Table 3. Treatment effectiveness analysis results – comparison of data sets.
| Original | SDV | Centrally monitored | |
| Overall Survival | |||
| HR* (95% CI)unadjusted | 1.18 (0.99 to 1.42) | 1.18 (0.99 to 1.41) | 1.18 (0.99 to 1.40) |
| adjusted for stage and performance status | 1.19 (0.99 to 1.43) | 1.17 (0.98 to 1.40) | |
| Number of patients | 533 | 533 | 533 |
| Number of deaths | 469 | 4981 | 499 |
| Log-rank statistic | 3.33 | 3.44 | 3.22 |
| Log-rank p-value | 0.068 | 0.064 | 0.073 |
| Progression Free Survival | |||
| HR* (95% CI) | 1.29 (1.08 to 1.54) | 1.30 (1.09 to 1.54) | |
| Number of patients | 5322 | 5323 | |
| Number of events | 501 | 522 | |
| Log-rank statistic | 7.99 | 8.76 | |
| Log-rank p-value | 0.005 | 0.003 | |
*
HR >1 indicates a benefit to experimental treatment.
1
Discrepancy in number of deaths between SDV and original data is due to the identification of 29 additional dates of death (all dates occurred before the censoring date used in this comparison) following source data verification. These patients were censored in the ‘original’ analysis using date of last follow-up.
2
Date of progression missing for one patient (id 113).
3
Date of progression is before date of randomisation for one patient (id 468).