Interim analysis of safety and efficacy of ruxolitinib in patients with myelofibrosis and low platelet counts

Table 2 Adverse events regardless of causality reported in the safety population (N = 50)

	All Grades, n (%)	Grade 3 or 4, n (%)
Nonhematologic AEs occurring in ≥10% of patients
Diarrhea	14 (28.0)	2 (4.0)
Peripheral edema	13 (26.0)	0
Nausea	12 (24.0)	2 (4.0)
Abdominal pain	12 (24.0)	2 (4.0)
Fatigue	11 (22.0)	2 (4.0)
Upper respiratory tract infection	7 (14.0)	0
Vomiting	7 (14.0)	2 (4.0)
Hyperuricemia	6 (12.0)	2 (4.0)
Muscle spasm	6 (12.0)	0
Pyrexia	6 (12.0)	0
Constipation	5 (10.0)	0
Decreased appetite	5 (10.0)	0
Dizziness	5 (10.0)	0
Pleural effusion	5 (10.0)	0
New-onset hematologic AEs
Hemorrhage	8 (16.0)*	1 (2.0)
Bruising (ecchymosis, contusion)	6 (12.0)	0
Laboratory values
Anemia†	29 (64.4)	19 (42.2)‡
Thrombocytopenia	32 (64.0)	28 (56.0)§

*Grade ≥2 hemorrhage reported in four patients (8.0%).
†Denominator for percent calculation includes patients with grade 0, 1, or 2 anemia at baseline.
‡Grade 3 anemia events only are listed. According to CTCAE v4.03, grade 4 anemia requires a clinical assessment of “life-threatening consequences; urgent intervention indicated” and is not defined by a specific laboratory cutoff. One patient was reported to have experienced grade 4 anemia as an adverse event based on investigator clinical assessment.
§Grade 3 thrombocytopenia = 20 patients (40.0%); grade 4 thrombocytopenia = 8 patients (16.0%).
AE, adverse event; CTCAE, Common Terminology Criteria for Adverse Events.

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