Table 4 Possible adverse events (AE) found in patients included in the analysis of the efficacy of artemether-lumefantrine (Coartemâ„¢) in the treatment of uncomplicated falciparum malaria in Laos*
Variables | Age groups | |||
|---|---|---|---|---|
|  | All (N = 549) | Children (age ≤ 15 years) (n = 357) | Adults (age > 15 years) (n = 192) | p-value |
At least one adverse event | 114/549 (21%) | 52/357 (15%) | 62/192 (32%) | <0.001 |
Headache | 32/403 (8%) | 13/211 (6%) | 19/192 (10%) | 0.16 |
Insomnia | 31/549 (6%) | 14/357 (4%) | 17/192 (9%) | 0.01 |
Weakness | 29/549 (5%) | 12/357 (3%) | 17/192 (9%) | 0.006 |
Anorexia | 30/549 (5%) | 14/357 (4%) | 16/192 (8%) | 0.03 |
Diarrhoea | 25/549 (5%) | 11/357 (3%) | 14/192 (7%) | 0.02 |
Nightmare | 17/403 (4%) | 4/211 (2%) | 13/192 (7%) | 0.02 |
Abdominal pain | 12/410 (3%) | 5/218 (3%) | 7/192 (4%) | 0.42 |
Dizziness | 11/403 (3%) | 4/211 (2%) | 7/192 (4%) | 0.36 |
Vomiting | 10/549 (2%) | 8/357 (2%) | 2/192 (1%) | 0.32 |
Nausea | 5/403 (1%) | 2/211 (1%) | 3/192 (2%) | 0.67 |
Palpitation | 5/404 (1%) | 0 | 5/192 (3%) | 0.02 |
Itch | 5/549 (1%) | 3/357 (1%) | 2/192 (1%) | 1.00 |
Vertigo | 1/403 (0.25%) | 0 | 1/192 (0.5%) | 0.47 |
Tinnitus | 1/404 (0.25%) | 0 | 1/192 (0.5%) | 0.47 |
Rash | 1/549 (0.2%) | 1/357 (0.3%) | 0 | 1.00 |
Urticaria | 1/549 (0.2%) | 0 | 1/192 (0.5%) | 0.35 |
Irritability | 0 | 0 | 0 | - |
Dyspnoea | 0 | 0 | 0 | - |
Hearing loss | 0 | 0 | 0 | - |