Table 1 Median values [95% range] in 10,000 simulated trials of median progression-free survival (PFS), hazard ratio, number of events and analysis time (in months), and power for the fictitious trials of Scenario 1 (N = 500 patients; target = 331 events) and Scenario 2 (N = 220 patients; target = 162 events) in the absence of the pandemic
Scenario | Parameter | Using exact time of events | Using tumor assessments every 2 months | Using tumor assessments every 2 months Interval-censoring method |
|---|---|---|---|---|
1 (N = 500 patients; target = 331 events) | Median PFS, control | 12.0 [10.0–14.4] | 13.0 [11.0–16.0] | Low: 11.0 [8.0–14.0] High: 13.0 [11.0–16.0] |
Median PFS, experimental | 17.2 [14.3–20.4] | 18.0 [16.0–22.0] | Low: 16.0 [14.0–20.0] High: 18.0 [16.0–22.0] | |
Hazard ratio | 0.70 [0.56–0.87] | 0.70 [0.56–0.87] | 0.70 [0.56–0.87] | |
Power | 90.2% | 90.0% | 90.0% | |
Number of events | 331 [331–331] | 331 [331–331] | 331 [331–331] | |
Analysis time | 29.9 [27.4–32.6] | 30.9 [28.4–33.6] | 30.9 [28.4–33.6] | |
2 (N = 220 patients; target = 162 events) | Median PFS, control | 12.0 [9.1–15.6] | 13.0 [10.0–16.0] | Low: 11.0 [8.0–14.0] High: 13.0 [10.0–16.0] |
Median PFS, experimental | 20.0 [15.1–25.9] | 21.0 [16.0–27.0] | Low: 19.0 [14.0–25.0] High: 21.0 [16.0–27.0] | |
Hazard ratio | 0.60 [0.44–0.82] | 0.60 [0.44–0.82] | 0.6 [0.44–0.82] | |
Power | 89.8% | 89.9% | 89.8% | |
Number of events | 162 [162–162] | 162 [162–162] | 162 [162–162] | |
Analysis time | 33.6 [28.9–38.9] | 34.6 [29.8–39.9] | 34.6 [29.8–39.9] |