Table 3.
Most frequent adverse events and serious adverse events during the double-blind treatment phase (safety population)
| DP alone (n=50) | Tafenoquine plus DP (n=50) | Primaquine plus DP (n=50) | |
|---|---|---|---|
| Most frequent adverse events occurring in ≥5% in any treatment group up to day 29* | |||
| Any event | 27 (54%) | 29 (58%) | 22 (44%) |
| Upper respiratory tract infection | 6 (12%) | 6 (12%) | 4 (8%) |
| Electrocardiogram QT prolonged | 4 (8%) | 6 (12%) | 2 (4%) |
| Nasopharyngitis | 3 (6%) | 4 (8%) | 1 (2%) |
| Vomiting | 1 (2%) | 3 (6%) | 0 |
| Chills | 0 | 3 (6%) | 0 |
| Headache | 2 (4%) | 2 (4%) | 3 (6%) |
| Dyspepsia | 1 (2%) | 1 (2%) | 3 (6%) |
| Asthenia | 3 (6%) | 1 (2%) | 1 (2%) |
| Serious adverse events | |||
| Any event | 1 (2%) | 2 (4%) | 2 (4%) |
| Cholelithiasis | 0 | 0 | 1 (2%) |
| Drug-induced liver injury | 0 | 1† (2%) | 0 |
| Hand fracture | 0 | 1 (2%) | 0 |
| Electrocardiogram QT prolonged | 1 (2%) | 0 | 0 |
| Hypertensive urgency | 0 | 0 | 1 (2%) |
Data are n (%). DP=dihydroartemisinin–piperaquine.
*
Only adverse events with an onset up to day 29 are presented. The interpretation of the incidence of adverse events after day 29 is likely to be confounded by medication administered to treat relapses (primaquine plus DP).
†
One patient was diagnosed with grade 1 drug-induced liver injury at the time of their first Plasmodium vivax relapse, 84 days after receiving tafenoquine plus DP.