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Table 3 Specific adverse events*,

From: Azacitidine in patients with WHO-defined AML – Results of 155 patients from the Austrian Azacitidine Registry of the AGMT-Study Group

Variable

Grade

n pts., (%)

n total events

Hematologic toxicity #

G3–4

69 (44.5)

148

Thrombopenia

G3–4

38 (24.5)

87

Neutropenia

G3–4

49 (31.6)

99

Anemia

G3–4

33 (21.3)

80

Bleeding events

14 (9.0)

31

Febrile neutropenia

28 (18.1)

46

Infectious complications

Total

98 (63.2)

256

 

G1

14 (9.0)

85

 

G2

39 (25.2)

107

 

G3

16 (10.3)

26

 

G4

29 (18.7)

38

Non-hematologic toxicity

   

Liver

G1-2

1 (0.6)

1

 

G3-4

0 (0.0)

0

Kidney

G1-2

5 (3.2)

5

 

G3-4

0 (0.0)

0

Heart

G1-2

3 (1.9)

5

 

G3-4

13 (8.4)

15

Blood pressure

G1-2

2 (1.3)

2

 

G3-4

1 (0.6)

1

Metabolic

G1-2

1 (0.6)

1

 

G3-4

0(0.0)

0

Thromboembolic

G1-2

9 (5.8)

10

 

G3-4

1 (0.6)

1

Neurologic

G1-2

11 (7.1)

18

 

G3-4

1 (0.6)

1

Nausea

G1-2

16 (10.3)

24

 

G3-4

0 (0.0)

0

Vomiting

G1-2

4 (2.6)

5

 

G3-4

0 (0.0)

0

Constipation

G1-2

3 (1.9)

5

 

G3-4

0 (0.0)

0

Diarrhea

G1-2

17 (11.0)

25

 

G3-4

0 (0.0)

0

GIT-others

G1-2

11 (7.1)

11

 

G3-4

0 (0.0)

0

Injection site reaction

G1-2

32 (20.6)

48

 

G3-4

0 (0.0)

0

Fatigue

Total

65 (41.9)

99

 

Relieved by rest

24 (15.5)

50

 

Not relieved by rest

25 (16.1)

32

 

Limiting self care

16 (10.3)

17

Pain

Total

46 (29.7)

78

 

Mild

25 (16.1)

52

 

Moderate

18 (11.6)

23

 

Severe

3 (1.9)

3

Surgery

Total

20 (12.9)

24

 

Elective

13 (8.4)

16

 

Emergency

7 (4.5)

8

Fall

Total

14 (9.0)

16

 

With fracture

8 (5.2)

9

 

With hemorrhage

5 (3.2)

8

Novel solid tumor

Yes

3 (1.9)

3

  1. *http://evs.nci.nih.gov/ftp1/CTCAE/About.html.
  2. †National Cancer Institution Toxicity Criteria (http://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm).
  3. #Grade 3–4 cytopenias reported, are those that were documented as adverse events, and thus felt to be a worsening of pre-existing cytopenia by the respective treating physicians.