Table 4.
Treatment-emergent CV AEs, treatment reduction, discontinuation, and deaths in the ASPIRE, ENDEAVOR, and FOCUS phase 3 trials
| ASPIRE | ENDEAVOR | FOCUS | ||||
|---|---|---|---|---|---|---|
| Carfilzomib (Krd) (n = 392) | Control (Rd) (n = 389) | Carfilzomib (Kd) (n = 463) | Control (Vd) (n = 456) | Carfilzomib (carfilzomib) (n = 157) | Control (BSC) (n = 153) | |
| Carfilzomib dose, mg/m2 | 20/27 | 20/56 | 20/27 | |||
| Treatment-emergent cardiac AEs of interest, any-grade | ||||||
| Cardiac failure | 25 (6.4) | 16 (4.1) | 38 (8.2) | 13 (2.9) | 12 (7.6) | 7 (4.6) |
| Hypertension | 62 (15.8) | 32 (8.2) | 120 (25.9) | 44 (9.6) | 25 (15.9) | 9 (5.9) |
| Dyspnea | 89 (22.7) | 70 (18.0) | 143 (30.9) | 78 (17.1) | 25 (15.9) | 19 (12.4) |
| Ischemic heart disease | 23 (5.9) | 18 (4.6) | 13 (2.8) | 9 (2.0) | 3 (1.9) | 0 |
| Treatment-emergent cardiac AEs of interest, grade ≥3 | ||||||
| Cardiac failure | 15 (3.8) | 7 (1.8) | 22 (4.8) | 8 (1.8) | 9 (5.7) | 5 (3.3) |
| Hypertension | 22 (5.6) | 8 (2.1) | 44 (9.5) | 12 (2.6) | 6 (3.8) | 0 |
| Dyspnea | 12 (3.1) | 8 (2.1) | 26 (5.6) | 10 (2.2) | 3 (1.9) | 0 |
| Ischemic heart disease | 13 (3.3) | 8 (2.1) | 8 (1.7) | 7 (1.5) | 1 (0.6) | 0 |
| Reason for treatment reduction | ||||||
| Cardiac failure | 4 (1.0) | 3 (0.8) | 7 (1.5) | 0 | 0 | 0 |
| Hypertension | 3 (0.8) | 3 (0.8) | 15 (3.2) | 3 (0.7) | 0 | 0 |
| Dyspnea | 5 (1.3) | 1 (0.3) | 13 (2.8) | 5 (1.1) | 0 | 0 |
| Ischemic heart disease | 1 (0.3) | 2 (0.5) | 3 (0.6) | 0 | 0 | 0 |
| Reason for treatment discontinuation | ||||||
| Cardiac failure | 2 (0.5) | 3 (0.8) | 13 (2.8) | 4 (0.9) | 4 (2.5) | 2 (1.3) |
| Hypertension | 1 (0.3) | 1 (0.3) | 2 (0.4) | 0 | 0 | 1 (0.7) |
| Dyspnea | 0 | 1 (0.3) | 5 (1.1) | 6 (1.3) | 0 | 2 (1.3) |
| Ischemic heart disease | 5 (1.3) | 2 (0.5) | 5 (1.1) | 3 (0.7) | 0 | 0 |
| Cause of death | ||||||
| Cardiac failure | 3 (0.8) | 4 (1.0) | 2 (0.4) | 2 (0.4) | 2 (1.3) | 2 (1.3) |
| Hypertension | 0 | 0 | 0 | 0 | 0 | 0 |
| Dyspnea | 0 | 0 | 0 | 0 | 0 | 0 |
| Ischemic heart disease | 3 (0.8) | 2 (0.5) | 0 | 3 (0.7) | 0 | 0 |
Cardiac failure and hypertension events are listed as standardized MedDRA query, narrow scope, and ischemic heart disease is listed as standardized MedDRA query, broad scope. All data are n (%), unless indicated otherwise.