TABLE A2.
Treatment-Emergent Serious AEs Occurring in at Least Two Patients
| Eventa | Subcutaneous Group (n = 206), No. (%) | Intravenous Group (n = 210), No. (%) |
|---|---|---|
| Pneumonitis | 9 (4) | 6 (3) |
| COVID-19 | 4 (2) | 4 (2) |
| Alanine aminotransferase increased | 4 (2) | 3 (1) |
| Pneumonia | 3 (1) | 7 (3) |
| Interstitial lung disease | 3 (1) | 1 (0.5) |
| Fatigue | 3 (1) | 1 (0.5) |
| Deep vein thrombosis | 2 (1) | 4 (2) |
| Asthenia | 2 (1) | 2 (1) |
| Respiratory failure | 2 (1) | 1 (0.5) |
| Vomiting | 2 (1) | 0 |
| Femur fracture | 2 (1) | 0 |
| Dyspnea | 1 (0.5) | 2 (1) |
| Pulmonary embolism | 1 (0.5) | 2 (1) |
| Skin infection | 1 (0.5) | 2 (1) |
| Aspartate aminotransferase increased | 1 (0.5) | 2 (1) |
| Back pain | 1 (0.5) | 2 (1) |
| Cerebral infarction | 0 | 3 (1) |
| Nausea | 0 | 3 (1) |
| Infusion-related reaction | 0 | 2 (1) |
| Hypoalbuminemia | 0 | 2 (1) |
| Rash | 0 | 2 (1) |
NOTE. The safety population included all patients who were randomly assigned and received at least one dose of any trial treatment.
a
Events in this category are listed according to decreasing incidence in the subcutaneous group.