Table 4.

Serious adverse events (SAEs)

	Lapatinib + vinorelbine ( N =44)
Subjects with any SAE, n (%)	22 (50)
With ≥2 (5%) patients, n (%)
Neutropenia	15 (34)*
Diarrhea	3 (7)
Febrile neutropenia	3 (7)
Abdominal pain	2 (5)
Dehydration	2 (5)
Drug-related fatal SAEs, n (%)	0 (0)

*Grade 4 laboratory abnormalities were protocol defined as SAEs.