Table 2.
Incidence rates (≥ 1%) of ADRs by preferred term (safety analysis set; N = 263)
| Incidence of ADRs n/N (%) | 130/263 (49.43) |
|---|---|
| Type of ADR | Incidence, n (%) |
| Nasopharyngitis | 3 (1.14) |
| Kidney transplant rejection | 3 (1.14) |
| Dyslipidemia | 6 (2.28) |
| Lipid metabolism disorder | 3 (1.14) |
| Hyperlipidemia | 14 (5.32) |
| Diarrhea | 3 (1.14) |
| Stomatitis | 42 (15.97) |
| Rash | 4 (1.52) |
| Proteinuria | 26 (9.89) |
| Renal impairment | 5 (1.90) |
| Concomitant disease aggravated | 3 (1.14) |
| Peripheral edema | 10 (3.80) |
| Albumin urine present | 7 (2.66) |
| Blood creatinine increased | 3 (1.14) |
| Protein urine | 3 (1.14) |
| Protein urine present | 5 (1.90) |
ADR adverse drug reaction