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

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

  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)§
  1. *Grade ≥2 hemorrhage reported in four patients (8.0%).
  2. †Denominator for percent calculation includes patients with grade 0, 1, or 2 anemia at baseline.
  3. ‡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.
  4. §Grade 3 thrombocytopenia = 20 patients (40.0%); grade 4 thrombocytopenia = 8 patients (16.0%).
  5. AE, adverse event; CTCAE, Common Terminology Criteria for Adverse Events.