TABLE 5.
Estimated required number of clusters I, subjects per cluster-period N, periods T , empirical type I error when only setting the first effect to zero and when only setting the second effect to zero (e1, e2), empirical power ¸ predicted power obtained from power formula for given effect size , within-period and between-period endpoint-specific ICCs (,), within-period and between-period between-endpoint ICCs (,), and intra-subject ICC () assuming a CAC of 0.5 with L = 2 co-primary endpoints.
(,) | (,) | (,) | (,) | I | N | T | (e1, e2) | ||||
---|---|---|---|---|---|---|---|---|---|---|---|
0.2 | (0.02, 0.01) | (0.02, 0.01) | (0.01, 0.005) | (0.43, 0.43) | 20 | 13 | 3 | (3.5, 3.0) | 84.5 | 83.0 | |
(0.10, 0.05) | (0.01, 0.005) | (0.40, 0.38) | 12 | 25 | 5 | (3.8, 4.6) | 85.2 | 86.7 | |||
(0.20, 0.10) | (0.01, 0.005) | (0.39, 0.56) | 12 | 25 | 4 | (3.9, 4.3) | 83.6 | 86.2 | |||
(0.10, 0.05) | (0.02, 0.01) | (0.01, 0.005) | (0.38, 0.33) | 12 | 25 | 5 | (3.5, 4.2) | 82.6 | 85.0 | ||
(0.1, 0.05) | (0.05, 0.025) | (0.49, 0.98) | 12 | 15 | 4 | (4.3, 3.7) | 85.6 | 88.1 | |||
(0.20, 0.10) | (0.05, 0.025) | (0.59, 0.99) | 12 | 20 | 3 | (4.6, 4.9) | 84.2 | 84.7 | |||
(0.20, 0.10) | (0.02, 0.01) | (0.01, 0.005) | (0.47, 0.22) | 20 | 18 | 5 | (5.5, 4.5) | 82.2 | 82.3 | ||
(0.10, 0.05) | (0.05, 0.025) | (0.92, 0.92) | 10 | 12 | 3 | (3.8, 3.5) | 84.1 | 84.8 | |||
(0.20, 0.10) | (0.10, 0.05) | (0.54, 0.81) | 12 | 25 | 4 | (4.9, 3.9) | 83.9 | 85.8 | |||
| |||||||||||
0.5 | (0.02, 0.01) | (0.02, 0.01) | (0.01, 0.005) | (0.30, 0.28) | 30 | 10 | 4 | (4.8, 4.7) | 84.4 | 84.1 | |
(0.10, 0.05) | (0.01, 0.005) | (0.34, 0.88) | 16 | 22 | 3 | (3.3, 4.2) | 82.4 | 81.3 | |||
(0.20, 0.10) | (0.01, 0.005) | (0.42, 0.83) | 8 | 20 | 5 | (1.2, 3.3) | 86.3 | 86.2 | |||
(0.10, 0.05) | (0.02, 0.01) | (0.01, 0.005) | (0.38, 0.55) | 21 | 10 | 4 | (4.8, 5.2) | 84.0 | 84.7 | ||
(0.10, 0.05) | (0.05, 0.025) | (0.52, 0.68) | 8 | 25 | 5 | (3.8, 3.1) | 84.8 | 88.7 | |||
(0.20, 0.10) | (0.05, 0.025) | (0.62, 0.62) | 22 | 8 | 3 | (5.4, 4.9) | 83.9 | 83.9 | |||
(0.20, 0.10) | (0.02, 0.01) | (0.01, 0.005) | (0.84, 0.29) | 26 | 18 | 3 | (4.9, 4.7) | 84.7 | 86.8 | ||
(0.10, 0.05) | (0.05, 0.025) | (0.60, 0.60) | 12 | 16 | 4 | (4.7, 5.3) | 85.0 | 85.8 | |||
(0.20, 0.10) | (0.10, 0.05) | (0.32, 0.84) | 24 | 24 | 5 | (5.1, 4.6) | 85.7 | 86.4 | |||
| |||||||||||
0.8 | (0.02, 0.01) | (0.02, 0.01) | (0.01, 0.005) | (0.31, 0.55) | 12 | 16 | 5 | (4.1, 5.0) | 84.4 | 82.6 | |
(0.10, 0.05) | (0.01, 0.005) | (0.29, 0.57) | 30 | 14 | 3 | (4.0, 4.7) | 83.1 | 84.6 | |||
(0.20, 0.10) | (0.01, 0.005) | (0.20, 0.84) | 30 | 17 | 4 | (4.4, 5.4) | 81.4 | 80.2 | |||
(0.10, 0.05) | (0.02, 0.01) | (0.01, 0.005) | (0.31, 0.62) | 20 | 13 | 5 | (5.1, 3.2) | 84.2 | 83.5 | ||
(0.10, 0.05) | (0.05, 0.025) | (0.82, 0.92) | 8 | 22 | 3 | (2.9, 2.8) | 85.2 | 87.4 | |||
(0.20, 0.10) | (0.05, 0.025) | (0.45, 0.45) | 18 | 18 | 4 | (5.2, 4.6) | 83.7 | 85.4 | |||
(0.20, 0.10) | (0.02, 0.01) | (0.01, 0.005) | (0.99, 0.25) | 28 | 25 | 3 | (5.1, 4.0) | 85.6 | 84.9 | ||
(0.10, 0.05) | (0.05, 0.025) | (0.63, 0.31) | 24 | 17 | 4 | (4.5, 5.6) | 84.1 | 84.6 | |||
(0.20, 0.10) | (0.10, 0.05) | (0.82, 0.82) | 8 | 10 | 5 | (3.2, 2.9) | 86.1 | 89.4 |