Table 2.
Overall incidence of adverse events
| MAS825 + SoC (N = 68) |
Placebo + SoC (N = 70) |
Total (N = 138) |
||||
|---|---|---|---|---|---|---|
| nE | nS (%) | nE | nS (%) | nE | nS (%) | |
| AE, patients with AE | 188 | 42 (61.8) | 225 | 53 (75.7) | 413 | 95 (68.8) |
| Mild AE | 54 | 28 (41.2) | 102 | 33 (47.1) | 156 | 61 (44.2) |
| Moderate AE | 65 | 24 (35.3) | 66 | 27 (38.6) | 131 | 51 (37.0) |
| Severe AE | 69 | 31 (45.6) | 57 | 29 (41.4) | 126 | 60 (43.5) |
| Study-drug–related AE | 0 | 0 | 2 | 2 (2.9) | 2 | 2 (1.4) |
| Study-drug–related SAE | 0 | 0 | 0 | 0 | 0 | 0 |
| SAE | 66 | 31 (45.6) | 48 | 28 (40.0) | 114 | 59 (42.8) |
| AE leading to discontinuation of study treatment | 0 | 0 | 0 | 0 | 0 | 0 |
| Study-drug-related AE leading to discontinuation of study treatment | 0 | 0 | 0 | 0 | 0 | 0 |
Percentages are based on the number of subjects. Only treatment-emergent AEs, i.e. from the date of administration of study treatment to Day 127, are considered.
Abbreviations: AE: adverse event; N: number of subjects studied; nE: number of AEs in the category; nS: number of subjects with at least one AE in the category; SAE: serious adverse event; SoC: standard of care.