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Table 3.3.6.1 Time-to-Event Variables for BDS Datasets

Variable NameVariable LabelTypeCodelist/ Controlled TermsCoreCDISC Notes
STARTDTTime-to-Event Origin Date for SubjectNum PermThe original date of risk for the time-to-event analysis. This is generally the point at which a subject is first at risk for the event of interest evaluation (as defined in the Protocol or SAP). For example, this may be the randomization date or the date of first study therapy exposure.
STARTDTMTime-to-Event Origin DatetimeNum PermThe original datetime of risk for the time-to-event analysis. This is generally the point at which a subject is first at risk for the event of interest evaluation (as defined in the Protocol or SAP). For example, this may be the randomization datetime or the datetime of first study therapy exposure.
STARTDTFOrigin Date Imputation FlagChar(DATEFL)CondThe level of imputation of the start date. See Section 3.1.3, Date and Time Imputation Flag Variables.
STARTTMFOrigin Time Imputation FlagChar(TIMEFL)CondThe level of imputation of the start time. See Section 3.1.3, Date and Time Imputation Flag Variables.
CNSRCensorNum CondDefines whether the event was censored for the subject within the parameter (period of observation truncated prior to event being observed). It is strongly recommended to use 0 as an event indicator and positive integers as censoring indicators. It is also recommended that unique positive integers be used to indicate coded descriptions of censoring reasons. CNSR is required for time-to-event parameters.
EVNTDESCEvent or Censoring DescriptionChar PermDescription of the event of interest or censoring reason for the subject within the parameter.
CNSDTDSCCensor Date DescriptionChar PermDescribes the circumstance represented by the censoring date if different from the event date that warrants censoring.

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