Table 2 Characteristics and structure of reported safety data (n = 18)
Characteristic | Number of articles (%) |
|---|---|
Data Monitoring and Safety Board | 14 (77.8) |
Data collection approach | |
 Scheduled visits | 1 (5.6) |
 Scheduled and non-scheduled visits | 10 (55.6) |
 Non-scheduled visits | 1 (5.6) |
 Not specified | 6 (33.3) |
Reported AE severity levels | 13 (72.2) |
Assessed AE vs adherence | 3 (16.7) |
Discontinue treatment due to AE | 18 (100) |
Reported continuous outcome dichotomization | 18 (100) |
Reported laboratory data | 18 (100) |
Multiple safety endpoints | 18 (100) |
Longitudinal safety endpoints | 18 (100) |
Reported recurrent AEs | 0 (0.0) |
Retention rate (IQR) | 89.4% (IQR: 82.5%, 92.4%) |