AEs and treatment exposure in frail and fit subgroups in ENDEAVOR
| . | Frail . | Fit . | ||
|---|---|---|---|---|
| . | Kd56 mg/m2, n = 168 . | Vd, n = 159 . | Kd56 mg/m2, n = 110 . | Vd, n = 119 . |
| Any-grade TEAE, n (%) | 168 (100) | 157 (99) | 110 (100) | 118 (99) |
| Grade ≥3 TEAE, n (%) | 142 (85) | 125 (79) | 91 (83) | 76 (64) |
| Grade ≥3 TEAEs of interest, n (%)* | ||||
| Peripheral neuropathy | 4 (2) | 15 (9) | 3 (3) | 12 (10) |
| Acute renal failure | 15 (9) | 7 (4) | 4 (4) | 2 (2) |
| Cardiac failure | 15 (9) | 7 (4) | 4 (4) | 2 (2) |
| Ischemic heart disease | 8 (5) | 6 (4) | 2 (2) | 1 (<1) |
| Pulmonary hypertension | 0 | 1 (<1) | 3 (3) | 0 |
| Hypertension | 27 (16) | 8 (5) | 19 (17) | 2 (2) |
| TEAEs leading to study treatment discontinuation, n (%) | 55 (33) | 48 (30) | 29 (26) | 34 (29) |
| TEAEs of interest leading to carfilzomib/bortezomib discontinuation, n (%)* | ||||
| Peripheral neuropathy | 0 | 15 (9) | 1 (<1) | 12 (10) |
| Acute renal failure | 1 (<1) | 0 | 2 (2) | 1 (<1) |
| Cardiac failure | 7 (4) | 2 (1) | 2 (2) | 1 (<1) |
| Ischemic heart disease | 3 (2) | 3 (2) | 0 | 0 |
| Pulmonary hypertension | 1 (<1) | 1 (<1) | 1 (<1) | 0 |
| TRAEs leading to study treatment discontinuation, n (%) | 35 (21) | 34 (21) | 23 (21) | 32 (27) |
| Median duration of study treatment, wk | 36.0 | 22.0 | 63.4 | 32.9 |
| Median carfilzomib/bortezomib relative dose intensity, % | 89.9 | 84.7 | 88.8 | 81.7 |
| . | Frail . | Fit . | ||
|---|---|---|---|---|
| . | Kd56 mg/m2, n = 168 . | Vd, n = 159 . | Kd56 mg/m2, n = 110 . | Vd, n = 119 . |
| Any-grade TEAE, n (%) | 168 (100) | 157 (99) | 110 (100) | 118 (99) |
| Grade ≥3 TEAE, n (%) | 142 (85) | 125 (79) | 91 (83) | 76 (64) |
| Grade ≥3 TEAEs of interest, n (%)* | ||||
| Peripheral neuropathy | 4 (2) | 15 (9) | 3 (3) | 12 (10) |
| Acute renal failure | 15 (9) | 7 (4) | 4 (4) | 2 (2) |
| Cardiac failure | 15 (9) | 7 (4) | 4 (4) | 2 (2) |
| Ischemic heart disease | 8 (5) | 6 (4) | 2 (2) | 1 (<1) |
| Pulmonary hypertension | 0 | 1 (<1) | 3 (3) | 0 |
| Hypertension | 27 (16) | 8 (5) | 19 (17) | 2 (2) |
| TEAEs leading to study treatment discontinuation, n (%) | 55 (33) | 48 (30) | 29 (26) | 34 (29) |
| TEAEs of interest leading to carfilzomib/bortezomib discontinuation, n (%)* | ||||
| Peripheral neuropathy | 0 | 15 (9) | 1 (<1) | 12 (10) |
| Acute renal failure | 1 (<1) | 0 | 2 (2) | 1 (<1) |
| Cardiac failure | 7 (4) | 2 (1) | 2 (2) | 1 (<1) |
| Ischemic heart disease | 3 (2) | 3 (2) | 0 | 0 |
| Pulmonary hypertension | 1 (<1) | 1 (<1) | 1 (<1) | 0 |
| TRAEs leading to study treatment discontinuation, n (%) | 35 (21) | 34 (21) | 23 (21) | 32 (27) |
| Median duration of study treatment, wk | 36.0 | 22.0 | 63.4 | 32.9 |
| Median carfilzomib/bortezomib relative dose intensity, % | 89.9 | 84.7 | 88.8 | 81.7 |
AEs were assessed in patients who received ≥1 dose of study drug (safety population).
Standardized MedDRA Query, narrow scope.