Table 1 Maximum grade of adverse events within the first 6 months and the entire follow-up period.
Adverse eventsa | First 6 months | Entire follow up |
|---|---|---|
Total adverse events | ||
Grade 0 | 739 (18%) | 608 (15%) |
Grade 1 | 960 (24%) | 932 (23%) |
Grade 2 | 1511 (37%) | 1643 (40%) |
Grade 3 | 779 (19%) | 853 (21%) |
Grade 4 | 57 (1.4%) | 63 (1.5%) |
Haematological adverse events | ||
Grade 0 | 2127 (53%) | 1991 (49%) |
Grade 1 | 962 (24%) | 1050 (26%) |
Grade 2 | 655 (16%) | 732 (18%) |
Grade 3 | 256 (6.3%) | 277 (6.8%) |
Grade 4 | 46 (1.1%) | 49 (1.2%) |
Gastrointestinal disorders | ||
Grade 0 | 2574 (64%) | 2477 (60%) |
Grade 1 | 878 (22%) | 973 (24%) |
Grade 2 | 419 (10%) | 469 (11%) |
Grade 3 | 173 (4.3%) | 177 (4.3%) |
Grade 4 | 2 (0.0%) | 3 (0.1%) |
Metabolism and nutrition disorders | ||
Grade 0 | 2869 (71%) | 2808 (69%) |
Grade 1 | 772 (19%) | 843 (21%) |
Grade 2 | 286 (7.1%) | 322 (7.9%) |
Grade 3 | 118 (2.9%) | 125 (3.0%) |
Grade 4 | 1 (0.0%) | 1 (0.0%) |
Skin and subcutaneous tissue disorders | ||
Grade 0 | 2584 (64%) | 2503 (61%) |
Grade 1 | 733 (18%) | 777 (19%) |
Grade 2 | 495 (12%) | 555 (14%) |
Grade 3 | 234 (5.8%) | 264 (6.4%) |
Grade 4 | 0 (0%) | 0 (0%) |
Hepatic disorders | ||
Grade 0 | 2450 (61%) | 2279 (56%) |
Grade 1 | 997 (25%) | 1,101 (27%) |
Grade 2 | 507 (13%) | 610 (15%) |
Grade 3 | 84 (2.1%) | 98 (2.4%) |
Grade 4 | 8 (0.2%) | 10 (0.2%) |
Renal disorders | ||
Grade 0 | 3840 (95%) | 3837 (94%) |
Grade 1 | 187 (4.6%) | 236 (5.8%) |
Grade 2 | 18 (0.4%) | 24 (0.6%) |
Grade 3 | 0 (0%) | 0 (0%) |
Grade 4 | 1 (0.0%) | 1 (0.0%) |
Other disorders | ||
Grade 0 | 1171 (63%) | 1168 (62%) |
Grade 1 | 351 (19%) | 354 (19%) |
Grade 2 | 283 (15%) | 283 (15%) |
Grade 3 | 68 (3.6%) | 68 (3.6%) |
Grade 4 | 0 (0%) | 0 (0%) |
