Abstract
This paper describes the method of survival and time to event analyses dataset generation with ADaM Basic Data Structure for Time-to-Event Analyses (ADTTE) standard with one clinical trial case study. The paper uses the simplest ADTTE model — single event with binary values for censoring variable among the three models. In this clinical trial case, the hierarchy structure is adopted to derive ADTTE analysis dataset transitioning among continuous analysis values and binary analysis values. To develop ADTTE dataset, in addition to following ADaM general rules, the key points are how to define STARTDT (Time to Event Origin Date for Subject) and ADT (Analysis Date) for study events, right censored, and other competing events for each parameter.
The author would like to thank Luyan Dai for the valuable inputs to the dataset design. The author would also like to thank Jingwei Gao and Nancy Bauer for the paper reviews.