Table 1.
Summary of Adverse Events by Category and Treatment Group in Phase 2
| All Adverse Events | Serious Adverse Events | |||
|---|---|---|---|---|
| Delayed On | Early On | Delayed On | Early On | |
| Programming | 6 (11%) | 0 | 0 | 0 |
| Psychiatric | 9 (17%) | 14 (27%) | 1 (14%) | 0 |
| General Medical | 38 (72%) | 38 (73%) | 6 (86%) | 8 (100%) |
| Event Subcategory | ||||
| Auditory/Ocular/Oral (HEENT) | 0 | 1 | 0 | 0 |
| Cardiovascular | 6 | 5 | 4 | 2 |
| Constitutional | 1 | 1 | 0 | 0 |
| Dermatological | 5 | 4 | 0 | 1 |
| Endocrine/Metabolic (Lab Abnormalties) | 1 | 0 | 0 | 0 |
| Gastrointestinal | 2 | 1 | 0 | 0 |
| Genitourinary | 4 | 1 | 0 | 0 |
| Hematology/Oncology | 0 | 2 | 0 | 0 |
| Infectious Disease | 1 | 0 | 0 | 0 |
| Neurological | 13 | 15 | 2 | 5 |
| Ortho/Musculoskeletal | 2 | 4 | 0 | 0 |
| Pulmonary/Upper Respiratory | 3 | 5 | 0 | 0 |
| Total | 53 | 52 | 7 | 8 |