Safety outcome type after treatment | Examples | Optimal statistical method(s) |
---|---|---|
Time to event | Time to infection/infestation occurrence, time to abortion | Survival methods (e.g. Kaplan–Meier plots, log rank test followed by cox regression model) |
Longitudinal continuous outcomes | QTc prolongation, haemoglobin, vital signs | Mixed effects linear/nonlinear models |
Recurrent events | recurrent hospitalizations, recurrent anaemia, recurrent opportunistic infections | Recurrent event models (e.g. Poisson model, negative binomial, Andersen Gill model) |
Safety outcomes with informative missing data, | Treatment switching, Dropout/withdrawal due to AE (i.e. AE-induced non-adherence) | Causal inference methods (e.g. mediation analysis) |
Multivariate outcomes | Abortion, miscarriage Haemoglobin, QTc, alanine aminotransferase level | Multivariate methods: methods for multiple outcomes (e.g. multivariate regression models based on outcome type), methods for repeated outcomes (e.g. multivariate longitudinal analysis, recurrent events models), advanced graphs |
Laboratory measurements with temporal variations | Vital signs, haemoglobin | Advanced graphical methods, multivariate methods |
Count | Seizure episodes, dizziness episodes | Incidence rate followed by Models for count data (Poisson regression, negative binomial regression) |
Outcomes with zero inflated counts | Seizure episodes, dizziness episodes, nausea episodes | Models for counts (Poisson zero inflated models, negative binomial zero-inflated models) |