Table 2.
Baseline characteristics of study subjects
| Characteristic | 2012 EGKINETIC4a | 2012 EGKINETIC6a | 2016 EGKINETIC6OPb | ||||
|---|---|---|---|---|---|---|---|
| E2 BID→E4 OD | E4 OD→E2 BID | EC2 TID→ES6 OD | ES6 OD→EC2 TID | E6 OD→ES6 OD | ES6 OD→E6 OD | ||
| (N = 8) | (N = 10) | (N = 10) | (N = 11) | (N = 15) | (N = 15) | ||
| Age, years | Mean ± SD | 25.0 ± 2.9 | 33.8 ± 6.2 | 28.2 ± 6.7 | 28.0 ± 6.7 | 30.7 ± 6.8 | 31.1 ± 7.6 |
| Median | 24.5 | 34.0 | 27.5 | 27.0 | 29.0 | 30.0 | |
| Range | 21–30 | 22–45 | 22–44 | 22–41 | 23–44 | 22–44 | |
| Sex M/F | (N, %) | M: 5 (62.5%) | M: 5 (50.0%) | M: 8 (80.0%) | M: 7 (63.6%) | M: 8 (53.3%) | M: 11 (73.3%) |
| F: 3 (37.5%) | F: 5 (50.0%) | F: 2 (20.0%) | F: 4 (36.4%) | F: 7 (46.7%) | F: 4 (26.7%) | ||
| Ethnicity | (N, %) | ||||||
| Caucasian | 8 (100.0%) | 10 (100.0%) | 10 (100.0%) | 11 (100.0%) | 15 (100.0%) | 15 (100.0%) | |
BID twice daily; OD once daily; TID three times daily
aData shown for the efficacy sample (excluding subjects who had protocol deviations)
bData shown for the safety analysis set (all subjects who received at least one dose of study treatment)