Table 2 Most common all grade (≥25%) and grade 3/4 (≥5%) TEAEs in the safety population.
Event | D-Rd (n = 283) | Rd (n = 281) | ||
|---|---|---|---|---|
All grade, n (%) | Grade 3/4, n (%) | All grade, n (%) | Grade 3/4, n (%) | |
Total | 281 (99.3) | 255 (90.1) | 274 (97.5) | 227 (80.8) |
Hematologic | ||||
Neutropenia | 179 (63.3) | 157 (55.5) | 135 (48.0) | 117 (41.6) |
Febrile neutropenia | 18 (6.4) | 18 (6.4) | 8 (2.8) | 8 (2.8) |
Anemia | 111 (39.2) | 50 (17.7) | 114 (40.6) | 60 (21.4) |
Thrombocytopenia | 87 (30.7) | 42 (14.8) | 88 (31.3) | 44 (15.7) |
Lymphopenia | 19 (6.7) | 16 (5.7) | 17 (6.0) | 12 (4.3) |
Nonhematologic | ||||
Diarrhea | 165 (58.3) | 28 (9.9) | 105 (37.4) | 11 (3.9) |
Upper respiratory tract infection | 121 (42.8) | 5 (1.8) | 78 (27.8) | 5 (1.8) |
Fatigue | 110 (38.9) | 19 (6.7) | 87 (31.0) | 12 (4.3) |
Cough | 99 (35.0) | 1 (0.4) | 42 (14.9) | 0 (0.0) |
Nasopharyngitis | 96 (33.9) | 0 (0.0) | 59 (21.0) | 0 (0.0) |
Constipation | 93 (32.9) | 3 (1.1) | 76 (27.0) | 2 (0.7) |
Muscle spasms | 84 (29.7) | 3 (1.1) | 60 (21.4) | 4 (1.4) |
Nausea | 82 (29.0) | 6 (2.1) | 51 (18.1) | 2 (0.7) |
Insomnia | 76 (26.9) | 6 (2.1) | 63 (22.4) | 4 (1.4) |
Pyrexia | 73 (25.8) | 9 (3.2) | 40 (14.2) | 7 (2.5) |
Back pain | 71 (25.1) | 8 (2.8) | 57 (20.3) | 5 (1.8) |
Pneumonia | 71 (25.1) | 43 (15.2) | 46 (16.4) | 28 (10.0) |
Edema peripheral | 67 (23.7) | 2 (0.7) | 47 (16.7) | 4 (1.4) |
Vomiting | 62 (21.9) | 3 (1.1) | 19 (6.8) | 4 (1.4) |
Dyspnea | 61 (21.6) | 12 (4.2) | 37 (13.2) | 2 (0.7) |
Bronchitis | 57 (20.1) | 7 (2.5) | 48 (17.1) | 9 (3.2) |
Asthenia | 54 (19.1) | 10 (3.5) | 46 (16.4) | 9 (3.2) |
Cataract | 54 (19.1) | 17 (6.0) | 33 (11.7) | 12 (4.3) |
Hypokalemia | 51 (18.0) | 17 (6.0) | 31 (11.0) | 9 (3.2) |
Headache | 49 (17.3) | 0 (0.0) | 24 (8.5) | 0 (0.0) |
