Table 3. Serious Adverse Events and Causes of Deaths.
| Adverse events, No. (%) | |||
|---|---|---|---|
| Event | Tocilizumab (n = 63) | Usual care (n = 67) | P value |
| Patients with at least 1 AE | 28 (44) | 36 (54) | 30a |
| Patients with multiple AEs | 16 (25) | 19 (28) | |
| No. of events | 66 | 86 | .21b |
| Serious adverse events | |||
| Patients with at least 1 SAE | 20 (32) | 29 (43) | .21a |
| Patients with multiple SAEs | 5 (8) | 10 (15) | |
| No. of events | 26 | 57 | |
| Atrial fibrillation | 0 | 1 | .003b |
| Anemia | 1 | 4 | |
| Hyperlipasemia | 0 | 1 | |
| Cholestasis | 0 | 2 | |
| Hepatic cytolysis | 4 | 4 | |
| Multiple organ failure (death) | 0 | 1 (1) | |
| Pulmonary embolism (death) | 0 | 3 (1) | |
| Fever | 2 | 0 | |
| Hyperkaliemia | 0 | 1 | |
| Hypoglycemia | 0 | 1 | |
| Hypertension | 1 | 0 | |
| Acute renal failure | 1 | 2 | |
| Arterial ischemia | 0 | 2 | |
| Lymphopenia | 1 | 0 | |
| Neutropenia | 4 | 0 | |
| Pneumothorax | 0 | 1 | |
| ARDS (death) | 9 (7) | 19 (9)c | |
| Bacterial sepsis | 2 | 11 | |
| Fungal sepsis | 0 | 2 | |
| Viral sepsis | 0 | 1 | |
| Tetraparesis | 0 | 1 | |
| Cough | 1 | 0 | |
Abbreviations: AE, adverse event; ARDS, acute respiratory distress syndrome; SAE, serious adverse event.
a
Fisher exact test.
b
Poisson model.
c
For 1 patient, the cause of death was reported as both ARDS and hemorrhagic shock.