Table 4.
Possible adverse events (AE) found in patients included in the analysis of the efficacy of artemether-lumefantrine (Coartem™) 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 | - |
* Symptoms are given for only those 467 patients aged ≥ 4 years old and able to answer questions about these symptoms, except that parents/guardians were asked about their charges insomnia, weakness, anorexia and itch.