1 Clinical remission (ITT analysis) |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Totals not selected |
2 Clinical remission according to disease location |
1 |
343 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.72 [0.57, 0.91] |
2.1 Distal Disease (combined proctosigmoiditis and left‐sided disease) |
1 |
274 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.74 [0.58, 0.96] |
2.2 Extensive disease (extending proximal to the splenic flexure) |
1 |
69 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.64 [0.39, 1.05] |
3 Therapeutic success (defined by Physician's Global Assessment) |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Totals not selected |
4 Therapeutic benefit (defined by Physician's Global Assessment) |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Totals not selected |
5 Endoscopic improvement |
2 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Totals not selected |
6 Endoscopic remission (EI ≤ 1) |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Totals not selected |
7 Histologic remission |
2 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Totals not selected |
8 Adverse events |
2 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Totals not selected |
9 Adverse events related to study medication |
2 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Totals not selected |
10 Withdrawal due to adverse events |
2 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Totals not selected |
11 Drop in cortisol below normal lower limit at final visit |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Totals not selected |
12 Remission (combined clinical and endoscopic remission) |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Totals not selected |
13 Clinical improvement |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Totals not selected |
14 Symptom resolution |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Totals not selected |
15 Serious adverse events |
2 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Totals not selected |
16 Potential glucocorticoid effects |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Totals not selected |