Appendix Table 1.
Total study size | Accrual rate (per day) | The entire study time (days) | Total number of events observed | Estimated upper bound of 95% confidence interval for hazard ratio | Estimated upper bound of 95% confidence interval for risk difference at 900 days |
---|---|---|---|---|---|
2216 | 5 | 949 | 160 | 1.56 | 4.4% |
2172 | 10 | 924 | 176 | 1.53 | 4.0% |
2094 | 30 | 908 | 182 | 1.52 | 3.6% |
Abbreviation: HR = hazard ratio; RD = risk difference; RMST = restricted mean survival time
Estimates of upper 95% confidence bounds for the HR and RD were calculated, assuming the following fixed inputs: total sample size, accrual rate, and total study time. All these configurations were figured out, so that the estimated upper bound of 95% confidence interval for difference in RMST at 900 days can meet a noninferiority margin of 18 days (2% of the 900 days).