ADaM ADTTE (Time-to-Event Analysis Dataset)

Analysis-ready time-to-event ADaM dataset derived from ADSL and event/source domains to support survival and TTE endpoints (e.g., PFS/OS), including analysis time, censoring, event indicators, and parameterized endpoints used for Kaplan–Meier and Cox models.

Deliverables

Specifications

• ADTTE Specifications

Programming

• Build ADTTE (R Derivation Program)

What you’ll find here

• Purpose: One or more TTE records per subject per endpoint (PARAM/PARAMCD), with event/censor status and analysis time
• Traceability: Spec → Program → Output alignment (including key date derivations and links back to sources)
• Typical variables: STUDYID, USUBJID, PARAM, PARAMCD, ADT, CNSR, EVNTDESC, STARTDT/ADT (endpoint date), AVAL (analysis time), AVALU (time unit), plus treatment variables from ADSL (e.g., TRT01A) and analysis flags like ANL01FL