Table 1. Description of Each Study in the Cross Trial Safety Analysis.
Study | Sponsor | Description | Randomization/Dose | Stratification | Planned Follow-Up Time |
---|---|---|---|---|---|
APC | NCI and Pfizer | Comparison of 2 doses of celecoxib with placebo for the prevention of colorectal adenoma recurrence | Celecoxib 200 mg BID, celecoxib 400 mg BID, or placebo | Center; low-dose aspirin use | 37 mo |
PreSAP | Pfizer | Comparison of celecoxib with placebo for the prevention of colorectal adenoma recurrence | Celecoxib 400 mg QD or placebo | Country; low-dose aspirin use | 37 mo |
MA27 | NCI, NCI of Canada, and Pfizer | Factorial design comparing 2 aromatase inhibitors with or without celecoxib in postmenopausal women with breast cancer | Factorial design: exemestane (2.5 mg/d) or anastrozole (1 mg/d); celecoxib (400 mg BID) or placebo | Lymph node status at diagnosis; adjuvant chemotherapy; low-dose aspirin use | Participants would take celecoxib for 3 y after randomization but were to be followed up until the study end, which was the time of ending treatment with aromatase inhibitor |
ADAPT | NIA | Comparison of naproxen sodium, celecoxib, and placebo for the prevention of Alzheimer's disease and attenuation of age-related cognitive decline | Naproxen sodium (220 mg BID), celecoxib (200 mg BID), or placebo | Field site; age categories: 70–74 y, 75–79 y, ≥80 y | Up to 7 y |
CDME | NEI | Factorial design comparing laser diode photocoagulation to focal photocoagulation and celecoxib or placebo for 3 months before and after laser coagulation | Celecoxib (200 mg BID) or placebo | None | 3 y |
Celecoxib/Selenium Trial | NCI | Factorial design study comparing celecoxib with placebo and selenium with placebo for the prevention of colonic polyp recurrence | Factorial design: celecoxib (400 mg QD) or placebo; selenium (200 μg/d) or placebo | Clinical center; low-dose aspirin use | 3 to 5 y after randomization; the planned length of follow-up depended on the recommendation by the participant's gastrointestinal physician for a follow-up colonoscopy |
NIA indicates National Institute on Aging.