Table 4A.
The TIMBER-K and TIMBER-N arms of the study were divided into treatment subgroups using the basal DSR plasma concentration of 3.5 μM. The arms were divided into “high” DSR subgroups (≥3.5 μM), TIMBER-K(H) and TIMBER-P(H) and “normal” DSR subgroups (< 3.5 μM), TIMBER-K(N) and TIMBER-P(N). The effect of Ket on basal DSR plasma concentrations at the end of the Ket infusion (40 min DSR) was examined by the determination of the percent change (%) of DSR concentration in each subject.
| Groups | Subject | Basal DSR (μM) | PCL Baseline | Response (days) | 40 min DSR (μM) | Percent change (%) |
|---|---|---|---|---|---|---|
| TIMBER-K (H) | 3 | 3.5 | 80 | 27 | 2.7 | −21 |
| 4 | 5.0 | 82 | 21 | 3.5 | −30 | |
| 9 | 6.2 | 81 | 20 | 4.7 | −25 | |
| Mean ± SD | 4.9 ± 1.4 | 81.0 ± 1.0 | 22.7 ± 3.8 | 3.6 ± 1.0 | 25 ± 5 | |
| TIMBER-K (N) | 1 | 3.2 | 76 | 71 | 2.8 | −14 |
| 16 | 3.3 | 70 | 55 | 2.4 | −7 | |
| 18 | 1.4 | 78 | 48 | 1.3 | −3 | |
| 20 | 1.6 | 67 | 29 | 1.5 | −3 | |
| 13 | 2.6 | 75 | 25 | 3.1 | +8 | |
| 17 | 3.0 | 67 | 14 | 2.6 | −14 | |
| Mean ± SD | 2.5 ± 0.8 | 72.2 ± 4.8 | 40.3 ± 21.3 | 2.3 ± 0.7 | 8 ± 6 | |
| TIMBER-P (H) | 11 | 3.6 | 60 | 15 | 3.1 | −14 |
| 15 | 4.5 | 75 | 8 | 4.2 | −5 | |
| 5 | 5.0 | 76 | 14 | 4.3 | −14 | |
| 6 | 5.4 | 77 | 4 | 4.8 | −11 | |
| 2 | 6.1 | 77 | 12 | 5.7 | −7 | |
| Mean ± SD | 4.9 ± 0.9 | 73.0 ± 7.3 | 10.6 ± 4.6 | 4.4 ± 0.9 | 10 ± 4 | |
| TIMBER-P (N) | 19 | 1.5 | 76 | 21 | 1.3 | −15 |
| 12 | 1.6 | 66 | 4 | 1.4 | −12 | |
| 10 | 2.3 | 62 | 28 | 1.9 | −16 | |
| 14 | 2.3 | 75 | 18 | 2.2 | −3 | |
| 7 | 3.2 | 60 | 41 | 2.7 | −14 | |
| Mean ± SD | 2.2 ± 0.7 | 67.8 ± 7.4 | 22.4 ± 13.9 | 1.9 ± 0.6 | 12 ± 5 |