Table 3.

Adverse Events and Early Discontinuations

	Neratinib (n=115)		Control (n=78)
Adverse Events	Grade 1–2	Grade 3–4	Grade 1–2	Grade 3–4
Hematologic, n (%)
Febrile neutropenia	0 (0%)	7 (6.1%)	0 (0%)	5 (6.4%)
Neutropenia	16 (15.7%)	18 (13.9%)	8 (10.3%)	9 (11.5%)
Thrombocytopenia	6 (5.2%)	1 (0.9%)	0 (0%)	2 (2.6%)
Anemia	34 (29.6%)	3 (2.6%)	16 (20.5%)	0 (0%)
Gastrointestinal, n (%)
Diarrhea	110 (95.6%)	44 (38.3%)	39 (50%)	3 (3.8%)
Nausea	94 (81.7%)	3 (2.6%)	65 (83.3%)	0 (0%)
Vomiting	46 (40%)	2 (1.7%)	20 (25.6%)	0 (0%)
Stomatitis*	52 (45.2%)	2 (1.7%)	31 (39.7%)	2 (2.6%)
Aspartate aminotransferase increased	30 (26.1%)	5 (4.3%)	5 (6.4%)	1 (1.3%)
Alanine aminotransferase increased	42 (36.5%)	13 (11.3%)	9 (11.5%)	1 (1.3%)
Dose Modifications
Early discontinuation, n (%)**
All	21 (18.3%)		3 (3.8%)
Toxicity	13 (11.3%)		1 (1.3%)
Progression	6 (5.2%)		0 (0%)
Other	2 (1.7%)		2 (2.6%)

^*Stomatitis includes CTCAE terms oral pain, oral hemorrhage, and mucositis oral.

^**Dose modification is for the taxane phase only and includes patients who went to AC early. This does not include patients who discontinued during AC.