2.4. Assessment of TEAEs

A TEAE was defined as an adverse event that (1) emerged during treatment, having been absent at pretreatment; or (2) re‐emerged during treatment, having been present at pretreatment but having stopped prior to treatment. TEAEs, using Medical Dictionary for Regulatory Activities (MedDRA) search terms, were assessed in patients who were receiving the perampanel 4‐mg/d dose at the onset of their TEAE(s) at any time during the double‐blind treatment phase (titration and maintenance periods). Serious TEAEs, TEAEs leading to discontinuation, and TEAEs related to hostility and/or aggression were also assessed in the same patient population. These patients may or may not have been receiving a modal dose of perampanel 4 mg/d; as such, this population is different from the safety analysis set defined above, in which all patients received a modal dose of perampanel 4 mg/d. Due to the differences in the lengths of time that patients received treatment with placebo versus perampanel 4 mg/d in the assessment of TEAEs, safety data are not reported here for placebo‐treated patients, as this would not be an appropriate comparison. TEAEs were also assessed by concomitant EIASM use.