AEs and treatment exposure in frail and fit subgroups in ARROW
| . | Frail . | Fit . | ||
|---|---|---|---|---|
| . | Once-weekly Kd70 mg/m2, n = 79 . | Twice-weekly Kd27 mg/m2, n = 60 . | Once-weekly Kd70 mg/m2, n = 60 . | Twice-weekly Kd27 mg/m2, n = 66 . |
| Any-grade TEAE, n (%) | 78 (99) | 60 (100) | 57 (95) | 66 (100) |
| Grade ≥3 TEAEs, n (%) | 64 (81) | 42 (70) | 33 (55) | 41 (62) |
| Grade ≥3 TEAEs of interest, n (%)* | ||||
| Peripheral neuropathy | 0 | 0 | 0 | 1 (2) |
| Acute renal failure | 3 (4) | 4 (7) | 0 | 3 (5) |
| Cardiac failure | 3 (4) | 5 (8) | 1 (2) | 1 (2) |
| Ischemic heart disease | 0 | 1 (2) | 1 (2) | 0 |
| Pulmonary hypertension | 0 | 1 (2) | 0 | 0 |
| Hypertension | 8 (10) | 4 (7) | 1 (2) | 5 (8) |
| TEAEs leading to carfilzomib discontinuation, % | 16 (20) | 11 (18) | 2 (3) | 5 (8) |
| TEAEs of interest leading to carfilzomib discontinuation, n (%)* | ||||
| Peripheral neuropathy | 0 | 0 | 0 | 0 |
| Acute renal failure | 3 (4) | 1 (2) | 0 | 1 (2) |
| Cardiac failure | 3 (4) | 3 (5) | 1 (2) | 0 |
| Ischemic heart disease | 0 | 0 | 0 | 0 |
| Pulmonary hypertension | 0 | 0 | 0 | 0 |
| TRAEs leading to carfilzomib discontinuation, n (%) | 7 (9) | 6 (10) | 2 (3.3) | 0 |
| Median duration of carfilzomib treatment, wk | 36.1 | 29.1 | 45.4 | 24.4 |
| Median carfilzomib relative dose intensity, % | 94.7 | 96.3 | 96.5 | 96.0 |
| . | Frail . | Fit . | ||
|---|---|---|---|---|
| . | Once-weekly Kd70 mg/m2, n = 79 . | Twice-weekly Kd27 mg/m2, n = 60 . | Once-weekly Kd70 mg/m2, n = 60 . | Twice-weekly Kd27 mg/m2, n = 66 . |
| Any-grade TEAE, n (%) | 78 (99) | 60 (100) | 57 (95) | 66 (100) |
| Grade ≥3 TEAEs, n (%) | 64 (81) | 42 (70) | 33 (55) | 41 (62) |
| Grade ≥3 TEAEs of interest, n (%)* | ||||
| Peripheral neuropathy | 0 | 0 | 0 | 1 (2) |
| Acute renal failure | 3 (4) | 4 (7) | 0 | 3 (5) |
| Cardiac failure | 3 (4) | 5 (8) | 1 (2) | 1 (2) |
| Ischemic heart disease | 0 | 1 (2) | 1 (2) | 0 |
| Pulmonary hypertension | 0 | 1 (2) | 0 | 0 |
| Hypertension | 8 (10) | 4 (7) | 1 (2) | 5 (8) |
| TEAEs leading to carfilzomib discontinuation, % | 16 (20) | 11 (18) | 2 (3) | 5 (8) |
| TEAEs of interest leading to carfilzomib discontinuation, n (%)* | ||||
| Peripheral neuropathy | 0 | 0 | 0 | 0 |
| Acute renal failure | 3 (4) | 1 (2) | 0 | 1 (2) |
| Cardiac failure | 3 (4) | 3 (5) | 1 (2) | 0 |
| Ischemic heart disease | 0 | 0 | 0 | 0 |
| Pulmonary hypertension | 0 | 0 | 0 | 0 |
| TRAEs leading to carfilzomib discontinuation, n (%) | 7 (9) | 6 (10) | 2 (3.3) | 0 |
| Median duration of carfilzomib treatment, wk | 36.1 | 29.1 | 45.4 | 24.4 |
| Median carfilzomib relative dose intensity, % | 94.7 | 96.3 | 96.5 | 96.0 |
AEs were assessed in patients who received ≥1 dose of study drug (safety population).
Standardized MedDRA Query, narrow scope.