Treatment-emergent AEs in the safety population
| . | Carfilzomib group (n = 474) . | Bortezomib group (n = 470) . | ||
|---|---|---|---|---|
| . | All grades . | Grade ≥3 . | All grades . | Grade ≥3 . |
| Any AE | 460 (97.0) | 354 (74.7) | 454 (96.6) | 358 (76.2) |
| Common hematologic AEs, preferred terms | ||||
| Anemia | 174 (36.7) | 80 (16.9) | 146 (31.1) | 64 (13.6) |
| Neutropenia/neutrophil count decreased | 170 (35.9) | 107 (22.6) | 186 (39.6) | 138 (29.4) |
| Thrombocytopenia/platelet count decreased | 127 (26.8) | 73 (15.4) | 151 (32.1) | 99 (21.1) |
| Leukopenia/white blood cell count decreased | 81 (17.1) | 42 (8.9) | 94 (20.0) | 60 (12.8) |
| Lymphopenia/lymphocyte count decreased | 37 (7.8) | 23 (4.9) | 34 (7.2) | 24 (5.1) |
| Common nonhematologic AEs, preferred terms | ||||
| Pyrexia | 172 (36.3) | 10 (2.1) | 86 (18.3) | 2 (0.4) |
| Peripheral edema | 84 (17.7) | 4 (0.8) | 54 (11.5) | 2 (0.4) |
| Fatigue | 79 (16.7) | 6 (1.3) | 85 (18.1) | 17 (3.6) |
| Asthenia | 72 (15.2) | 18 (3.8) | 70 (14.9) | 19 (4.0) |
| Pneumonia | 68 (14.3) | 46 (9.7) | 52 (11.1) | 35 (7.4) |
| Upper respiratory tract infection | 51 (10.8) | 4 (0.8) | 51 (10.9) | 7 (1.5) |
| Nausea | 168 (35.4) | 6 (1.3) | 133 (28.3) | 2 (0.4) |
| Vomiting | 118 (24.9) | 7 (1.5) | 91 (19.4) | 6 (1.3) |
| Diarrhea | 96 (20.3) | 6 (1.3) | 133 (28.3) | 27 (5.7) |
| Constipation | 66 (13.9) | 2 (0.4) | 114 (24.3) | 6 (1.3) |
| Decreased appetite | 67 (14.1) | 1 (0.2) | 88 (18.7) | 7 (1.5) |
| Hypokalemia | 53 (11.2) | 16 (3.4) | 63 (13.4) | 28 (6.0) |
| Dyspnea | 76 (16.0) | 16 (3.4) | 36 (7.7) | 3 (0.6) |
| Cough | 63 (13.3) | 0 | 63 (13.4) | 0 |
| PN | 29 (6.1) | 1 (0.2) | 155 (33.0) | 37 (7.9) |
| Peripheral sensory neuropathy | 8 (1.7) | 0 | 64 (13.6) | 7 (1.5) |
| Back pain | 57 (12.0) | 7 (1.5) | 59 (12.6) | 5 (1.1) |
| Hypertension | 104 (21.9) | 43 (9.1) | 32 (6.8) | 14 (3.0) |
| Rash | 26 (5.5) | 1 (0.2) | 49 (10.4) | 4 (0.9) |
| Insomnia | 49 (10.3) | 1 (0.2) | 65 (13.8) | 2 (0.4) |
| Cardiac failure | 31 (6.5) | 24 (5.1) | 10 (2.1) | 7 (1.5) |
| Acute kidney injury | 30 (6.3) | 20 (4.2) | 13 (2.8) | 7 (1.5) |
| Renal failure | 29 (6.1) | 14 (3.0) | 7 (1.5) | 3 (0.6) |
| Lung infection | 12 (2.5) | 10 (2.1) | 17 (3.6) | 13 (2.8) |
| Hyponatremia | 17 (3.6) | 9 (1.9) | 26 (5.5) | 15 (3.2) |
| Hypotension | 20 (4.2) | 3 (0.6) | 42 (8.9) | 16 (3.4) |
| . | Carfilzomib group (n = 474) . | Bortezomib group (n = 470) . | ||
|---|---|---|---|---|
