Evaluation of the value of attribution in the interpretation of adverse event data: A North Central Cancer Treatment Group and American College of Surgeons Oncology Group investigation
Adverse Drug Reaction Reporting Systems
Carcinoma, Non-Small-Cell Lung
Gastrointestinal Stromal Tumors
Nearly 50% of AEs were reported as attributed to study drug on the placebo arm of two randomized clinical trials. These data provide strong evidence that AE attribution is difficult to determine, unreliable, and of questionable value in interpreting AE data in randomized clinical trials.