Table 3.
Cumulative adverse events related to tolerability during the three days of treatment for both study cohorts (AL or ASAQ) at various sites in Mozambique
| Study site | ||||||
|---|---|---|---|---|---|---|
|
Cohort 1: Artemether-lumefantrine |
Montepuez |
Dondo |
Chokwe |
Manhiça |
Tete |
TOTAL |
|
Variable |
N = 88 |
N = 88 |
N = 86 |
N = 89 |
N = 88 |
N = 439 |
| Vomiting post dosing 1,2 or 3 n (%) |
1 (1.1) |
4 (3.2) |
1 (1.1) |
10 (11.2) |
4 (3.2) |
20 (4.5) |
| Diarrhoea n (%) |
0 (0) |
0 (0) |
0 (0) |
0 (0) |
1 (1.1) |
1 (0.2) |
| Weakness n (%) |
0 (0) |
0 (0) |
0 (0) |
0 (0) |
1 (1.1) |
1 (0.2) |
| Pruritus n (%) |
0 (0) |
0 (0) |
0 (0) |
0 (0) |
0 (0) |
0 (0) |
| Urticaria n (%) |
1 (1.1) |
0 (0) |
0 (0) |
1 (1.1) |
0 (0) |
2 (0.5)* |
|
Cohort 2: Artesunate-amodiaquine |
Montepuez |
Dondo |
Chokwe |
Manhiça |
Tete |
TOTAL |
|
Variable |
N = 87 |
N = 87 |
N = 87 |
N = 0 |
N = 0 |
N = 261 |
| Vomiting post dosing 1,2 or 3 n (%) |
11 (12.6) |
3 (3.5) |
11 (12.6) |
NA |
NA |
25 (9.6) |
| Diarrhoea n (%) |
0 (0) |
0 (0) |
6 (6.9) |
NA |
NA |
6 (2.3) |
| Weakness n (%) |
0 (0) |
0 (0) |
3 (3.5) |
NA |
NA |
3 (1.1) |
| Pruritus n (%) |
0 (0) |
0 (0) |
2 (2.3) |
NA |
NA |
2 (0.8) |
| Urticaria n (%) | 0 (0) | 0 (0) | 4 (4.6) | NA | NA | 4 (0.9)** |
*Urticaria in AL group deemed NOT related with study medication in both cases.
**Urticaria in AS-AQ deemed related to study medication in one of these 4 cases.
NA: Not applicable.