Table 3.
Summary of adverse events in patients with more than one adverse event
| Placebo (n=84) | Sarilumab 200 mg (n=159) | Sarilumab 400 mg (n=173) | ||
|---|---|---|---|---|
| Any treatment-emergent adverse event | 55 (65%) | 103 (65%) | 121 (70%) | |
| Any serious treatment-emergent adverse event | 20 (24%) | 42 (26%) | 51 (29%) | |
| Any serious infection | 10 (12%) | 18 (11%) | 22 (13%) | |
| Pneumonia | 0 | 1 (1%) | 6 (3%) | |
| COVID-19 pneumonia | 2 (2%) | 11 (7%) | 4 (2%) | |
| Bacterial pneumonia | 1 (1%) | 1 (1%) | 3 (2%) | |
| Any treatment-emergent adverse event leading to death | 9 (11%) | 17 (11%) | 18 (10%) | |
| Any adverse event of special interest | 18 (21%) | 53 (33%) | 76 (44%) | |
| Alanine aminotransferase increase | 16 (19%) | 48 (30%) | 55 (32%) | |
| Invasive bacterial or fungal infection | 3 (4%) | 8 (5%) | 15 (9%) | |
| Grade ≥2 hypersensitivity reaction | 0 | 1 (1%) | 7 (4%) | |
| Grade 4 neutropenia | 0 | 3 (2%) | 6 (3%) | |
| Grade ≥2 infusion-related reaction | 0 | 1 (1%) | 6 (3%) | |
Data are n (%).