Table 2. Adverse events of any severity in the different treatment groups in Burkina Faso.
| Treatment Group | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| G6PD Normal | G6PD Deficient | ||||||||||||||
| 0.25 mg/kg PQ + AL (n = 10) |
0.4 mg/kg PQ + AL (n = 10) |
AL only (n = 10) |
0.25mg/kg PQ + AL (n = 20) |
0.4mg/kg PQ + AL (n = 20) |
|||||||||||
| Adverse Event | No. subjectsa | No. AEs | Days after PQ | No. subjects | No. AEs | Days after PQ | No. subjects | No. AEs | Days after ALb | No. subjects | No. AEs | Days after PQ | No. subjects | No. AEs | Days after PQ |
| Abdominal pain | 2 | 2 | 0, 0 | ||||||||||||
| Abscess | 1 | 1 | 1 | ||||||||||||
| Anorexia | 1 | 1 | 0 | ||||||||||||
| Arthralgia | 2 | 2 | 1, 2 | 3 | 4 | 2, 2, 4, 13 | |||||||||
| Bronchitis | 1 | 1 | 1 | 1 | 2 | 4, 26 | 1 | 1 | 12 | 1 | 1 | 7 | |||
| Cough | 1 | 1 | 26 | ||||||||||||
| Constipation | 1 | 1 | 13 | ||||||||||||
| Dizziness | 1 | 1 | 13 | 4 | 4 | 0, 3, 8, 9 | |||||||||
| Dolor at blood draw site | 1 | 1 | 14 | ||||||||||||
| Drowsiness | 1 | 1 | 1 | ||||||||||||
| Dysuria | 2 | 2 | 8, 13 | ||||||||||||
| Enteritis | 1 | 1 | 3 | ||||||||||||
| Fatigue | 1 | 1 | 13 | 2 | 2 | 1, 1 | 1 | 1 | 27 | 1 | 1 | 3 | |||
| Fever | 1 | 1 | 1 | 1 | 1 | 0 | |||||||||
| Gastralgia | 1 | 1 | 12 | ||||||||||||
| Hemoglobinuriac | 1 | 1 | 2 | 2 | 2 | 0, 2 | 1 | 1 | 1 | 4 | 4 | 0, 2, 3, 3 | 2 | 4 | 0, 0, 28, 28 |
| Headache | 1 | 2 | 2, 13 | 2 | 2 | 2, 20 | 2 | 2 | 1, 13 | 6 | 6 | 1, 2, 2, 4, 5, 13 | |||
| Hepatitis B | 1 | 1 | 28 | ||||||||||||
| Low back pain | 1 | 1 | 5 | ||||||||||||
| Myalgia | 1 | 1 | 2 | 2 | 2 | 2, 4 | |||||||||
| Parasitosis | 1 | 1 | 9 | 2 | 2 | 1, 13 | 1 | 1 | 6 | ||||||
| Pharyngitis | 1 | 1 | 14 | ||||||||||||
| Pruritus | 2 | 2 | 0, 13 | ||||||||||||
| Rash | 1 | 1 | 10 | ||||||||||||
| Rhinitis | 2 | 2 | 3, 5 | 2 | 2 | 3, 8 | 3 | 3 | 6, 13, 13 | ||||||
| Superficial mycosis | 1 | 1 | 1 | ||||||||||||
| Tooth pain | 1 | 1 | 4 | ||||||||||||
| Wound on thigh | 1 | 1 | 21 | ||||||||||||
| Total no. subjects experiencing any AE, % | 3 (30%) | 7 | 9 (90%) | 18 | 4 (40%) | 6 | 10 (50%) | 16 | 13 (65%) | 35 | |||||
| Total no. subjects experiencing possible/probable AEs, % | 1 (10%) | 1 | 4 (40%) | 5 | 2 (20%) | 3 | 5 (25%) | 6 | 9 (45%) | 18 | |||||
Abbreviations: G6PD, glucose-6-phosphate dehydrogenase; PQ, primaquine; AL, artemether-lumefantrine; No., number; AE, adverse event.
a Subjects could have more than one adverse event.
b First dose of artemether-lumefantrine.
c Hemoglobinuria was reported as adverse event in combination with a positive urine dipstick. All cases of hemoglobinuria were probably or possibly related to the trial, except for two cases occurring on day 28 in the G6PD-deficient group receiving 0.40 mg/kg PQ.