Table 1.
THP, log10(THP), creatinine and log10(THP/creatinine) values obtained from the biomedical study (1) 2019-177-f-S, biomedical study (2) 2021-084-f-S and combined analysis of (1) and (2), including subgroup-analysis.
| n | Ø THP [µg/mL] ± SD (Median) | Creatinine mg/dL ± SD (Median) | ØLog10THP (µg/mL) ± SD | ØLog10([THP µg/Crea mg]) ± SD | |
|---|---|---|---|---|---|
| Study population (1) | |||||
| Total volunteers | 178 | 9.5 ± 10.5 (5.4) | 84.1 ± 60.9 (63.5) | 0.77 ± 0.42 | 0.96 ± 0.67 |
| Male (M) | 62 | 7.6 ± 7.9 (4.5) | 110.3 ± 71.8 (104.0) | 0.67 ± 0.41 | 0.75 ± 0.66 |
| Female (F) | 116 | 10.5 ± 11.6 (5.8) | 69.8 ± 48.4 (54.5) | 0.83 ± 0.41 | 1.08 ± 0.64 |
| Without hormonal contraceptives (F–C) | 61 | 11.7 ± 13.3 (5.3) | 60.9 ± 41.3 (54.5) | 0.87 ± 0.42 | 1.17 ± 0.63 |
| With hormonal contraceptives (F + C) | 55 | 9.1 ± 9.3 (6.2) | 81.1 ± 53.3 (66.7) | 0.78 ± 0.41 | 0.99 ± 0.64 |
| Study population (2) | |||||
| Total volunteers | 60 | 13.3 ± 12.06 (9.0) | 138.1 ± 69.2 (134.9) | 0.94 ± 0.43 | 0.87 ± 0.49 |
| Male (M) | 30 | 12.7 ± 11.0 (8.9) | 154.6 ± 61.6 (150.9) | 0.89 ± 0.48 | 0.74 ± 0.47 |
| Female (F) | 30 | 13.9 ± 12.9 (9.0) | 121.5 ± 72.5 (110.3) | 0.99 ± 0.36 | 0.99 ± 0.48 |
| Without hormonal contraceptives (F–C) | 16 | 12.2 ± 11.1 (8.6) | 94.3 ± 50.9 (82.9) | 0.93 ± 0.38 | 1.02 ± 0.47 |
| With hormonal contraceptives (F + C) | 14 | 15.9 ± 14.5 (10.0) | 152.7 ± 80.5 (155.2) | 1.06 ± 0.35 | 0.95 ± 0.49 |
| Study population (1 + 2) | |||||
| Total volunteers | 238 | 10.5 ± 11.1 (6.1) | 97.7 ± 67.3 (80.1) | 0.81 ± 0.4 | 0.92 ± 0.6 |
| Male (M) | 92 | 8.9 ± 8.9 (5.7) | 124.6 ± 71.7 (125.0) | 0.74 ± 0.4 | 0.73 ± 0.6 |
| Female (F) | 146 | 11.4 ± 12.2 (6.7) | 80.5 ± 58.0 (63.5) | 0.86 ± 0.4 | 1.03 ± 0.6 |
| Without hormonal contraceptives (F–C) | 77 | 12.0 ± 12.9 (6.1) | 68.0 ± 45.6 (58.5) | 0.88 ± 0.4 | 1.12 ± 0.6 |
| With hormonal contraceptives (F + C) | 69 | 10.7 ± 11.5 (7.1) | 95.8 ± 66.5 (76.3) | 0.83 ± 0.4 | 0.94 ± 0.6 |