Protocol Index	

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RSH OP PRO00038062 CAMBRIA-2 / ARM A	

Types:      Research Oncology Treatment
Synonyms:  CAMBRIA -2, ARM A

M1	Repeat 1 time	Cycle length: 30 days	Day 1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	For inclusion/exclusion criteria please refer to pages 61 through 66 in the protocol. Please ensure patient meets inclusion/exclusion criteria prior to proceeding with randomization.
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Randomization 
The patient should be randomized after all screening assessments have been completed within the 28-day window, with the exception of imaging assessment and mammogram/breast MRI which should be performed within 12 weeks and 9 months prior to randomization, respectively. Every effort should be made to minimize the time between randomization and starting study treatment (ie, ideally on the same day but within 3 business days of randomization). Please note that Month 1 Day 1 is defined as the day of first dose of study treatment.
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Medical history (past and current medical conditions)
**If screening assessments have been performed within 7 days prior to starting study treatment, they do not have to be repeated at Month 1 Day 1 if the patient's condition has not changed**
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Patient-reported Outcomes --

Train patients on ePRO
device
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Blood pressure, body temperature, heart rate
		  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	EORTC[RAC1]  IL-309 
PRO-CTCAE 
VSAQ items

Month 1 Day 1 before dosing and then weekly for the first 6 weeks then Q2W until Month 24 then Q3M relative to Month 1 Day 1 until EOT
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	EORTC IL-310 
Month 1 Day 1 before dosing and then Q2W until Month 24 then Q3M relative to Month 1 Day 1 until EOT
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	PGI-TT
Month 1 Day 1 before dosing and weekly for the first 24 months and then Q3M relative to Month 1 Day 1 until EOT
			Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	PGI-ST
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	EORTC IL-311 (cognitive, social, and emotional function, and HRQoL)
			Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	EQ-5D-5L
			Provider Communication
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Complete physical examination 

*If screening assessments have been performed within 7 days prior to starting study treatment, they do not have to be repeated at Month 1 Day 1 if the patient's condition has not changed*
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Determine and record ECOG performance status
ECOG Performance status:** date:**
			Imaging
  	NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Single 12-lead ECGs will be performed after the
patient has been resting semi-supine for at least 5 minutes and recorded while the patient
remains in that position using an ECG machine that automatically calculates the heart rate and
measures PR, QRS, QT, and QTcF intervals. Refer to Table 7 for QTcF withdrawal criteria and any additional QTcF readings that may be necessary.,
			Imaging
  	ECG 12-LEAD	Interval: --	Occurrences: --			Imaging
  	NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	As clinically indicated.

If PET/CT is performed, additional imaging modalities are not required.
		  	CT CHEST W WO CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --		  	PET CT WHOLE BODY	Interval: --	Occurrences: --		  	NM SPECT BONE SCAN	Interval: --	Occurrences: --		  	NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Breast imaging-- As clinically indicated..

The assessments will be performed either at yearly intervals, as recommended per international standard guidelines, or according
to local standards as part of routine medical care. Patients who have had a mastectomy should be followed per local practice.
		  	MAMMO BREAST DIAGNOSTIC TOMOSYNTHESIS BILATERAL	Interval: --	Occurrences: --		  	MRI BREAST W WO CONTRAST BILATERAL	Interval: --	Occurrences: --		  	NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Disease recurrence assessment --
As clinically indicated.
			Labs
  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Complete either serum or urine pregnancy test
		  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --		  	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --		  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --			Labs
  	NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Creatinine, Bilirubin, direct, indirect
Alkaline phosphatase, AST, ALT, Albumin, Potassium, Calcium, total ,Magnesium, Sodium
Glucose (random),Protein, total Urea/blood urea nitrogen (depending on local practice)
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --			Pharmacodynamic Assessments
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Disease recurrence
tumor sampled --as clinically indicated 
--Provision of a tumor biopsy collected at the time of disease recurrence is mandatory in cases where the sample is collected as part of routine clinical practice and submission for research is allowed per institutional policies. If a tumor biopsy is not routinely performed, then this sample is not required
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Disease recurrence
blood sample for
ctDNA analyses 
-- As clinically indicated
			Pharmacodynamic Assessments
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Mandatory blood
samples for ctDNA
analyses
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Pre-dose blood
sample for PK
testing 
--

