Table 1. Adverse events considered related to panobinostat by treatment schedule and initial dose cohort.
Panobinostat-related toxicity |
Arm A, n (%) |
Arm B, n (%) |
||||
---|---|---|---|---|---|---|
G1 and 2 | G3 | G4 | G1 and 2 | G3 | G4 | |
Blood/bone marrow | ||||||
Leukocytopenia | 0 | 2 (10) | 0 | 0 | 2 (10) | 0 |
Neutropenia | 0 | 1 (5) | 1 (5) | 0 | 4 (19) | 0 |
Thrombocytopenia | 0 | 5 (24) | 1 (5) | 0 | 3 (14) | 1 (5) |
Anemia | 0 | 2 (10) | 0 | 0 | 0 | 0 |
Cardiac | 1 (5) | 0 | 0 | 1 (5) | 0 | 0 |
Constitutional symptoms | ||||||
Fatigue | 2 (10) | 4 (19) | 0 | 0 | 0 | 0 |
Weight loss | 1 (5) | 0 | 0 | 0 | 0 | 0 |
Gastrointestinal symptoms | ||||||
Nausea/vomiting | 4 (19) | 1 (5) | 0 | 3 (14) | 0 | 0 |
Diarrhea | 3 (14) | 1 (5) | 0 | 1 (5) | 2 (10) | 0 |
Colitis | 0 | 1 (5) | 0 | 0 | 0 | 0 |
Anorexia | 1 (5) | 0 | 0 | 0 | 0 | 0 |
Oral mucositis | 0 | 0 | 0 | 1 (5) | 0 | 0 |
Taste alteration | 0 | 0 | 0 | 1 (5) | 0 | 0 |
Pain | 1 (5) | 1 (5) | 0 | 1 (5) | 0 | 0 |
Headache | 0 | 0 | 0 | 0 | 1 (5) | 0 |
Renal failure | 0 | 1 (5) | 0 | 0 | 0 | 0 |
Rash | 0 | 0 | 0 | 1 (5) | 0 | 0 |
Sensory neuropathy | 0 | 0 | 0 | 0 | 1 (5) | 0 |
Metabolic/laboratory | ||||||
Elevated liver function tests | 0 | 0 | 0 | 2 (10) | 2 (10) | 0 |
Creatinine increased | 1 (5) | 0 | 0 | 0 | 0 | 0 |
Hyperuricemia | 0 | 1 (5) | 0 | 0 | 0 | 0 |