Table 2 Incidence of common adverse events reported in 20% of patients by maximum NCI CTCAE toxicity grade

From: Lapatinib monotherapy in patients with relapsed, advanced, or metastatic breast cancer: efficacy, safety, and biomarker results from Japanese patients phase II studies

 

All grades

Grades 3/4

MedDRA preferred term

No patients

%

Number of patients

%

Any event

120

98.4

41

33.6

Diarrhoea

86

70.5

7

5.7

Rash

59

48.4

1

0.8

Stomatitis

54

44.3

0

0

Nausea

48

39.3

1

0.8

Anorexia

48

39.3

10

8.2

Fatigue

47

38.5

4

3.3

Pruritus

36

29.5

0

0

Nasopharyngitis

33

27.0

0

0

Aspartate aminotransferase increased

28

23.0

5

4.1

Dry skin

27

22.1

0

0

Vomiting

27

22.1

2

1.6

Pyrexia

24

19.7

1

0.8

Weight decreased

22

18.0

0

0

Alanine aminotransferase increased

21

17.2

3

2.5

Blood alkaline phosphatase increased

20

16.4

4

3.3

Dyspnoea

20

16.4

2

1.6

  1. Abbreviations: MedDRA=Medical Dictionary for Regulatory Activities; NCI CTCAE=National Cancer Institute Common Terminology for Adverse Events.