Event Description
AdverseEventTreatingDescriptionText
text
Serious Adverse Events
AdverseEventCommonTerminologyforAdverseEventsVersion4TermName
text
AdverseEventOnsetTime
time
AdverseEventEndTime
time
AdverseEventSeverityGrade
text
CTCAdverseEventAttributionScale
text
AdverseEventActionType
text
AdverseEventPresentStatus
text
AdverseEventSeriousnessAttributionScale
text
Laboratory Tests - Question
AbnormalPhysicalExaminationLaboratoryProcedureOutcomeInd-2
text
Laboratory Test
LaboratoryProcedurePhysicalExaminationAssessmentType
text
LaboratoryProcedurePerformedSpecify
text
AdverseEventWorstSymptomValue
double
AdverseEventWorstSymptomDate
date
AdverseEventWorstSymptomUOM
text
LaboratoryProcedurePerformedLowerLimitofNormalValue
double
LaboratoryProcedurePerformedUpperLimitofNormalValue
double
LaboratoryFindingRecoveryInd-2
text
AdverseEventMostRecentRecoveryValue
text
AdverseEventMostRecentRecoveryDate
date
PathologyCoreFacilityLaboratoryIdentifierName
text
Blood Pressure - Question
AbnormalBloodPressureLaboratoryProcedureOutcomeInd-2
text
Blood Pressure
AdverseEventWorstSymptomDate
date
Systolic blood pressure
double
Systolic blood pressure
double
Diastolic blood pressure
double
Diastolic blood pressure
double
LaboratoryFindingRecoveryInd-2
text
AdverseEventMostRecentRecoveryDate
date
Other Investigations - Question
AbnormalOtherLaboratoryProcedureOutcomeInd-2
text
Other Investigations - Question
LaboratoryProcedurePhysicalExaminationAssessmentType
text
LaboratoryProcedurePerformedSpecify
text
LaboratoryProcedureEvaluationPerformedDate
date
AdverseEventAssessmentText
text
Protocol Treatment
TreatmentAssignmentCode
text
AgentAdministeredDose
double
UnitsText
text
AgentAdministrationType
text
AgentAdministeredFrequency
text
PatientRandomizationDate
date
TreatmentLastAdministeredDate
date
AgentSourceText
text
PatientRetreatmentInd
text
SeriousAdverseEventRepeatOccurrenceInd-2
text
Prior Systemic Therapy - Question
SystemicTherapyAdministeredInd-3
text
Prior Radiation Therapy - Question
AdjuvantRadiationTherapyAdministeredInd-3
text
Relevant Major Medical Problems - Question
ConcomitantDiseasePersonalMedicalHistoryInd-2
text
Relevant Major Medical Problems
PatientMedicalConditionDate
date
ConcomitantDiseaseOrganSystemPersonalMedicalHistoryType
text
ConcomitantDiseaseOrganSystemPersonalMedicalHistorySpecify
text
PatientHistoryText
text
Concomitant Medications - Question
ConcomitantMedicationUseInd-3
text
Concomitant Medications
ConcomitantMedicationReceivedText
text
ConcomitantMedicationAdministeredReasonText
text
SeriousAdverseEventTherapyInd-2
text
AgentBeginDate
date
AgentEndDate
date
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