Table 1 Baseline characteristics of study population proof of concept phase IIa study
Demographic data | DIMS0150 (n = 22) | Placebo (n = 12) | |
|---|---|---|---|
Gender | Male (%) | 12 (54.55) | 6 (50.00) |
| Â | Female (%) | 10 (45.45) | 6 (50.00) |
Race | Caucasian | 22 (100.00) | 12 (100.00) |
Age (years) | Mean (SD) | 41.3 (14.96) | 39.7 (12.37) |
| Â | Min, Max | 23.0, 72.0 | 22.0, 56.0 |
Other characteristics | DIMS0150 (n = 22) | Placebo (n = 12) | |
Disease duration (days) | n | 16 | 7 |
| Â | Missing | 6 | 5 |
| Â | Mean (SD) | 916.1 (871.85) | 1760.6 (806.71) |
| Â | (Min, Max) | (154.0, 3555.0) | (922.0, 3003.0) |
DAI score at screening | n | 22 | 12 |
| Â | Missing | 0 | 0 |
| Â | Mean (SD) | 7.9 (1.19) | 7.9 (1.56) |
| Â | (Min, Max) | 7.0, 10.0 | 6.0, 11.0 |
UC extent | Beyond splenic flexure | 3 (13.64%) | 2 (16.67%) |
| Â | Up to splenic flexure | 10 (45.45%) | 6 (50.00%) |
| Â | Up to sigmoid descending junction | 7 (31.82%) | 3 (25.00%) |
| Â | Up to recto-sigmoid junction | 1 (4.55%) | 1 (8.33%) |
| Â | Not known | 1 (4.55%) | 0 (0.00%) |
Number of subjects taking glucocorticoids medication during the study | Â | 20 (90.91%) | 11 (91.67%) |
Corticoids acting locally | Number of steroid medications (PT) | 3 | Â |
| Â | Budenoside | 2 (9.09%) | Â |
| Â | Prednisolone sodium phosphate | 1 (4.55%) | Â |
Glucocorticoids | Number of steroid medications (PT) | 21 | 12 |
| Â | Hydrocortisone | 1 (4.55%) | 1 (8.33%) |
| Â | Methylprednisolone | 1 (4.55%) | 1 (8.33%) |
| Â | Prednisolone | 19 (86.36%) | 10 (83.33%) |