Table 4.
Solution for fixed effects | Estimate of ddQTc at Cmax of vonoprazan | |||||||
---|---|---|---|---|---|---|---|---|
Intercept | Slope | Vonoprazan 40 mg | Vonoprazan 120 mg | |||||
ECG parameter (ms) | Estimate | P‐Value | Estimate | P‐Value | Estimate | 90% CIa | Estimate | 90% CI |
QTcFb | 0.814 | 0.204 | –0.0117 | 0.00160d | 0.263 | –0.787, 1.31 | –1.83 | –3.39, –0.263 |
QTcB | –0.209 | 0.747 | –0.0190 | ≤.0001e | –1.10 | –2.16, –0.0454 | –4.49 | –6.26, –2.73 |
QTcI | 0.812 | 0.206 | –0.0129 | 0.00140d | 0.204 | –0.853, 1.26 | –2.11 | –3.77, –0.445 |
QTcss | 0.825 | 0.200 | –0.0117 | 0.00160d | 0.274 | –0.781, 1.33 | –1.82 | –3.39, –0.246 |
QT | 2.71 | 0.0217c | 0.00230 | 0.697 | 2.82 | 0.920, 4.72 | 3.24 | 0.541, 5.93 |
CI, confidence interval; Cmax, maximum observed concentration; ddQTc, change from baseline, placebo‐corrected QT; ECG, electrocardiogram; QTcB, QT interval corrected by Bazett's formula; QTcF, QT interval corrected by Fridericia formula; QTcI, QT interval corrected by individual; QTcss, QT interval study specific corrected.
aTwo‐sided 90% CI.
bddQTcF at a particular concentration = 0.8139 – 0.0117 × concentration.
cIndicates statistical significance at the 0.05 level.
dIndicates statistical significance at the 0.01 level.
eIndicates statistical significance at the 0.001 level.