Report of specific cardiovascular outcomes of the ADVANTAGE trial [1]

Annals of Internal Medicine

Volumn 144, Issue 10, 2006, Pages 781-

  Egilman, David S ^a   Presler, Amos H ^a  

^a BROWN UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

NAPROXEN; ROFECOXIB;

CARDIOVASCULAR RISK; CLINICAL TRIAL; DRUG FATALITY; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; HEALTH HAZARD; HEART INFARCTION; HUMAN; LETTER; MEDICAL INFORMATION; PRESCRIPTION; PRIORITY JOURNAL; CONTROLLED CLINICAL TRIAL; DRUG INDUSTRY; ETHICS; INSTITUTIONAL ETHICS; NOTE; RANDOMIZED CONTROLLED TRIAL; STANDARD; STATISTICAL ANALYSIS;

DATA INTERPRETATION, STATISTICAL; DRUG INDUSTRY; ETHICS, INSTITUTIONAL; HUMANS; RANDOMIZED CONTROLLED TRIALS;

EID: 33646843909     PISSN: 00034819     EISSN: None     Source Type: Journal    
DOI: 10.7326/0003-4819-144-10-200605160-00016     Document Type: Letter

References (6)

1. Braunstein N, Polis A. Report of specific cardiovascular outcomes of the ADVANTAGE trial [Letter]. Ann Intern Med. 2005;143:158-9.
2. Lisse JR, Perlman M, Johansson G, Shoemaker JR, Schechtman J, Skalky CS, et al. Gastrointestinal tolerability and effectiveness of rofecoxib versus naproxen in the treatment of osteoarthritis: a randomized, controlled trial. Ann Intern Med. 2003;139:539-46.
3. Silverman RE. Merck Research Laboratories letter to FDA, Center for Drug Evaluation and Research: NDA 21-042/S-007: Vioxx (rofecoxib tablets). Response to FDA request for information; 2001. Presented in evidence in Cona v. Merck, 2006.
4. Villalba ML. Medical officer review, NDA 21-042 and NDA 21-052 (rofecoxib tablets and rofecoxib oral solution). Re: Complete response to approvable letter for 21-042/S 007 and 21-052/S 004. U.S. Food and Drug Administration; 2001.
5. Smith B. Communication to J. Webb re: Vioxx seeding study selection. 8 January 1999. Bates no. MRK-AFB0001598. Presented in evidence in Humeston v. Merck, 2005.
6. Weiner JD. E-mail to K. Lindemann, C. Fanelle, and R. Higbee. Subject: ADVANTAGE ideas. 19 March 1999. Bates nos. MRK-ADI0024344-MRKADI0024346. Presented in evidence in Humeston v. Merck, 2005.