Header
Form ID CALGB
text
Protocol ID CALGB
Trial subject ID CALGB
Adverse Event Start Date
date
Adverse Event End Date
Data amended
boolean
Patient demographics
Patient Initials
Medical Record Number
Institution Name
Participating Group
Study Number Participating Group
Trial subject ID Participating Group
Adverse Event Expedited Reporting System filed?
AdverseEventReportInd-3
Cycle Number
integer
Expected Adverse Events
MedDRACode
float
AdverseEventCommonTerminologyforAdverseEventsVersion4TermName
AdverseEventSeverityGrade
CTC Adverse Event Attribution Category
Footer module
Person Completing Form
Date Form Completed