Table 4 Adverse event incidence by age group, PZQ 40 mg/kg
Adverse event | Pre-school aged | School-aged | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
No. of study arms | No. of subjects | Incidence (95% CI) | No. of study arms | No. of subjects | Incidence (95% CI) | |||||
% | Lower bound | Upper bound | % | Lower bound | Upper bound | |||||
Any adverse event (at least one) | 1 | 243 | 34.2 | 28.2 | 40.2 | 8 | 1,342 | 54.2 | 37.0 | 72.2 |
Drowsiness | 2 | 503 | 29.1 | 28.0 | 30.1 | 2 | 285 | 42.4 | 35.8 | 49.0 |
Dizziness | 3 | 737 | 22.4 | 1.3 | 33.9 | 13 | 3,132 | 9.3 | 5.4 | 14.1 |
Fatigue | 3 | 737 | 13.3 | 0.9 | 20.9 | 3 | 781 | 13.2 | 0.4 | 28.9 |
Itching/rash | 2 | 503 | 8.6 | 8.0 | 9.1 | 8 | 1,504 | 5.5 | 2.3 | 9.3 |
Nausea | 3 | 737 | 7.8 | 2.1 | 12.6 | 12 | 3,058 | 12.9 | 6.4 | 20.2 |
Abdominal pain | 3 | 737 | 7.2 | 3.0 | 9.4 | 19 | 3,495 | 33.4 | 22.6 | 43.9 |
Vomiting | 3 | 737 | 6.8 | 1.7 | 9.6 | 15 | 2,911 | 7.9 | 3.8 | 13.2 |
Headache | 3 | 737 | 4.4 | 0.4 | 6.7 | 17 | 3,314 | 16.6 | 9.8 | 24.0 |
Diarrhoea | 3 | 737 | 4.3 | 2.6 | 6.3 | 16 | 3,106 | 12.1 | 6.5 | 19.3 |