Table 3.
RESPONSE: Treatment Emergent Adverse Events in ≥6% of Patients Receiving Ruxolitinib Up to Week 32
| Adverse events | Patients receiving ruxolitinib (N = 110) |
Patients receiving best available therapy (N = 111) |
||
|---|---|---|---|---|
| All grades,a % | Grade 3–4,a % | All grades,a % | Grade 3–4,a % | |
| Headache | 16 | <1 | 19 | <1 |
| Abdominal painb | 15 | <1 | 15 | <1 |
| Diarrhea | 15 | 0 | 7 | <1 |
| Dizziness + vertigo | 15 | 0 | 13 | 0 |
| Fatigue | 15 | 0 | 15 | 3 |
| Pruritus | 14 | <1 | 23 | 4 |
| Dyspneac | 13 | 3 | 4 | 0 |
| Muscle spasms | 12 | <1 | 5 | 0 |
| Nasopharyngitis | 9 | 0 | 8 | 0 |
| Constipation | 8 | 0 | 3 | 0 |
| Cough | 8 | 0 | 5 | 0 |
| Edema + peripheral edema | 8 | 0 | 7 | 0 |
| Arthralgia | 7 | 0 | 6 | <1 |
| Asthenia | 7 | 0 | 11 | 2 |
| Epistaxis | 6 | 0 | 3 | 0 |
| Herpes zoster + postherpetic neuralgia | 6 | <1 | 0 | 0 |
| Nausea | 6 | 0 | 4 | 0 |
a
National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.0.
b
Including lower and upper abdominal pain.
c
Including dyspnea exertional.
Source: Jakafi (ruxolitinib) tablets prescribing information; December 2014.