Profile of a large-scale cohort study.

An event-monitoring, observational cohort study was conducted in 10,800 patients treated with the nonsteroidal anti-inflammatory agent (NSAID) nabumetone and in 2005 patients treated with a selection of other NSAIDs. A total of 2986 doctors in general practice in the UK participated in the study, which involved the provision of a registration report at the beginning of the study and follow-up reports at 1, 3, 6, and 12 months. The methodology which was developed was successful in collecting demographic, diagnostic, drug use, clinical event and adverse reaction data in everyday medical practice.