Table 3.
Analysis of maximum increase from baseline in QTcI interval (msec) within 1-h postdose.
| Parameter | Placebo MI 0.4 |
Placebo MI 1.5 |
Lumason MI 0.4 | Lumason MI 1.5 |
|---|---|---|---|---|
| (N = 50) | (N = 50) | (N = 50) | (N = 50) | |
| Baselinea | ||||
| Mean (SD) | 403.0 (24.0) | 402.4 (24.1) | 401.1 (24.7) | 402.1 (23.8) |
| Median | 400.0 | 397.0 | 399.5 | 400.0 |
| Min—Max | 358–454 | 360–460 | 349–454 | 363–458 |
| Maximum Postdose Valueb | ||||
| Mean (SD) | 421.4 (26.8) | 420.0 (26.5) | 420.0 (26.4) | 418.8 (25.7) |
| Median | 419.0 | 418.0 | 420.5 | 415.0 |
| Min—Max | 364–487 | 378–486 | 365–475 | 375–480 |
| Maximum Increase from Baselinec | ||||
| LS Mean Change (SE) | 18.5 (1.3) | 17.7 (1.3) | 18.9 (1.3) | 16.7 (1.3) |
| 95% CI for LS Mean Change | (15.8, 21.1) | (15.0, 20.3) | (16.3, 21.6) | (14.0, 19.3) |
| Placebo MI 0.4– Lumason MI 0.4 | ||||
| Difference in LS Mean Change (SE) | −0.49 (1.59) | |||
| 95% CI for Difference of LS Mean Change | (−3.63, 2.66) | |||
| Placebo MI 1.5– Lumason MI 1.5 | ||||
| Difference in LS Mean Change (SE) | 1.03 (1.59) | |||
| 95% CI for Difference of LS Mean Change | (−2.11, 4.18) | |||
QTc Interval Normal Range: 320-440 msec.
Only 50 of 53 enrolled patients were evaluated. Three patients were excluded from the analysis population due to technically inadequate ECG data.
MI, Mechanical Index; QTcI, Individual subject corrected QT interval; SD, Standard deviation; SE, Standard error; LS, Least squares; CI, Confidence interval; Min, Minimum; Max, Maximum.
a
Baseline is the mean of all technically adequate recorded values from 3 h predose to immediately predose.
b
Postdose value from +1 min to +1 h where the maximum increase from baseline occurred.
c
Based on an ANOVA model including treatment and period as fixed effects and subject as random effect.