Published Date:
ADaM BDS for TTE Analyses v1.0 provides definitions and examples of BDS datasets, variables, and metadata that support time-to-event analyses. The document addresses three scenarios 1) A Single Endpoint with a Binary Value for Censoring, 2) A Single Endpoint with Multiple Values for Censoring, and 3) Composite Endpoints. The document also provides descriptions of typical TTE analyses including example outputs and associated results-level metadata, clear step-by-step information about how to create and populate the supportive and analyzed datasets, and variables required for both TTE analysis and traceability.