Table 5.

Serious adverse events (SAEs)

	Lapatinib + nab-paclitaxel (n = 60)
Any SAE, n (%)	18 (30)
With ≥2 (3 %) patients, n (%)
Dehydration	3 (5)
Diarrhea	3 (5)
Anemia	2 (3)
Cellulitis	2 (3)
Febrile neutropenia	2 (3)
Hypokalemia	2 (3)
Renal failure acute	2 (3)
Drug-related fatal SAEs, n (%)	2 (3)a

Irrespective of relationship to study treatment

^aOne patient (lapatinib 750 mg/day, nab-paclitaxel 100 mg/m² weekly) with a history of arrhythmia experienced a sudden death of presumed cardiac origin. One patient (lapatinib 1,000 mg/day, nab-paclitaxel 100 mg/m² weekly) with uncontrolled diabetes developed acute renal failure and dehydration