TABLE 2.
Occurrence of AEs, SAEs, and deathsa
| Patient group (n) | Overall total no. of AEs | No. (%) of patients: |
Overall total no. of SAEs | No. (%) of patients: |
Total no. of deaths | ||
|---|---|---|---|---|---|---|---|
| With ≥1 AE | With study drug-related AEs | With ≥1 SAE | With study drug-related SAEs | ||||
| Placebo+OTV (56) | 187 | 45 (80.4%) | 5 (8.9%) | 13 | 8 (14.3%) | 1 (1.8%) | 4 (7.1%) |
| 3,600 mg MHAA4549A+OTV (55) | 196 | 37 (67.3%) | 7 (12.7%) | 20 | 11 (20.0%) | 0 | 6 (10.9%) |
| 8,400 mg MHAA4549A+OTV (47) | 128 | 35 (74.5%) | 4 (8.5%) | 17 | 12 (25.5%) | 1 (2.1%) | 4 (8.5%) |
| All patients (158) | 511 | 117 (74.1%) | 16 (10.1%) | 50 | 31 (19.6%) | 2 (1.3%) | 14 (8.9%) |
a
Abbreviations: AE, adverse event; SAE, serious adverse event.