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Table 3 Treatment emergent adverse events

From: A phase I study of a dual PI3-kinase/mTOR inhibitor BEZ235 in adult patients with relapsed or refractory acute leukemia

  400 mg (n = 6) 300 mg (n = 18) All patients (N = 24)
  All grades G 3/4 All grades G 3/4 All grades G 3/4
  n (%) n (%) n (%) n (%) n (%) n (%)
Nausea,Vomiting 6 100 0 0 11 61 0 0 19 79 0 0
Diarrhea 6 100 2 33 11 61 0 0 17 71 2 8
Mucositis oral 6 100 1 17 11 61 0 0 17 71 1 4
Liver function tests increased 1 0 1 0 10 56 1 6 11 46 2 8
Anorexia 5 83 0 0 3 17 0 0 8 33 0 0
Hyperglycemia 1 17 1 17 7 39 1 6 8 33 2 8
Dyspepsia 2 33 0 0 3 17 0 0 5 21 0 0
Stomach or abdominal pain 2 33 0 0 3 17 0 0 5 21 0 0
Neutropenia 1 17 1 17 4 22 1 6 5 21 2 8
Anemia 1 17 0 0 3 17 2 11 4 17 2 8
Fatigue 2 33 0 0 2 11 0 0 4 17 0 0
Platelet count decreased 0 0 0 0 4 22 4 22 4 17 4 17
Bloating, Flatulence 2 33 0 0 2 11 0 0 4 17 0 0
Anal pain 3 50 0 0 0 0 0 0 3 13 0 0
C-peptide increase 0 0 0 0 3 17 0 0 3 13 0 0
Constipation 2 33 0 0 0 0 0 0 2 8 0 0
Alkaline phosphatase increased 0 0 0 0 2 11 0 0 2 8 0 0
Lipase increased 0 0 0 0 2 11 1 6 2 8 1 4
Weight loss 2 33 0 0 0 0 0 0 2 8 0 0
Hypertriglyceridemia 2 33 0 0 0 0 0 0 2 8 0 0
Hoarseness 2 33 0 0 0 0 0 0 2 8 0 0
Colitis 0 0 0 0 1 6 0 0 1 4 0 0
Gastroenteritis 0 0 0 0 1 6 1 6 1 4 1 4
Esophagitis 0 0 0 0 1 6 1 6 1 4 1 4
Erythema multiforme 1 17 0 0 0 0 0 0 1 4 0 0
Skin infection 1 17 0 0 0 0 0 0 1 4 0 0
Nail ridging 0 0 0 0 1 6 0 0 1 4 0 0
Urea increased 0 0 0 0 1 6 0 0 1 4 0 0
Serum amylase increased 0 0 0 0 1 6 1 6 1 4 1 4
Dry skin 0 0 0 0 1 6 0 0 1 4 0 0
Insomnia 0 0 0 0 1 6 0 0 1 4 0 0
Muscle cramps 1 17 0 0 0 0 0 0 1 4 0 0
Dizziness 1 17 0 0 0 0 0 0 1 4 0 0
Dysgeusia 1 17 0 0 0 0 0 0 1 4 0 0
Alopecia 1 17 0 0 0 0 0 0 1 4 0 0
  1. Treatment associated adverse events are listed according to frequency. Gastrointestinal AEs like vomiting, diarrhea and oral mucositis were most frequent but only in rare cases with higher grades (3/4). The most frequent AE with higher grade was lowering of thrombocyte count