Table 3.
Results across 1,000 simulated studies for design version a). Average values and interquartile ranges provided
| S | T1E/ Power | Enrolled patients |
ESS | %Stop (1st interim) |
%Stop (2nd interim) |
w
(1st interim) |
w
(2nd interim) |
|---|---|---|---|---|---|---|---|
| 1 | 0.044* |
1497 (796–1586) |
16 (10–18) | 33 | 44 |
0.47 (0.4–0.56) |
0.42 (0.25–0.59) |
| 2 | 0.8 |
1850 (1576–2358) |
20 (12–28) | 13 | 38 |
0.45 (0.37–0.56) |
0.52 (0.40–0.66) |
| 3 | 0.048* |
1506 (796–1778) |
15 (8–19) | 34 | 41 |
0.4 (0.28–0.52) |
0.47 (0.33–0.62) |
| 4 | 0.83 |
1835 (1578–2376) |
10 (5–15) | 15 | 39 |
0.36 (0.24–0.49) |
0.21 (0.08–0.3) |
| 5 | 0.05* |
1509 (796–2350) |
11 (4–15) | 35 | 39 |
0.32 (0.20–0.44) |
0.29 (0.12–0.44) |
| 6 | 0.85 |
1829 (1582–2381) |
6 (2–9) | 14 | 41 |
0.29 (0.16–0.41) |
0.09 (0.03–0.12) |
| 7 | 0.04* |
1480 (796–1590) |
6 (2–7) | 35 | 44 |
0.20 (0.11–0.26) |
0.13 (0.05–0.17) |
| 8 | 0.88 |
1792 (1586–2383) |
3 (1–4) | 15 | 44 |
0.19 (0.1–0.25) |
0.03 (0.01–0.04) |
T1E: Type I Error rate (*); ESS: Effective Sample Size