Adverse events of special interest
ideation, sudden death, cardiac arrhythmias, overdose, syncope, seizures, MDMA abuse, self-harm
SUDDEN DEATH, CARDIAC ARRHYTHMIAS, VENTRICULAR TACHYCARDIA, ADVERSE EVENTS, TORSADE DE POINTES, VENTRICULAR FIBRILLATION AND FLUTTER, VENTRICULAR EXTRASYSTOLES
In accordance with FDA guidance, special attention was paid to a subset of adverse events, TEAESIs, relating to cardiac function, suicide risk and MDMA abuse, misuse or diversion. TEAESIs involving cardiac function that could be indicative of QT prolongation or cardiac arrhythmias were collected, including torsade de pointes, sudden death, ventricular extrasystoles, ventricular tachycardia, ventricular fibrillation and flutter, non-postural syncope and seizures. TEAESIs involving suicide risk included suicide, suicide attempts, self-harm associated with suicidal ideation, suicide ideation assessed as a score of 4 or 5 on the C-SSRS and suicidal ideation judged by the investigator to be serious/severe. TEAESIs involving terms of MDMA abuse, misuse, drug diversion, dependence or overdose were also collected.