Table 6.
Selected adverse events in patients who received at least one infusion of study drug
| Safety population | Placebo (n = 120) | CER-001, 3 mg/kg (n = 120) | CER-001, 6 mg/kg (n = 124) | CER-001, 12 mg/kg (n = 122) |
|---|---|---|---|---|
| Any serious AE (%) | 8 (6.7) | 14 (11.7) | 14 (11.3) | 11 (9.0) |
| Any adverse event (%) | 96 (80.0) | 98 (81.7) | 86 (69.4) | 90 (73.8) |
| Infusion-type reaction (%) | 0 (0) | 0 (0) | 3 (2.4) | 3 (2.5) |
| Drug hypersensitivity (%) | 2 (1.7) | 1 (0.8) | 3 (2.4) | 6 (4.9) |
| Rash (%) | 0 (0) | 2 (1.7) | 1 (0.8) | 3 (2.5) |
| Dyspnoea (%) | 3 (2.5) | 3 (2.5) | 6 (4.8) | 7 (5.7) |
| Nausea (%) | 8 (6.7) | 11 (9.2) | 4 (3.2) | 2 (1.6) |
| Diarrhoea (%) | 3 (2.5) | 7 (5.8) | 4 (3.2) | 3 (2.5) |
AE, adverse event.