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OP RSH PRO00045829 2138-CL-0301 GUAN SCREENING	

Types:      Research Oncology Treatment
Synonyms:  PRO00045829, GUAN SCREENING, 2138-CL-0301

Screening (- 45 days)	Repeat 1 time	Cycle length: 45 days	Day -45	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	ONC NURSING COMMUNICATION 38	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:2138-CL-0301 _Guan
		  	ONC NURSING COMMUNICATION 35	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for ASP2138/Placebo: Refer to Section 6.5. Protocol Access Hyperlink:   2138-CL-0301 _Guan
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Main study ICF
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Demographics, medical and disease history
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Confirmation of inclusion/exclusion criteria
		  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	Physical examination
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ECG 12-LEAD	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Concomitant medications
		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Adverse events and SAEs
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	HRQoL questionnaire
			Labs
  	TB SKIN TEST	Interval: --	Occurrences: --	Comments:	Per local requirements.
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	Cytokine/chemokine and/or tryptase. IF CLINICALLY INDICATED.
		  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	DPD deficiency testing. DPD labs if required for FOLFOX
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Hepatitis and HIV labs if required per local guidelines
			Labs
  	HEPATITIS B SURFACE ANTIGEN	Interval: --	Occurrences: --		  	HEPATITIS B SURFACE AB, QUANTITATIVE	Interval: --	Occurrences: --		  	HEPATITIS B SURFACE ANTIBODY	Interval: --	Occurrences: --		  	HEPATITIS B CORE ANTIBODY TOTAL	Interval: --	Occurrences: --		  	HEPATITIS B CORE ANTIBODY IGM	Interval: --	Occurrences: --		  	HEPATITIS B VIRUS (HBV), QUANTITATIVE PCR	Interval: --	Occurrences: --		  	HEPATITIS C VIRUS (HCV), QUANTITATIVE PCR	Interval: --	Occurrences: --	Comments:	Qualitative HCV RNA (if HCV-Positive)
			Labs
  	HIV 1/2 ANTIGEN/ANTIBODY, FOURTH GENERATION, WITH REFLEXES	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Exploratory biomarkers (plasma)
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Biopsy (if applicable)
				Day -28	Perform every 1 day x1			Research tolerance: -0/+0 days	Imaging
  	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --			Imaging
  	NM BONE SCAN WHOLE BODY	Interval: --	Occurrences: --	Comments:	Perform only if metastatic disease in bone is suspected.
			Imaging
◉	MRI BRAIN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Perform only if metastatic disease in brain is suspected.
		◯	MRI BRAIN W CONTRAST	Interval: --	Occurrences: --	Comments:	Perform only if metastatic disease in brain is suspected.
		◯	MRI BRAIN WO CONTRAST	Interval: --	Occurrences: --	Comments:	Perform only if metastatic disease in brain is suspected.
				Day -14	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	ONC NURSING COMMUNICATION 38	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:2138-CL-0301 _Guan
		  	ONC NURSING COMMUNICATION 35	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for ASP2138/Placebo: Refer to Section 6.5. Protocol Access Hyperlink:   2138-CL-0301 _Guan
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Hematology
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Biochemistry
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	TSH and free T4
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Coagulation
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Urinalysis
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	For WOCBP: Pregnancy test (serum)