Table 2. Adverse Events.
Type of adverse event | Number of events | Time period | Dose Cohort(s) | SAE? |
---|---|---|---|---|
Vomiting due to gastrointestinal infection | 1 | During treatment | 50g | No |
Hip pain | 1 | During treatment | 50g | No |
Vaso-occlusive pain episode with hospitalization | 2 | During treatment | 50g, 100g | Yes |
Shortness of breath with hospitalization | 1 | After treatment | 100g | Yes |
Increased proteinuria | 2 | During treatment | 100g, 150g | No |
Abdominal pain, vaso-occlusive pain episode, and QT prolongation, with hospitalization | 1 | During treatment | 150g | Yes |
Chest pain with hospitalization | 1 | After treatment | 150g | Yes |
All adverse events were not thought to be related to BSH consumption. Adverse events occurred as follows: one patient experienced both the vaso-occlusive pain episode (50g) and abdominal pain (150g) events. Another patient experienced the vaso-occlusive pain episode (100g), shortness of breath (100g), and chest pain (150g) episodes, and a different individual experienced both incidences of proteinuria (100g, 150g). All other events occurred within other, single patients.