Table 4.
Nonlaboratory adverse reactions occurring through Cycle 7 Day 1 of randomized treatment in the REACH-3 safety population.
| Adverse reactionsb | Ruxolitinib (N = 165) |
Best available therapy (N = 158) |
||
|---|---|---|---|---|
| All gradesa (%) |
Grade ≥3 (%) | All grades (%) | Grade ≥3 (%) | |
| Infections and infestations | ||||
| Infections (pathogen not specified) | 45 | 15 | 44 | 16 |
| Viral infections | 28 | 5 | 23 | 5 |
| Musculoskeletal and connective tissue disorders | ||||
| Musculoskeletal pain | 18 | 1 | 13 | 0 |
| General disorders and administration site conditions | ||||
| Pyrexia | 16 | 2 | 9 | 1 |
| Fatigue | 13 | 1 | 10 | 2 |
| Edema | 10 | 1 | 12 | 1 |
| Vascular disorders | ||||
| Hypertension | 16 | 5 | 13 | 7 |
| Hemorrhage | 12 | 2 | 15 | 2 |
| Respiratory, thoracic, and mediastinal disorders | ||||
| Cough | 13 | 0 | 8 | 0 |
| Dyspnea | 11 | 1 | 8 | 1 |
| Gastrointestinal disorders | ||||
| Nausea | 12 | 0 | 13 | 2 |
| Diarrhea | 10 | 1 | 13 | 1 |
National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.
Includes grouped terms (see Supplementary Table S2). Limited to adverse reactions with all-grade incidence ≥10%.