Table 1.
Summary of adverse events.
| Body system | Hydroxyurea | Sanguinate | Sanguinate |
|---|---|---|---|
| 160 mg/kg | 320 mg/kg | ||
| Cardiac disorders | 0 | 0 | 1 |
| Tricuspid valve incompetence | 0 | 0 | 1 |
| Ear and labyrinth disorders | 0 | 1 | 0 |
| Ear pain | 0 | 1 | 0 |
| Gastrointestinal disorders | 0 | 1 | 4 |
| Abdominal pain | 0 | 0 | 2 |
| Abdominal pain upper | 0 | 0 | 1 |
| Nausea | 0 | 1 | 1 |
| General disorders/administration site conditions | 1 | 2 | 1 |
| Chest pain | 0 | 1 | 0 |
| Feeling cold | 0 | 0 | 1 |
| Infusion site erythema | 0 | 1 | 0 |
| Non-cardiac chest pain | 1 | 0 | 0 |
| Infections and infestations | 1 | 2 | 1 |
| Influenza | 0 | 2 | 0 |
| Upper respiratory tract infection | 0 | 0 | 1 |
| Viral infection | 1 | 0 | 0 |
| Injury/procedural complications | 0 | 1 | 0 |
| Contusion | 0 | 1 | 0 |
| Investigations | 1 | 0 | 1 |
| Oxygen saturation decreased | 1 | 0 | 0 |
| Troponin I increased | 0 | 0 | 1 |
| Musculoskeletal/connective tissue disorders | 3 | 10 | 9 |
| Arthralgia | 1 | 4 | 5 |
| Back pain | 1 | 1 | 0 |
| Bone pain | 0 | 0 | 1 |
| Musculoskeletal chest pain | 0 | 1 | 0 |
| Musculoskeletal pain | 0 | 1 | 2 |
| Neck pain | 0 | 0 | 1 |
| Pain in extremity | 1 | 3 | 0 |
| Nervous system disorders | 1 | 2 | 2 |
| Dizziness | 0 | 0 | 1 |
| Headache | 1 | 2 | 1 |
| Respiratory, thoracic, mediastinal disorders | 0 | 0 | 2 |
| Pulmonary hypertension | 0 | 0 | 1 |
| Tachypnoea | 0 | 0 | 1 |
| Skin and subcutaneous tissue disorders | 0 | 1 | 1 |
| Erythema | 0 | 1 | 0 |
| Pruritus | 0 | 0 | 1 |
| Vascular disorders | 0 | 1 | 1 |
| Endothelial dysfunction | 0 | 0 | 1 |
| Orthostatic hypotension | 0 | 1 | 0 |