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