Table 1. Demographics and baseline characteristics.
| Asia (n=2359) | Africa (n=11 809) | South America (n=159)* |
Overall (n=14 327) | |
|---|---|---|---|---|
| Study period | 1998–2010 | 2002–12 | 2007–08 | 1998–2012 |
| Sex† | ||||
| Female | 929 (39%) | 5538 (47%) | 63 (40%) | 6530 (46%) |
| Male | 1430 (61%) | 5973 (51%) | 96 (60%) | 7499 (52%) |
| Age, years | ||||
| Median (range) | 16·0 (0·5–80·0) | 3·5 (0·0–77·0) | 23·0 (12·0–56·0) | 4·0 (0·0–80·0) |
| <1 | 6 (<1%) | 809 (7%) | 0 | 815 (6%) |
| 1 to <5 | 373 (16%) | 6960 (59%) | 0 | 7333 (51%) |
| 5 to <12 | 503 (21%) | 2477 (21%) | 0 | 2980 (21%) |
| ≥12 | 1477 (63%) | 1563 (13%) | 159 (100%) | 3199 (22%) |
| Weight, kg | ||||
| Median (range) | 41·0 (6·0–88·0) | 13·7 (5·0–102·0) | 64·0 (30·0–110·0) | 15·0 (5·0–110·0) |
| 5 to <10 | 61 (3%) | 2013 (17%) | 0 | 2074 (14%) |
| 10 to <15 | 334 (14%) | 4623 (39%) | 0 | 4957 (35%) |
| 15 to <25 | 404 (17%) | 2992 (25%) | 0 | 3396 (24%) |
| 25 to <35 | 206 (9%) | 753 (6%) | 4 (3%) | 963 (7%) |
| 35 to <70 | 1341 (57%) | 1278 (11%) | 105 (66%) | 2724 (19%) |
| ≥70 | 13 (1%) | 150 (1%) | 50 (31%) | 213 (1%) |
| Treatment supervision‡ | ||||
| Full | 1824 (77%) | 9086 (77%) | 159 (100%) | 11 069 (77%) |
| Partial | 373 (16%) | 1563 (13%) | 0 | 1936 (14%) |
| Unsupervised | 162 (7%) | 1160 (10%) | 0 | 1322 (9%) |
| Treatment coadministration | ||||
| With fatty meal | 656 (28%) | 5635 (48%) | 159 (100%) | 6450 (45%) |
| Without fatty meal | 0 | 1191 (10%) | 0 | 1191 (8%) |
| Advised to consume with fat | 820 (35%) | 1326 (11%) | 0 | 2146 (15%) |
| Not stated | 883 (37%) | 3657 (31%) | 0 | 4540 (32%) |
| Drug tradename | ||||
| Coartem (Novartis) | 2359 (100%) | 11 126 (94%) | 159 (100%) | 13 644 (95%) |
| Coartem dispersible (Novartis) | 0 | 431 (4%) | 0 | 431 (3%) |
| Co-artesiane (Dafra, Turnhout, Belgium) | 0 | 134 (1%) | 0 | 134 (1%) |
| Atrin (LIC Pharmaceuticals, Abidjan, Côte d’Ivoire) | 0 | 118 (1%) | 0 | 118 (1%) |
| Enrolment clinical variables | ||||
| Parasitaemia, parasites per μL | 9559 (13–450 440) | 21 360 (16–420 360) | 4241 (1008–44 744) | 19 921 (13–450 440) |
| Parasitaemia >100 000/μL | 226 (10%) | 1131 (10%) | 0 | 1357 (9%) |
| Mixed infection with Plasmodium vivax | 134 (6%) | 0 | 0 | 134 (1%) |
| Haemoglobin, g/L | 114 (25·8) | 101 (21·2) | NR | 104 (22·9) |
| Anaemic, haemoglobin <100 g/L | 600/2179 (28%) | 4030/8287 (49%) | NR | 4630/10 466 (44%) |
| Gametocytes present | 128/1118 (11%) | 541/7850 (7%) | 10 (6%) | 679/9127 (7%) |
| Fever, temperature >37·5°C | 1199/2195 (55%) | 6973/10 854 (64%) | 103 (65%) | 8275/13 208 (63%) |
| Children underweight for age§ | 173/471 (37%) | 1352/7825 (17%) | NR | 1525/8296 (18%) |
Data are number (%), median (IQR), or mean (SD), unless otherwise specified. Some percentages do not add up to 100 because of rounding. NR=not reported.
*
Data from one study done in Colombia.
†
Data were not available for 298 patients from Africa.
‡
Patients with only morning daily doses supervised and evening doses taken at home with no supervision were classified as partly supervised. Patients were classified as unsupervised if all six doses were unobserved or if the first dose was observed at the clinic with remaining five doses unobserved.
§
Defined using a weight-for-age score <−2 in children <5 years of age. Scores outside the range −6 to 6 were treated as outliers.