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Comparison · NCT05369832-8b7e1c4b

Cohort 1: Ozanimod Advanced Therapy Naïve vs Cohort 2: Ozanimod Advanced Therapy Exposed: Number of Participants With Clinically Significant Changes in Laboratory Assessments

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

2 sourcestrial-comparisons-2026-03-23-0.1.0

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ConductScience Library. Cohort 1: Ozanimod Advanced Therapy Naïve vs Cohort 2: Ozanimod Advanced Therapy Exposed: Number of Participants With Clinically Significant Changes in Laboratory Assessments. Trial comparisons, record NCT05369832-8b7e1c4b. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT05369832-8b7e1c4b

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 1000.0374wilson
Risk in group 2000.0876wilson
Risk difference, group 1 minus group 20-0.08760.0374newcombe hybrid score
Risk ratio, group 1 over group 2loga group has no participants with the outcome
Odds ratio, group 1 over group 2loga cell of the two-by-two table is zero
Number needed to treatfrom the risk difference intervalthe two groups' risks are equal

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Cohort 1: Ozanimod Advanced Therapy NaïveAdvanced therapy naïve participants received ozanimod 0.92 mg daily099OG000
Group 2Cohort 2: Ozanimod Advanced Therapy ExposedAdvanced therapy exposed participants received ozanimod 0.92 mg daily040OG001

Outcome

Type
SECONDARY
Title
Number of Participants With Clinically Significant Changes in Laboratory Assessments
Description
Number of participants experiencing clinically significant abnormalities in laboratory testing including hematology, chemistry and urinalysis.
Time frame
From first dose of study medication through end of study (Up to approximately 728 days)
Population
Treated participants

Source ClinicalTrials.gov

Trial

Title
An Open-label Study of Ozanimod in Moderate to Severe Ulcerative Colitis in Clinical Practice
NCT number
NCT05369832
Phases
PHASE4
Conditions
Colitis, Ulcerative
Interventions
Ozanimod
Lead sponsor
Bristol-Myers Squibb
Results first posted
2026-02-10

Source ClinicalTrials.gov

Source

Release
trial-comparisons-2026-03-23-0.1.0
Release manifest SHA-256
f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
AACT copy
2026-03-23
Tables read
outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet

Source ClinicalTrials.gov

Sources 2

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.

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