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. 2018 Jul 10;2(13):1633–1644. doi: 10.1182/bloodadvances.2017015545

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.