Table 3. Most common adverse events overall (regardless of causality) occurring in at least two patients in either treatment group (intention-to-treat/safety population).
| Adverse event, n (%) | Tafenoquine (N = 46) | Chloroquine/ primaquine (N = 24) |
|---|---|---|
| ANY EVENT | 46 (100.0) | 22 (91.7) |
| Blood and lymphatic disorders | ||
| Eosinophilia | 8 (17.4) | 7 (29.2) |
| Thrombocytopenia | 6 (13.0) | 0 |
| Anemia | 2 (4.3) | 0 |
| Eye disorders | ||
| Keratopathy* | 14 (31.8) | 0 |
| Retinopathy/retinal disorder* | 10 (22.7) | 1 (4.2)† |
| Conjunctivitis | 0 | 2 (8.3) |
| Gastrointestinal disorders | ||
| Abdominal pain | 6 (13.0) | 5 (20.8) |
| Nausea | 6 (13.0) | 3 (12.5) |
| Dyspepsia | 3 (6.5) | 1 (4.2) |
| Diarrhea | 3 (6.5) | 0 |
| Vomiting | 2 (4.3) | 1 (4.2) |
| General disorders | ||
| Pyrexia | 5 (10.9) | 3 (12.5) |
| Asthenia | 4 (8.7) | 2 (8.3) |
| Hepatobiliary disorders | ||
| Hepatomegaly | 3 (6.5) | 0 |
| Infections and infestations | ||
| Upper respiratory tract infection | 14 (30.4) | 5 (20.8) |
| Subcutaneous abscess | 2 (4.3) | 1 (4.2) |
| Limb abscess | 2 (4.3) | 0 |
| Intestinal parasitic infection | 0 | 2 (8.3) |
| Plasmodium falciparum infection | 0 | 2 (8.3) |
| Investigations | ||
| Methemoglobinemia (≥8.5%) | 22 (47.8) | 0 |
| Eosinophil count increased | 5 (10.9) | 3 (12.5) |
| Abnormal hepatic enzymes | 2 (4.3) | 0 |
| Metabolism and nutrition disorders | ||
| Hypokalemia | 3 (6.5) | 1 (4.2) |
| Musculoskeletal/connective tissue disorders | ||
| Myalgia | 3 (6.5) | 1 (4.2) |
| Nervous system disorders | ||
| Headache | 14 (30.4) | 4 (16.7) |
| Dizziness | 12 (26.1) | 3 (12.5) |
| Respiratory, thoracic and mediastinal disorders | ||
| Nasal congestion | 2 (4.3) | 0 |
| Skin and subcutaneous tissue disorders | ||
| Eczema | 2 (4.3) | 1 (4.2) |
*Note that 44/46 patients had a post-baseline eye assessment in the tafenoquine group. Eye examination was performed at baseline and days 28 and 90.
†One additional patient receiving chloroquine had bilateral baseline retinal hemorrhage which considered pre-existing and not noted as an adverse event.