Time-to-Event Variables for BDS Datasets

The table below describes variables useful for time-to-event analysis. The ADaM Basic Data Structure for Time-to-Event Analyses (available at https://www.cdisc.org/standards/foundational/adam) provides discussion and examples of the use of these variables and other ADaM variables to support time- to-event analyses. For example, the document describes using AVAL for the length of time from the start of the at-risk period to the event of interest, ADT for the date of event or censoring, and AVISIT for the analysis visit where event or censoring occurred.

Variable Name	Variable Label	Type	Codelist/ Controlled Terms	Core	CDISC Notes
STARTDT	Time-to-Event Origin Date for Subject	Num		Perm	The 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.
STARTDTM	Time-to-Event Origin Datetime	Num		Perm	The 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.
STARTDTF	Origin Date Imputation Flag	Char	(DATEFL)	Cond	The level of imputation of the start date. See Section 2.9.3.3, Date and Time Imputation Flag Variables.
STARTTMF	Origin Time Imputation Flag	Char	(TIMEFL)	Cond	The level of imputation of the start time. See Section 2.9.3.3, Date and Time Imputation Flag Variables.
CNSR	Censor	Num		Cond	Defines 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.
EVNTDESC	Event or Censoring Description	Char		Perm	Description of the event of interest or censoring reason for the subject within the parameter.
CNSDTDSC	Censor Date Description	Char		Perm	Describes the circumstance represented by the censoring date if different from the event date that warrants censoring.

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Time-to-Event Variables for BDS Datasets