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. 2017 Feb 15;10(3):208–216. doi: 10.1111/cts.12452

Table 4.

Linear relationship between ddQTc and plasma vonoprazan concentration

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.