Table 3. Frequent adverse events (⩾20%) regardless of study drug relationship by initial dose group of PAN in the phase 1b portion.
|
PAN+AZA 20 mg (n=6) |
PAN+AZA 30 mg (n=18) |
PAN+AZA 40 mg (n=7) |
All patients (N=31) |
|||||
|---|---|---|---|---|---|---|---|---|
| All grades, n (%) | Grades 3/4, n (%) | All grades, n (%) | Grades 3/4, n (%) | All grades, n (%) | Grades 3/4, n (%) | All grades, n (%) | Grades 3/4, n (%) | |
| Nausea | 4 (66.7) | 0 | 14 (77.8) | 3 (16.7) | 7 (100.0) | 1 (14.3) | 25 (80.6) | 4 (12.9) |
| Diarrhea | 4 (66.7) | 1 (16.7) | 15 (83.3) | 1 (5.6) | 4 (57.1) | 0 | 23 (74.2) | 2 (6.5) |
| Fatigue | 4 (66.7) | 0 | 13 (72.2) | 4 (22.2) | 5 (71.4) | 0 | 22 (71.0) | 4 (12.9) |
| Thrombocytopenia | 3 (50.0) | 2 (33.3) | 12 (66.7) | 11 (61.1) | 5 (71.4) | 4 (57.1) | 20 (64.5) | 17 (54.8) |
| Vomiting | 5 (83.3) | 0 | 9 (50.0) | 2 (11.1) | 4 (57.1) | 1 (14.3) | 18 (58.1) | 3 (9.7) |
| Constipation | 2 (33.3) | 0 | 11 (61.1) | 1 (5.6) | 3 (42.9) | 0 | 16 (51.6) | 1 (3.2) |
| Neutropenia | 2 (33.3) | 2 (33.3) | 9 (50.0) | 8 (44.4) | 3 (42.9) | 3 (42.9) | 14 (45.2) | 13 (41.9) |
| Decreased appetite | 3 (50.0) | 0 | 6 (33.3) | 0 | 5 (71.4) | 0 | 14 (45.2) | 0 |
| Anemia | 2 (33.3) | 1 (16.7) | 8 (44.4) | 6 (33.3) | 3 (42.9) | 3 (42.9) | 13 (41.9) | 10 (32.3) |
| Pyrexia | 2 (33.3) | 0 | 7 (38.9) | 1 (5.6) | 4 (57.1) | 0 | 13 (41.9) | 1 (3.2) |
| Hypokalemia | 1 (16.7) | 1 (16.7) | 9 (50.0) | 4 (22.2) | 3 (42.9) | 0 | 13 (41.9) | 5 (16.1) |
| Asthenia | 3 (50.0) | 1 (16.7) | 6 (33.3) | 0 | 3 (42.9) | 2 (28.6) | 12 (38.7) | 3 (9.7) |
| Hypocalcemia | 3 (50.0) | 0 | 7 (38.9) | 1 (5.6) | 1 (14.3) | 0 | 11 (35.5) | 1 (3.2) |
| Febrile neutropenia | 2 (33.3) | 2 (33.3) | 6 (33.3) | 5 (27.8) | 2 (28.6) | 2 (28.6) | 10 (32.3) | 9 (29.0) |
| Blood creatinine increased | 1 (16.7) | 0 | 5 (27.8) | 0 | 4 (57.1) | 1 (14.3) | 10 (32.3) | 1 (3.2) |
| Dyspnea | 3 (50.0) | 1 (16.7) | 5 (27.8) | 0 | 2 (28.6) | 1 (14.3) | 10 (32.3) | 2 (6.5) |
| Abdominal pain | 3 (50.0) | 0 | 5 (27.8) | 0 | 1 (14.3) | 0 | 9 (29.0) | 0 |
| Peripheral edema | 2 (33.3) | 0 | 4 (22.2) | 0 | 3 (42.9) | 0 | 9 (29.0) | 0 |
Abbreviations: AZA, azacitidine; PAN, panobinostat.