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The per-treatment arm sample sizes were generated based on an assumption of a 28-day adverse event proportion of 30%.
Analysis of the primary safety endpoint will be focused on characterizing the adverse event proportion in each treatment arm, whereas the secondary efficacy endpoints will be used for the design of larger efficacy studies.
Therefore, we ordered the levels by decreasing the number of studies, decreasing the control event proportion and increasing the heterogeneity.
For the dichotomous outcomes, the event proportion in the control group was based on the data from the meta-analysis.
In other words, we observe an interaction between the extent of selection and the control event proportion.
For renal replacement therapy, bleedings, and serious adverse events we used an anticipated effect of 35%, since we expected a much lower event proportion for these outcomes.
Similar(42)
Combined event proportions were compared with other combined event proportions, according to differences in an intervention or an alternative characteristic.
Intergroup event proportions were compared using Chi-square or Fisher's exact testing, as appropriate.
We described the study population and adverse event proportions using descriptive statistics.
There is considerable variation in the censoring proportions (which equal 1 minus the event proportions) across studies (Web Figure 1).
For dichotomous outcomes, we retrieved event proportions in the control and active group (P1, P2) or treatment effect of interest (difference of proportions).
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