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Table 2 Sample size estimations based on background incidence, case/comparator ratio and anticipated relative risk including continuity correction

From: Protocol for a drugs exposure pregnancy registry for implementation in resource-limited settings

 

1 case / 1 comparator

1 case / 4 comparators

 

RR to be detected : 2

RR to be detected : 10

RR to be detected : 2

RR to be detected : 10

Incidence in comparator group

Cases

Comparators

Cases

Comparators

Cases

Comparators

Cases

Comparators

5%

474

474

19

19

274

1096

10

40

1%

2515

2515

121

121

1445

5780

61

244

0.1%

25471

25471

1272

1272

14621

58484

628

2512