Table 1.
Prevalence at baseline and cumulative occurrence of different signs and symptoms according to treatment group and cohorta
| Sign, symptom, or parameter | Children age 5–10 yr |
Children age 1–5 yr |
|||||||
|---|---|---|---|---|---|---|---|---|---|
| Baseline |
P valueb | Days 1–14 (cumulative) |
P valueb | n/141 (%) at baseline for group 3 (ART + PQ) | n/141 (%) at days 1–14 for group 3 (ART + PQ) | P valuec | |||
| n/252 (%) for group 1 (CQ + PQ) | n/259 (%) for group 2 (CQ + placebo) | n/252 (%) for group 1 (CQ + PQ) | n/259 (%) for group 2 (CQ + placebo) | ||||||
| Signs and symptoms | |||||||||
| Feverd | 29 (11.5) | 24 (9.3) | 0.41 | 11 (4.4) | 10 (3.9) | 0.83 | 26 (18.4) | 11 (7.8) | 0.16 |
| Yellow sclera | 0 | 0 | 3 (2.1) | 0.043 | |||||
| Dizziness | 0 | 1 (0.4) | 1.00 | 0 | 2 (0.8) | 0.50 | 1 (0.7) | 0.36 | |
| Headache | 5 (2.0) | 6 (2.3) | 0.80 | 8 (3.2) | 10 (3.9) | 0.81 | 2 (1.4) | 4 (2.8) | 0.85 |
| Earache | 2 (0.8) | 0 | 0.24 | 0 | |||||
| Tiredness | 1.00 | 5 (2.0) | 7 (2.7) | 0.77 | 5 (3.6) | 0.35 | |||
| Itchiness | 3 (1.2) | 1 (0.4) | 0.37 | 1 (0.7) | 1.00 | ||||
| Skin rash | 1 (0.4) | 1 (0.4) | 1.00 | 2 (1.3) | 1.00 | ||||
| Chest tightness | 1 (0.4) | 0 | 0.49 | 0 | |||||
| Cough | 13 (5.2) | 13 (5.0) | 0.94 | 19 (7.5) | 16 (6.2) | 0.60 | 16 (11.4) | 17 (12.1) | 0.15 |
| Shortness of breath | 1 (0.4) | 3 (1.2) | 0.62 | 1 (0.4) | 1 (0.4) | 1.00 | 2 (1.4) | 2 (1.4) | 0.30 |
| Nausea | 1 (0.4) | 0 | 0.49 | 8 (3.2) | 5 (1.9) | 0.42 | 4 (2.8) | 4 (2.8) | 0.85 |
| Vomiting | 0 | 1 (0.4) | 1.00 | 6 (2.4) | 3 (1.2) | 0.33 | 0 | 2 (1.4) | 0.72 |
| Stomachache | 0 | 0 | 1 (0.4) | 0 | 0.49 | 2 (1.4) | 6 (4.3) | 0.010 | |
| Diarrhea | 0 | 0 | 1 (0.4) | 2 (0.8) | 1.00 | 4 (2.8) | 2 (1.4) | 0.30 | |
| Myalgia | 1 (0.4) | 0 | 0.49 | 2 (1.4) | 0.30 | ||||
| Any sign or symptom | 30 (11.9) | 25 (9.7) | 0.41 | 29 (11.5) | 26 (10.0) | 0.67 | 30 (21.3) | 27 (19.2) | 0.05 |
| Laboratory measures | |||||||||
| Mean hemoglobin (gl/dl)e | 10.8 | 10.9 | 0.71 | 10.3 | 10.5 | 0.007 | 9.31 | 9.81 | |
| ΔHb | −0.56 | −0.34 | 0.24 | 0.48 | |||||
| CI95 | −0.29 to −0.81 | −0.59 to −0.08 | 0.30 to 0.66 | ||||||
a
ART, artesunate; CQ, chloroquine; PQ, primaquine; CI95, 95% confidence interval. Only limited clinical assessment was conducted at baseline for the cohort of children 1 to 5 years of age.
b
P value for comparison of groups 1 and 2.
c
P value for comparison of groups 1 and 3 for days 1 to 14 (cumulative).
d
Axillary temperature >37.5°C or reported fever.
e
Hemoglobin levels assessed at baseline and day 8 (5 to 10 years of age) and day 14 (1 to 5 years of age) of follow-up.