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Table 4 Adverse events grade 3/4 with dosage correlation

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)
  Grade 3/4   Grade 3/4   Grade 3/4  
  n (%) n (%) n (%)
Diarrhea 2 33 0 0 2 8
Mucositis oral 1 17 0 0 1 4
Neutropenia (Neutrophil count decreased and/or WBC decreased) 1 17 1 6 2 8
Liver function test: values increased 1 17 1 6 2 8
Gastroenteritis 0 0 1 6 1 4
Esophagitis 0 0 1 6 1 4
Serum amylase increased 0 0 1 6 1 4
Lipase increased 0 0 1 6 1 4
Anemia 0 0 2 11 2 8
Platelet count decreased 0 0 4 22 4 17
  1. Grade 3/4 AEs showed no clear dose correlation but predominance of gastrointestinal AEs in the 400 mg BIS cohort and a higher heamatotoxicity rate in the 300 mg BID cohort