TABLE 3.
Factors associated with QTcP by multilevel univariable and multivariable linear regressiona
| Variable | Univariable linear regression results |
Multivariable linear regression results |
||||
|---|---|---|---|---|---|---|
| No. of patients | Mean difference (95% CI) | P value | No. of patients | Mean difference (95% CI) | P value | |
| Time and treatment type (interaction) | ||||||
| Day peak | ||||||
| AL+ | 70 | Reference | 70 | Reference | ||
| ASMQ | 74 | −0.37 (−5.54 to 4.81) | 0.89 | 76 | 2.45 (−4.20 to 9.10) | 0.47 |
| DP | 79 | 17.49 (12.37 to 22.62) | <0.001 | 79 | 17.84 (11.58 to 24.10) | <0.001 |
| CHQ | 15 | 13.62 (5.41 to 21.82) | 0.001 | 14 | 18.31 (8.78 to 27.84) | <0.001 |
| Day 7 | ||||||
| AL+ | 64 | Reference | 64 | Reference | ||
| ASMQ | 66 | −0.05 (−5.54 to 5.44) | 0.99 | 67 | −0.05 (−5.59 to 5.48) | 0.99 |
| DP | 62 | −4.06 (−9.53 to 1.42) | 0.15 | 62 | −5.11 (−10.70 to −0.48) | 0.07 |
| CHQ | 20 | −0.13 (−7.72 to 7.45) | 0.97 | 20 | 1.07 (−6.64 to 8.77) | 0.79 |
| Day (for AL+) | ||||||
| 0 | 83 | Reference | 83 | Reference | ||
| Peak | 64 | 6.28 (2.49 to 10.06) | 0.001 | 64 | 6.78 (1.36 to 12.19) | 0.01 |
| 7 | 70 | 3.57 (−0.44 to 7.57) | 0.081 | 70 | 5.64 (0.76 to 10.52) | 0.02 |
| Age | 748 | 0.53 (0.25 to 0.81) | <0.001 | 720 | 0.53 (0.24 to 0.81) | <0.001 |
| Gravidity | 748 | 1.76 (0.80 to 2.73) | <0.001 | |||
| Height | 748 | 0.06 (−0.29 to 0.42) | 0.72 | |||
| Smoking | 154/748 | 0.78 (−4.21 to 5.77) | 0.76 | |||
| EGA | 748 | −0.43 (−0.65 to −0.21) | <0.001 | 720 | −0.40 (−0.62 to −0.18) | <0.001 |
| Weight | 745 | 0.004 (−0.25 to 0.26) | 0.97 | |||
| Fever (>37.5°C) | 80/683 | 2.57 (−1.68 to 6.82) | 0.24 | |||
| Body temperature | 679 | −1.47 (−4.07 to 1.13) | 0.27 | |||
| Heart rate | 748 | 0.07 (−0.03 to 0.16) | 0.18 | |||
| Hematocrit | 584 | −0.33 (−0.78 to 0.12) | 0.15 | |||
| Malaria species infection | ||||||
| Negative | 438 | Reference | ||||
| P. falciparum monoinfection | 110 | 0.09 (−5.58 to 5.77) | 0.97 | |||
| P. vivax monoinfection | 192 | −1.35 (−7.35 to 4.66) | 0.66 | |||
| P. falciparum plus P. vivax | 5 | −3.71 (−18.42 to 11.00) | 0.62 | |||
| P. malariae monoinfection | 1 | 0.47 (−30.77 to 31.70) | 0.98 | |||
| Asexual parasitemia | 746 | 0.12 (0.03 to 0.21) | 0.007 | 720 | 0.11 (0.02 to 0.19) | 0.02 |
| Gametocytemia | 135/747 | 135/720 | ||||
| Between women | 16.63 (6.17 to 27.10) | 0.002 | 13.53 (3.17 to 23.90) | 0.01 | ||
| Within the same woman | −0.79 (−4.77 to 3.19) | 0.70 | −1.08 (−5.06 to 2.91) | 0.60 | ||
| Anorexia | 135/721 | |||||
| Between women | 8.80 (1.69 to 15.92) | 0.02 | ||||
| Within the same woman | −2.10 (−6.27 to 2.08) | 0.33 | ||||
| Vomiting | 55/723 | 5.23 (0.41 to 10.06) | 0.03 | |||
| Diarrhea | 5/722 | 27.49 (12.25 to 42.73) | <0.001 | 5/720 | 23.16 (8.18 to 38.14) | 0.002 |
| Time ECG assessed | ||||||
| 0:00 to 5:59 | 39 | 2.31 (−4.28 to 8.91) | 0.49 | 36 | 3.13 (−3.68 to 9.93) | 0.37 |
| 6:00 to 11:59 | 313 | −1.69 (−4.78 to 1.40) | 0.29 | 296 | −0.32 (−3.47 to 2.83) | 0.84 |
| 12:00 to 17:59 | 309 | Reference | 302 | Reference | ||
| 18:00 to 23:59 | 87 | −2.07 (−6.74 to 2.60) | 0.39 | 86 | −2.85 (−7.49 to 1.79) | 0.23 |
a
AL+, extended artemether-lumefantrine; ASMQ, artesunate-mefloquine; CHQ, chloroquine; CI, confidence interval; DP, dihydroartemisinin-piperaquine; ECG, electrocardiogram; EGA, estimated gestational age. P value by Wald test. Random-slope models were used for accounting for within-person correlation. Day and interaction between day and treatment were included in the models as forced variables. Multivariable model includes all the variables listed in the column.