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Table 2 Characteristics and structure of reported safety data (n = 18)

From: Systematic review of statistical methods for safety data in malaria chemoprevention in pregnancy trials

CharacteristicNumber of articles (%)
Data Monitoring and Safety Board14 (77.8)
Data collection approach
 Scheduled visits1 (5.6)
 Scheduled and non-scheduled visits10 (55.6)
 Non-scheduled visits1 (5.6)
 Not specified6 (33.3)
Reported AE severity levels13 (72.2)
Assessed AE vs adherence3 (16.7)
Discontinue treatment due to AE18 (100)
Reported continuous outcome dichotomization18 (100)
Reported laboratory data18 (100)
Multiple safety endpoints18 (100)
Longitudinal safety endpoints18 (100)
Reported recurrent AEs0 (0.0)
Retention rate (IQR)89.4% (IQR: 82.5%, 92.4%)
  1. The retention rate is based on primary outcome reported in trial flow diagram
  2. IQR: interquartile range