Figure 8.

Serious adverse events during treatment. There are 15 trials providing data. The diversity‐adjusted required information size (DARIS) was calculated based on an incidence rate of serious adverse events in the control group of 36%; risk ratio reduction of 20% in the glucocorticosteroid group; type I error of 1%; and type II error of 20% (80% power). Trial diversity was 70%. The required information size was 6566 participants. The cumulative Z‐curve (blue line) did not cross the trial sequential monitoring boundaries for benefit or harm (red inward sloping lines), but it entered the trial sequential monitoring area for futility (inner‐wedge futility line red outward sloping lines) indicating that sufficient information was provided. The green dotted lines show the conventional boundaries of the naive alpha of 5% equal to Z‐scores of +1.96 and ‐1.96.