Table 1 Sample size estimation.

From: Randomised, double-blind, placebo-controlled, parallel-group, multicentric, phase IIA clinical trial for evaluating the safety, tolerability, and therapeutic efficacy of daily oral administration of NFX88 to treat neuropathic pain in individuals with spinal cord injury

Sample Size

If true risk of AE is…

Per arm

Treated

2.5%

5%

10%

15%

15

45

68%

90%

99%

99.9%

14

42

66%

88%

99%

99.9%

13

39

63%

87%

98%

99.9%

12

36

60%

84%

98%

99.7%

11

33

57%

82%

97%

99.5%

10

30

53%

79%

96%

99.2%

Sample size required

Powers to detect AE (probability of seeing at least one case of AE)

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