Table 2.
Treatment Group | Largest Change Between Days 0 and 10 | Change From Days 0 to 7 | Change From Days 0 to 28 | Mean Follow-up Day of Largest Change, Mean (95% CI) | |||
---|---|---|---|---|---|---|---|
Percentage (95% CI)a | P b | Percentage (95% CI)a | P b | Percentage (95% CI)a | P b | ||
Part 1 | |||||||
G6PD-n control groupc (n = 7) | −7.89 (−11.4 to −4.37) | −2.13 (−8.10–3.84) | −2.49 (−6.88–1.91) | 7.9 (5.0–10.8) | |||
G6PD-d group, by PQ dose | |||||||
0.40 mg/kg (n = 4) | −16.8 (−24.7 to −8.93) | <.001 | −7.53 (−19.2–4.11) | .009 | −1.00 (−19.4–17.4) | .215 | 7.0 (3.6–10.4) |
0.45 mg/kg (n = 7) | −7.63 (−12.5 to −2.75) | .662 | −4.62 (−10.9–1.68) | .587 | −2.33 (−8.99–4.32) | .638 | 9.4 (1.6–17.2) |
0.50 mg/kg (n = 7) | −9.72 (−13.5 to −5.90) | .320 | −3.77 (−9.77–2.23) | .606 | −0.754 (−6.67–5.16) | .481 | 7.7 (3.9–11.5) |
Part 2 | |||||||
Age 11–17 y | |||||||
G6PD-n group (n = 7) | −6.86 (−11.3 to −2.46) | 0.314 (−3.69–4.31) | −0.662 (−5.23–3.90) | 9.0 (.9–17.1) | |||
G6PD-d group (n = 7) | −11.5 (−16.1 to −6.96) | −6.89 (−10.5 to −3.30) | .006 | −6.59 (−13.5–.300) | .111 | 13.4 (4.0–22.8) | |
Age 5–10 y | |||||||
G6PD-n group (n = 7) | −5.24 (−10.2 to −.252) | 4.46 (−3.01–11.9) | 1.89 (−6.62–10.4) | 7.6 (−1.8–16.9) | |||
G6PD-d group (n = 5) | −9.61 (−16.1 to −3.08) | .199 | 0.017 (−13.2–13.3) | .378 | −1.02 (−11.9–9.89) | .407 | 11.4 (4.1–18.7) |
Part 1 was a PQ dose de-escalation trial in men (age ≥18 years). Part 2 was an age de-escalation trial in boys given 0.40 mg/kg PQ.
Abbreviations: CI, confidence interval; G6PD-d, glucose-6-phosphate dehydrogenase deficient; G6PD-n, glucose-6-phosphate dehydrogenase normal; Hb, hemoglobin.
aNegative values indicate drops in the Hb level.
bAdjusted for baseline Hb level. Within age groups, we used a regression model that adjusted for baseline Hb level to compare G6PD-d and G6PD-n participants.
cReceived 0.50 mg/kg PQ.