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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.