Table 3 Incidence of non-hematological toxicities grade 3 and 4 by randomization

From: Sequential high-dose cytarabine and mitoxantrone (S-HAM) versus standard double induction in acute myeloid leukemia—a phase 3 study

Treatment arm

All randomized and evaluable patients in the study

Total patients

Standard

S-HAM

n/N (%)

n/N (%)

n/N (%)

Alopecia

141/259

(54.4)

70/132

(53.0)

71/127

(56.0)

Infection

166/349

(47.6)

80/181

(44.2)

86/168

(51.2)

Pulmonary toxicity

66/352

(18.8)

28/181

(15.5)

38/171

(22.2)

Prothrombin

17/281

(6.0)

6/149

(4.0)

11/132

(8.3)

Fever

45/353

(12.7)

26/183

(14.2)

19/170

(11.2)

Diarrhea

39/352

(11.1)

17/181

(9.4)

22/171

(12.9)

Pain

55/351

(15.7)

22/180

(12.2)

33/171

(19.3)

Nausea/vomiting

31/351

(8.8)

16/180

(8.9)

15/171

(8.8)

PCHE

3/209

(1.4)

1/110

(0.9)

2/99

(2.0)

Hypoproteinemia

30/296

(10.1)

15/151

(9.9)

15/145

(10.3)

Mucositis

22/344

(6.4)

5/177

(2.8)

17/167

(10.2)

Weight gain

43/352

(12.2)

22/183

(12.0)

21/169

(12.4)

Cardiac function

12/346

(3.5)

8/179

(4.5)

4/167

(2.4)

Bleeding

25/350

(7.1)

8/183

(4.4)

17/167

(10.2)

SGOT/SGPT

37/351

(10.5)

18/180

(10.0)

19/171

(11.1)

Central nervous system

18/349

(5.2)

5/179

(2.8)

13/170

(7.7)

Bilirubin

16/352

(4.5)

6/181

(3.3)

10/171

(5.9)

Effusion

17/350

(4.9)

8/180

(4.4)

9/170

(5.3)

Edema

21/350

(6.0)

8/179

(4.5)

13/171

(7.6)

Cutaneous toxicity

8/348

(2.3)

2/181

(1.1)

6/167

(3.6)

Alkaline phosphatase

4/306

(1.3)

2/156

(1.3)

2/150

(1.3)

Cardiac rhythm

7/344

(2.0)

3/180

(1.7)

4/164

(2.4)

Creatinine/renal toxicity

3/352

(0.9)

3/181

(1.7)

0/171

(0.0)

Obstipation

5/351

(1.4)

2/181

(1.1)

3/170

(1.8)

Hematuria

1/347

(0.3)

1/179

(0.6)

0/168

(0.0)

Extrapyramidal symptoms

4/350

(1.1)

2/180

(1.1)

2/170

(1.2)

Allergic reaction

2/346

(0.6)

1/181

(0.6)

1/165

(0.6)

Peripheral nervous system

3/351

(0.9)

2/181

(1.1)

1/170

(0.6)

Pericarditis

0/346

(0.0)

0/178

(0.0)

0/168

(0.0)

  1. PCHE pseudocholinesterase, SGOT/SGPT serum-glutamat-oxalacetat-transaminase/serum-glutamat-pyruvat-transferase