Empirical comparison of methods for analyzing multiple time-to-event outcomes in a non-inferiority trial: a breast cancer study

BackgroundSubjects with breast cancer enrolled in trials may experience multiple events such as local recurrence, distant recurrence or death. These events are not independent; the occurrence of one may increase the risk of another, or prevent another from occurring. The most commonly used Cox proportional hazards (Cox-PH) model ignores the relationships between events, resulting in a potential impact on the treatment effect and conclusions. …