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Table 2 Most common (≥ 20%) adverse events (all grades and grade 3–4) in patients treated with oral azacitidine in QUAZAR AML-001 [22]

From: Management of adverse events in patients with acute myeloid leukemia in remission receiving oral azacitidine: experience from the phase 3 randomized QUAZAR AML-001 trial

 

Oral azacitidine (N = 236)

Placebo (N = 233)

All grades

Grade 3–4

All grades

Grade 3–4

n (%)

Patients with ≥ 1 AE

231 (98)

169 (72)

225 (97)

147 (63)

Nausea

153 (65)

6 (3)

55 (24)

1 (< 1)

Vomiting

141 (60)

7 (3)

23 (10)

0

Diarrhea

119 (50)

12 (5)

50 (21)

3 (1)

Neutropenia

105 (44)

97 (41)

61 (26)

55 (24)

Constipation

91 (39)

3 (1)

56 (24)

0

Thrombocytopenia

79 (33)

53 (22)

63 (27)

50 (21)

Fatigue

70 (30)

7 (3)

45 (19)

2 (1)

Anemia

48 (20)

33 (14)

42 (18)

30 (13)

  1. Adverse events were evaluated from the date of the first dose of oral azacitidine or placebo through 28 days after the last dose. Preferred terms were defined using the Medical Dictionary of Regulatory Activities, version 22.0, and events were graded using the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0. Patients are counted only once for multiple events within each preferred term
  2. AE adverse event
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Journal of Hematology & Oncology

ISSN: 1756-8722

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