Table 1.
AEs by Grade, Regardless of Study-drug Relationship (≥20% of Patients, All Grades, Safety Set)
| Preferred terms, n (%) | All patients escalation phase (N = 38) | Panobinostat 25 mg Ruxolitinib 15 mg expansion phase (N = 23) | Patients treated at MTD/RP2D (N = 34) | Total patients (N = 61) | ||||
|---|---|---|---|---|---|---|---|---|
| All grades | Grade ≥3 | All grades | Grade ≥3 | All grades | Grade ≥3 | All grades | Grade ≥3 | |
| Number of subjects with at least one event | 38 (100.0) | 33 (86.8) | 23 (100.0) | 21 (91.3) | 34 (100.0) | 31 (91.2) | 61 (100.0) | 54 (88.5) |
| Anemia | 24 (63.2) | 18 (47.4) | 21 (91.3) | 13 (56.5) | 29 (85.3) | 17 (50.0) | 45 (73.8) | 31 (50.8) |
| Diarrhea | 25 (65.8) | 6 (15.8) | 17 (73.9) | 5 (21.7) | 26 (76.5) | 9 (26.5) | 42 (68.9) | 11 (18.0) |
| Thrombocytopenia | 22 (57.9) | 10 (26.3) | 12 (52.2) | 7 (30.4) | 18 (52.9) | 10 (29.4) | 34 (55.7) | 17 (27.9) |
| Asthenia | 16 (42.1) | 5 (13.2) | 11 (47.8) | 1 (4.3) | 18 (52.9) | 5 (14.7) | 27 (44.3) | 6 (9.8) |
| Cough | 12 (31.6) | 0 (0.0) | 11 (47.8) | 0 (0.0) | 14 (41.2) | 0 (0.0) | 23 (37.7) | 0 (0.0) |
| Edema peripheral | 14 (36.8) | 0 (0.0) | 9 (39.1) | 0 (0.0) | 13 (38.2) | 0 (0.0) | 23 (37.7) | 0 (0.0) |
| Muscle spasms | 14 (36.8) | 0 (0.0) | 8 (34.8) | 0 (0.0) | 13 (38.2) | 0 (0.0) | 22 (36.1) | 0 (0.0) |
| Nausea | 14 (36.8) | 3 (7.9) | 7 (30.4) | 0 (0.0) | 13 (38.2) | 2 (5.9) | 21 (34.4) | 3 (4.9) |
| Headache | 13 (34.2) | 0 (0.0) | 7 (30.4) | 0 (0.0) | 12 (35.3) | 0 (0.0) | 20 (32.8) | 0 (0.0) |
MTD/RP2D = maximum tolerated dose/recommended phase 2 dose.