TABLE 2.
All grade 3 or higher treatment-related AEs for subjects receiving at least one dose of combination therapy. Grade 2 treatment-related AES are included if >10% frequency
| Events (N) | Participants (n = 27) | ||||
|---|---|---|---|---|---|
| Grade 2 | Grade 3 | Grade 4 | N (%) | ||
| Immune-mediated | Pneumonitis | 0 | 1 | 0 | 1 (3.7%) |
| Increased creatinine | 0 | 1 | 0 | 1 (3.7%) | |
| Hematologic | Anemia | 41 | 7 | 2 | 18 (66.7%) |
| Low lymphocyte count | 15 | 10 | 2 | 11 (40.7%) | |
| Neutrophil count decreased | 5 | 2 | 0 | 3 (11.1%) | |
| Low white blood cell count | 6 | 4 | 0 | 2 (7.4%) | |
| Gastrointestinal | Diarrhea | 1 | 2 | 0 | 3 (11.1%) |
| Nausea | 3 | 0 | 0 | 3 (11.1%) | |
| Vomiting | 1 | 2 | 0 | 3 (11.1%) | |
| Anorexia | 2 | 1 | 0 | 3 (11.1%) | |
| Alanine aminotransferase increased | 1 | 1 | 0 | 2 (7.4%) | |
| Aspartate aminotransferase increased | 1 | 1 | 0 | 2 (7.4%) | |
| Gastrointestinal—other | 0 | 1 | 0 | 1 (3.7%) | |
| Endocrine | Hyperglycemia | 18 | 10 | 0 | 10 (37.0%) |
| Hyperthyroid | 0 | 1 | 0 | 1 (3.7%) | |
| Hypothyroid | 4 | 0 | 0 | 3 (11.1%) | |
| Neurologic | Headache | 0 | 1 | 0 | 1 (3.7%) |
| Weakness | 3 | 1 | 0 | 3 (11.1%) | |
| Paresthesia | 0 | 1 | 0 | 1 (3.7%) | |
| Fatigue | 9 | 2 | 0 | 9 (33.3%) | |
| Musculoskeletal | Arthralgia | 1 | 1 | 0 | 2 (7.4%) |
| Myalgia | 0 | 1 | 0 | 1 (3.7%) | |
| Cardiovascular | Hypotension | 0 | 1 | 0 | 1 (3.7%) |
| Cutaneous | Pruritus | 0 | 1 | 0 | 1 (3.7%) |