Table 1. Stroke Hyperglycemia Insulin Network Effort Study Frequentist Interim Analyses and Boundaries.
No. of patients enrolled | No. of patients analyzed | Stopping boundaries | No. of patients with 90-d outcome in analysis population | Favorable outcome, unadjusted, No./total No. (%) | Adjusted risk difference, %a | P value | ||||
---|---|---|---|---|---|---|---|---|---|---|
Efficacy | Futility | Intensive | Standard | |||||||
z Value | P value | z Value | P value | |||||||
579 | 500 | 2.97 | .003 | 0.06 | .95 | 482 | 68/254 (26.8) | 53/228 (23.3) | 2.8 | .13 |
771 | 700 | 2.86 | .004 | 0.13 | .90 | 677 | 83/344 (24.1) | 78/333 (23.4) | 0.9 | .56 |
936 | 900 | 2.65 | .008 | 0.45 | .65 | 869 | 97/444 (21.9) | 97/425 (22.8) | 0.1 | .96 |
1137 | 1100 | 2.42 | .02 | 1.05 | .29 | 1061 | 115/540 (21.3) | 115/521 (22.1) | −0.1 | .92 |
With multiple imputation for missing outcome data.