Serious TEAEs
| Grade 3 TEAEs . | No. of events . | No. of patients (%) . |
|---|---|---|
| All | 39 | 11 (73.3) |
| VOC∗ | 28 | 10 (66.7) |
| Lung infection | 3 | 3 (20) |
| Back pain | 1 | 1 (6.7) |
| Hypoxia | 1 | 1 (6.7) |
| Gout flare | 2 | 1 (6.7) |
| Opioid withdrawal | 1 | 1 (6.7) |
| Pain | 1 | 1 (6.7) |
| COVID-19 infection | 1 | 1 (6.7) |
| Vomiting | 1 | 1 (6.7) |
| Grade 3 TEAEs . | No. of events . | No. of patients (%) . |
|---|---|---|
| All | 39 | 11 (73.3) |
| VOC∗ | 28 | 10 (66.7) |
| Lung infection | 3 | 3 (20) |
| Back pain | 1 | 1 (6.7) |
| Hypoxia | 1 | 1 (6.7) |
| Gout flare | 2 | 1 (6.7) |
| Opioid withdrawal | 1 | 1 (6.7) |
| Pain | 1 | 1 (6.7) |
| COVID-19 infection | 1 | 1 (6.7) |
| Vomiting | 1 | 1 (6.7) |
A total of 39 serious TEAEs occurred in 11 patients, of which 28 were VOCs in 10 patients: 1 in 3 patients, 2 in 2 patients, 3 in 2 patients, 4 in 1 patient, 5 in 1 patient, and 6 in 1 patient. Overall, 4 of 16 VOCs in 3 patients were possibly related to study drug (1 during drug escalation, 1 after drug taper). A cluster of 5 VOCs over 10 months in 1 patient could be considered as possibly drug related because the frequency was above his calculated annualized baseline of 3.7 per year. However, these VOCs occurred in a setting of known VOC triggers.
VOC is defined as acute clinical events that have no evident cause other than SCD, including acute episodes of pain requiring treatment with parenteral opioids at a medical facility, acute chest syndrome, hepatic sequestration, splenic sequestration, and priapism.