Table 3.
Summary of LVEF at protocol specified time points and changes from baseline values
Baseline | 12 weeks | 6 months | 1 year | |||||
---|---|---|---|---|---|---|---|---|
| ||||||||
N=406 | % | N=406 | % | N=406 | % | N=406 | % | |
LVEF reduction from baseline | ||||||||
<10% | . | 343 | 84 | 325 | 80 | 302 | 74 | |
10-15% | . | 29 | 7 | 36 | 9 | 35 | 9 | |
≥16% | . | 2 | < 1 | 5 | 1 | 7 | 2 | |
Required, not evaluated 1 | . | 7 | 1 | 9 | 2 | 22 | 5 | |
Not required2 | . | 25 | 6 | 31 | 8 | 40 | 10 | |
LVEF level (%) | ||||||||
Median(Range) | 65 (50-81) | . | 64 (45-81) | . | 64 (45-83) | . | 64 (41-90) |
For each time point, patients for whom cardiac evaluation was required but reported as not done were counted as “required but not evaluated” at that time point
Cardiac evaluations were not required for patients who went off protocol therapy due to non-cardiac toxicity. For patients who went off treatment before completing 1-year protocol specified therapy due to non-cardiac-toxicity reasons, assessments after the off-treatment visit were counted as “not required”.
LVEF=left ventricular ejection fraction