| Core Study | Extension | ||
|---|---|---|---|
| PBO (N=107) | LESU400 (N=107) | LESU400 (N=143*) | |
| Patients experiencing any TEAE | 70 (65.4%) | 83 (77.6%) | 105 (73.4%) |
| Patients with serious TEAEs | 4 (3.7%) | 9 (8.4%) | 15 (10.5%) |
| Patients with renal-related AEs | 0 (0%) | 19 (17.8%) | 24 (16.8%) |
| Patients with serious renal-related AEs | 0 (0%) | 5 (4.7%) | 2 (1.4%) |
| Patients with kidney stones | 0 (0%) | 1 (0.9%) | 6 (4.2%) |
| Patients with ≥2.0x increase in sCr | 0 (0%) | 9 (8.4%) | 9 (6.3%) |
| Number (%) sCr elevations resolved at last study visit | – | 6/11 (54.5%) | 6/10 (60%) |
Data are n (%). *Extension study safety population.