Endpoints and assessments
Number of treatment-emergent adverse events (AEs) and AEs assessed by the investigator as possibly related to the investigational medicinal product (IMP-related) were summarised by treatment group and MedDRA System Organ Class (SOC), MedDRA Preferred Term and classified by severity (mild, moderate, severe), seriousness, action taken, time from first intake to AE (onset day), and reoccurrence after IMP administration. AEs were recorded from the point in time when subjects signed the informed consent form and up until the last follow-up. All AEs were coded according to the current MedDRA version at the time of trial conduct. For the pooled population, AEs were re-coded to MedDRA version 19.0.
The severity of an AE was a clinical observation assessed by the investigator using the following definitions:
An AE was considered treatment-emergent if the time of onset was after the time of first IMP dose. However, if a subject discontinued, only AEs recorded up until 7 days after the discontinuation date were considered treatment emergent.