Table 3.
Incidence of prespecified ADRs by grade (n = 843)
| ADR, n (%) | Grade 1 | Grade 2 | Grade 3 | Grade 4 | Grade 5 | Total |
|---|---|---|---|---|---|---|
| ILD (IRC confirmed) | 19 (2.3) | 13 (1.5) | 17 (2.0) | 1 (0.1) | 2 (0.2) | 52 (6.2) |
| Skin disorders | 309 (36.7) | 234 (27.8) | 44 (5.2) | 1 (0.1) | 0 (0.0) | 589 (69.9) |
| Rash | 304 (36.1) | 197 (23.4) | 34 (4.0) | 0 (0.0) | 0 (0.0) | 536 (63.6) |
| Dry skin | 38 (4.5) | 12 (1.4) | 1 (0.1) | 0 (0.0) | 0 (0.0) | 51 (6.0) |
| Pruritus | 20 (2.4) | 5 (0.6) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 25 (2.9) |
| Paronychia | 38 (4.5) | 45 (5.3) | 7 (0.8) | 0 (0.0) | 0 (0.0) | 90 (10.7) |
| Liver disorder | 41 (4.9) | 33 (3.9) | 31 (3.7) | 2 (0.2) | 0 (0.0) | 107 (12.7) |
| Diarrhea | 85 (10.8) | 49 (5.8) | 13 (1.5) | 2 (0.2) | 0 (0.0) | 148 (17.6) |
| Eye disorders | 12 (1.4) | 3 (0.4) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 15 (1.8) |
| Hemorrhage | 23 (2.7) | 4 (0.5) | 9 (1.1) | 2 (0.2) | 4 (0.5) | 42 (5.0) |
| Thrombotic microangiopathy | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Myocardial infarction | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Cerebral disorders | 1 (0.1) | 1 (0.1) | 1 (0.1) | 0 (0.0) | 2 (0.2) | 5 (0.6) |
| Gastrointestinal perforation | 0 (0.0) | 1 (0.1) | 1 (0.1) | 0 (0.0) | 0 (0.0) | 2 (0.2) |
| Gastrointestinal ulcer | 1 (0.1) | 4 (0.5) | 4 (0.5) | 0 (0.0) | 0 (0.0) | 9 (1.1) |
| Renal failure | 0 (0.0) | 0 (0.0) | 1 (0.1) | 0 (0.0) | 0 (0.0) | 1 (0.1) |