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STATISTICS AND MEDICINE Volume 355:113-117 July 13, 2006 Number 2 Next

	Since this article has no abstract, we have provided an extract of the first 100 words of the full text and any section headings.

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The Adenomatous Polyp Prevention on Vioxx (APPROVe) trial¹ compared rofecoxib with placebo in the prevention of recurrent colorectal polyps, but the researchers also collected data on adverse cardiovascular events, including confirmed serious thrombotic events. Assessment of the cardiovascular data raises important issues about the analysis and interpretation of a time-to-event end point in a randomized, placebo-controlled trial evaluating a long-term treatment. These issues include the appropriate period of follow-up for safety outcomes after the discontinuation of treatment; the purpose and implications of checking the assumption of proportional hazards, which underlies the commonly used log-rank test and Cox model; and what . . . [Full Text of this Article]

Source Information

Dr. Lagakos is a professor of biostatistics at the Harvard School of Public Health, Boston, and a statistical consultant to the Journal.

This article was published at www.nejm.org on June 26, 2006.

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