Table 5.
Examples of trial monitoring boundaries
Information Fraction (% of Total Events) | Reject H0 RR ≥ 0.80 |
Nominal one-sided p- values for rejection of H0 | Reject H1 RR ≤ 0.60 |
---|---|---|---|
25% (85 events) | ≤ 0.3352 | P ≤ 0.00001; Z = 4.010 | ≥ 1.4320 |
50% (170 events) | ≤ 0.5178 | P ≤ 0.0023; Z = 2.836 | ≥ 0.9269 |
75% (255 events) | ≤ 0.5986 | P ≤ 0.0103; Z = 2.315 | ≥ 0.8018 |
100% (340 events) | ≤ 0.6436 | P ≤ 0.0225; Z = 2.005 | ≥ 0.7457 |