VX2 | FDA, Review of cardiovascular safety database, dated February 1, 2001. Original memo by Shari L. Targum, MD, to the FDA anti-inflammatory-drug division. The copy is preserved in FDA's later PDF correspondence compilation, PDF pp. 3, 20, 36-39. Verify against the linked scan; table spacing standardized for readability, numerical entries transcribed from PDF p. 20. These are sponsor-submitted adjudicated VIGOR counts as discussed by the FDA reviewer, not a claim about placebo effects.

PDF p. 20, memo p. 18: Summary of Adjudicated Thrombotic Cardiovascular Serious Adverse Experiences, VIGOR Study in Patients With Rheumatoid Arthritis, Updated Application Data:
Treatment groups: rofecoxib (N=4047); naproxen (N=4029).
Event | rofecoxib n | naproxen n
Any Event | 47 | 20
Cardiac Events (Fatal/Nonfatal) | 28 | 10
Acute Myocardial Infarction | 20 | 4
Cardiovascular Death | 6 | 6
Note on the source table: "Patients may be counted in more than 1 row, but are only counted once within a row."

PDF p. 36, memo p. 34, reviewer assessment: "The VIGOR study was a large study with a longer drug exposure and follow-up than the two smaller studies (085 and 090). The cardiovascular thrombotic event rates, while not high, were significantly different between the two groups; most striking were the myocardial infarction event rates." "As there is no placebo group, it will be difficult to assess the CV thrombotic risk with rofecoxib use compared with no therapy at all."

PDF p. 39, memo p. 37, recommendation: "It would be difficult to imagine inclusion of VIGOR results in the rofecoxib labeling without mentioning cardiovascular safety results in the study description as well as the Warnings sections."
