Table 3. Safety by Treatment Group and Severe Heart Failure Classification.
| Event | No. (%) | RR (95% CI) | P value | |
|---|---|---|---|---|
| Omecamtiv mecarbil | Placebo | |||
| Severe heart failure | ||||
| Total patients, No. | 1103 | 1148 | NA | NA |
| Any treatment-emergent SAE | 742 (67.3) | 790 (68.8) | 0.98 (0.92-1.03) | .43 |
| AE associated with ventricular tachyarrhythmia | 80 (7.3) | 86 (7.5) | 0.98 (0.73-1.31) | .89 |
| Positively adjudicated MI | 42 (3.8) | 29 (2.5) | 1.51 (0.95-2.40) | .08 |
| First stroke | 18 (1.6) | 31 (2.7) | 0.60 (0.34-1.07) | .08 |
| No severe heart failure | ||||
| Total patients, No. | 3007 | 2953 | NA | NA |
| Any treatment-emergent SAE | 1631 (54.2) | 1645 (55.7) | 0.97 (0.93-1.02) | .26 |
| AE associated with ventricular tachyarrhythmia | 210 (7.0) | 218 (7.4) | 0.95 (0.79-1.14) | .58 |
| Positively adjudicated MI | 80 (2.7) | 89 (3.0) | 0.88 (0.66-1.19) | .41 |
| First stroke | 58 (1.9) | 81 (2.7) | 0.70 (0.50-0.98) | .04 |
Abbreviations: AE, adverse event; MI, myocardial infarction; NA, not applicable; RR, relative risk; SAE, serious adverse event.