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:
- Mild: Transient symptoms, no interference with the subject’s daily
activities
- Moderate: Marked symptoms, moderate interference with the subject’s
daily activities
- Severe: Considerable interference with the subject’s daily activities,
unacceptable
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.