Subject_AdverseEvent data set

Data Series Title	Description	Location in Oracle Argus Safety
AE_VerbatimTerm	Symptom or description of the adverse event as entered by the Oracle InForm user. Required.	Case Form / Events / Event Information / Description as Reported
AE_LowLevelTerm	MedDRA lower-level term (LLT) for the adverse event or reaction. Note: Do not map this data series if the item will be encoded in Oracle Argus Safety.	Case Form / Events / Event Encoding / Lower Level Term
AE_PreferredTerm	MedDRA preferred term (PT) for the adverse event or reaction. Note: Do not map this data series if the item will be encoded in Oracle Argus Safety.	Case Form / Events / Event Encoding / Preferred Term
AE_LLTMedDRAVersion	Version of MedDRA that was used to code the verbatim term to the lower-level term. Note: Do not map this data series if the item will be encoded in Oracle Argus Safety.	For items to be encoded in Oracle Argus Safety, MedDRA version is required by the format used for transmitting data but does not appear in Oracle Argus Safety.
AE_PTMedDRAVersion	Version of MedDRA that was used to code the verbatim term to the preferred term. Note: Do not map this data series if the item will be encoded in Oracle Argus Safety.	For items to be encoded in Oracle Argus Safety, MedDRA version is required by the format used for transmitting data but does not appear in Oracle Argus Safety.
AE_TermHighlightedCode	Term highlighted by the reporter (for example, highlighted as serious, highlighted as not serious, serious and not highlighted, not serious, and not highlighted).	Case Form / Events / Event Information / Term Highlighted by Reporter
AE_StartDateTime	Onset or start date of the adverse event.	Case Form / Events / Event Information / Onset Date/Time
AE_EndDateTime	End date of the adverse event.	Case Form / Events / Event Information / Stop Date/Time
AE_FirstDoseToOnset Duration	Duration between the first dose of the study drug and the onset date of the adverse event if exact tart and end dates are not known or the duration is less than one day.	Case Form / Events/ Event Information / Onset Latency
AE_FirstDoseToOnsetDuration Unit	Unit for the first dose to onset duration (Minutes, Hours).	Case Form / Events/ Event Information / Onset Latency
AE_LastDoseToOnset Duration	Duration between the last dose of the study drug and the onset date of the adverse event if exact start and end dates are not known or the duration is less than one day.	Case Form / Events/ Event Information / Onset From Last Dose
AE_LastDoseToOnsetDuration Unit	Unit for the last dose to onset duration (Minutes, Hours).	Case Form / Events/ Event Information / Onset From Last Dose
AE_OutcomeCode	Outcome of the adverse event at the last observation (for example, Recovered, Fatal).	Case Form / Events/ Event Information / Outcome of Event
AE_SeverityCode	Severity of the adverse event (for example, Severe, Moderate, Mild).	Case Form / Events/ Event Information / Event Intensity
AE_HospitalizationStart DateTime	Date that the patient was admitted to the hospital as a result of the adverse event.	Case Form / Event / <event name> / Seriousness Criteria / Hospitalization / Details / Start Date
AE_HosptializationEnd DateTime	Date that the patient was discharged from the hospital after having been admitted as a result of the adverse event.	Case Form / Event / <event name> / Seriousness Criteria / Hospitalization / Details / End Date
AE_InterventionRequired Indicator	Indicates whether the adverse event required intervention.	Case Form / Event / <event name> / Seriousness Criteria / Intervention Required
AE_Duration	Duration of the adverse event if exact start and end dates are not known or if the duration is less than one day.	Case Form / Events / Event Information / Duration
AE_DurationUnit	Unit for the duration of the adverse event.	Case Form / Events / Event Information / Duration
AE_SeriousnessDeathIndicator	Whether the adverse event resulted in death.	Case Form / Event / <event name> / Seriousness Criteria / Death
AE_SeriousnessLifeThreatening Indicator	Whether the adverse event was life threatening.	Case Form / Event / <event name> / Seriousness Criteria / Life Threatening
AE_SeriousnessHospitalization Indicator	Whether the adverse event resulted in hospitalization or prolonged existing hospitalization.	Case Form / Event / <event name> / Seriousness Criteria / Hospitalization
AE_SeriousnessDisabling Indicator	Whether the adverse event resulted in persistent or significant disability or incapacity.	Case Form / Event / <event name> / Seriousness Criteria / Disability
AE_SeriousnessCongenital AnomalyIndicator	Whether the adverse event resulted in a congenital anomaly or birth defect.	Case Form / Event / <event name> / Seriousness Criteria / Congenital Anomaly
AE_SeriousnessOtherIndicator	Whether the adverse event was a medically important condition.	Case Form / Event / <event name> / Seriousness Criteria / Other
AE_SeriousnessOtherComment	The medically important condition indicated by the Other Indicator item.	Case Form / Event / <event name> / Seriousness Criteria / <Other Comment Text>
AE_MedicallySignificant Indicator	Whether the adverse event was medically significant.	Case Form / Event / <event name> / Seriousness Criteria / Medically Significant
AE_SubjectDroppedFromStudy Indicator	Whether the subject dropped out of the study because of the adverse event.	Case Form / Event / <event name> / Diagnosis / Dropped From Study Due to Event
AE_RelatedToStudyConduct Code	Whether the adverse event was related to a study procedure.	Case Form / Event / <event name> / Diagnosis / Related to Study Conduct
AE_ReceivedTreatmentCode	Whether the patient received treatment for the adverse event (Yes, No, Unknown).	Case Form / Event / <event name> / Diagnosis / Treatment Received
AE_SubjectHasPriorHistory Code	Whether the patient had experienced the adverse event in the past (Yes, No, Unknown).	Case Form / Event / <event name> / Diagnosis / Patient Has Prior History
AE_LackOfEfficacyIndicator	Whether the adverse event indicates a lack of efficacy of the study drug.	Case Form / Event / <event name> / Diagnosis / Lack of Efficacy
AE_DiseaseProgression Indicator	Whether the adverse event caused the disease to progress.	Case Form / Event / <event name> / Diagnosis / Progression of Disease
AE_AdverseDrugWithdrawal ReactionIndicator	Whether the adverse event was caused by withdrawal of the drug.	Case Form / Event / <event name> / Diagnosis / Adverse Drug Withdrawal Reaction
AE_InfectionIndicator	Whether the adverse event resulted in an infection.	Case Form / Event / <event name> / Diagnosis / Infection
AE_CaseNarrative	An item from an AE form that needs to appear in the narrative for the case in Oracle Argus Safety. If multiple AEs are selected using the dynamic grid functionality, the item mapped will appear for each AE selected in the order it was selected in the dynamic grid. This information will appear in the case narrative in Oracle Argus Safety before the items on the SAE form mapped at the Safety_Case level. Note: Compound items are not supported as a narrative field. Note: Only one text item is supported as a narrative in an itemset in a Safety form.	Case Form / Analysis / Case Analysis / Narrative