Most common adverse events reported during treatment in the safety population
| Adverse event, n (%) . | D-RVd, n = 99 . | RVd, n = 102 . | |||
|---|---|---|---|---|---|
| Any grade . | Grade 3/4 . | Any grade . | Grade 3/4 . | ||
| Hematologic | |||||
| Neutropenia | 57 (57.6) | 41 (41.4) | 36 (35.3) | 22 (21.6) | |
| Thrombocytopenia | 43 (43.4) | 16 (16.2) | 36 (35.3) | 9 (8.8) | |
| Leukopenia | 36 (36.4) | 16 (16.2) | 29 (28.4) | 7 (6.9) | |
| Anemia | 35 (35.4) | 9 (9.1) | 33 (32.4) | 6 (5.9) | |
| Lymphopenia | 30 (30.3) | 23 (23.2) | 28 (27.5) | 22 (21.6) | |
| Nonhematologic | |||||
| Fatigue | 68 (68.7) | 6 (6.1) | 62 (60.8) | 6 (5.9) | |
| Upper respiratory tract infection | 62 (62.6) | 1 (1.0) | 45 (44.1) | 2 (2.0) | |
| Peripheral neuropathy* | 59 (59.6) | 7 (7.1) | 74 (72.5) | 8 (7.8) | |
| Diarrhea | 59 (59.6) | 7 (7.1) | 51 (50.0) | 4 (3.9) | |
| Constipation | 51 (51.5) | 2 (2.0) | 40 (39.2) | 1 (1.0) | |
| Cough | 50 (50.5) | 0 | 27 (26.5) | 0 | |
| Nausea | 49 (49.5) | 2 (2.0) | 50 (49.0) | 1 (1.0) | |
| Pyrexia | 45 (45.5) | 2 (2.0) | 28 (27.5) | 3 (2.9) | |
| Insomnia | 42 (42.4) | 2 (2.0) | 31 (30.4) | 1 (1.0) | |
| Back pain | 36 (36.4) | 1 (1.0) | 34 (33.3) | 4 (3.9) | |
| Peripheral edema | 34 (34.3) | 2 (2.0) | 35 (34.3) | 3 (2.9) | |
| Arthralgia | 33 (33.3) | 0 | 33 (32.4) | 2 (2.0) | |
| Infusion-related reaction | 42 (42.4) | 6 (6.1)† | NA | NA | |
| Adverse event, n (%) . | D-RVd, n = 99 . | RVd, n = 102 . | |||
|---|---|---|---|---|---|
| Any grade . | Grade 3/4 . | Any grade . | Grade 3/4 . | ||
| Hematologic | |||||
| Neutropenia | 57 (57.6) | 41 (41.4) | 36 (35.3) | 22 (21.6) | |
| Thrombocytopenia | 43 (43.4) | 16 (16.2) | 36 (35.3) | 9 (8.8) | |
| Leukopenia | 36 (36.4) | 16 (16.2) | 29 (28.4) | 7 (6.9) | |
| Anemia | 35 (35.4) | 9 (9.1) | 33 (32.4) | 6 (5.9) | |
| Lymphopenia | 30 (30.3) | 23 (23.2) | 28 (27.5) | 22 (21.6) | |
| Nonhematologic | |||||
| Fatigue | 68 (68.7) | 6 (6.1) | 62 (60.8) | 6 (5.9) | |
| Upper respiratory tract infection | 62 (62.6) | 1 (1.0) | 45 (44.1) | 2 (2.0) | |
| Peripheral neuropathy* | 59 (59.6) | 7 (7.1) | 74 (72.5) | 8 (7.8) | |
| Diarrhea | 59 (59.6) | 7 (7.1) | 51 (50.0) | 4 (3.9) | |
| Constipation | 51 (51.5) | 2 (2.0) | 40 (39.2) | 1 (1.0) | |
| Cough | 50 (50.5) | 0 | 27 (26.5) | 0 | |
| Nausea | 49 (49.5) | 2 (2.0) | 50 (49.0) | 1 (1.0) | |
| Pyrexia | 45 (45.5) | 2 (2.0) | 28 (27.5) | 3 (2.9) | |
| Insomnia | 42 (42.4) | 2 (2.0) | 31 (30.4) | 1 (1.0) | |
| Back pain | 36 (36.4) | 1 (1.0) | 34 (33.3) | 4 (3.9) | |
| Peripheral edema | 34 (34.3) | 2 (2.0) | 35 (34.3) | 3 (2.9) | |
| Arthralgia | 33 (33.3) | 0 | 33 (32.4) | 2 (2.0) | |
| Infusion-related reaction | 42 (42.4) | 6 (6.1)† | NA | NA | |
The safety analysis population included all randomized patients who received ≥1 dose of study treatment; analysis was according to treatment received. Adverse events of any grade that are listed are those that occurred in 30% or more of the patients in either group. The safety analysis occurred at a median follow-up of 22.1 months.
NA, not applicable.
Includes patients with neuropathy peripheral and peripheral sensory neuropathy.
There were no grade 4 infusion-related reactions.