AEs and treatment exposure in the frail and fit subgroups in ASPIRE
| . | Frail . | Fit . | ||
|---|---|---|---|---|
| KRd27 mg/m2, n = 92 . | Rd, n = 100 . | KRd27 mg/m2, n = 115 . | Rd, n = 114 . | |
| Any-grade TEAE, n (%) | 91 (99) | 100 (100) | 114 (99) | 113 (99) |
| Grade ≥3 TEAE, n (%) | 86 (93) | 94 (94) | 102 (89) | 96 (84) |
| Grade ≥3 TEAEs of interest, n (%)* | ||||
| Peripheral neuropathy | 2 (2) | 5 (5) | 4 (3) | 1 (<1) |
| Acute renal failure | 3 (3) | 6 (6) | 5 (4) | 3 (3) |
| Cardiac failure | 9 (10) | 1 (1) | 5 (4) | 2 (2) |
| Ischemic heart disease | 7 (8) | 4 (4) | 4 (3) | 3 (3) |
| Pulmonary hypertension | 1 (1) | 0 | 0 | 0 |
| Hypertension | 7 (8) | 1 (1) | 11 (10) | 1 (1) |
| TEAEs leading to study treatment discontinuation, n (%) | 34 (37) | 43 (43) | 38 (33) | 34 (30) |
| TEAEs of interest leading to carfilzomib or lenalidomide discontinuation, n (%)* | ||||
| Peripheral neuropathy | 0 | 1 (1) | 2 (2) | 0 |
| Acute renal failure | 2 (2) | 3 (3) | 0 | 1 (<1) |
| Cardiac failure | 2 (2) | 1 (1) | 0 | 0 |
| Ischemic heart disease | 3 (3) | 0 | 1 (<1) | 3 (3) |
| Pulmonary hypertension | 0 | 0 | 0 | 0 |
| TRAEs leading to study treatment discontinuation, n (%) | 17 (18) | 27 (27) | 27 (23) | 22 (19) |
| Median duration of study treatment, weeks | 82.4 | 57.1 | 102.1 | 73.5 |
| Median carfilzomib relative dose intensity, % | 91.2 | N/A | 93.7 | N/A |
| . | Frail . | Fit . | ||
|---|---|---|---|---|
| KRd27 mg/m2, n = 92 . | Rd, n = 100 . | KRd27 mg/m2, n = 115 . | Rd, n = 114 . | |
| Any-grade TEAE, n (%) | 91 (99) | 100 (100) | 114 (99) | 113 (99) |
| Grade ≥3 TEAE, n (%) | 86 (93) | 94 (94) | 102 (89) | 96 (84) |
| Grade ≥3 TEAEs of interest, n (%)* | ||||
| Peripheral neuropathy | 2 (2) | 5 (5) | 4 (3) | 1 (<1) |
| Acute renal failure | 3 (3) | 6 (6) | 5 (4) | 3 (3) |
| Cardiac failure | 9 (10) | 1 (1) | 5 (4) | 2 (2) |
| Ischemic heart disease | 7 (8) | 4 (4) | 4 (3) | 3 (3) |
| Pulmonary hypertension | 1 (1) | 0 | 0 | 0 |
| Hypertension | 7 (8) | 1 (1) | 11 (10) | 1 (1) |
| TEAEs leading to study treatment discontinuation, n (%) | 34 (37) | 43 (43) | 38 (33) | 34 (30) |
| TEAEs of interest leading to carfilzomib or lenalidomide discontinuation, n (%)* | ||||
| Peripheral neuropathy | 0 | 1 (1) | 2 (2) | 0 |
| Acute renal failure | 2 (2) | 3 (3) | 0 | 1 (<1) |
| Cardiac failure | 2 (2) | 1 (1) | 0 | 0 |
| Ischemic heart disease | 3 (3) | 0 | 1 (<1) | 3 (3) |
| Pulmonary hypertension | 0 | 0 | 0 | 0 |
| TRAEs leading to study treatment discontinuation, n (%) | 17 (18) | 27 (27) | 27 (23) | 22 (19) |
| Median duration of study treatment, weeks | 82.4 | 57.1 | 102.1 | 73.5 |
| Median carfilzomib relative dose intensity, % | 91.2 | N/A | 93.7 | N/A |
AEs were assessed in patients who received ≥1 dose of study drug (safety population).
MedDRA, Medical Dictionary of Regulatory Activities; N/A, not applicable.
Standardized MedDRA Query, narrow scope.