Table 6.
All renal and urinary treatment-emergent adverse events
| Renal and urinary TEAEs by MedDRA SOC | Renal and urinary TEAEs by MedDRA preferred term | Vidofludimus (N = 122) | Placebo (N = 119) | Total (N = 241) |
|---|---|---|---|---|
| Renal and urinary disorders | 6 (4.9) | 5 (4.2) | 11 (4.6) | |
| Hematuria | 1 (0.8) | 1 (0.8) | 2 (0.8) | |
| Bladder pain | 1 (0.8) | 0 (0.0) | 1 (0.4) | |
| Dysuria | 0 (0.0) | 1 (0.8) | 1 (0.4) | |
| Hemorrhage urinary tract | 0 (0.0) | 1 (0.8) | 1 (0.4) | |
| Ketonuria | 1 (0.8) | 0 (0.0) | 1 (0.4) | |
| Leukocyturia | 1 (0.8) | 0 (0.0) | 1 (0.4) | |
| Nephrolithiasis | 0 (0.0) | 1 (0.8) | 1 (0.4) | |
| Nocturia | 1 (0.8) | 0 (0.0) | 1 (0.4) | |
| Renal amyloidosis | 1 (0.8) | 0 (0.0) | 1 (0.4) | |
| Renal failure | 0 (0.0) | 1 (0.8) | 1 (0.4) | |
| Renal failure chronic | 1 (0.8) | 0 (0.0) | 1 (0.4) | |
| Renal pain | 0 (0.0) | 1 (0.8) | 1 (0.4) |
Data are expressed as n (%)
MedDRA Medical Dictionary for Regulatory Activities, N number of patients, SOC system organ class, TEAEs treatment-emergent adverse events