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Table 4 Statistical Power Assuming a Sample Size of 500 Randomized Patients

From: Design and rationale of a multi-center, pragmatic, open-label randomized trial of antimicrobial therapy – the study of clinical efficacy of antimicrobial therapy strategy using pragmatic design in Idiopathic Pulmonary Fibrosis (CleanUP-IPF) clinical trial

Standard-of-care event rate*

Antimicrobial therapy strategy event rate*

One-year Event Rate Reduction

Power

24%

16.8%

30%

78%

30%

21.0%

30%

87%

36%

25.2%

30%

93%

24%

16.0%

33.3%

86%

30%

20.0%

33.3%

93%

36%

24.0%

33.3%

97%

24%

15.6%

35%

89%

30%

19.5%

35%

95%

36%

23.4%

35%

98%

  1. *12-month event rates. Calculations assume a 2-sided Type-I error rate of 0.05. The minimum follow-up is planned to be 12 months and the maximum follow-up is 42 months. Drop-out rates are assumed to be approximately 2% per year. Power calculations were based on a log-rank test with assumed event rates were exponentially distributed. Calculations were computing using nQuery 7.0 software