Table 3 Sample size calculation
Significance level (α) | 0.05 |
|---|---|
Power (1-β) | 0.80 |
Hazard Ratio (HR), θ (non-inferiority margin) | 1.3 |
Null-Hypothesis Hazard Ratio, θ0 | 1.0 |
Recruitment time/study accrual (months) | 36 |
Follow-up time (months) | 60 |
Ratio control vs. experimental: m2/m1 | 1.0 |
Total sample size (NS)/total number to be randomized (NR) | 599 |
Accounting for 3% loss to follow-up after randomization (NLTFU) | 18 |
Accounting for 10% drop-out ratio pre-randomization (NDO) | 69 |
Initial pre-randomization sample size – number of included patients (NI) | 687 |