Table 2.
Safety summary for the CONNECTED study.
| Variable, n (%) | All participants (N = 20) |
|---|---|
| Summary of AEs | |
| Any AE | 18 (90) |
| Any moderate or severe AE | 6 (30) |
| Any severe AE | 1 (5) |
| Any AE related to DMF | 8 (40) |
| Any SAE | 2 (10) |
| Any SAE related to DMF | 0 |
| Discontinued treatment due to AE | 0 |
| Withdrew from study due to AE | 0 |
| Most common AEs (incidence ≥20%) | |
| Flushing | 5 (25) |
| MS relapse | 4 (20) |
| AEs of special interest | |
| PML or lymphopenia | 0 |
| Pancreatitis | 0 |
| Renal dysfunction | 0 |
| Hepatic dysfunction | 0 |
| Skin reaction | 0 |
| Rash | 0 |
AE, adverse event; DMF, delayed-release dimethyl fumarate; MS, multiple sclerosis; PML, progressive multifocal leukoencephalopathy; SAE, serious adverse event.