TABLE 6.
Treatment-emergent adverse events suspected to be related to the study treatment administration (ITT population)
| System organ class and preferred term | No. and % of patients in each DHA/PQP treatment group |
|||
|---|---|---|---|---|
| Dispersible tablet (n = 199) |
Crushed tablet (n = 99) |
|||
| n | % | n | % | |
| Patient with at least one TEAEa | 67 | 33.7 | 42 | 42.4 |
| Blood and lymphatic system disorders | ||||
| Anemia | 1 | 0.5 | 0 | 0.0 |
| Thrombocytosis | 1 | 0.5 | 0 | 0.0 |
| Gastrointestinal disorders | ||||
| Diarrhea | 0 | 0.0 | 2 | 2.0 |
| Vomiting | 45 | 22.6 | 31 | 31.3 |
| Nausea | 1 | 0.5 | 0 | 0.0 |
| Salivary hypersecretion | 3 | 1.5 | 1 | 1.0 |
| General disorders and administration site conditions | ||||
| Pyrexia | 0 | 0.0 | 1 | 1.0 |
| Infections and infestations | ||||
| Gastroenteritis | 1 | 0.5 | 2 | 2.0 |
| Malaria | 1 | 0.5 | 0 | 0.0 |
| Investigations | ||||
| Electrocardiogram QTcF prolonged (>60 ms) | 23 | 11.6 | 15 | 15.2 |
| Metabolism and nutrition disorders | ||||
| Decreased appetite | 1 | 0.5 | 1 | 1.0 |
| Respiratory, thoracic, and mediastinal disorders | ||||
| Cough | 1 | 0.5 | 0 | 0.0 |
| Skin and subcutaneous tissue disorders | ||||
| Papulosquamous rash | 0 | 0.0 | 1 | 1.0 |
a
TEAE, treatment-emergent adverse event.