Table 5.
All Treatment-related TEAEs: MATRIX-1 and MATRIX-2 populations combined (safety population)
| Preferred term, n (%) | INL-001 (n = 411) | Placebo collagen-matrix (n = 208) |
|---|---|---|
| Patients reporting any treatment-related TEAE | 14 (3) | 6 (3) |
| Dysgeusia | 6 (2) | 2 (1) |
| Dizziness | 4 (1) | 1 (< 1) |
| Incision-site complicationa | 3 (< 1) | 0 |
| Headache | 1 (< 1) | 0 |
| Somnolence | 1 (< 1) | 0 |
| Tremor | 1 (< 1) | 0 |
| Tinnitus | 1 (< 1) | 1 (< 1) |
| Vision blurred | 1 (< 1) | 1 (< 1) |
| Constipation | 0 | 1 (< 1) |
| Hypoesthesia oral | 0 | 1 (< 1) |
| Paresthesia oral | 0 | 1 (< 1) |
| Anxiety | 0 | 1 (< 1) |
| Restlessness | 0 | 1 (< 1) |
TEAE treatment-emergent adverse event
aFor these events, verbatim terms include sensation of warmth at the incision site, hardness at incision site, and popping sensation at surgical site