Table 1.
SCr levels in the LTE and Phase 3 studies: number (percentage) of patients with maximum confirmed increase in SCr in the LTE studies versus increase at EoT in the Phase 3 studies
| SCr increase at EoT in Phase 3 (%) | LTE study: maximum percentage confirmed increase in creatinine (n = 1,651) | ||||
|---|---|---|---|---|---|
| ≤10% | >10 to <33% | ≥33 to ≤50% | >50% | Total | |
| ≤10% | 634 (69.8) | 264 (29.0) | 9 (1.0) | 2 (0.2) | 909 (100.0) |
| >10 to <33% | 208 (31.9) | 395 (60.5) | 43 (6.6) | 7 (1.1) | 653 (100.0) |
| ≥33 to ≤50% | 24 (29.3) | 28 (34.2) | 24 (29.3) | 6 (7.3) | 82 (100.0) |
| >50% | 0 (0.0) | 2 (28.6) | 2 (28.6) | 3 (42.9) | 7 (100.0) |
EoT, end of treatment; LTE, long-term extension; SCr, serum creatinine.