LEXICON
No.20 November 1, 2010

(Serious) adverse event (SAE)
(重篤な)有害事象
Adverse drug reaction (ADR)
薬物有害反応(薬事上の副作用)
Side effect
副作用

Adverse events (有害事象) refer to all undesirable or unintended medical events (symptoms, signs and diseases) subjects experience during a clinical study regardless of the causal relationship with the investigational drug (治験薬). Among adverse events, those with causal relationship with the...

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