Table 3.
Percentage of patients with adverse drug reactions ‡1% in the COMFORT studies.
| Adverse event | COMFORT-I |
COMFORT-II |
||||||
|---|---|---|---|---|---|---|---|---|
| Ruxolitinib (n = 155) |
Placebo (n = 151) |
Ruxolitinib (n = 146) |
Best available therapy (n = 73) |
|||||
| All grades (%) | ≥grade 3 (%) | All grades (%) | ≥grade 3 (%) | All grades (%) | ≥grade 3 (%) | All grades (%) | ≥grade 3 (%) | |
| Any bleeding | 37 | 5 | 26 | 3 | 27 | 5 | 18 | 3 |
| Bruising | 27 | <1 | 15 | 0 | 15 | 0 | 6 | 0 |
| Other bleeding | 13 | 3 | 9 | <1 | 14 | 2 | 14 | 3 |
| Gastrointestinal bleeding | 4 | 1 | 4 | 2 | 6 | 1 | 1 | 0 |
| Intracranial bleeding | <1 | <1 | 1 | 1 | 1 | 1 | 0 | 0 |
| Flatulence | 5 | 0 | 1 | 0 | 1 | 0 | 0 | 0 |
| Pyrexia | 12 | <1 | 8 | <1 | 15 | 2 | 10 | 0 |
| Urinary tract infections | 10 | 0 | 5 | 1 | 15 | 2 | 7 | 0 |
| Herpes zoster | 2 | 0 | 1 | <1 | 7 | <1 | 0 | 0 |
| Weight gain | 9 | <1 | 1 | <1 | 11 | 2 | 1 | <1 |
| Dizziness | 19 | <1 | 8 | 0 | 10 | 3 | 10 | 3 |
| Headache | 16 | 0 | 6 | 0 | 12 | 1 | 6 | 0 |
| Angina pectoris/unstable angina | 0 | 0 | 0 | 0 | 4 | 0 | 1 | 0 |
| Bradycardia/sinus bradycardia | 3 | 0 | 1 | 0 | 3 | 0 | 0 | 0 |
| Palpitation | 3 | 0 | <1 | 0 | 5 | 0 | 1 | 0 |
Data taken from [17].