Table 2.
Probabilities (×100%) that the Trial Will Report Each of the Results Efficacy, Potential Harm, Non-Efficacy, and High Efficacy: Scenario (A) [Time-Constant VE(0-18)]*; Scenario (B) [Halved VE in First 6 Months]*.
| Scenario A [Time-Constant VE(0-18)] | ||||||||
|---|---|---|---|---|---|---|---|---|
| Avg VE (0-18) | Avg RR (1-18) | Eff | Harm | Harm Time | Non-Eff | Non-Eff Time | High-Eff | High-Eff Time |
| - | 3.0 | 0.0 | 100.0 | 6.8 (4.9-9.2) | 0.0 | 14.1 (14.1-14.1) | 0.0 | - (---) |
| - | 2.5 | 0.0 | 99.3 | 7.6 (5.5-10.5) | 0.7 | 12.8 (11.8-13.9) | 0.0 | - (---) |
| - | 2.0 | 0.0 | 88.9 | 9.2 (6.2-12.3) | 11.1 | 13.1 (12.3-14.2) | 0.0 | - (---) |
| - | 1.5 | 0.0 | 42.9 | 10.1 (6.4-13.0) | 57.1 | 13.4 (12.5-14.8) | 0.0 | - (---) |
| 0% | 1.0 | 2.7 | 4.2 | 8.6 (6.1-12.4) | 93.0 | 14.6 (13.1-17.8) | 0.0 | - (---) |
| 20% | 0.8 | 30.5 | 1.2 | 7.4 (5.9-10.5) | 68.3 | 16.7 (13.7-22.0) | 0.0 | - (---) |
| 30% | 0.7 | 63.0 | 0.6 | 7.0 (5.8-10.2) | 36.4 | 18.1 (14.2-23.4) | 0.0 | 17.0 (17.0-17.0) |
| 40% | 0.6 | 89.5 | 0.2 | 6.7 (5.8-9.2) | 9.9 | 19.5 (14.5-24.8) | 0.4 | 20.0 (15.5-21.3) |
| 50% | 0.5 | 94.8 | 0.1 | 6.8 (5.8-9.1) | 1.0 | 18.1 (14.2-24.8) | 4.1 | 21.0 (16.8-29.7) |
| 60% | 0.4 | 68.1 | 0.0 | 6.9 (5.9-8.9) | 0.0 | 20.0 (15.8-21.3) | 31.9 | 22.7 (17.4-29.8) |
| 70% | 0.3 | 14.5 | 0.0 | - (---) | 0.0 | - (---) | 85.5 | 22.4 (17.1-29.6) |
| 80% | 0.2 | 0.2 | 0.0 | - (---) | 0.0 | - (---) | 99.8 | 18.8 (13.4-23.8) |
| Scenario B [Halved VE in First 6 Months] | ||||||||
|---|---|---|---|---|---|---|---|---|
| Avg VE (0-18) | Avg RR (1-18) | Eff | Harm | Harm Time | Non-Eff | Non-Eff Time | High-Eff | High-Eff Time |
| - | 3.0 | 0.0 | 96.0 | 8.6 (6.1-11.2) | 4.0 | 12.3 (11.1-12.9) | 0.0 | - (---) |
| - | 2.5 | 0.0 | 84.9 | 9.5 (6.3-12.1) | 15.1 | 12.5 (11.7-13.3) | 0.0 | - (---) |
| - | 2.0 | 0.0 | 57.5 | 10.1 (6.5-12.6) | 42.5 | 12.7 (12.1-13.7) | 0.0 | - (---) |
| - | 1.5 | 0.0 | 22.5 | 10.2 (6.4-12.9) | 77.5 | 13.2 (12.4-14.4) | 0.0 | - (---) |
| 0% | 1.0 | 2.7 | 4.2 | 8.6 (6.1-12.4) | 93.0 | 15.8 (13.6-21.2) | 0.0 | - (---) |
| 20% | 0.8 | 25.9 | 1.9 | 7.7 (6.0-10.9) | 72.3 | 15.8 (13.6-21.2) | 0.0 | - (---) |
| 30% | 0.7 | 54.3 | 1.2 | 7.3 (5.9-10.8) | 44.4 | 16.1 (13.8-22.0) | 0.0 | - (---) |
| 40% | 0.6 | 81.3 | 0.8 | 7.0 (5.9-9.8) | 17.9 | 15.9 (13.9-21.5) | 0.1 | 21.3 (19.3-24.4) |
| 50% | 0.5 | 92.5 | 0.6 | 6.8 (5.8-8.9) | 4.6 | 15.6 (13.8-18.4) | 2.3 | 28.5 (20.2-29.9) |
| 60% | 0.4 | 72.4 | 0.3 | 6.6 (5.4-8.7) | 0.8 | 15.3 (14.1-16.7) | 26.5 | 29.1 (21.2-29.2) |
| 70% | 0.3 | 16.2 | 0.2 | 6.4 (5.1-7.4) | 0.1 | 15.3 (14.1-16.3) | 83.5 | 25.2 (21.4-29.8) |
| 80% | 0.2 | 0.2 | 0.2 | 6.6 (5.0-7.9) | - | - (---) | 99.7 | 24.1 (18.2-29.3) |
Efficacy (Eff in the third column) is the result that VE(0-18) > 0% with reported 95% confidence interval lying above 0%. Potential Harm (Harm) is the result that the potential harm boundary is reached. Non-efficacy (Non-Eff) is the result that the reported 95% confidence interval for VE(0-18) does not lie above 0%; this occurs if the non-efficacy boundary is reached at an interim analysis or the final analysis for assessing VE(0-18). High efficacy (High-Eff) is the result that the reported 95% confidence interval for VE(0-18) lies above 50%. The Times for the various events show the 50th (10th-90th) percentiles of the number of months until the event is reached.