Table 2.
Observed incidence of thrombocytopenia and anemia in clinical trials of ruxolitinib
| Treatment group | Phase I/II trial73 | Phase III COMFORT-I trial75,76 | Phase III COMFORT-II trial74 | ||
|---|---|---|---|---|---|
|
|
|
|
|||
| Ruxolitinib | Ruxolitinib | Placebo | Ruxolitinib | Best available therapy | |
| nn | 82a | 155 | 154 | 146 | 73 |
| Thrombocytopenia grade 3 or 4b | 3%–29% | 12.9% | 1.3% | 8.3% | 7.2% |
| Anemia grade 3 or 4b | 8%–27% | 45.2% | 19.2% | 42.4% | 31.4% |
Notes:
a
Includes only patients on 15 mg/bid and 25 mg/bid regimens;
b
According to Common Terminology Criteria for Adverse Events, version 3.0.
Abbreviation: COMFORT, Controlled Myelofibrosis Study with Oral Janus kinase 1 and 2 Inhibitor Treatment.