Table 2.

Adverse events in a pooled analysis of 882 patients receiving T-DM1

Adverse event, n (%)All gradeGrade 3Grade 4
All grade adverse events, ≥20% incidence in total population
Fatigue400 (45.4)27 (3.1)0
Nausea373 (42.3)9 (1.0)0
Headache253 (28.7)5 (0.6)0
Thrombocytopenia253 (28.7)73 (8.3)17 (1.9)
Constipation225 (25.5)5 (0.6)0
Epistaxis205 (23.2)4 (0.5)0
Increased AST203 (23.0)35 (4.0)1 (0.1)
Pyrexia202 (22.9)2 (0.2)0
Decreased appetite195 (22.1)5 (0.6)0
Vomiting183 (20.7)7 (0.8)0
Diarrhea179 (20.3)8 (0.9)0
Cough172 (19.5)1 (0.1)0
Grade 3–4 adverse events, ≥2% incidence in total population
Thrombocytopenia253 (28.7)73 (8.3)17 (1.9)
Increased AST203 (23.0)35 (4.0)1 (0.1)
Fatigue400 (45.4)27 (3.1)0
Hypokalemia127 (14.4)26 (2.9)0
Increased ALT134 (15.2)25 (2.8)0
Anemia121 (13.7)22 (2.5)0

NOTE: Adapted from Diéras et al. (16).

Abbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase.