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Trial sequential analysis of remdesivir versus placebo on nonserious adverse events.

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posted on 17.09.2020, 19:23 by Sophie Juul, Emil Eik Nielsen, Joshua Feinberg, Faiza Siddiqui, Caroline Kamp Jørgensen, Emily Barot, Niklas Nielsen, Peter Bentzer, Areti Angeliki Veroniki, Lehana Thabane, Fanlong Bu, Sarah Klingenberg, Christian Gluud, Janus Christian Jakobsen

Trial sequential analysis on remdesivir versus placebo on nonserious adverse events in 2 high risk of bias trials. The DARIS was calculated based on an event rate in the control group of 37%; risk ratio reduction of 20% in the experimental group; type I error of 3.3%; and type II error of 10% (90% power). Diversity was 4%. The required information size was 1,970 participants. The cumulative Z‐curve (blue line) did not cross the trial sequential monitoring boundaries for benefit or harm (red inward sloping lines). The cumulative Z‐curve crossed the inner‐wedge futility line (red outward sloping lines). The green dotted line shows conventional boundaries (alpha 5%). DARIS, diversity‐adjusted required information size; Pc, proportion of participants in control group; RRR, relative risk reduction.