Table 4. Frequent adverse events (⩾15%) regardless of study drug relationship by treatment group in the phase 2b portion.
|
PAN+AZA (n=38)a |
AZA (n=42)a |
All patients (N=80) |
||||
|---|---|---|---|---|---|---|
| All grades, n (%) | Grades 3/4, n (%) | All grades, n (%) | Grades 3/4, n (%) | All grades, n (%) | Grades 3/4, n (%) | |
| Nausea | 23 (60.5) | 4 (10.5) | 18 (42.9) | 1 (2.4) | 41 (51.3) | 5 (6.3) |
| Thrombocytopenia | 21 (55.3) | 21 (55.3) | 11 (26.2) | 8 (19.0) | 32 (40.0) | 29 (36.3) |
| Diarrhea | 19 (50.0) | 3 (7.9) | 9 (21.4) | 1 (2.4) | 28 (35.0) | 4 (5.0) |
| Neutropenia | 16 (42.1) | 16 (42.1) | 11 (26.2) | 11 (26.2) | 27 (33.8) | 27 (33.8) |
| Vomiting | 16 (42.1) | 3 (7.9) | 11 (26.2) | 1 (2.4) | 27 (33.8) | 4 (5.0) |
| Pyrexia | 19 (50.0) | 2 (5.3) | 8 (19.0) | 1 (2.4) | 27 (33.8) | 3 (3.8) |
| Anemia | 12 (31.6) | 8 (21.1) | 13 (31.0) | 5 (11.9) | 25 (31.3) | 13 (16.3) |
| Constipation | 10 (26.3) | 2 (5.3) | 15 (35.7) | 0 | 25 (31.3) | 2 (2.5) |
| Fatigue | 8 (21.1) | 2 (5.3) | 16 (38.1) | 0 | 24 (30.0) | 2 (2.5) |
| Febrile neutropenia | 13 (34.2) | 12 (31.6) | 8 (19.0) | 8 (19.0) | 21 (26.3) | 20 (25.0) |
| Peripheral edema | 8 (21.1) | 0 | 8 (19.0) | 0 | 16 (20.0) | 0 |
| Decreased appetite | 10 (26.3) | 2 (5.3) | 6 (14.3) | 0 | 16 (20.0) | 2 (2.5) |
| Asthenia | 8 (21.1) | 1 (2.6) | 6 (14.3) | 0 | 14 (17.5) | 1 (1.3) |
| Pneumonia | 8 (21.1) | 6 (15.8) | 6 (14.3) | 5 (11.9) | 14 (17.5) | 11 (13.8) |
| Headache | 6 (15.8) | 0 | 7 (16.7) | 2 (4.8) | 13 (16.3) | 2 (2.5) |
| Epistaxis | 6 (15.8) | 1 (2.6) | 6 (14.3) | 0 | 12 (15.0) | 1 (1.3) |
| Hypokalemia | 6 (15.8) | 4 (10.5) | 6 (14.3) | 1 (2.4) | 12 (15.0) | 5 (6.3) |
| Weight decreased | 7 (18.4) | 0 | 4 (9.5) | 0 | 11 (13.8) | 0 |
| Cough | 6 (15.8) | 0 | 5 (11.9) | 0 | 11 (13.8) | 0 |
| Platelet count decreased | 7 (18.4) | 5 (13.2) | 2 (4.8) | 2 (4.8) | 9 (11.3) | 7 (8.8) |
| Abdominal pain | 6 (15.8) | 1 (2.6) | 1 (2.4) | 0 | 7 (8.8) | 1 (1.3) |
Abbreviations: AZA, azacitidine; PAN, panobinostat.
a
Two patients enrolled in the AZA arm did not receive medication. In addition, two patients enrolled in the PAN+AZA arm received only AZA and were therefore included in the AZA group for analysis.