Table 1.
Disposition of populations for long-term OS analysis of study AB10015 and its associated NPP.
| Cohort | PBO (n) | M4.5 (n) | M3.0 (n) | Total (n) |
|---|---|---|---|---|
| Overall (mITT) population | 133 | 130 | 131 | 394 |
| Survival status verified less than 7 months prior to cut-offa | 128 (96.2%) | 124 (95.4%) | 126 (96.2%) | 378 (95.9%) |
| Survival status older than 7 months | 5 (3.8%) | 6 (4.6%) | 5 (3.8%) | 16 (4.1%) |
| Patients available for NPP OS analysisb | 25 (18.8%) | 29 (22.3%) | 30 (22.9%) | 84 (21.3%) |
| Patients not available for NPP OS analysis | 108 (81.2%) | 101 (77.7%) | 101 (77.1%) | 310 (78.7%) |
a
Survival status (also referred to as vital status) verified by investigational site within 7 months prior to cut-off (June 2020) for long-term OS analysis.
b
Patients from study AB10015 that entered the optional NPP.
NPP, Named Patient Program; OS, overall survival; PBO, placebo.