Table 3 Statistical approaches for safety data analysis
Statistical method/approach | Number of articles (%) |
|---|---|
Descriptive statistics | 18 (100) |
 Proportion/count | 18 (100) |
 Mean/median | 1 (5.6) |
 Incidence rate | 6 (33.3) |
Inferential methods | Â |
Univariate methods | Â |
 Fisher`s exact test/Chi square | 12 (66.7) |
 t-test | 4 (22.2) |
 Linear regression | 1 (5.6) |
 Mann–Whitney/Wilcoxon | 1 (5.6) |
Multivariable modelling | |
 Poisson regression | 3 (16.7) |
 Negative binomial | 1 (5.6) |
Number of inferential methods | |
 None | 3 (16.7) |
 One method | 10 (55.6) |
 More than one method | 5 (27.8) |
Analysis approach | |
 Reporting missing data |  |
 Missing efficacy data reported | 7 (38.9) |
Handling missing efficacy data | Â |
 Imputation | 1 (5.6) |
Analysis population definition | |
 ITT | 4 (22.2) |
 PP | 5 (27.8) |
 ITT + PP | 2 (11.1) |
 Not specified | 7 (38.9) |
Multiplicity adjustment for treatment | 0 (0.0) |
Results presentation | |
 Graphs | 0 (0.0) |
 Tables | 16 (88.9) |
 Point estimate and confidence interval | 10 (55.6) |
 P value | 16 (88.9) |