Table 1: Number of
Patients requiring Treatment with a Drug to have 100 (1 - α)% Confidence of Observing at least (≥) 1 AE given the true AE rate
is P
P \(1-α) |
0.90 |
0.95 |
0.99 |
0.999 |
0.9999 |
0.001 |
2302 |
2995 |
4604 |
6906 |
9208 |
0.005 |
460 |
599 |
920 |
1380 |
1840 |
0.01 |
230 |
300 |
460 |
690 |
920 |
0.015 |
153 |
200 |
306 |
459 |
612 |
0.02 |
114 |
149 |
228 |
342 |
456 |
0.03 |
76 |
99 |
152 |
218 |
304 |
0.04 |
57 |
75 |
114 |
171 |
228 |
0.05 |
45 |
59 |
90 |
135 |
180 |
0.06 |
38 |
50 |
76 |
114 |
152 |
0.07 |
32 |
42 |
64 |
96 |
128 |
0.08 |
28 |
37 |
56 |
88 |
112 |
0.09 |
25 |
33 |
50 |
75 |
100 |
0.10 |
22 |
29 |
44 |
66 |
88 |
0.15 |
15 |
20 |
30 |
45 |
60 |
0.20 |
11 |
15 |
22 |
33 |
44 |
0.30 |
07 |
10 |
14 |
21 |
28 |
0.40 |
05 |
07 |
10 |
15 |
20 |
0.50 |
04 |
06 |
08 |
12 |
16 |