Statistical analysis
arterial thromboembolism, stroke, death, venous thromboembolism
ARTERIAL THROMBOEMBOLISM, MYOCARDIAL INFARCTION, STROKE, EVENT, SECONDARY, REGRESSION, EVENTS
Sample size calculation was based on the primary endpoint The primary efficacy endpoint, The co-primary endpoint, the seven-category ordinal scale recommended by the WHO at day 7 post randomization, adjusted for baseline score was analyzed using a nonparametric Wilcoxon (Mann–Whitney) rank-sum test stratified by baseline score dichotomized as smaller or equal 3 vs. larger 3. The treatment effect was reported as relative effect, i.e. the probability that an observation in the treatment group is smaller (more favorable) than an observation in the control group, with a 95% confidence interval.The secondary composite endpoint, time to first event of either venous thromboembolism, arterial thromboembolism, new myocardial infarction, non-hemorrhagic stroke, all-cause death or progression to intubation and invasive ventilation until day 35 post randomization, was analyzed using a Cox proportional hazards regression model with treatment group as factor. Due to the small number of events it was not adjusted for stratification factors of the randomization. Reported were a hazard ratio (HR) with 95% confidence interval and a p-value for the null hypothesis H0: HR = 1. The secondary composite endpoint was visualized as Kaplan–Meier curves.Analyses were performed using the intention-to-treat population (IIT population). Patients that were erroneously randomized with a wrong stratum were analyzed as if they were randomized correctly, i.e. in their true stratum according to their baseline characteristics.Additionally, as explorative analysis the primary and co-primary endpoint were analyzed in a subgroup of patients with a very high risk as defined by The statistical analysis and the graphics were generated with the software R, Version 4.1.3.