Table 9.
Baseline to Treatment Period Laboratory Test Shift Tables for Patients from Randomized Placebo-Controlled Trials with Renal Dysfunction At baseline (Creatinine)
| Treatment period, confirmed observation | |||||||
|---|---|---|---|---|---|---|---|
| Creatinine, mg/dL | Baseline | Unknown | ≤1.4 | >1.4–1.7 | >1.7–2.1 | >2.1–4.2 | >4.2 |
| Placebo (N = 6) | Unknown | 0 | 0 | 0 | 0 | 0 | 0 |
| ≤1.4 | 0 | 2 | 0 | 0 | 0 | 0 | |
| >1.4–1.7 | 0 | 1 | 2 | 0 | 0 | 0 | |
| >1.7–2.1 | 0 | 0 | 0 | 0 | 0 | 0 | |
| >2.1–4.2 | 0 | 1 | 0 | 0 | 0 | 0 | |
| >4.2 | 0 | 0 | 0 | 0 | 0 | 0 | |
| Total ASO (N = 12) | Unknown | 0 | 0 | 0 | 0 | 0 | 0 |
| ≤1.4 | 0 | 2 | 0 | 0 | 0 | 0 | |
| >1.4–1.7 | 0 | 5 | 2 | 0 | 1 | 0 | |
| >1.7–2.1 | 1 | 0 | 1 | 0 | 0 | 0 | |
| >2.1–4.2 | 0 | 0 | 0 | 0 | 0 | 0 | |
| >4.2 | 0 | 0 | 0 | 0 | 0 | 0 | |
Bold values represent the middle line where no change was observed between baseline and the highest confirmed measure in the treatment period.