Event reporting and adjudication
EVENTS, EVENT, EVENTS
Trial events were reported by investigators using an electronic case report form that captured the date events occurred, the date they were reported, and relevant clinical details. Events were adjudicated by an independent committee, blinded to treatment allocation. Upon receipt of a site-reported event, an adjudication packet was assembled, containing prespecified clinical information according to event type. Completed packets were distributed to trained adjudicators, and following review, an adjudication decision was recorded in the trial database.