Safety assessments
ADVERSE EVENTS
All adverse events (AEs) that occur after the screening visit (or as soon as the medical history of the patient has been examined) are documented. The period of observation ends with the last study visit. All patients who have AEs, whether considered associated with the use of the investigational medical products or not, are monitored for outcome determination. AEs are collected systematically based on patients’ answers to applicable questions by the investigator, but spontaneous reports are recorded as well if AE criteria apply. For analyses, AEs are centrally coded according to MedDRA. The Data Monitoring Committee (DMC) is composed of three independent experts, meets regularly to review all data relevant to safety, and provides the sponsor with recommendations regarding trial modification, continuation, or termination.