Table 3.
Safety Outcomes.
| Event | Artemether- Lumefantrine (N = 881) |
Amodiaquine- Artesunate (N = 842) |
Dihydroartemisinin- Piperaquine (N = 855) |
Mefloquine- Artesunate (N = 850) |
| percent of patients | ||||
| Any serious adverse event during 63 days of follow-up |
0.7 | 2.6 | 2.1 | 2.9 |
| Mild | 0 | 0.2 | 0.2 | 0.5 |
| Moderate | 0.2 | 1.3 | 1.2 | 1.5 |
| Severe | 0.2 | 0.7 | 0.5 | 0.5 |
| Life-threatening | 0.2 | 0.4 | 0.2 | 0.5 |
| Specific serious adverse event during 63 days of follow-up |
||||
| Blood disorder | 0 | 0.7 | 0.2 | 0 |
| Moderate | 0 | 0.2 | 0 | 0 |
| Severe | 0 | 0.4 | 0.2 | 0 |
| Life-threatening | 0 | 0.1 | 0 | 0 |
| Moderate abdominal pain | 0 | 0.2 | 0 | 0.1 |
| Severe diarrhea | 0.1 | 0 | 0 | 0 |
| Vomiting | 0 | 0 | 0 | 0.2 |
| Moderate | 0 | 0 | 0 | 0.1 |
| Severe | 0 | 0 | 0 | 0.1 |
| Malaise | 0 | 0.2 | 0 | 0.1 |
| Mild | 0 | 0.2 | 0 | 0 |
| Moderate | 0 | 0 | 0 | 0.1 |
| Moderate adverse drug reaction | 0 | 0 | 0.1 | 0 |
| Infection | 0.5 | 1.0 | 1.1 | 1.5 |
| Mild | 0 | 0 | 0.2 | 0.2 |
| Moderate | 0.2 | 0.8 | 0.8 | 0.9 |
| Severe | 0 | 0.1 | 0 | 0.2 |
| Life-threatening | 0.2 | 0 | 0 | 0.1 |
| Complications of pregnancy and delivery | 0.1 | 0.5 | 0.5 | 0.7 |
| Mild | 0 | 0.1 | 0 | 0 |
| Moderate | 0 | 0 | 0.1 | 0.2 |
| Severe | 0.1 | 0.1 | 0.1 | 0.1 |
| Life-threatening | 0 | 0.2 | 0.2 | 0.4 |
| Mild asthma | 0 | 0 | 0 | 0.1 |
| Any adverse event during 63 days of follow-up | 72.8 | 79.0 | 70.4 | 84.9 |
| Mild | 54.4 | 56.7 | 59.1 | 68.8 |
| Moderate | 18.2 | 21.5 | 11.1 | 15.2 |
| Severe | 0.1 | 0.7 | 0.2 | 0.8 |
| Life-threatening | 0.1 | 0.1 | 0 | 0.1 |
| Any event during first 7 days | 24.3 | 59.5 | 34.2 | 60.7 |
| Any drug-related event | 11.5 | 48.5 | 20.6 | 50.6 |
| Mild | 10.1 | 37.1 | 18.4 | 41.9 |
| Moderate | 1.2 | 11.2 | 2.1 | 8.2 |
| Severe | 0.1 | 0.2 | 0.1 | 0.5 |
| Specific drug-related adverse event* | ||||
| Abdominal pain | 2.7 | 7.1 | 2.1 | 5.3 |
| Mild | 2.2 | 6.3 | 2.0 | 4.2 |
| Moderate | 0.6 | 0.8 | 0.1 | 1.1 |
| Asthenia | 1.8 | 26.6 | 6.8 | 14.2 |
| Mild | 1.6 | 16.7 | 6.0 | 10.4 |
| Moderate | 0.2 | 9.9 | 0.8 | 3.5 |
| Severe | 0 | 0 | 0 | 0.4 |
| Decreased appetite | 0.3 | 8.2 | 2.1 | 7.1 |
| Mild | 0.3 | 7.1 | 2.0 | 6.6 |
| Moderate | 0 | 1.1 | 0.1 | 0.5 |
| Dizziness | 1.2 | 23.5 | 1.6 | 30.6 |
| Mild | 1.2 | 16.2 | 1.4 | 24.2 |
| Moderate | 0 | 7.2 | 0.2 | 6.2 |
| Severe | 0 | 0.1 | 0 | 0.1 |
| Headache | 4.3 | 6.3 | 5.1 | 7.5 |
| Mild | 3.7 | 4.8 | 4.4 | 6.6 |
| Moderate | 0.6 | 1.5 | 0.7 | 0.9 |
| Musculoskeletal pain | 0.8 | 7.2 | 2.6 | 4.5 |
| Mild | 0.8 | 5.8 | 2.3 | 3.2 |
| Moderate | 0 | 1.4 | 0.2 | 1.2 |
| Severe | 0 | 0 | 0 | 0.1 |
| Nausea | 0.9 | 11.5 | 4.0 | 13.9 |
| Mild | 0.9 | 10.6 | 3.7 | 12.6 |
| Moderate | 0 | 1.0 | 0.2 | 1.3 |
| Vomiting | 0.9 | 15.9 | 5.7 | 18.9 |
| Mild | 0.8 | 12.5 | 5.1 | 13.5 |
| Moderate | 0.1 | 3.4 | 0.6 | 5.4 |
| Abnormality in vital sign during treatment† | ||||
| Pulse rate <60 beats/min | 1.1 | 2.1 | 1.6 | 1.5 |
| Diastolic blood pressure <50 mm Hg | 8.4 | 15.1 | 7.7 | 4.7 |
| Systolic blood pressure <90 mm Hg | 5.1 | 12.2 | 6.3 | 4.1 |
*
The specific drug-related adverse events reported here were those that occurred in more than 5% of the patients in at least one treatment group.
†
Abnormality in vital signs during treatment was assessed during days 1, 2, and 3; the percentage of patients shown is the percentage of those with an abnormality on any of these days.