Table 2.
Adverse Event | Ruxolitinib (N=155) % of patients |
Placebo (N=151) % of patients |
||
---|---|---|---|---|
| ||||
All Grades | Grade 3 or 4 | All Grades | Grade 3 or 4 | |
Nonhematologic | ||||
Fatigue | 25.2 | 5.2 | 33.8 | 6.6 |
Diarrhea | 23.2 | 1.9 | 21.2 | 0 |
Peripheral edema | 18.7 | 0 | 22.5 | 1.3 |
Ecchymosis | 18.7 | 0 | 9.3 | 0 |
Dyspnea | 17.4 | 1.3 | 17.2 | 4.0 |
Dizziness | 14.8 | 0.6 | 6.6 | 0 |
Nausea | 14.8 | 0 | 19.2 | 0.7 |
Headache | 14.8 | 0 | 5.3 | 0 |
Constipation | 12.9 | 0 | 11.9 | 0 |
Vomiting | 12.3 | 0.6 | 9.9 | 0.7 |
Pain in extremity | 12.3 | 1.3 | 9.9 | 0 |
Insomnia | 11.6 | 0 | 9.9 | 0 |
Arthralgia | 11.0 | 1.9 | 8.6 | 0.7 |
Pyrexia | 11.0 | 0.6 | 7.3 | 0.7 |
Abdominal pain | 10.3 | 2.6 | 41.1 | 11.3 |
Hematologic (laboratory values)* | ||||
Hemoglobin | 96.1 | 45.2 | 86.8 | 19.2 |
Platelets | 69.7 | 12.9 | 30.5 | 1.3 |
Neutrophils | 18.7 | 7.1 | 4.0 | 2.0 |
Patients are included at their worst grade on study regardless of whether this represents a change from their baseline.