TRAEs in the safety population
| Preferred term . | Cohort 1 No RUX anemia (n = 22) . | Cohort 3A RUX anemia (n = 14) . | Cohort 2 No RUX TD (n = 21) . | Cohort 3B RUX TD (n = 38) . | Total (N = 95) . | |||||
|---|---|---|---|---|---|---|---|---|---|---|
| Any grade . | Grade ≥3 . | Any grade . | Grade ≥3 . | Any grade . | Grade ≥3 . | Any grade . | Grade ≥3 . | Any grade . | Grade ≥3 . | |
| Patients with ≥1 TRAEs∗ | 14 (63.6) | 0 | 7 (50.0) | 2 (14.3) | 5 (23.8) | 1 (4.8) | 19 (50.0) | 7 (18.4) | 45 (47.4) | 10 (10.5) |
| Hypertension | 4 (18.2) | 0 | 4 (28.6) | 2 (14.3) | 1 (4.8) | 0 | 8 (21.1) | 3 (7.9) | 17 (17.9) | 5 (5.3) |
| Bone pain | 2 (9.1) | 0 | 3 (21.4) | 0 | 2 (9.5) | 0 | 0 | 0 | 7 (7.4) | 0 |
| Diarrhea | 1 (4.5) | 0 | 0 | 0 | 2 (9.5) | 1 (4.8) | 3 (7.9) | 1 (2.6) | 6 (6.3) | 2 (2.1) |
| Fatigue | 1 (4.5) | 0 | 0 | 0 | 0 | 0 | 3 (7.9) | 0 | 4 (4.2) | 0 |
| Hyperuricemia | 2 (9.1) | 0 | 0 | 0 | 1 (4.8) | 0 | 1 (2.6) | 0 | 4 (4.2) | 0 |
| Dizziness | 1 (4.5) | 0 | 0 | 0 | 1 (4.8) | 0 | 1 (2.6) | 0 | 3 (3.2) | 0 |
| Headache | 0 | 0 | 0 | 0 | 1 (4.8) | 0 | 1 (2.6) | 0 | 2 (2.1) | 0 |
| Thrombocytopenia | 0 | 0 | 0 | 0 | 0 | 0 | 2 (5.3) | 2 (5.3) | 2 (2.1) | 2 (2.1) |
| Back pain | 0 | 0 | 1 (7.1) | 0 | 0 | 0 | 1 (2.6) | 0 | 2 (2.1) | 0 |
| Myalgia | 1 (4.5) | 0 | 0 | 0 | 0 | 0 | 1 (2.6) | 0 | 2 (2.1) | 0 |
| Abdominal pain | 2 (9.1) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 (2.1) | 0 |
| Nausea | 1 (4.5) | 0 | 0 | 0 | 1 (4.8) | 0 | 0 | 0 | 2 (2.1) | 0 |
| Peripheral edema | 0 | 0 | 0 | 0 | 0 | 0 | 2 (5.3) | 0 | 2 (2.1) | 0 |
| Alanine aminotransferase increased | 0 | 0 | 1 (7.1) | 0 | 0 | 0 | 1 (2.6) | 0 | 2 (2.1) | 0 |
| Blood alkaline phosphatase increased | 0 | 0 | 1 (7.1) | 0 | 1 (4.8) | 0 | 0 | 0 | 2 (2.1) | 0 |
| Preferred term . | Cohort 1 No RUX anemia (n = 22) . | Cohort 3A RUX anemia (n = 14) . | Cohort 2 No RUX TD (n = 21) . | Cohort 3B RUX TD (n = 38) . | Total (N = 95) . | |||||
|---|---|---|---|---|---|---|---|---|---|---|
| Any grade . | Grade ≥3 . | Any grade . | Grade ≥3 . | Any grade . | Grade ≥3 . | Any grade . | Grade ≥3 . | Any grade . | Grade ≥3 . | |
| Patients with ≥1 TRAEs∗ | 14 (63.6) | 0 | 7 (50.0) | 2 (14.3) | 5 (23.8) | 1 (4.8) | 19 (50.0) | 7 (18.4) | 45 (47.4) | 10 (10.5) |
| Hypertension | 4 (18.2) | 0 | 4 (28.6) | 2 (14.3) | 1 (4.8) | 0 | 8 (21.1) | 3 (7.9) | 17 (17.9) | 5 (5.3) |
| Bone pain | 2 (9.1) | 0 | 3 (21.4) | 0 | 2 (9.5) | 0 | 0 | 0 | 7 (7.4) | 0 |
| Diarrhea | 1 (4.5) | 0 | 0 | 0 | 2 (9.5) | 1 (4.8) | 3 (7.9) | 1 (2.6) | 6 (6.3) | 2 (2.1) |
| Fatigue | 1 (4.5) | 0 | 0 | 0 | 0 | 0 | 3 (7.9) | 0 | 4 (4.2) | 0 |
| Hyperuricemia | 2 (9.1) | 0 | 0 | 0 | 1 (4.8) | 0 | 1 (2.6) | 0 | 4 (4.2) | 0 |
| Dizziness | 1 (4.5) | 0 | 0 | 0 | 1 (4.8) | 0 | 1 (2.6) | 0 | 3 (3.2) | 0 |
| Headache | 0 | 0 | 0 | 0 | 1 (4.8) | 0 | 1 (2.6) | 0 | 2 (2.1) | 0 |
| Thrombocytopenia | 0 | 0 | 0 | 0 | 0 | 0 | 2 (5.3) | 2 (5.3) | 2 (2.1) | 2 (2.1) |
| Back pain | 0 | 0 | 1 (7.1) | 0 | 0 | 0 | 1 (2.6) | 0 | 2 (2.1) | 0 |
| Myalgia | 1 (4.5) | 0 | 0 | 0 | 0 | 0 | 1 (2.6) | 0 | 2 (2.1) | 0 |
| Abdominal pain | 2 (9.1) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 (2.1) | 0 |
| Nausea | 1 (4.5) | 0 | 0 | 0 | 1 (4.8) | 0 | 0 | 0 | 2 (2.1) | 0 |
| Peripheral edema | 0 | 0 | 0 | 0 | 0 | 0 | 2 (5.3) | 0 | 2 (2.1) | 0 |
| Alanine aminotransferase increased | 0 | 0 | 1 (7.1) | 0 | 0 | 0 | 1 (2.6) | 0 | 2 (2.1) | 0 |
| Blood alkaline phosphatase increased | 0 | 0 | 1 (7.1) | 0 | 1 (4.8) | 0 | 0 | 0 | 2 (2.1) | 0 |
Data are n (%) unless otherwise indicated.
RUX, ruxolitinib.
Only preferred terms occurring in ≥2 patients shown; therefore, overall total may not match values shown below.