Nonhematologic AEs regardless of study drug
| Adjusted rate per 100 patient-year exposure . | Ruxolitinib randomized (n = 146) . | Ruxolitinib randomized + extension (n = 146) . | BAT randomized (n = 73) . | Ruxolitinib crossover (n = 45) . |
|---|---|---|---|---|
| Patient-year exposure | 170.12 | 304.87 | 66.98 | 44.95 |
| Peripheral edema | 20.0 (0) | 17.4 (0) | 31.4 (1.5) | 17.8 (2.2) |
| Diarrhea | 22.3 (1.2) | 15.4 (0.7) | 19.4 (0) | 20.0 (0) |
| Asthenia | 16.5 (2.4) | 11.5 (1.6) | 13.4 (1.5) | 17.8 (2.2) |
| Dyspnea | 14.1 (1.2) | 11.2 (1.3) | 22.4 (4.5) | 20.0 (2.2) |
| Pyrexia | 12.9 (1.8) | 11.5 (1.3) | 10.5 (0) | 13.3 (0) |
| Fatigue | 13.5 (0.6) | 11.2 (0.7) | 11.9 (0) | 13.3 (2.2) |
| Nasopharyngitis | 15.9 (0) | 11.8 (0) | 14.9 (0) | 8.9 (0) |
| Bronchitis | 10.6 (1.2) | 11.5 (1.3) | 9.0 (1.5) | 6.7 (0) |
| Cough | 12.9 (0) | 10.5 (0) | 17.9 (1.5) | 11.1 (2.2) |
| Arthralgia | 11.2 (1.2) | 8.9 (0.7) | 10.5 (0) | 13.3 (2.2) |
| Weight gain | 13.5 (1.8) | 9.5 (1.0) | 1.5 (0) | 8.9 (0) |
| Nausea | 12.3 (0.6) | 8.9 (0.3) | 10.5 (0) | 8.9 (0) |
| Pain in extremity | 10.0 (0.6) | 7.2 (0.3) | 6.0 (0) | 20.0 (0) |
| Headache | 10.6 (1.2) | 6.9 (0.7) | 6.0 (0) | 15.6 (0) |
| Back pain | 10.6 (1.8) | 7.5 (1.3) | 14.9 (0) | 6.7 (0) |
| Insomnia | 5.3 (0) | 3.9 (0) | 10.5 (0) | 8.9 (0) |
| Abdominal pain | 10.0 (2.9) | 6.6 (1.6) | 19.4 (4.5) | 6.7 (2.2) |
| Epistaxis | 7.6 (0) | 5.2 (0.7) | 7.5 (0) | 11.1 (0) |
| Pruritus | 5.3 (0) | 5.2 (0) | 19.4 (0) | 8.9 (0) |
| Adjusted rate per 100 patient-year exposure . | Ruxolitinib randomized (n = 146) . | Ruxolitinib randomized + extension (n = 146) . | BAT randomized (n = 73) . | Ruxolitinib crossover (n = 45) . |
|---|---|---|---|---|
| Patient-year exposure | 170.12 | 304.87 | 66.98 | 44.95 |
| Peripheral edema | 20.0 (0) | 17.4 (0) | 31.4 (1.5) | 17.8 (2.2) |
| Diarrhea | 22.3 (1.2) | 15.4 (0.7) | 19.4 (0) | 20.0 (0) |
| Asthenia | 16.5 (2.4) | 11.5 (1.6) | 13.4 (1.5) | 17.8 (2.2) |
| Dyspnea | 14.1 (1.2) | 11.2 (1.3) | 22.4 (4.5) | 20.0 (2.2) |
| Pyrexia | 12.9 (1.8) | 11.5 (1.3) | 10.5 (0) | 13.3 (0) |
| Fatigue | 13.5 (0.6) | 11.2 (0.7) | 11.9 (0) | 13.3 (2.2) |
| Nasopharyngitis | 15.9 (0) | 11.8 (0) | 14.9 (0) | 8.9 (0) |
| Bronchitis | 10.6 (1.2) | 11.5 (1.3) | 9.0 (1.5) | 6.7 (0) |
| Cough | 12.9 (0) | 10.5 (0) | 17.9 (1.5) | 11.1 (2.2) |
| Arthralgia | 11.2 (1.2) | 8.9 (0.7) | 10.5 (0) | 13.3 (2.2) |
| Weight gain | 13.5 (1.8) | 9.5 (1.0) | 1.5 (0) | 8.9 (0) |
| Nausea | 12.3 (0.6) | 8.9 (0.3) | 10.5 (0) | 8.9 (0) |
| Pain in extremity | 10.0 (0.6) | 7.2 (0.3) | 6.0 (0) | 20.0 (0) |
| Headache | 10.6 (1.2) | 6.9 (0.7) | 6.0 (0) | 15.6 (0) |
| Back pain | 10.6 (1.8) | 7.5 (1.3) | 14.9 (0) | 6.7 (0) |
| Insomnia | 5.3 (0) | 3.9 (0) | 10.5 (0) | 8.9 (0) |
| Abdominal pain | 10.0 (2.9) | 6.6 (1.6) | 19.4 (4.5) | 6.7 (2.2) |
| Epistaxis | 7.6 (0) | 5.2 (0.7) | 7.5 (0) | 11.1 (0) |
| Pruritus | 5.3 (0) | 5.2 (0) | 19.4 (0) | 8.9 (0) |
Data are presented as adjusted rates for all grades, with grades 3/4 given in parentheses. Relationship adjusted for patient-year exposure (rate of ≥10 per 100 patient-years in either arm) by preferred term. AEs regardless of study drug relationship occurring >28 days after discontinuation of study medication are not summarized. A patient with multiple occurrences of an AE under 1 treatment is counted only once in the AE category for that treatment.