Table 2.
Adverse event | Before dose reduction (N = 311) | After dose reduction | |||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Cycle 1 (N = 310) | Cycle 2 (N = 284) | Cycle 3 (N = 267) | Cycle 4 (N = 253) | Cycle 5 (N = 241) | Cycle 6 (N = 228) | ||||||||||||||||
Grade, n (%) | Grade, n (%) | Grade, n (%) | Grade, n (%) | Grade, n (%) | Grade, n (%) | Grade, n (%) | |||||||||||||||
All | 3 | 4 | All | 3 | 4 | All | 3 | 4 | All | 3 | 4 | All | 3 | 4 | All | 3 | 4 | All | 3 | 4 | |
Leukopenia* | 130 (41.8) | 86 (27.7) | 2 (0.6) | 88 (28.4) | 25 (8.1) | 0 | 83 (29.2) | 22 (7.7) | 0 | 71 (26.6) | 22 (8.2) | 0 | 64 (25.3) | 17 (6.7) | 0 | 60 (24.9) | 12 (5.0) | 0 | 56 (24.6) | 15 (6.6) | 0 |
Thrombocytopenia† | 48 (15.4) | 5 (1.6) | 1 (0.3) | 36 (11.6) | 3 (1.0) | 0 | 29 (10.2) | 3 (1.1) | 0 | 23 (8.6) | 2 (0.7) | 0 | 21 (8.3) | 2 (0.8) | 0 | 20 (8.3) | 0 | 0 | 20 (8.8) | 1 (0.4) | 0 |
Anemia‡ | 38 (12.2) | 8 (2.6) | 0 | 55 (17.7) | 5 (1.6) | 0 | 54 (19.0) | 3 (1.1) | 0 | 49 (18.4) | 2 (0.7) | 0 | 43 (17.0) | 2 (0.8) | 0 | 38 (15.8) | 2 (0.8) | 0 | 39 (17.1) | 1 (0.4) | 0 |
Febrile neutropenia | 7 (2.3) | 6 (1.9) | 1 (0.3) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (0.4) | 1 (0.4) | 0 | 0 | 0 | 0 |
*Leukopenia includes the following preferred terms: leukopenia or white blood cell count decreased
†Thrombocytopenia includes the following preferred terms: platelet count decreased or thrombocytopenia
‡Anemia includes the following preferred terms: anemia or hematocrit decreased or hemoglobin decreased