Patient demographics
Patient Initials
text
Protocol Number ECOG
text
Patient ID ECOG
text
Study Number Participating Group
text
Trial subject ID Participating Group
text
Institution Name
text
Data amendment
Data amended
text
Data amended date
date
On Treatment
Cycle number
text
Cycle number
text
Chemotherapy cycle
text
Off Treatment
PersonOff-TreatmentTimePeriodType
text
Adverse event report
AdverseEventCurrentAssessmentInd
text
Adverse Event Start Date
date
Adverse Event End Date
date
Blood/bone Marrow - Labs
CTC Adverse Event Term
text
CTC Adverse Event Grade
float
CTC Adverse Event Attribution Category
text
AdverseEventInvestigationalClinicalStudyTherapyAttributionind-2
boolean
II. NON-HEMATOLOGIC
CTC Adverse Event Term
text
CommonToxicityCriteriaAdverseEventShortNameType
text
CTC Adverse Event Term
text
CTC Adverse Event Grade
float
CTC Adverse Event Grade
float
CTC Adverse Event Attribution Category
text
CTC Adverse Event Attribution Category
text
AdverseEventInvestigationalClinicalStudyTherapyAttributionind-2
boolean
AdverseEventInvestigationalClinicalStudyTherapyAttributionind-2
boolean
III. NON-HEMATOLOGIC
CTC Adverse Event Term
text
CTC Adverse Event Grade
float
CTC Adverse Event Attribution Category
text
AdverseEventInvestigationalClinicalStudyTherapyAttributionind-2
boolean
Other Adverse Events
CTC Adverse Event Term
text
CTC Adverse Event Reported Term
text
CTC Adverse Event Grade
float
CTC Adverse Event Attribution Category
text
AdverseEventInvestigationalClinicalStudyTherapyAttributionind-2
boolean
V. INFECTIONS
CommonToxicityCriteriaAdverseEventShortNameType
text
CTC Adverse Event Term
text
CTC Adverse Event Grade
float
CTC Adverse Event Attribution Category
text
AdverseEventInvestigationalClinicalStudyTherapyAttributionind-2
boolean
Comments
Investigator Signature
text
Investigator Signature Date
date