TABLE 3.
QTcS—Study‐specific correction (ms) | QTcF—Fridericia correction (ms) | QTcB—Bazett correction (ms) | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Univariable analyses | Multivariable analyses | Univariable analyses | Multivariable analyses | Univariable analyses | Multivariable analyses | ||||||||
Number of observations | Crude estimate (95% CI) | P value | Adjusted estimate (95% CI) | P value | Crude estimate (95% CI) | P value | Adjusted estimate (95% CI) | P value | Crude estimate (95% CI) | P value | Adjusted estimate (95% CI) | P value | |
Total plasma concentration of amodiaquine and desethylamodiaquine, per 750 a nmol/L increase | 356 | 12.98 (8.73–17.16) | <.0001 | 10.43 (5.92–15.00) | <.0001 | 20.35 (15.56–25.15) | <.0001 | 10.67 (6.13–15.21) | <.0001 | 6.10 (1.80–10.38) | .0055 | 10.26 (5.71–14.81) | <.0001 |
Body temperature change, per 1°C increase | 356 | −5.30 (−7.12 to −3.47) | <.0001 | −3.97 (−6.49 to −1.46) | .0021 | −10.59 (−12.52 to −8.65) | <.0001 | −4.04 (−6.57 to −1.52) | .0018 | −0.374 (−2.25 to 1.50) | .6948 | −3.90 (−6.43 to −1.37) | .0026 |
Sex | 356 | ||||||||||||
Female | 187 | Reference | Reference | Reference | Reference | Reference | Reference | ||||||
Male | 169 | −16.24 (−25.48 to −7.00) | .0009 | −17.35 (−26.62 to −8.08) | .0004 | −12.72 (−22.11 to −3.34) | .0088 | −13.30 (−22.94 to −3.66) | .0078 | −19.54 (−29.00 to −10.08) | .0001 | −21.05 (−30.57 to −11.52) | <.0001 |
Age, per 10‐year increase | 356 | 2.33 (−0.25 to 0.71) | .3339 | 4.16 (−0.17 to 8.49) | .0595 | 2.87 (−1.78 to 7.52) | .2209 | 4.47 (−0.30 to 8.98) | .0515 | 1.78 (−3.32 to 6.88) | .4859 | 3.87 (−0.57 to 8.32) | .0864 |
RR interval change, per 300 b ms increase | 356 | 7.50 (4.46–10.54) | <.0001 | −0.42 (−4.80 to 3.95) | .8475 | 19.69 (16.65–22.74) | <.0001 | 11.63 (7.25–16.01) | <.0001 | −3.69 (−6.75 to −0.65) | .0177 | −11.45 (−15.84 to −7.06) | <.0001 |
where RR is in units of s.
Mean maximum total plasma drug concentration (rounded) after a 3‐day course of amodiaquine from pharmacokinetic analysis of same study.
Mean change in RR interval from baseline (rounded) after last dose of amodiaquine treatment in this study.
CI, confidence interval.