Table 5. Left ventricular ejection fraction (LVEF) in the mITT population.
Arm A | Arm B | ||
---|---|---|---|
At baseline | N = 38 | N = 41 | |
Median (IQR) | 65.0% (58.0 to 69.3) | 64.0% (61.0 to 68.5) | |
Week 12 | N = 34 | N = 40 | |
Median change from baseline (IQR) | –1.5% (–6.6 to 1.2) | –1.0% (–6.8 to 4.0) | |
LVEF measurement (N, %) | P = 0.032 | ||
No decrease or decrease <10%, still above LLN | 32 (94.1%) | 33 (82.5%) | |
Decrease <10%, below LLN | 1 (2.9%) | 1 (2.5%) | |
Decrease 10–15%, still above LLN | 0 (0.0%) | 6 (15.0%) | |
Decrease 10–15%, below LLN | 0 (0.0%) | 0 (0.0%) | |
Decrease >15%, still above LLN | 1 (2.9%) | 0 (0.0%) | |
Decrease >15%, below LLN | 0 (0.0%) | 0 (0.0%) | |
End of treatment | N = 32 | N = 37 | |
Median change from baseline (IQR) | –4.0% (–6.0 to –1.8) | –5.0% (–7.5 to –1.0) | |
LVEF measurement (N, %) | |||
No decrease or decrease <10%, still above LLN | 27 (84.4%) | 30 (81.1%) | P = 0.409 |
Decrease <10%, below LLN | 1 (3.1%) | 0 (0.0%) | |
Decrease 10–15%, still above LLN | 2 (6.3%) | 3 (8.1%) | |
Decrease 10–15%, below LLN | 0 (0.0%) | 3 (8.1%) | |
Decrease >15%, still above LLN | 2 (6.3%) | 1 (2.7%) | |
Decrease >15%, below LLN | 0 (0.0%) | 0 (0.0%) |
Data are median (IQR) or N (%) unless stated otherwise.
LLN, lower limit of institutional normal; LVEF, left ventricular ejection fraction.