Treatment-related adverse events
| Adverse event . | No. of patients (%) with treatment-related adverse events∗ . | |||
|---|---|---|---|---|
| Any grade . | Grade 1 . | Grade 2 . | Grade 3† . | |
| Any adverse event | 9 (42.9) | 4 (19.0) | 5 (23.8) | 1 (4.7) |
| IRRs | 3 (14.3) | 0 | 2 (9.5) | 1 (4.7) |
| Urticaria | 1 (4.7) | 0 | 1 (4.7) | 0 |
| Fever | 1 (4.7) | 0 | 1 (4.7) | 0 |
| IRR | 1 (4.7) | 0 | 0 | 1 (4.7) |
| Injection site reaction | 2 (9.5) | 2 (9.5) | 0 | 0 |
| Erythematous rush | 2 (9.5) | 2 (9.5) | 0 | 0 |
| Injection site discoloration | 1 (4.7) | 1 (4.7) | 0 | 0 |
| Infections | 1 (4.7) | 1 (4.7) | 1 (4.7) | 0 |
| Upper respiratory tract infections | 1 (4.7) | 0 | 1 (4.7) | 0 |
| Sinusitis | 1 (4.7) | 1 (4.7) | 0 | 0 |
| Diarrhea | 2 (9.5) | 0 | 2 (9.5) | 0 |
| Headache | 1 (4.7) | 1 (4.7) | 0 | 0 |
| Nausea | 1 (4.7) | 0 | 1 (4.7) | 0 |
| Vomiting | 1 (4.7) | 0 | 1 (4.7) | 0 |
| Weight gain | 1 (4.7) | 1 (4.7) | 0 | 0 |
| Adverse event . | No. of patients (%) with treatment-related adverse events∗ . | |||
|---|---|---|---|---|
| Any grade . | Grade 1 . | Grade 2 . | Grade 3† . | |
| Any adverse event | 9 (42.9) | 4 (19.0) | 5 (23.8) | 1 (4.7) |
| IRRs | 3 (14.3) | 0 | 2 (9.5) | 1 (4.7) |
| Urticaria | 1 (4.7) | 0 | 1 (4.7) | 0 |
| Fever | 1 (4.7) | 0 | 1 (4.7) | 0 |
| IRR | 1 (4.7) | 0 | 0 | 1 (4.7) |
| Injection site reaction | 2 (9.5) | 2 (9.5) | 0 | 0 |
| Erythematous rush | 2 (9.5) | 2 (9.5) | 0 | 0 |
| Injection site discoloration | 1 (4.7) | 1 (4.7) | 0 | 0 |
| Infections | 1 (4.7) | 1 (4.7) | 1 (4.7) | 0 |
| Upper respiratory tract infections | 1 (4.7) | 0 | 1 (4.7) | 0 |
| Sinusitis | 1 (4.7) | 1 (4.7) | 0 | 0 |
| Diarrhea | 2 (9.5) | 0 | 2 (9.5) | 0 |
| Headache | 1 (4.7) | 1 (4.7) | 0 | 0 |
| Nausea | 1 (4.7) | 0 | 1 (4.7) | 0 |
| Vomiting | 1 (4.7) | 0 | 1 (4.7) | 0 |
| Weight gain | 1 (4.7) | 1 (4.7) | 0 | 0 |
Relatedness to treatment was determined by the study investigators. Four patients had >1 treatment-related adverse event.
In total, 3 adverse events of grade 3 were reported in 2 patients. Only 1 (IRR) was related to treatment. The second patient contracted severe acute respiratory syndrome coronavirus 2 infection complicated with acute renal failure. No grade 4 or grade 5 adverse events appeared during the study.