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Table 2 Grade 3 and grade 4 treatment-emergent adverse events (TEAEs) reported in treated patients fully assessable for all study endpoints, as assessed by the Common Terminology Criteria for Adverse Events, version 4.0

From: A multicenter, randomized study of decitabine as epigenetic priming with induction chemotherapy in children with AML

  Decitabine+ Chemotherapy Chemotherapy only
Adverse event Grade 3 n (%) Grade 4 n (%) Grade 3 n (%) Grade 4 n (%)
Any Grade 3 or Grade 4 TEAEs 7 (87.5) 7 (87.5) 7 (77.8) 7 (77.8)
Blood and lymphatic system disorders
 Anemia 6 (75.0) 2 (25.0) 4 (44.4) 1 (11.1)
 Febrile neutropenia 1 (12.5) 0 4 (44.4) 0
 Other: Neutropenia 1 (12.3) 3 (37.5) 1 (11.1) 1 (11.1)
 Other: Thrombocytopenia 4 (50.0) 4 (50.0) 0 2 (22.2)
Gastrointestinal disorders
 Colitis 2 (25.0) 0 2 (25.0) 0
Investigations
 Neutrophil count decreased 0 0 1 (11.1) 3 (33.3)
 Platelet count decreased 0 1 (12.5) 2 (22.2) 3 (33.3)
 White blood cell count decreased 6 (75.0) 6 (75.0) 3 (33.3) 5 (55.6)
Metabolism and nutrition disorders
 Decreased appetite 3 (37.5) 0 0 0
 Hypokalemia 3 (37.5) 0 1 (11.1) 0
 Hypophosphatemia 2 (25.0) 0 0 0