Table 4.
Adverse events (AEs) suspected be related to panobinostant (PAN) during inducation phase. All grades and grade 3 or 4 (≥ 15% in any dose group).
| PAN 15 mg N = 11 |
PAN 20 mg N = 15 |
PAN 25 mg N = 8 |
PAN 20 mg (expansion phase) N = 12 |
All patients N = 46 |
||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Preferred term | Any grade, n (%) | Grade 3 or 4, n (%) | Any grade, n (%) | Grade 3 or 4, n (%) | Any grade, n (%) | Grade 3 or 4, n (%) | Any grade, n (%) | Grade 3 or 4, n (%) | Any grade, n (%) | Grade 3 or 4, n (%) |
| Hematologic | ||||||||||
| Thrombocytopenia | 7 (63.6) | 7 (63.6) | 9 (60.0) | 9 (60.0) | 1 (12.5) | 1 (12.5) | 4 (33.3) | 4 (33.3) | 21 (45.7) | 21 (45.7) |
| Anemia | 7 (63.6) | 5 (45.5) | 4 (26.7) | 4 (26.7) | 3 (37.5) | 3 (37.5) | 3 (25.0) | 3 (25.0) | 17 (37.0) | 15 (32.6) |
| Febrile neutropenia | 5 (45.5) | 4 (36.4) | 6 (40.0) | 6 (40.0) | 2 (25.0) | 2 (25.0) | 4 (33.3) | 4 (33.3) | 17 (37.0) | 16 (34.8) |
| Neutropenia | 3 (27.3) | 3 (27.3) | 3 (20.0) | 3 (20.0) | 1 (12.5) | 1 (12.5) | 2 (16.7) | 2 (16.7) | 9 (19.6) | 9 (19.6) |
| Leukopenia | 2 (18.2) | 2 (18.2) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (4.3) | 2 (4.3) |
| Cardiac disorders | ||||||||||
| Left ventricular dysfunction | 0 (0.0) | 0 (0.0) | 3 (20.0) | 2 (13.3) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 3 (6.5) | 2 (4.3) |
| Gastrointestinal disorders | ||||||||||
| Diarrhea | 7 (63.6) | 0 (0.0) | 8 (53.3) | 1 (6.7) | 5 (62.5) | 1 (12.5) | 5 (41.7) | 1 (8.3) | 25 (54.3) | 3 (6.5) |
| Nausea | 3 (27.3) | 0 (0.0) | 7 (46.7) | 0 (0.0) | 2 (25.0) | 0 (0.0) | 6 (50.0) | 0 (0.0) | 18 (39.1) | 0 (0.0) |
| Vomiting | 1 (9.1) | 0 (0.0) | 3 (20.0) | 0 (0.0) | 1 (12.5) | 0 (0.0) | 5 (41.7) | 0 (0.0) | 10 (21.7) | 0 (0.0) |
| Stomatitis | 2 (18.2) | 0 (0.0) | 2 (13.3) | 0 (0.0) | 1 (12.5) | 0 (0.0) | 4 (33.3) | 0 (0.0) | 9 (19.6) | 0 (0.0) |
| Abdominal pain | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 3 (25.0) | 0 (0.0) | 3 (6.5) | 0 (0.0) |
| Dyspepsia | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (16.7) | 0 (0.0) | 2 (4.3) | 0 (0.0) |
| General disorders and administration site conditions | ||||||||||
| Fatigue | 1 (9.1) | 0 (0.0) | 5 (33.3) | 1 (6.7) | 1 (12.5) | 0 (0.0) | 1 (8.3) | 0 (0.0) | 8 (17.4) | 1 (2.2) |
| Pyrexia | 2 (18.2) | 0 (0.0) | 2 (13.3) | 0 (0.0) | 1 (12.5) | 0 (0.0) | 1 (8.3) | 0 (0.0) | 6 (13.0) | 0 (0.0) |
| Metabolism and nutrition disorders | ||||||||||
| Decreased appetite | 4 (36.4) | 0 (0.0) | 3 (20.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 3 (25.0) | 1 (8.3) | 10 (21.7) | 1 (2.2) |
| Hypokalemia | 1 (9.1) | 0 (0.0) | 3 (20.0) | 2 (13.3) | 0 (0.0) | 0 (0.0) | 3 (25.0) | 1 (8.3) | 7 (15.2) | 3 (6.5) |
| Skin and subcutaneous tissue disorders | ||||||||||
| Alopecia | 1 (9.1) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (16.7) | 0 (0.0) | 3 (6.5) | 0 (0.0) |
A patient with multiple occurrences of an AE under one treatment is counted only once in the AE category for that treatment. A patient with multiple AEs within a primary system organ class is counted only once in the total row. Adverse events occurring more than 28 days after the discontinuation of study treatment are not summarized.