Table 2.
Baseline characteristics and dose groups assignment of subjects in the fimaporfin dose-finding part.
Dose group | Control | Low | Intermediate | High | Non-tolerated | Overall | Safety run-in | |
---|---|---|---|---|---|---|---|---|
(N=12) | (N=46) | (N=6) | (N=6) | (N=18) | (N=88) | (N=8) | ||
Fimaporfin dose | 0 μg | 0.75– 7.5 μg | 12.5 μg | 17.5 μg | 25–50 μg | 0– 50 μg | 50– 100 µg | |
Age, years (median, range) | 33 (19–55) | 34–42 (19–53) | 44 (21–52) | 44 (25–55) | 30–47 (19–55) | 36 (19–55) | 45 (21–55) | |
Sex | Male | 9 (75.0%) | 37 (80.4%) | 5 (83.3%) | 4 (66.7%) | 12 (66.7%) | 67 (76.1%) | 4 (50.0%) |
Female | 3 (25.0%) | 9 (19.6%) | 1 (16.7%) | 2 (33.3%) | 6 (33.3%) | 21 (23.9%) | 4 (50.0%) | |
Race | White | 12 (100.0%) | 46 (100.0%) | 6 (100.0%) | 6 (100.0%) | 18 (100.0%) | 88 (100.0%) | 8 (100.0%) |
Ethnicity | Not Hispanic or Latino | 11 (91.7%) | 46 (100.0%) | 6 (100.0%) | 6 (100.0%) | 17 (94.4%) | 86 (97.7%) | 8 (100.0%) |
Hispanic or Latino | 1 (8.3%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 1 (5.6%) | 2 (2.3%) | 0 (0.0%) |
Median (range) or number of subject (with percentage) are given for the different characteristics.