Table 4:
Adverse events
| Cumulative doxorubicin dose |
||||||
|---|---|---|---|---|---|---|
| <450 mg/m2 (n=251) |
450 – <600 mg/m2 (n=165) |
≥600 mg/m2 (n=90) |
||||
| Any grade | ≥Grade 3 | Any grade | ≥Grade 3 | Any grade | ≥Grade 3 | |
| Cardiac dysfunctiona | 10 (4.0) | 5 (2.0) | 13 (7.9) | 5 (3.0) | 3 (3.3) | 1 (1.1) |
| LVEF decrease/ LV dysfunction | 9 (3.6) | 4 (1.6) | 11 (6.7) | 4 (2.4) | 2 (2.2) | 1 (1.1) |
| Cardiac failure | 1 (0.4) | 1 (0.4) | 1 (0.6) | 1b (0.6) | 0 | 0 |
| Diastolic dysfunction | 0 | 0 | 1 (0.6) | 0 | 1 (1.1) | 0 |
Data are presented as n (%). Abbreviations: LV, left ventricle; LVEF, left ventricular ejection fraction.
a
Cardiac dysfunction was defined by pre-selected terms from Standardized Medical Dictionary for Regulatory Activities (MedDRA) Query “cardiac failure,” omitting non-specific terms “edema” and “peripheral edema”, and was graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
b
Grade 5 event (resulting in death)