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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.