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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