Developed by Shray Alag, The Harker School
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Clinical Trials, and HPO
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Navigate: Correlations HPO
There is one clinical trial.
The purpose of this study is to evaluate the long-term safety and efficacy of repeat administration of darvadstrocel in participants with Crohn's Disease (CD) and complex perianal fistula by evaluation of adverse events (AEs), serious adverse events (SAEs), adverse events of special interest (AESIs), and special situation reports (SSRs).
Description: An AE is any untoward medical occurrence in a participant administered a medicinal product and which does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an AE with an onset that occurs after receiving study drug.
Measure: Percentage of Participants with at Least 1 Treatment-Emergent Adverse Event (TEAE) Time: From administration of repeat dose up to 156 weeks post-repeat administrationDescription: An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Measure: Percentage of Participants with at Least 1 Treatment Emergent Serious Adverse Event (TESAE) Time: From administration of repeat dose up to 156 weeks post-repeat administrationDescription: An SSR includes pregnancy, any case in which a pregnant participant is exposed to a study product or in which a female participant or female partner of a male participant becomes pregnant following treatment with a study product. Exposure is considered either through maternal exposure or via semen following paternal exposure or infant exposure from breast milk.
Measure: Percentage of Participants with Special Situation Reports (SSRs) Time: From administration of repeat dose up to 156 weeks post-repeat administrationDescription: AESI includes immunogenicity/alloimmune reactions, hypersensitivity, transmission of infectious agents, tumorgenicity, ectopic tissue formation, medication errors.
Measure: Percentage of Participants with Adverse Event of Special Interest (AESI) Time: From administration of repeat dose up to 156 weeks post-repeat administrationDescription: Combined remission is defined as the closure of all treated external openings that were draining at baseline (i.e., baseline visit), despite gentle finger compression and absence of collection(s) >2 cm (in at least 2 dimensions) of the treated perianal fistula(s) confirmed by central magnetic resonance imaging (MRI) assessment.
Measure: Percentage of Participants who Achieve Combined Remission of Perianal Fistula(s) Time: At Week 24 and at Week 156 post-repeat administrationDescription: Clinical remission is defined as closure of all treated external fistula openings that were draining at baseline despite gentle finger compression.
Measure: Percentage of Participants who Achieve Clinical Remission Time: At Weeks 6, 24, 52, 104, and 156 post-repeat administrationDescription: Clinical response is defined as closure of at least 50% of all treated external fistula openings that were draining at baseline despite gentle finger compression.
Measure: Percentage of Participants who Achieve Clinical Response Time: At Weeks 6, 24, 52, 104, and 156 post-repeat administrationDescription: Relapse is defined as reopening of any of the treated fistula(s) external openings with active drainage as clinically assessed that were in the combined remission at Week 24 or the development of a collection >2 cm (in at least 2 dimensions) confirmed by centrally read MRI assessment.
Measure: Percentage of Participants with Relapse From Week 24 Combined Remission Time: From Week 24 to Week 156 post-repeat administrationDescription: Time to Relapse is defined as the time in days to reopening of any of the treated fistula(s) external openings with active drainage as clinically assessed, relative to Week 24.
Measure: Time to Relapse Time: From Week 24 to the Day of relapse post-repeat administrationDescription: The PDAI is a scoring system to evaluate the severity of perianal lesion associated with Crohn's disease. It includes the following 5 items: (a) discharge; (b) pain; (c) restriction of sexual activity; (d) type of perianal disease; and (e) degree of induration. Each item is graded on a 5-point scale ranging from no symptoms (score of 0) to severe symptoms (score of 4) and total range of score is from 0 to 20. Higher score means more severe disease.
Measure: Change From Baseline in Score of Discharge and Pain Items of Perianal Disease Activity Index (PDAI) Score Time: Baseline to Weeks 6, 24, 52, 104, and 156 post-repeat administrationAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on September 26, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
Drug Reports MeSH Reports HPO Reports