| VI | FF/VI |
ITT: n( %) | 25 (N=818) | 50/25 (N=820) | 100/25 (N=806) | 200/25 (N=811) |
AE* | 575 (70) | 620 (76) | 621 (77) | 622 (77) |
AE* (drug-related) | 113 (14) | 169 (21) | 134 (17) | 140 (17) |
Serious AE* | 126 (15) | 136 (17) | 123 (15) | 124 (15) |
Fatal AE† | 13 (2) | 16 (2) | 10 (1) | 14 (2) |
LSE* | 96 (12) | 142 (17) | 121 (15) | 140 (17) |
BD* | 9 (1) | 24 (3) | 27 (3) | 21 (3) |
Pneumonia* | 27 (3) | 48 (6) | 51 (6) | 55 (7) |
Pneumonia Hazard Ratio (HR) (95%CI) vs VI | | 1.7 (1.1, 2.8) p=0.025 | 1.8 (1.2, 3.0) p=0.010 | 2.0 (1.3, 3.2) p=0.003 |
* On-treatment † On-/Post-treatment |