AEs of special interest by 6-month intervals
| Ruxolitinib randomized + extension, % . | Week . | ||||||
|---|---|---|---|---|---|---|---|
| 0-24 (n = 146) . | 24-48 (n = 134) . | 48-72 (n = 116) . | 72-96 (n = 101) . | 96-120 (n = 93) . | 120-144 (n = 81) . | 144-168 (n = 72) . | |
| Anemia* | 34.9 | 12.7 | 8.6 | 13.9 | 8.6 | 7.4 | 8.3 |
| Thrombocytopenia† | 43.2 | 22.4 | 15.5 | 12.9 | 10.8 | 12.3 | 2.8 |
| Bleeding | 17.1 | 14.2 | 9.5 | 11.9 | 7.5 | 9.9 | 6.9 |
| Epistaxis | 6.8 | 1.5 | 0.9 | 4.0 | 0 | 1.2 | 1.4 |
| Hematoma | 5.5 | 4.5 | 3.4 | 1.0 | 0 | 2.5 | 1.4 |
| Infections | 50.0 | 35.1 | 37.9 | 25.7 | 43.0 | 33.3 | 25.0 |
| Bronchitis | 3.4 | 6.7 | 8.6 | 3.0 | 10.8 | 4.9 | 4.2 |
| Gastroenteritis | 5.5 | 3.0 | 0.9 | 1.0 | 2.2 | 1.2 | 0 |
| Nasopharyngitis | 13.7 | 5.2 | 7.8 | 4.0 | 10.8 | 3.7 | 4.2 |
| Urinary tract infection | 4.8 | 2.2 | 5.2 | 4.0 | 5.4 | 3.7 | 2.8 |
| Weight gain | 8.2 | 8.2 | 5.2 | 5.0 | 2.2 | 0 | 0 |
| Ruxolitinib randomized + extension, % . | Week . | ||||||
|---|---|---|---|---|---|---|---|
| 0-24 (n = 146) . | 24-48 (n = 134) . | 48-72 (n = 116) . | 72-96 (n = 101) . | 96-120 (n = 93) . | 120-144 (n = 81) . | 144-168 (n = 72) . | |
| Anemia* | 34.9 | 12.7 | 8.6 | 13.9 | 8.6 | 7.4 | 8.3 |
| Thrombocytopenia† | 43.2 | 22.4 | 15.5 | 12.9 | 10.8 | 12.3 | 2.8 |
| Bleeding | 17.1 | 14.2 | 9.5 | 11.9 | 7.5 | 9.9 | 6.9 |
| Epistaxis | 6.8 | 1.5 | 0.9 | 4.0 | 0 | 1.2 | 1.4 |
| Hematoma | 5.5 | 4.5 | 3.4 | 1.0 | 0 | 2.5 | 1.4 |
| Infections | 50.0 | 35.1 | 37.9 | 25.7 | 43.0 | 33.3 | 25.0 |
| Bronchitis | 3.4 | 6.7 | 8.6 | 3.0 | 10.8 | 4.9 | 4.2 |
| Gastroenteritis | 5.5 | 3.0 | 0.9 | 1.0 | 2.2 | 1.2 | 0 |
| Nasopharyngitis | 13.7 | 5.2 | 7.8 | 4.0 | 10.8 | 3.7 | 4.2 |
| Urinary tract infection | 4.8 | 2.2 | 5.2 | 4.0 | 5.4 | 3.7 | 2.8 |
| Weight gain | 8.2 | 8.2 | 5.2 | 5.0 | 2.2 | 0 | 0 |
Data are presented as the percentage of patients. All grades for ≥5% of patients in any preferred term within the standardized MedDRA queries (SMQ) and any interval. Patients are counted only once in each category and time interval. AEs of special interest include anemia, thrombocytopenia, leukopenia, bleeding, infections, thromboembolic events, weight gain, elevated transaminase levels, increased systolic blood pressure, and secondary malignancies.
Includes preferred terms of anemia and normochromic normocytic anemia; the SMQ term is erythropenia.
Includes preferred terms of thrombocytopenia and platelet count decreased.