Table 3.
Any Related TEAEs reported in Safety Run-In part.
| Dose group | 50 μg fimaporfin (N=4) | 100 μg fimaporfin(N=4) | ||
|---|---|---|---|---|
| Preferred Term | Mild | Moderate | Mild | Moderate |
| Any related TEAE | – | 1 (25.0%) [1] | 4 (100.0%) [6] | – |
| Local TEAE | – | – | 4 (100.0%) [6] | – |
| IS ulcer | – | – | 3 (75.0%) [4] | – |
| IS extravasation | – | – | 1 (25.0%) [1] | – |
| IS paresthesia | – | – | 1 (25.0%) [1] | – |
| Systemic TEAE | – | 1 (25.0%) [1] | – | – |
| Syncope | – | 1 (25.0%) [1] | – | – |
AEs were considered to be local symptoms were anywhere the MedDRA Preferred Term contained the term ‘Injection site’. For Related to Study Treatment this counts all TEAE that have been recorded as having a suspected relationship to study treatment with and/or without red light. N, Number of subjects studied; (), Percentage of subjects with adverse events; [], Number of adverse events. Events were coded using MedDRA (Version 19.0).