Table 1.
Any-grade AEs | Grade ≥3 AEs | Serious-grade AEs | |
---|---|---|---|
Cardiac failure | 137 (6.7) | 90 (4.4) | 79 (3.9) |
Cardiac failure congestive | 51 (2.5) | 36 (1.8) | 34 (1.7) |
Cardiac failure | 38 (1.9) | 20 (1.0) | 19 (0.9) |
Pulmonary edema | 31 (1.5) | 19 (0.9) | 17 (0.8) |
Ejection fraction decreased | 16 (0.8) | 6 (0.3) | 0 |
Cardiac failure acute | 7 (0.3) | 5 (0.2) | 4 (0.2) |
Acute pulmonary edema | 6 (0.3) | 6 (0.3) | 5 (0.2) |
RV failure | 3 (0.1) | 3 (0.1) | 2 (<0.1) |
Acute left ventricular failure | 2 (<0.1) | 1 (<0.1) | 2 (<0.1) |
Cardiopulmonary failure | 2 (<0.1) | 1 (<0.1) | 1 (<0.1) |
Hepatic congestion | 2 (<0.1) | 2 (<0.1) | 0 |
Cardiac failure chronic | 1 (<0.1) | 1 (<0.1) | 0 |
Cardiogenic shock | 1 (<0.1) | 1 (<0.1) | 0 |
Hepatojugular reflux | 1 (<0.1) | 0 | 0 |
Hypertension | 378 (18.5) | 120 (5.9) | 13 (0.6) |
Dyspnea | 653 (31.9) | 92 (4.5) | 48 (2.3) |
Ischemic heart disease | 75 (3.7) | 40 (2.0) | 36 (1.8) |
Pooled analysis is from the phase 1 trials (PX-171-001, PX-171-002, PX-171-006, PX-171-008), the phase 2 trials (PX-171-003-A0, PX-171-003-A1, PX-171-004, PX-171-005, and 2011-002), and the phase 3 ASPIRE (PX-171-009), ENDEAVOR (2011-003), and FOCUS trials (PX-171-011). All data are n (%). Cardiac failure and hypertension events are listed as standardized MedDRA query, narrow scope, and ischemic heart disease event is listed as standardized MedDRA query, broad scope.