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Overlap between adverse events (AEs) and serious adverse events (SAEs): a case study of a phase III cancer clinical trial.

Elizabeth C JamesDavid T DunnAdrian D CookAndrew R ClampMatthew Robert Sydes
Published in: Trials (2020)
There was low agreement in mapping serious adverse events to already reported adverse events, with nearly 40% of serious adverse events included in the mapping exercise not mapped to an already reported adverse event. Any analyses of safety data that use only adverse event datasets or do not clearly account for serious adverse event data will likely be missing important safety information. Reporting standards should make clear which datasets were used for analyses.
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