Table 2. Summary of reported toxicities.
| Adverse event | All grades | Panobinostat 10 mg (n=4) | Panobinostat 20 mg (n=7) | Panobinostat 30 mg (n=23) | Panobinostat 40 mg (n=5) | ||||
|---|---|---|---|---|---|---|---|---|---|
| Panobinostat 10–40 mg | Grade 1–2 | Grade 3–4 | Grade 1–2 | Grade 3–4 | Grade 1–2 | Grade 3–4 | Grade 1–2 | Grade 3–4 | |
| |
n (%) |
n |
n |
n |
n |
n (%) |
n (%) |
n |
n |
| Fatigue | 20 (60.0) | 4 | 1 DLT | 12 (52) | 3 (13) (1 DLT) | 1 | 3 DLTsa | ||
| Injection site reaction | 23 (58.0) | 4 | 4 | 12 (52) | 3 | ||||
| Nausea | 18 (45.0) | 2 | 2 | 7 (30) | 4 (17) | 3 | |||
| Anorexia | 12 (30.0) | 1 | 1 | 7 (30) | 1 (4) | 2 | |||
| Diarrhea | 11 (28.0) | 1 | 1 | 6 (26) | 1 (4) | 2 | |||
| Infection | 13 (33.0) | 1 | 5 (22) | 3 (13) 1xGr 5b | 3 1xGr 5b | ||||
| Constipation | 8 (20.0) | 1 | 6 (26) | 1 (4) | |||||
| Vomiting | 8 (20.0) | 1 | 1 | 5 (22) | 1 | ||||
| Dyspnea | 7 (18.0) | 1 | 1 (4) | 4 (17) | 1 | ||||
| Bleeding | 9 (22.5) | 2 | 4 (17) | 3 | |||||
| Pain | 6 (15.0) | 1 | 4 (17) | 1 (4) | |||||
| Febrile neutropenia | 6 (15.0) | 5 (22) | 1 | ||||||
| Fever | 5 (12.5) | 5 (22) | |||||||
| Mucositis | 5 (12.5) | 2 | 1 | 2 (9) | |||||
| Hyperglycemia | 5 (12.5) | 1 | 1 | 2 (9) | 1 | ||||
| Rash | 5 (12.5) | 1 | 2 (9) | 1 (4) | 1 | ||||
| Headache | 4 (10.0) | 1 | 3 (13) | ||||||
| Edema | 4 (10.0) | 4 (17) | |||||||
| Petechial rash | 4 (10.0) | 1 | 1 | 1 (4) | 1 | ||||
| Syncope | 1 (3) | 1 DLT | |||||||
Abbreviations: AE, adverse event; CTCAE, Common terminology criteria for adverse events version 3; DLT, dose-limiting toxicity.
DLT (deemed related to study drug):
a
includes fatigue related to hyponatremia and somnolence,
b
includes 2 x fungal lung infection (Aspergillus) Grade 5.