SAE, n (%) | Overall | Treatment phase | Annual follow-up |
---|---|---|---|
 | (N = 509) | (n = 509) | phase (n = 250) |
Any cardiac event | 25a (4.9) | 22 (4.3) | 4 (1.6) |
Reduced LVEF | 14 (2.8) | 12 (2.4) | 2 (0.8) |
Myocardial infarction | 4 (0.8) | 4 (0.8) | 0 |
Cardiomyopathy | 5 (1.0) | 3 (0.6) | 2 (0.8) |
Congestive heart failure | 2 (0.4) | 2 (0.4) | 0 |
Cardiorespiratory arrest | 1 (0.2) | 1 (0.2) | 0 |
Mitral valve incompetence | 1 (0.2) | 1 (0.2) | 0 |
Tachycardia | 2 (0.4) | 1 (0.2) | 1 (0.4) |
Ventricular hypokinesia | 1 (0.2) | 1 (0.2) | 0 |