Table
2: Exact Confidence intervals (95% & 99% CI)
on true incidence (P) of a Rare SAE under various scenarios; n = number
treated, nP = expected number of SAEs, P (X 1)
= Probability of at least 1 SAE among n patients; Outcome = probable number of
SAEs among n patients.
|
P |
n |
nP* |
P(X ≥ 1) |
95% CI |
99% CI |
Outcome |
|
.001 |
25 |
0 |
0.025 |
(0;0.1372) |
(0;0.1910) |
0 |
|
|
50 |
0 |
0.049 |
(0;0.0711) |
(0;0.1005) |
0 |
|
|
100 |
0 |
0.095 |
(0;0.0362) |
(0;0.0516) |
0 |
|
|
150 |
0 |
0.139 |
(0;0.0243) |
(0;0.0347) |
0 |
|
|
250 |
0 |
0.221 |
(0;0.0146) |
(0;0.0210) |
0 |
|
|
500 |
0 |
0.394 |
(0;0.0074) |
(0;0.0105) |
0 |
|
|
1000 |
1 |
0.632 |
(0;0.0037) |
(0;0.0053) |
0 |
|
|
1000 |
1 |
0.632 |
(0;0.0056) |
(0;0.0074) |
1 |
|
|
10,000 |
10 |
0.99996 |
(0;0.0004) |
(0;0.0005) |
0 |
|
|
10,000 |
10 |
0.99996 |
(0.0002;0.0012) |
(0.0001;0.0014) |
5 |
|
|
10,000 |
10 |
0.99996 |
(0.0005;0.0018) |
(0.0040;0.0021) |
10 |