Table 4. Solicited adverse events reported 24 hours following PZQ administration (n = 93).
Total no. of reports | Reports graded as severe | ||||||
Organ class | Symptoms | 40 mg/kg | 75 mg/kg | p * | 40 mg/kg | 75 mg/kg | p * |
(n = 40) | (n = 39) | (n = 40) | (n = 39) | ||||
Systemic | Allergic reaction | 1 | 0 | 0.32 | 0 | 0 | |
Fever | 0 | 2 | 0.15 | 0 | 0 | ||
Headache | 27 | 31 | 0.23 | 0 | 0 | ||
Anxiety | 1 | 2 | 0.54 | 0 | 0 | ||
Fatigue | 24 | 28 | 0.27 | 0 | 0 | ||
Vertigo/dizziness | 20 | 23 | 0.42 | 0 | 1 | 0.31 | |
Gastro-intestinal | Nausea | 9 | 12 | 0.41 | 0 | 0 | |
Vomiting | 5 | 11 | 0.08 | 0 | 2 | 0.15 | |
Diarrhea | 7 | 5 | 0.56 | 0 | 0 | ||
Constipation | 2 | 0 | 0.16 | 0 | 0 | ||
Abdominal pain | 23 | 27 | 0.28 | 0 | 0 | ||
Cardiovascular | Palpitations | 4 | 6 | 0.47 | 0 | 0 | |
Hypotension | 1 | 7 | 0.02 | 0 | 0 | ||
Respiratory | Cough | 1 | 1 | 0.99 | 0 | 0 | |
Bronchospasm | 1 | 1 | 0.99 | 0 | 0 | ||
Dyspnea | 1 | 1 | 0.99 | 0 | 0 |
*: according to exact χ2 test.
The two study groups were 40 mg/kg vs. 75 mg/kg divided into 2 doses of 50 mg/kg+25 mg/kg, 4 hours apart.