Table 4.
Adverse events occurring in more than 5% of patients, by study period
| Artesunate–mefloquine | Artemether–lumefantrine | ||
|---|---|---|---|
| First 63-day follow-up | |||
| Number of patients | 468 | 465 | |
| Blood and lymphatic system disorders | |||
| Anaemia | 130 (27·8%) | 104 (22·4%) | |
| Gastrointestinal disorders | |||
| Diarrhoea | 57 (12·2%) | 43 (9·2%) | |
| Vomiting | 69 (14·7%) | 77 (16·6%) | |
| General disorders and administration site conditions | |||
| Pyrexia | 34 (7·3%) | 22 (4·7%) | |
| Infections and infestations | |||
| Bronchitis | 56 (12·0%) | 52 (11·2%) | |
| Gastroenteritis | 27 (5·8%) | 19 (4·1%) | |
| Pneumonia | 24 (5·1%) | 21 (4·5%) | |
| Rhinitis | 41 (8·8%) | 48 (10·3%) | |
| Tinea capitis | 38 (8·1%) | 19 (4·1%) | |
| Upper respiratory tract infection | 93 (19·9%) | 87 (18·7%) | |
| Metabolism and nutrition disorders | |||
| Decreased appetite | 34 (7·3%) | 23 (4·9%) | |
| Respiratory, thoracic, and mediastinal disorders | |||
| Cough | 98 (20·9%) | 92 (19·8%) | |
| Rhinorrhoea | 40 (8·5%) | 30 (6·5%) | |
| Skin and subcutaneous tissue disorders | |||
| Rash | 32 (6·8%) | 22 (4·7%) | |
| Second 63-day follow-up after treatment with the alternative test treatment | |||
| Number of patients | 192 | 171 | |
| General disorders and administration site conditions | |||
| Pyrexia | 10 (5·2%) | 4 (2·3%) | |
| Infections and infestations | |||
| Bronchitis | 6 (3·1%) | 9 (5·3%) | |
| Rhinitis | 5 (2·6%) | 12 (7·0%) | |
| Upper respiratory tract infection | 19 (9·9%) | 16 (9·4%) | |
| Respiratory, thoracic, and mediastinal disorders | |||
| Cough | 18 (9·4%) | 15 (8·8%) | |
| Second 63-day follow-up after treatment with antimalarial other than artesunate–mefloquine or artemether–lumefantrine | |||
| Number of patients | 33 | 48 | |
| Blood and lymphatic system disorders | |||
| Anaemia | 2 (6·1%) | 1 (2·1%) | |
| Gastrointestinal disorders | |||
| Diarrhoea | 1 (3·0%) | 3 (6·3%) | |
| Infections and infestations | |||
| Malaria | 4 (12·1%) | 3 (6·3%) | |
Data are n (%). Data show adverse events occurring in more than 5% of patients during the first follow-up (up to day 63 or until the day before start of rescue treatment); the second follow-up of patients receiving, as rescue treatment, the alternative investigated drug; and the second follow-up of patients receiving, as rescue treatment, an antimalarial drug other than the alternative investigated drug.