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Table 3 AEs by Maximum Toxicity Grade (ITT population)

From: Phase II study of lapatinib in combination with vinorelbine, as first or second-line therapy in women with HER2 overexpressing metastatic breast cancer

Adverse events

Lapatinib + vinorelbine (N=44)

Number of subjects, n(%)

Total

Grade 1

Grade 2

Grade 3

Grade 4

Common AEs with >15% incidence

     

Diarrhea

36 (82)

22 (50)

9 (20)

5 (11)

0

Neutropenia

29 (66)

1 (2)

6 (14)

7 (16)

15 (34)

Nausea

27 (61)

17 (39)

8 (18)

2 (5)

0

Fatigue

23 (52)

13 (30)

8 (18)

2 (5)

0

Rash

22 (50)

12 (27)

9 (20)

1 (2)

0

Constipation

15 (34)

10 (23)

5 (11)

0

0

Vomiting

14 (32)

8 (18)

5 (11)

1 (2)

0

Hypokalaemia

12 (27)

8 (18)

2 (5)

2 (5)

0

Anaemia

11 (25)

4 (9)

6 (14)

1 (2)

0

Insomnia

11 (25)

7 (16)

4 (9)

0

0

Abdominal pain

10 (23)

4 (9)

4 (9)

2 (5)

0

Decreased appetite

10 (23)

6 (14)

4 (9)

0

0

Dehydration

8 (18)

0

5 (11)

3 (7)

0

Back pain

8 (18)

5 (11)

3 (7)

0

0

Dyspepsia

8 (18)

6 (14)

2 (5)

0

0

Mucosal inflammation

7 (16)

2 (5)

4 (9)

1 (2)

0

Neutrophil count decreased

7 (16)

1 (2)

6 (14)

0

0

Pain in extremity

7 (16)

4 (9)

3 (7)

0

0

Pyrexia

7 (16)

5 (11)

2 (5)

0

0

Cough

7 (16)

6 (14)

1 (2)

0

0

AEs of special interest

     

Hepatobiliary events

5 (11)

3 (7)

1 (2)

1 (2)

0

Febrile neutropenia*

3 (7)

0

0

1 (2)

2 (5)

Interstitial lung disease

0

0

0

0

0

Cardiac events

1 (2)

0

0

1 (2)

0

  1. AE, adverse event; ITT, intent-to-treat.
  2. *2/3 patients reporting febrile neutropenia are also counted among the 29 patients reporting neutropenia.