Skip to main content

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