Table
3: 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
|
|
.005
|
25
|
0
|
0.118
|
(0;0.1372)
|
(0;0.1910)
|
0
|
|
|
50
|
0
|
0.222
|
(0;0.0711)
|
(0;0.1005)
|
0
|
|
|
100
|
0
|
0.394
|
(0;0.0362)
|
(0;0.0516)
|
0
|
|
|
150
|
0
|
0.529
|
(0;0.0243)
|
(0;0.0347)
|
0
|
|
|
150
|
0
|
0.529
|
(0;0.0366)
|
(0;0.0485)
|
1
|
|
|
250
|
1.25
|
0.714
|
(0;0.0146)
|
(0;0.0210)
|
0
|
|
|
250
|
1.25
|
0.714
|
(0.0001;0.0221)
|
(0;0.0293)
|
1
|
|
|
500
|
2.50
|
0.918
|
(0;0.0074)
|
(0;0.0105)
|
0
|
|
|
500
|
2.50
|
0.918
|
(0.0001;0.0111)
|
(0;0.0148)
|
1
|
|
|
500
|
2.50
|
0.918
|
(0.0005;0.0144)
|
(0.0002;0.0184)
|
2
|
|
|
1,000
|
5
|
0.993
|
(0;0.0037)
|
(0;0.0053)
|
0
|
|
|
1,000
|
5
|
0.993
|
(0.0016;0.0116)
|
(0.0011;0.0141)
|
5
|
|
|
10,000
|
50
|
0.99999
|
(0;0.0004)
|
(0;0.0005)
|
0
|
|
|
10,000
|
50
|
0.99999
|
(0.0016;0.0037)
|
(0.0014:0.0041)
|
25
|
|
|
10,000
|
50
|
0.99999
|
(0.0037;0.0066)
|
(0.0034;0.0071)
|
50
|