Table 3.
Estimated means and confidence intervals of the effect of placebo and trabectedin on the QTcB interval (ms) in patients with advanced solid tumor malignancies treated with a single dose of 1.3 mg/m2 trabectedin (3-h infusion) (evaluable analysis set)
| N | Scheduled time | Arithmetic mean trabectedin concentration (ng/ml) | Arithmetic mean (ms) (95% CI) | Arithmetic Mean CFB (ms) (95% CI) | Placebo-adjusted LS mean CFB (ms) (90% CI) |
|---|---|---|---|---|---|
| Placebo (Day 1) | |||||
| n = 74 | Predose | – |
426.3 (422.3;430.3) |
– | – |
| n = 74 | 1 h | – |
425.1 (420.9;429.3) |
−1.2 (−3.4;1.0) |
– |
| n = 74 | 2 h | – |
428.0 (423.4;432.5) |
1.7 (−0.7;4.0) |
– |
| n = 74 | 2 h 45 min | – |
430.4 (426.1;434.7) |
4.1 (1.7;6.4) |
– |
| n = 74 | 4 h | – |
435.4 (431.3;439.5) |
9.1 (6.4;11.8) |
– |
| n = 74 | 6 h | – |
435.5 (431.0;440.0) |
9.2 (6.6;11.7) |
– |
| n = 73 | 8 h | – |
433.3 (429.0;437.6) |
6.7 (4.1;9.4) |
– |
| n = 74 | 24 h | – |
426.4 (422.3;430.4) |
0.1 (−2.3;2.4) |
– |
| Trabectedin 1.3 mg/m2 (Day 2) | |||||
| n = 74 | Predose | – |
426.4 (422.3;430.4) |
– | – |
| n = 74 | 1 h | 7.15 |
423.7 (419.6;427.9) |
−2.6 (−5.4;0.1) |
−1.4 (−4.04;1.23) |
| n = 74 | 2 h | 8.07 |
426.0 (421.7;430.3) |
−0.3 (−3.1;2.4) |
−2.0 (−4.65;0.65) |
| n = 72 | 2 h 45 min | 6.98 |
430.8 (426.4;435.1) |
4.0 (1.3;6.6) |
−0.1 (−2.66;2.50) |
| n = 72 | 4 h | 1.70 |
439.1 (435.4;442.7) |
12.5 (9.6;15.4) |
3.4 (0.07;6.65) |
| n = 73 | 6 h | 0.909 |
439.0 (435.3;442.7) |
12.4 (9.8;15.0) |
3.2 (0.56;5.92) |
| n = 73 | 8 h | 0.690 |
435.9 (432.0;439.8) |
9.3 (6.7;11.9) |
2.6 (−0.38;5.63) |
| n = 73 | 24 h | 0.443 |
425.1 (420.8;429.4) |
−1.5 (−4.7;1.7) |
−1.6 (−4.83;1.72) |
Sample sizes provided in the table refer to the QTcB results. The descriptive statistical analyses of the trabectedin concentrations included 67–73 patients at each time point
CFB change from base line, CI confidence interval, ms milliseconds