Table 3 Treatment-related adverse event occurring during the first cycle according to treatment arm and CTCAE category.

From: Randomized phase-III study of low-dose cytarabine and etoposide + /− all-trans retinoic acid in older unfit patients with NPM1-mutated acute myeloid leukemia

 

Standard-arm (n = 78) < grade 3

 ≥ grade 3

ATRA-Arm (n = 66) < grade 3

 ≥ grade 3

Cardiac Arrhythmia, no

1

0

0

1

Cardiac general, no

1

1

6

1

coagulation, no

1

0

1

0

Constitutional Symptoms, no

28

3

24

2

Dermatology/skin, no

9

0

7

1

Endocrine, no

0

0

1

0

Gastrointestinal, no

48

4

42

6

Hemorrhage/bleeding, no

9

1

10

2

Hepatobiliary/pancreas, no

2

0

0

0

infection, no

15

25

13

27

Lymphatics, no

2

0

6

0

Metabolic/laboratory, No

22

5

26

7

Neurology, no

9

0

5

1

Ocular/visual, no

0

0

2

0

pain, no

11

2

16

2

Pulmonary/upper respiratory, no

0

0

8

5

Renal/genitourinary, no

6

5

6

3

Syndromes, no

1

1

0

0

Vascular, no

1

0

1

1

  1. CTCAE Common terminology criteria for adverse events, ATRA All-trans retinoic acid.