Differences between self-reported and verified adverse cardiovascular events in a randomised clinical trial.

ABSTRACT: In clinical trials, adverse events are usually self-reported but may be adjudicated if serious or of particular interest. After adjudicating cardiovascular events for a 5-year calcium supplement trial, we observed discrepancies between self-reported and verified events. We systematically analysed those differences to assess their importance. Secondary analysis of adverse cardiovascular events in a 5-year, randomised, placebo-controlled trial of calcium supplementation (1 g calcium daily) in 1471 postmenopausal women (mean age 74 years). Clinical research centre. The participant's medical records were reviewed for all self-reported myocardial infarctions (MIs) or strokes, and the event independently adjudicated. Cause of death was obtained from hospital records or death certificates. To ide

SUBMITTER: Bolland MJ 

PROVIDER: S-EPMC3612743 | biostudies-literature | 2013 Mar

REPOSITORIES: biostudies-literature