Table 2.
Characteristic | Grade 1–2 | Grade 3 | Grade 4 | Total Grade 3 and 4 |
---|---|---|---|---|
Hematologic | ||||
Anemia | 12 (46.2) | 2 (7.7) | 0 (0) | 2 (7.7) |
Neutropenia | 8 (30.8) | 9 (34.6) | 4 (15.4) | 13 (50) |
Lymphopenia | 9 (34.6) | 6 (23.1) | 1 (3.8) | 7 (26.9) |
Thrombocytopenia | 10 (38.5) | 4 (15.4) | 1 (3.8) | 5 (19.2) |
Non-hematologic | ||||
Fatigue | 9 (34.6) | 0 (0) | 0 (0) | 0 (0) |
Elevated AST / ALT | 9 (34.6) | 1 (3.8) | 0 (0) | 1 (3.8) |
Infection | 7 (26.9) | 1 (3.8) | 0 (0) | 1 (3.8) |
Rash | 6 (23.1) | 1 (3.8) | 0 (0) | 1 (3.8) |
Musculoskeletal pain | 5 (19.2) | 0 (0) | 0 (0) | 0 (0) |
Creatinine elevation | 4 (15.4) | 0 (0) | 0 (0) | 0 (0) |
Cough | 4 (15.4) | 0 (0) | 0 (0) | 0 (0) |
Constipation | 4 (15.4) | 0 (0) | 0 (0) | 0 (0) |
Psychiatric disturbance | 3 (11.5) | 0 (0) | 0 (0) | 0 (0) |
Pulmonary embolism | 0 (0) | 1 (3.8) | 0 (0) | 1 (3.8) |
Pancreatitis | 0 (0) | 1 (3.8) | 0 (0) | 1 (3.8) |
Laboratory | ||||
Low calcium | 6 (23.1) | 0 (0) | 0 (0) | 0 (0) |
Low phosphorous | 0 (0) | 1 (3.8) | 0 (0) | 1 (3.8) |
Low potassium | 4 (15.4) | 2 (7.7) | 2 (7.7) | 4 (15.4) |
Low sodium | 3 (11.6) | 0 (0) | 0 (0) | 0 (0) |
Table includes all grade 1–2 AEs occurring in at least 10% of patients and all grade ≥3 AEs that occurred in one or more patients. Only AEs determined by the investigators to be at least possibly related to the study drug are displayed.