Event Description
AdverseEventTreatingDescriptionText
text
Serious Adverse Events
AdverseEventCommonTerminologyforAdverseEventsVersion4TermName
text
AdverseEventOnsetTime
time
AdverseEventEndTime
time
AdverseEventSeverityGrade
text
CTC Adverse Event Attribution Category
text
AdverseEventActionType
text
Adverse Event Outcome
text
AdverseEventSeriousnessAttributionScale
text
Laboratory Tests - Question
AbnormalPhysicalExaminationLaboratoryProcedureOutcomeInd-2
boolean
Laboratory Test
LaboratoryProcedurePhysicalExaminationAssessmentType
text
LaboratoryProcedurePerformedSpecify
text
AdverseEventWorstSymptomValue
float
AdverseEventWorstSymptomDate
date
AdverseEventWorstSymptomUOM
text
LaboratoryProcedurePerformedLowerLimitofNormalValue
float
LaboratoryProcedurePerformedUpperLimitofNormalValue
float
LaboratoryFindingRecoveryInd-2
boolean
AdverseEventMostRecentRecoveryValue
text
AdverseEventMostRecentRecoveryDate
date
PathologyCoreFacilityLaboratoryIdentifierName
text
Blood Pressure - Question
AbnormalBloodPressureLaboratoryProcedureOutcomeInd-2
boolean
Blood Pressure
AdverseEventWorstSymptomDate
date
Systolic blood pressure
float
Systolic blood pressure
float
Diastolic blood pressure
float
Diastolic blood pressure
float
LaboratoryFindingRecoveryInd-2
boolean
AdverseEventMostRecentRecoveryDate
date
Other Investigations - Question
AbnormalOtherLaboratoryProcedureOutcomeInd-2
boolean
Other Investigations - Question
LaboratoryProcedurePhysicalExaminationAssessmentType
text
LaboratoryProcedurePerformedSpecify
text
Laboratory Procedure Date
date
AdverseEventAssessmentText
text
Protocol Treatment
TreatmentAssignmentCode
text
Medication Dose
float
UnitsText
text
Drug administration method
text
Medication frequency
text
PatientRandomizationDate
date
TreatmentLastAdministeredDate
date
AgentSourceText
text
PatientRetreatmentInd
text
SeriousAdverseEventRepeatOccurrenceInd-2
boolean
Prior Systemic Therapy - Question
SystemicTherapyAdministeredInd-3
boolean
Prior Radiation Therapy - Question
AdjuvantRadiationTherapyAdministeredInd-3
boolean
Relevant Major Medical Problems - Question
ConcomitantDiseasePersonalMedicalHistoryInd-2
boolean
Relevant Major Medical Problems
PatientMedicalConditionDate
date
ConcomitantDiseaseOrganSystemPersonalMedicalHistoryType
text
ConcomitantDiseaseOrganSystemPersonalMedicalHistorySpecify
text
PatientHistoryText
text
Concomitant Medications - Question
ConcomitantMedicationUseInd-3
boolean
Concomitant Medications
Concomitant Medication
text
Concomitant Medication Use Indication
text
SeriousAdverseEventTherapyInd-2
boolean
Medication Start Date
date
Medication End Date
date
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