Table 3.
Artesunate–mefloquine (n=472) | Artemether–lumefantrine (n=472) | |||
---|---|---|---|---|
Completed study | 204 (43·2%) | 202 (42·8%) | ||
Withdrawal from study | 268 (56·8%) | 270 (57·2%) | ||
Reasons for withdrawal* | ||||
Early treatment failure | ||||
Parasitaemia with sign/danger of severe malaria on days 0, 1, or 2 | 2 (0·7%) | 0 | ||
Higher parasitaemia on day 2 than day 0 | 0 | 0 | ||
Parasitaemia on day 3 with axillary temperature of ≥37·5°C | 0 | 0 | ||
Parasitaemia count on day 3 ≥25% than on day 0 | 0 | 0 | ||
Late treatment failure | ||||
Late clinical failure | 61 (22·8%) | 69 (25·6%) | ||
Late parasitological failure | 153 (57·1%) | 142 (52·6%) | ||
Adverse event | 8 (3·0%) | 4 (1·5%) | ||
Serious adverse event | 0 | 2 (0·7%) | ||
Parent or guardian's decision | 12 (4·5%) | 21 (7·8%) | ||
Intake of other antimalarial drugs | 2 (0·7%) | 0 | ||
Intake of antibiotics with antimalarial activity | 2 (0·7%) | 2 (0·7%) | ||
Investigator's decision | 1 (0·4%) | 0 | ||
Lost to follow-up | 25 (9·3%) | 24 (8·9%) | ||
Other reason | 2 (0·7%) | 6 (2·2%) |
Data are n (%).
Percentage values indicate proportion of withdrawals.