Table 2 Median values [95% range] in 10,000 simulated trials of median progression-sree survival (PFS), hazard ratio, number of events and analysis time (in months), and power for the fictitious trial of Scenario 1 (N = 500 patients; target = 331 events), with 6-month shutdown periods occurring at various times
Shut-down period | Parameter | Treatment policy strategy | Hypothetical strategy | Hypothetical strategy, delayed analysis | Interval censoring |
|---|---|---|---|---|---|
6 to 12 months | Median PFS, control | 13.0 [11.8–16.0] | 14.0 [12.0–18.0] | 14.0 [12.0–18.0] | Low: 11.0 [8.0–14.0] High: 13.0 [11.8–16.0] |
Median PFS, experimental | 18.0 [16.0–22.0] | 20.0 [18.0–24.0] | 20.0 [18.0–24.0] | Low: 16.0 [14.0–18.0] High: 18.0 [16.0–22.0] | |
Hazard ratio | 0.70 [0.56–0.87] | 0.70 [0.55–0.88] | 0.70 [0.56–0.88] | 0.70 [0.56–0.87] | |
Power | 89.7% | 86.3% | 90.0% | 89.0% | |
Number of events | 331 [331–331] | 289 [277–301] | 331 [331–331] | 331 [331–331] | |
Analysis time | 35.3 [32.9–37.9] | 41.3 [38.0–44.9] | 35.3 [32.9–37.9] | ||
12 to 18 months | Median PFS, control | 14.0 [12.0–16.0] | 18.0 [16.0–22.0] | 18.0 [16.0–22.0] | Low: 10.0 [7.0–12.0] High: 14.0 [12.0–16.0] |
Median PFS, experimental | 18.0 [16.0–22.0] | 24.0 [20.0–28.0] 119 median estimates not reached | 24.0 [20.0–28.0] | Low: 16.0 [12.0–20.0] High: 18.0 [16.0–22.0] | |
Hazard ratio | 0.70 [0.56–0.87] | 0.69 [0.53–0.90] | 0.69 [0.56–0.86] | 0.70 [0.56–0.87] | |
Power | 89.7% | 78.5% | 90.9% | 89.4% | |
Number of events | 331 [331–331] | 225 [207–243] | 331 [331–331] | 331 [331–331] | |
Analysis time | 30.9 [28.4–33.6] | 51.8 [45.7–60.8] | 30.9 [28.4–33.6] | ||
18 to 24 months | Median PFS, control | 14.8 [13.1–16.9] | 18.0 [14.0–20.0] | 18.0 [14.0–20.0] | Low: 8.0 [8.0–11.0] High: 14.8 [ 13.1– 16.9] |
Median PFS, experimental | 19.4 [16.7–22.0] | 24.0 [20.0–28.0] 162 median estimates not reached | 24.0 [20.0–28.0] | Low: 14.0 [11.0–18.0 ] High: 19.7 [16.8–22.0] | |
Hazard ratio | 0.70 [0.56–0.87] | 0.70 [0.54–0.89] | 0.70 [0.56–0.87] | 0.70 [0.56–0.87] | |
Power | 89.7% | 81.4% | 90.4% | 89.4% | |
Number of events | 331 [331–331] | 253 [236–268] | 331 [331–331] | 331 [331–331] | |
Analysis time | 30.9 [28.4–33.6] | 44.1 [39.7–49.5] | 30.9 [28.4–33.6] | ||
24 to 30 months | Median PFS, control | 13.0 [11.0–16.0] | 13.0 [11.0–16.0] | 13.0 [11.0–16.0] | Low: 11.0 [9.0–12.0] High: 13.0 [11.0–16.0] |
Median PFS, experimental | 19.0 [16.0–22.5] | 20.0 [16.0–28.0] 238 median estimates not reached | 22.0 [16.0–26.0] | Low: 12.0 [12.0–16.0] High: 20.0 [16.0- 23.7] | |
Hazard ratio | 0.71 [0.57–0.89] | 0.70 [0.55–0.88] | 0.70 [0.56–0.86] | 0.69 [0.55–0.87] | |
Power | 86.5% | 83.8% | 90.6% | 89.0% | |
Number of events | 331 [331–331] | 274 [260–288] | 331 [331–331] | 331 [331–331] | |
Analysis time | 30.9 [30.0–33.6] | 39.8 [36.2–44.1] | 30.9 [28.4–33.6] | ||