Table 3.

AEs by Maximum Toxicity Grade (ITT population)

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

AE, adverse event; ITT, intent-to-treat.

*2/3 patients reporting febrile neutropenia are also counted among the 29 patients reporting neutropenia.