Safety evaluation of XXXX in United States clinical trials.

@entity1 @entity2852 @entity309 @entity571
A total of 1,924 @entity1 ( @entity309 , 835; @entity571 , 1,073; volunteers, 16) received @entity2852 in United States clinical trials. Nine hundred eighty-eight @entity1 have received @entity2852 treatment for periods of more than one year, and 375 @entity1 have received treatment for longer than two years. Four hundred eighty @entity1 over 65 years of age have received treatment with @entity2852 , and 224 of these elderly @entity1 have received treatment for periods of more than one year. The @entity2852 dose most commonly used in all double-blind trials was 1,000 mg at night. In long-term, open-label studies, which were usually extensions of the double-blind trials, @entity1 could increase the dose to 2,000 mg per day. Nine hundred nineteen @entity1 received doses of more than 1,000 mg per day. Adverse experience information was collected at each visit, including information for some @entity1 receiving treatment for more than three years. Laboratory data were collected periodically throughout the trials, and the data were assessed for trends over time. The adverse experience pattern observed for @entity2852 is similar to that described for clinical trial data for other nonsteroidal anti-inflammatory drugs. However, it is noteworthy that the pattern observed for @entity2852 is from clinical trials with approximately 1,000 @entity1 receiving treatment for periods of one year or more. This long-term @entity1 exposure in clinical trials far exceeds long-term clinical trial data for other agents. The types and frequencies of adverse experiences reported by @entity1 treated with @entity2852 are relatively constant over the long time period covered by these trials. Also, the adverse experience patterns remained generally constant over time for various populations: all @entity1 , @entity1 65 or older, female @entity1 , male @entity1 , and @entity1 who received an increased dose of @entity2852 . Although some statistically significant trends were detected for some laboratory parameters, there was little indication of significant clinical patterns. Although there were @entity1 with individually important laboratory values, @entity2852 was not associated with clinically important adverse laboratory patterns. Overall, the adverse experience data and laboratory data indicate that @entity2852 is safe for the treatment of adult @entity1 with @entity309 or @entity571 .