(Anytime within 60 minutes pre-dose)
			Pharmacodynamic Assessments
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Exploratory genetic blood sample 
--(Optional)
			Chemotherapy
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Patients who have abemaciclib dispensed via IRT will have to return to the site for drug dispensing visits monthly for the first 3 months, and then every 3 months until discontinuation or completion of abemaciclib treatment (2 years). If dose changes are required after 3 months, this may require additional unscheduled visits for abemaciclib dispensation.
			Chemotherapy
  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Tamoxifen Once Daily

At the beginning of each cycle, please ensure patient has a script for the med.
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Letrozole, anastrozole, or exemestane Once Daily

At the beginning of each cycle, please ensure patient has a script for one of these medications:   Letrozole, Anastrozole, or Exemestane
					
M2	Repeat 1 time	Cycle length: 30 days	Day 1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	PGI-ST
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	EORTC IL-311 (cognitive, social, and emotional function, and HRQoL)
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Ocular assessment 

(+21 days; only if an abnormality had been reported at screening or during
treatment) and Safety Follow-up (+21 days; only if treatment discontinuation occurred due to ocular toxicity)
			Chemotherapy
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Patients who have abemaciclib dispensed via IRT will have to return to the site for drug dispensing visits monthly for the first 3 months, and then every 3 months until discontinuation or completion of abemaciclib treatment (2 years). If dose changes are required after 3 months, this may require additional unscheduled visits for abemaciclib dispensation.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --					
M3	Repeat 1 time	Cycle length: 30 days	Day 1	Perform every 1 day x1		Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --			Chemotherapy
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Patients who have abemaciclib dispensed via IRT will have to return to the site for drug dispensing visits monthly for the first 3 months, and then every 3 months until discontinuation or completion of abemaciclib treatment (2 years). If dose changes are required after 3 months, this may require additional unscheduled visits for abemaciclib dispensation.
			Chemotherapy
  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Tamoxifen Once Daily

At the beginning of each cycle, please ensure patient has a script for the med.
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Letrozole, anastrozole, or exemestane Once Daily

At the beginning of each cycle, please ensure patient has a script for one of these medications:   Letrozole, Anastrozole, or Exemestane
					
M4	Repeat 1 time	Cycle length: 30 days	Day 1	Perform every 1 day x1		Provider Communication
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Complete physical examination 

*If screening assessments have been performed within 7 days prior to starting study treatment, they do not have to be repeated at Month 1 Day 1 if the patient's condition has not changed*
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Determine and record ECOG performance status
ECOG Performance status:** date:**
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Ocular assessment 

(+21 days; only if an abnormality had been reported at screening or during
treatment) and Safety Follow-up (+21 days; only if treatment discontinuation occurred due to ocular toxicity)
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Study treatment
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Blood pressure, body temperature, heart rate
		  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	EORTC[RAC1]  IL-309 
PRO-CTCAE 
VSAQ items

Month 1 Day 1 before dosing and then weekly for the first 6 weeks then Q2W until Month 24 then Q3M relative to Month 1 Day 1 until EOT
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	EORTC IL-310 
Month 1 Day 1 before dosing and then Q2W until Month 24 then Q3M relative to Month 1 Day 1 until EOT
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	PGI-TT
Month 1 Day 1 before dosing and weekly for the first 24 months and then Q3M relative to Month 1 Day 1 until EOT
			Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	PGI-ST
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	EORTC IL-311 (cognitive, social, and emotional function, and HRQoL)
			Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	EQ-5D-5L
			Imaging
  	NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Single 12-lead ECGs will be performed after the
patient has been resting semi-supine for at least 5 minutes and recorded while the patient
remains in that position using an ECG machine that automatically calculates the heart rate and
measures PR, QRS, QT, and QTcF intervals. Refer to Table 7 for QTcF withdrawal criteria and any additional QTcF readings that may be necessary.,
			Imaging
  	ECG 12-LEAD	Interval: --	Occurrences: --			Pharmacodynamic Assessments
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Mandatory blood
samples for ctDNA
analyses
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Pre-dose blood
sample for PK
testing 
--

