURSING COMMUNICATION 38	Interval: --	Occurrences: --	Comments:	PROMIS-29 (ePRO)
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	Adverse Events
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Serious Adverse Events
		  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	Health Resource Utilization
		  	ONC NURSING COMMUNICATION 65	Interval: --	Occurrences: --	Comments:	Antineoplastic therapies since discontinuation of study treatment
			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
☑	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --	Comments:	As clinically indicated
		☑	T3, FREE	Interval: --	Occurrences: --	Comments:	As clinically indicated
		☑	T4, FREE	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Only for females of childbearing potential
			Labs
☑	NABFERON IFN-B ANTIBODY - ATHENA	Interval: --	Occurrences: --	Comments:	Anytime when suspected Cytokine Release Syndrome Occurs
		☑	INTERLEUKIN 6	Interval: --	Occurrences: --	Comments:	Anytime when suspected Cytokine Release Syndrome Occurs
		☑	MISCELLANEOUS REFERRAL TEST	Interval: --	Occurrences: --	Comments:	Interleukin 1. 
Anytime when suspected Cytokine Release Syndrome Occurs.
		☑	TUMOR NECROSIS FACTOR - ALPHA	Interval: --	Occurrences: --	Comments:	Perform ONLY at HMH and HMCL. 
Anytime when suspected Cytokine Release Syndrome Occurs.
			Imaging
  	CV ECHOCARDIOGRAM RESEARCH ONLY	Interval: --	Occurrences: --	Comments:	As clinically indicated.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Samples will not be collected if the safety follow-up assessment is performed remotely.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Samples will not be collected if the safety follow-up assessment is  performed remotely
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Samples will not be collected if the safety follow-up assessment is  performed remotely
				At 90 Days	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 60	Interval: --	Occurrences: --	Comments:	Concomitant Medications
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Prior Concomitant Procedures and significant non-drug therapies
		  	ONC NURSING COMMUNICATION 64	Interval: --	Occurrences: --	Comments:	PGIC (ePRO)
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	EQ-5D-5L, PGIS (ePRO)
		  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	PRO-CTCAE, FACT-GP5 (ePRO)
		  	ONC NURSING COMMUNICATION 38	Interval: --	Occurrences: --	Comments:	PROMIS-29 (ePRO)
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	Adverse Events
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Serious Adverse Events
		  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	Health Resource Utilization
		  	ONC NURSING COMMUNICATION 65	Interval: --	Occurrences: --	Comments:	Antineoplastic therapies since discontinuation of study treatment
			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
☑	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --	Comments:	As clinically indicated
		☑	T3, FREE	Interval: --	Occurrences: --	Comments:	As clinically indicated
		☑	T4, FREE	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Only for females of childbearing potential
			Labs
☑	NABFERON IFN-B ANTIBODY - ATHENA	Interval: --	Occurrences: --	Comments:	Anytime when suspected Cytokine Release Syndrome Occurs
		☑	INTERLEUKIN 6	Interval: --	Occurrences: --	Comments:	Anytime when suspected Cytokine Release Syndrome Occurs
		☑	MISCELLANEOUS REFERRAL TEST	Interval: --	Occurrences: --	Comments:	Interleukin 1. 
Anytime when suspected Cytokine Release Syndrome Occurs.
		☑	TUMOR NECROSIS FACTOR - ALPHA	Interval: --	Occurrences: --	Comments:	Perform ONLY at HMH and HMCL. 
Anytime when suspected Cytokine Release Syndrome Occurs.
			Imaging
  	CV ECHOCARDIOGRAM RESEARCH ONLY	Interval: --	Occurrences: --	Comments:	As clinically indicated.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Samples will not be collected if the safety follow-up assessment is performed remotely.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Samples will not be collected if the safety follow-up assessment is  performed remotely
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Samples will not be collected if the safety follow-up assessment is  performed remotely
					
Post Treatment Efficacy Follow Up	Repeat 1 time	Cycle length: 32 days	Day 1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 60	Interval: --	Occurrences: --	Comments:	Concomitant Medications
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Serious Adverse Events
		  	ONC NURSING COMMUNICATION 65	Interval: --	Occurrences: --	Comments:	Antineoplastic therapies since discontinuation of study treatment
		  	ONC NURSING COMMUNICATION 59	Interval: --	Occurrences: --	Comments:	Disposition
			Labs
  	CANCER ANTIGEN 19-9	Interval: --	Occurrences: --			Imaging
☑	CT HEAD W WO CONTRAST	Interval: --	Occurrences: --	Comments:	As clinically indicated. Or MRI
		☐	MRI BRAIN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	As clinically indicated. Or CT
		☑	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	As clinically indicated  for Tumor Evaluation per RECIST. Or MRI
		☐	MRI CHEST W CONTRAST	Interval: --	Occurrences: --	Comments:	As clinically indicated  for Tumor Evaluation per RECIST. Or CT
		☐	MRI ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	As clinically indicated  for Tumor Evaluation per RECIST. Or CT
		☐	MRI PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	As clinically indicated  for Tumor Evaluation per RECIST. Or CT
		☑	NM BONE SCAN WHOLE BODY	Interval: --	Occurrences: --	Comments:	As clinically indicated.
		☑	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	If Clinically Indicated Localized bone CT scan, MRI or Xray.
					
Survival Follow Every 8 Weeks	Repeat 4 times	Cycle length: 32 days	Day 1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 60	Interval: --	Occurrences: --	Comments:	Concomitant Medications
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Serious Adverse Events
		  	ONC NURSING COMMUNICATION 65	Interval: --	Occurrences: --	Comments:	Antineoplastic therapies since discontinuation of study treatment
		  	ONC NURSING COMMUNICATION 70	Interval: --	Occurrences: --	Comments:	Survival Contact