Table 5.
Total 14 subjects discontinued dosing either due to development of AEs or Dose stopping criteria being met in the cohort.
| Fimaporfin dose | Subject | Reason for discontinued treatment |
|---|---|---|
| 50 µg | 207 | Cohort discontinued |
| 208 | Cohort discontinued | |
| 209 | Ulceration (Stopping criteria met) | |
| 210 | Cohort discontinued | |
| 211 | Cohort discontinued | |
| 212 | Ulceration (Stopping criteria met) | |
| 25 µg | 215 | Unable to tolerate light dose1 |
| 224 | Unable to tolerate light dose2 | |
| 17.5 µg | 250 | Cohort discontinued |
| 251 | Cohort discontinued | |
| 252 | Erythema (Stopping criteria met)3 | |
| 253 | Cohort discontinued | |
| 254 | Erythema (Stopping criteria met)3 | |
| 7.5 µg | 264 | Local reaction/erythema3 |
When the stopping criteria for a dose cohort was met, all subjects in that cohort discontinued further treatment. 1withdrawn after second ID dosing due to pain (completed 2 KLH doses but only one HPV dose), 2withdrawn due to pain during first dosing (physician decision), 3local erythema ≥10 cm in ≥2 subjects.