(Anytime within 60 minutes pre-dose)
			Chemotherapy
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Patients who have abemaciclib dispensed via IRT will have to return to the site for drug dispensing visits monthly for the first 3 months, and then every 3 months until discontinuation or completion of abemaciclib treatment (2 years). If dose changes are required after 3 months, this may require additional unscheduled visits for abemaciclib dispensation.
			Chemotherapy
  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Tamoxifen Once Daily

At the beginning of each cycle, please ensure patient has a script for the med.
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Letrozole, anastrozole, or exemestane Once Daily

At the beginning of each cycle, please ensure patient has a script for one of these medications:   Letrozole, Anastrozole, or Exemestane
					
M7	Repeat 1 time	Cycle length: 90 days	Day 1	Perform every 1 day x1		Provider Communication
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Complete physical examination 

*If screening assessments have been performed within 7 days prior to starting study treatment, they do not have to be repeated at Month 1 Day 1 if the patient's condition has not changed*
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Determine and record ECOG performance status
ECOG Performance status:** date:**
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Ocular assessment 

(+21 days; only if an abnormality had been reported at screening or during
treatment) and Safety Follow-up (+21 days; only if treatment discontinuation occurred due to ocular toxicity)
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Study treatment
			Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	EORTC[RAC1]  IL-309 
PRO-CTCAE 
VSAQ items

Month 1 Day 1 before dosing and then weekly for the first 6 weeks then Q2W until Month 24 then Q3M relative to Month 1 Day 1 until EOT
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	EORTC IL-310 
Month 1 Day 1 before dosing and then Q2W until Month 24 then Q3M relative to Month 1 Day 1 until EOT
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	PGI-TT
Month 1 Day 1 before dosing and weekly for the first 24 months and then Q3M relative to Month 1 Day 1 until EOT
			Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	EQ-5D-5L
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Blood pressure, body temperature, heart rate
		  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --			Pharmacodynamic Assessments
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Mandatory blood
samples for ctDNA
analyses
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Pre-dose blood
sample for PK
testing 
--

(Anytime within 60 minutes pre-dose)
			Chemotherapy
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Patients who have abemaciclib dispensed via IRT will have to return to the site for drug dispensing visits monthly for the first 3 months, and then every 3 months until discontinuation or completion of abemaciclib treatment (2 years). If dose changes are required after 3 months, this may require additional unscheduled visits for abemaciclib dispensation.
			Chemotherapy
  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Tamoxifen Once Daily

At the beginning of each cycle, please ensure patient has a script for the med.
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Letrozole, anastrozole, or exemestane Once Daily

At the beginning of each cycle, please ensure patient has a script for one of these medications:   Letrozole, Anastrozole, or Exemestane
					
Q3M Patient-reported Outcomes / EORTC-IL-311 / PGI-ST	Repeat 1 time	Cycle length: 90 days	Day 1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	PGI-ST
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	EORTC IL-311 (cognitive, social, and emotional function, and HRQoL)
					
Q6 M ( up to 84 months)	Repeat 1 time	Cycle length: 180 days	Day 1	Perform every 1 day x1		Provider Communication
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Complete physical examination 

*If screening assessments have been performed within 7 days prior to starting study treatment, they do not have to be repeated at Month 1 Day 1 if the patient's condition has not changed*
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Determine and record ECOG performance status
ECOG Performance status:** date:**
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Ocular assessment 

(+21 days; only if an abnormality had been reported at screening or during
treatment) and Safety Follow-up (+21 days; only if treatment discontinuation occurred due to ocular toxicity)
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Blood pressure, body temperature, heart rate
		  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Study treatment
			Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	EORTC[RAC1]  IL-309 
PRO-CTCAE 
VSAQ items

