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Table 3 Statistical approaches for safety data analysis

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

Statistical method/approachNumber of articles (%)
Descriptive statistics18 (100)
 Proportion/count18 (100)
 Mean/median1 (5.6)
 Incidence rate6 (33.3)
Inferential methods 
Univariate methods 
 Fisher`s exact test/Chi square12 (66.7)
 t-test4 (22.2)
 Linear regression1 (5.6)
 Mann–Whitney/Wilcoxon1 (5.6)
Multivariable modelling
 Poisson regression3 (16.7)
 Negative binomial1 (5.6)
Number of inferential methods
 None3 (16.7)
 One method10 (55.6)
 More than one method5 (27.8)
Analysis approach
 Reporting missing data 
 Missing efficacy data reported7 (38.9)
Handling missing efficacy data 
 Imputation1 (5.6)
Analysis population definition
 ITT4 (22.2)
 PP5 (27.8)
 ITT + PP2 (11.1)
 Not specified7 (38.9)
Multiplicity adjustment for treatment0 (0.0)
Results presentation
 Graphs0 (0.0)
 Tables16 (88.9)
 Point estimate and confidence interval10 (55.6)
 P value16 (88.9)
  1. Entries in this table are mutually exclusive and may not add up to the total 26 articles since some articles used more than one approach
  2. ITT: intention to treat; PP: per protocol