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SEE REAL WORLD EVIDENCE SAFETY RESULTS
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SUMMARY OF TEAEs FROM THE CORE II TRIAL | ||
---|---|---|
Placebo (n=129) | Cortiment (n=128) | |
Related TEAEs | 24% | 25.8% |
Any serious TEAEs | 3.9% | 3.1% |
TEAEs (%) CORTIMENT vs placebo
WORSENING OF POTENTIAL GLUCOCORTICOID – RELATED EFFECTS FROM THE CORE II STUDY (n) | ||
---|---|---|
Placebo (n=129) | Cortiment (n=128) | |
Mood Changes | 7 | 2 |
Sleep changes | 4 | 3 |
Insomnia | 2 | 1 |
Acne | 2 | 1 |
Moon face | 4 | 2 |
Worsening of potential glucocorticoid – related effects of the CORE II study occurring within the safety population during treatment
TEAEs = treatment-emergent adverse events
STUDY SUMMARY
Travis SPL, et al. Gut. 2014;63:433–41. doi:10.1136/gutjnl-2012-304258
To compare the efficacy of budesonide MMX (CORTIMENT) with placebo, in patients with active, mild to moderate ulcerative colitis.
Phase III, randomised, double-blind, double-dummy, placebo-controlled, parallel group trial carried out in 15 countries in Europe.
Combined clinical and endoscopic remission at 8 weeks (defined as a UC-DAI score ≤ 1, a score of 0 for rectal bleeding and stool frequency, no mucosal friability on colonoscopy, and a ≥ 1-point reduction in endoscopic index score from baseline).
Patients were randomised to receive 9 mg or 6 mg of CORTIMENT, or 9 mg of Entocort EC or placebo, once-daily for 8 weeks.
UC-DAI = UC disease activity index
KEY INCLUSION CRITERIA
KEY EXCLUSION CRITERIA
anti-TNF = anti-tumor necrosis factor,
UC-DAI = UC disease activity index
Job Code: UK-COR-2200001 - Date of preparation: January 2022