Month 1 Day 1 before dosing and then weekly for the first 6 weeks then Q2W until Month 24 then Q3M relative to Month 1 Day 1 until EOT
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	EORTC IL-310 
Month 1 Day 1 before dosing and then Q2W until Month 24 then Q3M relative to Month 1 Day 1 until EOT
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	PGI-TT
Month 1 Day 1 before dosing and weekly for the first 24 months and then Q3M relative to Month 1 Day 1 until EOT
			Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	EQ-5D-5L
			Pharmacodynamic Assessments
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Mandatory blood
samples for ctDNA
analyses
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Pre-dose blood
sample for PK
testing 
--

(Anytime within 60 minutes pre-dose)
			Chemotherapy
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Patients who have abemaciclib dispensed via IRT will have to return to the site for drug dispensing visits monthly for the first 3 months, and then every 3 months until discontinuation or completion of abemaciclib treatment (2 years). If dose changes are required after 3 months, this may require additional unscheduled visits for abemaciclib dispensation.
			Chemotherapy
  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Tamoxifen Once Daily

At the beginning of each cycle, please ensure patient has a script for the med.
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Letrozole, anastrozole, or exemestane Once Daily

At the beginning of each cycle, please ensure patient has a script for one of these medications:   Letrozole, Anastrozole, or Exemestane
					
EOT	Repeat 1 time	Cycle length: 30 days	Day 1	Perform every 1 day x1		Provider Communication
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Complete physical examination 

*If screening assessments have been performed within 7 days prior to starting study treatment, they do not have to be repeated at Month 1 Day 1 if the patient's condition has not changed*
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Determine and record ECOG performance status
ECOG Performance status:** date:**
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Ocular assessment 

(+21 days; only if an abnormality had been reported at screening or during
treatment) and Safety Follow-up (+21 days; only if treatment discontinuation occurred due to ocular toxicity)
			Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	PGI-ST
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	EORTC IL-311 (cognitive, social, and emotional function, and HRQoL)
			Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	EQ-5D-5L
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Blood pressure, body temperature, heart rate
		  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --			Labs
  	NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Creatinine, Bilirubin, direct, indirect
Alkaline phosphatase, AST, ALT, Albumin, Potassium, Calcium, total ,Magnesium, Sodium
Glucose (random),Protein, total Urea/blood urea nitrogen (depending on local practice)
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --					
Safety FU	Repeat 1 time	Cycle length: 30 days	Day 1	Perform every 1 day x1		Provider Communication
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Complete physical examination 

*If screening assessments have been performed within 7 days prior to starting study treatment, they do not have to be repeated at Month 1 Day 1 if the patient's condition has not changed*
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Determine and record ECOG performance status
ECOG Performance status:** date:**
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Ocular assessment 

(+21 days; only if an abnormality had been reported at screening or during
treatment) and Safety Follow-up (+21 days; only if treatment discontinuation occurred due to ocular toxicity)
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Blood pressure, body temperature, heart rate
		  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	PGI-ST
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	EORTC IL-311 (cognitive, social, and emotional function, and HRQoL)
			Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	EQ-5D-5L
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --			Labs
  	NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Creatinine, Bilirubin, direct, indirect
Alkaline phosphatase, AST, ALT, Albumin, Potassium, Calcium, total ,Magnesium, Sodium
Glucose (random),Protein, total Urea/blood urea nitrogen (depending on local practice)
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --					
LtFU	Repeat 1 time	Cycle length: 30 days	Day 1	Perform every 1 day x1		Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Determine and record ECOG performance status
ECOG Performance status:** date:**
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Ocular assessment 

(+21 days; only if an abnormality had been reported at screening or during
treatment) and Safety Follow-up (+21 days; only if treatment discontinuation occurred due to ocular toxicity)
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Blood pressure, body temperature, heart rate
		  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	PGI-ST
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	EORTC IL-311 (cognitive, social, and emotional function, and HRQoL)
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --			Labs
  	NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Creatinine, Bilirubin, direct, indirect
Alkaline phosphatase, AST, ALT, Albumin, Potassium, Calcium, total ,Magnesium, Sodium
Glucose (random),Protein, total Urea/blood urea nitrogen (depending on local practice)
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --