Table 2.
Analysis of maximum increase from baseline in QTcI interval (msec) within 1-h postdose.
| Parameter | Placebo | Lumason 0.1 ml/kg | Lumason 0.5 ml/kg |
|---|---|---|---|
| (N = 48) | (N = 48) | (N = 48) | |
| Baselinea | |||
| Mean (SD) | 404.6 (22.7) | 403.9 (24.5) | 401.8 (23.0) |
| Median | 404.5 | 399.0 | 401.0 |
| Range (Min—Max) | 362–456 | 366–465 | 360–451 |
| Maximum Postdose Valueb | |||
| Mean (SD) | 422.9 (21.9) | 420.7 (26.4) | 419.3 (23.0) |
| Median | 420.5 | 414.0 | 417.0 |
| Range (Min—Max) | 385–475 | 373–486 | 377–468 |
| Maximum Increase from Baselinec | |||
| LS Mean Change (SE) | 18.4 (1.3) | 16.8 (1.3) | 17.5 (1.3) |
| 95% CI for LS Mean Change | (15.9, 20.8) | (14.3, 19.2) | (15.0, 20.0) |
| Lumason—Placebo | |||
| Difference in LS Mean Change (SE) | –1.60 (1.60) | –0.85 (1.60) | |
| 95% CI for Difference of LS Mean Change | (–4.79, 1.58) | (–4.04, 2.33) | |
| Lumason 0.5 ml/kg—Lumason 0.1 ml/kg | |||
| Difference in LS Mean Change (SE) | 0.75 (1.60) | ||
| 95% CI for Difference of LS Mean Change | (–2.43, 3.93) | ||
QTc Interval Normal Range: 320–440 msec.
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 dose and period as fixed effects and subject as random effect.