Recent media reports have focused on the U.S. Food and Drug Administration's (FDA's) medical review of unblinded data from this study, in which the FDA reviewer commented that the death of 1 patient in the rofecoxib group, which the investigator had listed as from “hypertensive heart disease” on the basis of autopsy findings, was, in the FDA reviewer's opinion, a case of sudden death. Although the term retrospectively proposed by the FDA reviewer would have met criteria as a potential thrombotic event eligible for adjudication if used by the investigator, the term hypertensive heart disease did not trigger adjudication in the existing standard operating procedure. Therefore, this case was not prospectively adjudicated and is not included as a confirmed thrombotic event in Table 1. However, on the basis of internal blinded review, it was determined prospectively that this patient's death met the criteria of the APTC combined end point, and as shown in Table 2, this patient's death was included in the combined APTC end point in the article by Lisse and colleagues (1). It was also included in the pooled analyses of cardiovascular events with rofecoxib published by Konstam and associates (4) and Weir and coworkers (5).