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Table 3 Maximum severity of gastrointestinal adverse events reported in > 5% of patients receiving oral azacitidine

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

Preferred term

Total

Oral azacitidine (N = 236)

Maximum CTCAE grade

1

2

3

4

5

n (%)

Any GI adverse event

215 (91)

63 (27)

118 (50)

30 (13)

4 (2)

0

Nausea

153 (65)

81 (34)

66 (28)

6 (3)

0

0

Vomiting

141 (60)

81 (34)

53 (22)

7 (3)

0

0

Diarrhea

119 (50)

62 (26)

45 (19)

11 (5)

1 (< 1)

0

Constipation

91 (39)

52 (22)

36 (15)

3 (1)

0

0

Abdominal pain

31 (13)

19 (8)

10 (4)

2 (1)

0

0

Upper abdominal pain

21 (9)

14 (6)

5 (2)

2 (1)

0

0

Flatulence

13 (6)

9 (4)

4 (2)

0

0

0

  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. CTCAE Common Terminology Criteria for Adverse Events, GI gastrointestinal