TABLE 2.
Event | Grade 1 | Grade 2 | Grade 3 | Grade 4 |
---|---|---|---|---|
Any adverse event | 6 (100%) | 3 (50%) | 1 (17%) | 0 |
Treatment-related adverse events | ||||
Chills | 5 (83%) | 0 | 0 | 0 |
Fatigue | 5 (83%) | 0 | 0 | 0 |
Malaise | 5 (83%) | 0 | 0 | 0 |
Fever | 4 (67%) | 0 | 0 | 0 |
Nausea | 4 (67%) | 0 | 0 | 0 |
Injection site pain | 4 (67%) | 0 | 0 | 0 |
Myalgia | 4 (67%) | 0 | 0 | 0 |
Vomiting | 2 (33%) | 0 | 0 | 0 |
Diarrhea | 2 (33%) | 0 | 0 | 0 |
Neutropenia | 1 (17%) | 1 (17%) | 0 | 0 |
Rash | 2 (33%) | 0 | 0 | 0 |
Pruritus | 2 (33%) | 0 | 0 | 0 |
Syncope | 0 | 0 | 1 (17%) | 0 |
AKI | 1 (17%) | 0 | 0 | 0 |
Immune-related adverse events | 0 | |||
Hypothyroidism | 0 | 3 (50%) | 0 | 0 |
Hyperthyroidism | 3 (50%) | 0 | 0 | 0 |
Transaminitis | 2 (33%) | 0 | 0 | 0 |
Adrenal insufficiency | 1 (17%) | 0 | 0 | 0 |
Type 1 diabetes mellitus | 0 | 0 | 1 (17%) | 0 |
NOTE: All treatment-related adverse events occurred during the trial period or within 30 days of the trial period (within 90 days for serious events). The severity of the adverse events was graded according to the Common Terminology Criteria for Adverse Events (version 5.0) of the NCI. Patients may have experienced more than one adverse event.
Abbreviation: AKI, acute kidney injury.