Table 3.
Occurrence status of adverse drug reactions with an overall frequency of more than 3% (safety analysis set, n = 547)
| Overall, n (%) | Serious, n (%) | |
|---|---|---|
| No. of patients with adverse drug reactions (%) | 380 (69.5) | 223 (40.8) |
| No. of adverse drug reactions | 850 | 365 |
| Diarrhea | 68 (12.4) | 28 (5.1) |
| Liver disorder | 54 (9.9) | 38 (6.9) |
| Colitis | 44 (8.0) | 34 (6.2) |
| Pyrexia | 42 (7.7) | 16 (2.9) |
| Hypothyroidism | 40 (7.3) | 6 (1.1) |
| Rash | 31 (5.7) | 3 (0.5) |
| Hepatic function abnormal | 30 (5.5) | 22 (4.0) |
| Pruritus | 24 (4.4) | 1 (0.2) |
| Hypopituitarism | 21 (3.8) | 16 (2.9) |
| Adrenal insufficiency | 20 (3.7) | 16 (2.9) |
| Interstitial lung disease | 19 (3.5) | 13 (2.4) |
| Aspartate aminotransferase increased | 19 (3.5) | 7 (1.3) |
| Hypophysitis | 19 (3.5) | 16 (2.9) |
| Malaise | 18 (3.3) | 1 (0.2) |
| Alanine aminotransferase increased | 18 (3.3) | 8 (1.5) |
Medical Dictionary for Regulatory Activities version 21.1.