Key result
Assessment of cardiovascular data from the APPROVe trial highlights methodological issues in time-to-event analyses, including proportional hazards assumptions and follow-up for long-term treatments.
Population
Patients in the APPROVe trial for the prevention of recurrent colorectal polyps
Comparison
Rofecoxib vs Placebo
Design
Review, randomized, placebo-controlled
Authors
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Requires cautious interpretation of time-to-event safety data from long-term trials; leaves open optimal analytic methods.
This paper highlights important methodological issues regarding the analysis and interpretation of time-to-event safety endpoints in long-term randomized trials, using the APPROVe trial as a case study.
Stephen W. Lagakos (2006) conducted a review in Recurrent colorectal polyps. Rofecoxib vs. Placebo was evaluated on Adverse cardiovascular events, including confirmed serious thrombotic events. Assessment of cardiovascular data from the APPROVe trial highlights methodological issues in time-to-event analyses, including proportional hazards assumptions and follow-up for long-term treatments.
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