Major adverse events of grade 3 or above
. | VDCR n = 48 . | VDR n = 42 . | VDC n = 33 . | VDC-mod n = 17 . |
---|---|---|---|---|
Hematological AEs, n (%) | ||||
Neutropenia | 21 (44) | 4 (10) | 10 (30) | 4 (24) |
Febrile neutropenia | 4 (8) | 1 (2) | 2 (6) | 0 |
Thrombocytopenia | 7 (15) | 5 (12) | 4 (12) | 0 |
Leukopenia | 6 (13) | 0 | 3 (9) | 1 (6) |
Anemia | 4 (8) | 3 (7) | 0 | 2 (12) |
Lymphopenia | 4 (8) | 1 (2) | 4 (12) | 0 |
Nonhematological AEs | ||||
Pneumonia | 2 (4) | 2 (5) | 0 | 1 (6) |
Neuropathy | 6 (13) | 7 (17) | 3 (9) | 3 (18) |
Fatigue | 8 (17) | 3 (7) | 1 (3) | 0 |
Diarrhea | 3 (6) | 1 (2) | 1 (3) | 1 (6) |
Nausea | 0 | 1 (2) | 0 | 0 |
Thromboembolism | 1 (2) | 0 | 0 | 0 |
Constipation | 0 | 0 | 0 | 0 |
Hyperglycemia | 0 | 0 | 0 | 0 |
Summary | ||||
At least one grade 3 or above AE | 40 (83) | 32 (76) | 26 (79) | 15 (88) |
At least one drug-related grade 3 or above AE | 38 (79) | 25 (60) | 20 (61) | 12 (71) |
At least one grade 3 or above hematological AE | 28 (58) | 11 (26) | 17 (52) | 5 (29) |
AE resulting in discontinuation | 10 (21) | 8 (19) | 4 (12) | 1 (6) |
. | VDCR n = 48 . | VDR n = 42 . | VDC n = 33 . | VDC-mod n = 17 . |
---|---|---|---|---|
Hematological AEs, n (%) | ||||
Neutropenia | 21 (44) | 4 (10) | 10 (30) | 4 (24) |
Febrile neutropenia | 4 (8) | 1 (2) | 2 (6) | 0 |
Thrombocytopenia | 7 (15) | 5 (12) | 4 (12) | 0 |
Leukopenia | 6 (13) | 0 | 3 (9) | 1 (6) |
Anemia | 4 (8) | 3 (7) | 0 | 2 (12) |
Lymphopenia | 4 (8) | 1 (2) | 4 (12) | 0 |
Nonhematological AEs | ||||
Pneumonia | 2 (4) | 2 (5) | 0 | 1 (6) |
Neuropathy | 6 (13) | 7 (17) | 3 (9) | 3 (18) |
Fatigue | 8 (17) | 3 (7) | 1 (3) | 0 |
Diarrhea | 3 (6) | 1 (2) | 1 (3) | 1 (6) |
Nausea | 0 | 1 (2) | 0 | 0 |
Thromboembolism | 1 (2) | 0 | 0 | 0 |
Constipation | 0 | 0 | 0 | 0 |
Hyperglycemia | 0 | 0 | 0 | 0 |
Summary | ||||
At least one grade 3 or above AE | 40 (83) | 32 (76) | 26 (79) | 15 (88) |
At least one drug-related grade 3 or above AE | 38 (79) | 25 (60) | 20 (61) | 12 (71) |
At least one grade 3 or above hematological AE | 28 (58) | 11 (26) | 17 (52) | 5 (29) |
AE resulting in discontinuation | 10 (21) | 8 (19) | 4 (12) | 1 (6) |
V indicates bortezomib; D, dexamethasone; R, lenalidomide; C, cyclophosphamide; VDC-mod, VDC plus a day 15 dose of C; and AE, adverse event.