| . | All grades . | Grade ≥3 . | All grades . | Grade ≥3 . |
| Any AE | 460 (97.0) | 354 (74.7) | 454 (96.6) | 358 (76.2) |
| Common hematologic AEs, preferred terms | ||||
| Anemia | 174 (36.7) | 80 (16.9) | 146 (31.1) | 64 (13.6) |
| Neutropenia/neutrophil count decreased | 170 (35.9) | 107 (22.6) | 186 (39.6) | 138 (29.4) |
| Thrombocytopenia/platelet count decreased | 127 (26.8) | 73 (15.4) | 151 (32.1) | 99 (21.1) |
| Leukopenia/white blood cell count decreased | 81 (17.1) | 42 (8.9) | 94 (20.0) | 60 (12.8) |
| Lymphopenia/lymphocyte count decreased | 37 (7.8) | 23 (4.9) | 34 (7.2) | 24 (5.1) |
| Common nonhematologic AEs, preferred terms | ||||
| Pyrexia | 172 (36.3) | 10 (2.1) | 86 (18.3) | 2 (0.4) |
| Peripheral edema | 84 (17.7) | 4 (0.8) | 54 (11.5) | 2 (0.4) |
| Fatigue | 79 (16.7) | 6 (1.3) | 85 (18.1) | 17 (3.6) |
| Asthenia | 72 (15.2) | 18 (3.8) | 70 (14.9) | 19 (4.0) |
| Pneumonia | 68 (14.3) | 46 (9.7) | 52 (11.1) | 35 (7.4) |
| Upper respiratory tract infection | 51 (10.8) | 4 (0.8) | 51 (10.9) | 7 (1.5) |
| Nausea | 168 (35.4) | 6 (1.3) | 133 (28.3) | 2 (0.4) |
| Vomiting | 118 (24.9) | 7 (1.5) | 91 (19.4) | 6 (1.3) |
| Diarrhea | 96 (20.3) | 6 (1.3) | 133 (28.3) | 27 (5.7) |
| Constipation | 66 (13.9) | 2 (0.4) | 114 (24.3) | 6 (1.3) |
| Decreased appetite | 67 (14.1) | 1 (0.2) | 88 (18.7) | 7 (1.5) |
| Hypokalemia | 53 (11.2) | 16 (3.4) | 63 (13.4) | 28 (6.0) |
| Dyspnea | 76 (16.0) | 16 (3.4) | 36 (7.7) | 3 (0.6) |
| Cough | 63 (13.3) | 0 | 63 (13.4) | 0 |
| PN | 29 (6.1) | 1 (0.2) | 155 (33.0) | 37 (7.9) |
| Peripheral sensory neuropathy | 8 (1.7) | 0 | 64 (13.6) | 7 (1.5) |
| Back pain | 57 (12.0) | 7 (1.5) | 59 (12.6) | 5 (1.1) |
| Hypertension | 104 (21.9) | 43 (9.1) | 32 (6.8) | 14 (3.0) |
| Rash | 26 (5.5) | 1 (0.2) | 49 (10.4) | 4 (0.9) |
| Insomnia | 49 (10.3) | 1 (0.2) | 65 (13.8) | 2 (0.4) |
| Cardiac failure | 31 (6.5) | 24 (5.1) | 10 (2.1) | 7 (1.5) |
| Acute kidney injury | 30 (6.3) | 20 (4.2) | 13 (2.8) | 7 (1.5) |
| Renal failure | 29 (6.1) | 14 (3.0) | 7 (1.5) | 3 (0.6) |
| Lung infection | 12 (2.5) | 10 (2.1) | 17 (3.6) | 13 (2.8) |
| Hyponatremia | 17 (3.6) | 9 (1.9) | 26 (5.5) | 15 (3.2) |
| Hypotension | 20 (4.2) | 3 (0.6) | 42 (8.9) | 16 (3.4) |
Data are n (%). AEs (preferred terms) reported in at least 10% (any grade) or 2% (grade ≥3) of patients in either treatment group are listed. The safety population included all patients who received at least 1 dose of a study drug.