Header
Protocol Number ECOG
text
Patient ID ECOG
Generic drug form
Registration Number
Patient Initials
Study Number Participating Group
Institution Name
Trial subject ID Participating Group
Data amended
Data amended date
date
Research Comments
Investigator Signature
Investigator Signature Date
On Treatment Reporting Period
Cycle number
Reporting Period Start Date
Reporting Period End Date
Off Treatment
PersonOff-TreatmentTimePeriodType
Section I - Corticosteroid Medication
ConcomitantMedicationCorticosteroidTherapeuticProcedureRelationshipAdverseEventAdministeredInd-2
boolean
ConcomitantMedicationCorticosteroidTherapeuticProcedureRelationshipAdverseEventAdministeredName
CommonTerminologyCriteriaforAdverseEventsVersion4.0LowLevelTermName
AgentAdministeredDose
float
AgentConcomitantAdministrationUOM
AgentAdministeredFrequency
AgentAdministeredFrequencySpecify
Drug Administration Route
MedicationAdministrationRouteSpecify
Concomitant Medication Start Date
Medication continued
Concomitant Medication End Date
Section II - Immunosuppressant Medication
ConcomitantMedicationImmunosuppressantTherapeuticProcedureRelationshipAdverseEventAdministeredInd-2
ConcomitantMedicationImmunosuppressantTherapeuticProcedureRelationshipAdverseEventAdministeredName
ConcomitantMedicationImmunosuppressantTherapeuticProcedureRelationshipAdverseEventAdministeredSpecify
Section III - Hormonal Replacement Therapy Medication
ConcomitantMedicationHormoneReplacementTherapyTherapeuticProcedureRelationshipAdverseEventAdministeredTherapyInd-2
ConcomitantMedicationHormoneReplacementTherapyTherapeuticProcedureRelationshipAdverseEventAdministeredName
ConcomitantMedicationHormoneReplacementTherapyTherapeuticProcedureRelationshipAdverseEventAdministeredSpecify