TABLE 3.

Final model of the change in QTcF after dose^a

Parameter	Value (% RSE)
Typical ΔQTcF in all participants, θTYP (ms)	3.7 (44.6)
Effect of taking both clofazimine and moxifloxacin on ΔQTcF, θCFZ+MFX (ms)	13.0 (55.4)
Effect of age on ΔQTcF, θage (ms/yr)	1.3 (24.6)
Effect of predose QTcF on ΔQTcF, ${\theta }_{{\text{QTcF}}_0}$ (ms/10 ms)	−3.4 (14.0)
Between-subject variability, ηBSV (ms)	7.2 (20.8)
Between-occasion variability, ηBOV (ms)	9.2 (12.8)
Residual additive error, ε (ms)	11.1 (4.2)

^a

Abbreviations: RSE, relative standard error; ΔQTcF, change in QTcF (ms) after drug administration; QTcF, QT interval corrected by Fridericia formula; ΔQTcF values after drug administration for levofloxacin-based regimens (ΔQTcF_LFX) and moxifloxacin- or clofazimine-based regimens (ΔQTcF_MFX/CFZ) were described as a function of age (θ_age), predose QTcF (i.e., QTcF at time zero [QTcF₀]), and concomitant drug use as described below:

$${\Delta \text{QTcF}}_{\text{LFX}}\hspace{0.17em}\text{=}\hspace{0.17em}{\theta }_{\text{TYP}}\hspace{0.17em}+\hspace{0.17em}{\theta }_{\text{age}}\hspace{0.17em}\times \hspace{0.17em}\left(\text{age}-2.83\right)\hspace{0.17em}+\hspace{0.17em}{\theta }_{{\text{QTcF}}_{\text{0}}}\hspace{0.17em}\times \hspace{0.17em}\left(\frac{{\text{QTcF}}_0-363}{\text{10}}\right)\hspace{0.17em}+\hspace{0.17em}{\eta }_{\text{BSV}}\hspace{0.17em}+\hspace{0.17em}{\eta }_{\text{BOV}}\hspace{0.17em}+\hspace{0.17em}\epsilon$$

$${\Delta \text{QTcF}}_{\text{MFX/CFZ}}\hspace{0.17em}=\hspace{0.17em}{\theta }_{\text{TYP}}\hspace{0.17em}\times \hspace{0.17em}\left(\text{1}\hspace{0.17em}+\hspace{0.17em}{\theta }_{\text{CFZ+MFX}}\right)\hspace{0.17em}+\hspace{0.17em}{\theta }_{\text{age}}\hspace{0.17em}\times \hspace{0.17em}\left(\text{age}\hspace{0.17em}-\hspace{0.17em}2.83\right)\hspace{0.17em}+\hspace{0.17em}{\theta }_{{\text{QTcF}}_0}\hspace{0.17em}\times \hspace{0.17em}\left(\frac{{\text{QTcF}}_{\text{0}}\hspace{0.17em}-\hspace{0.17em}\text{363}}{\text{10}}\right)\hspace{0.17em}+{\text{η}}_{\text{BSV}}\hspace{0.17em}+{\text{η}}_{\text{BOV}}\hspace{0.17em}+\hspace{0.17em}\epsilon$$