TABLE 2.
Measurement | Data for day (time): |
||||||
---|---|---|---|---|---|---|---|
0a | 1 (9 a.m.) | 1 (1 p.m.) | 1 (6 p.m.) | 2b | 4c | 28 | |
Chloroquine concentrations (nmol/L) (95% CI) | 815 (325–1,307) | 2,903 (2,246–3,560) | 2,968 (2,359–3,579) | 3,375 (2,850–3,900) | 2,734 (2,179–3,290) | 3,562 (2,996–4,129) | 122 (87–157) |
QTc0.4 (ms) (95% CI)d | 375 (363–386) | 387 (379–395) | 396 (384–408) | 401 (383–418) | 399 (387–411) | 391 (382–400) | 369 (363–376) |
QTc Bazett (ms) (95% CI) | 400 (390–420) | 410 (400–420) | 420 (410–430) | 420 (400–440) | 420 (410–440) | 410 (400–430) | 390 (380–400) |
ΔQTc0.4 compared to day 0 (median [range]) | 7 (−56 to 52) | 15 (−58 to 64) | 13 (−34 to 59) | 12 (−26 to 46) | 14 (−33 to 38) | −11 (−84 to 23) | |
Heart rate (bpm) (95% CI) | 128 (118–138) | 107 (104–110) | 107 (101–113) | 113 (104–122) | 101 (92–110) | 97 (90–104) | 92 (83–101) |
Systolic blood pressure (95% CI)e | 99 (96–101) | 95 (91–98) | 94 (91–97) | 95 (92–97) | 95 (92–98) | 101 (96–106) | 98 (94–101) |
Diastolic blood pressure (95% CI) | 56 (50–61) | 56 (53–59) | 56 (54–58) | 57 (55–58) | 58 (52–63) | 60 (49–71) | 59 (54–63) |
Mean arterial pressure (95% CI) | 66 (62–70) | 66 (63–68) | 65 (63–67) | 65 (63–67) | 67 (62–71) | 70 (61–79) | 68 (64–71) |
Day 0 values are those determined before/at treatment start.
50 mg/kg group only.
70 mg/kg group only.
QTc0.4 increases of 52, 64, 59, and 47 ms on day 1 (9 a.m., 1 p.m., and 6 p.m.) and day 2, respectively, occurred in the same child. In parallel, the chloroquine concentrations were 1,556, 2,253, 2,809, and 2,225 nmol/liter, respectively, and the heart rate decreased from 135 upon inclusion to 111, 104, 104, and 101 on day 1 (9 a.m., 1 p.m., and 6 p.m.) and day 2, respectively.
Blood pressure was measured as mm/Hg.