TABLE 4.
Summary of drug‐related treatment‐emergent adverse events (all grades and ≥3): Safety population
|
Primary system organ class Preferred term, n (%) |
Isatuximab 20 mg/kg (N = 14) Drug‐related |
|
|---|---|---|
| All grades | Grade ≥ 3 | |
| Any event | 10 (71.4) | 3 (21.4) |
| Infections and infestations | 1 (7.1) | 1 (7.1) |
| Bronchiolitis | 1 (7.1) | 0 |
| Pneumonia | 1 (7.1) | 1 (7.1) |
| Blood and lymphatic system disorders | 1 (7.1) | 1 (7.1) |
| Neutropenia | 1 (7.1) | 1 (7.1) |
| Thrombocytopenia | 1 (7.1) | 1 (7.1) |
| Immune system disorders | 1 (7.1) | 0 |
| Cytokine release syndrome | 1 (7.1) | 0 |
| Gastrointestinal disorders | 1 (7.1) | 1 (7.1) |
| Pancreatitis | 1 (7.1) | 1 (7.1) |
| Renal and urinary disorders | 1 (7.1) | 0 |
| Urinary retention | 1 (7.1) | 0 |
| Injury, poisoning and procedural complications | 8 (57.1) | 0 |
| Infusion reactions | 8 (57.1) | 0 |