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Comparison · NCT05188521-sae

Cutaneous LP vs Dose Escalation Extension Group: serious adverse events

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. Cutaneous LP vs Dose Escalation Extension Group: serious adverse events. Trial comparisons, record NCT05188521-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT05188521-sae

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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 10.08330.01490.354wilson
Risk in group 2000.434wilson
Risk difference, group 1 minus group 20.0833-0.3570.354newcombe 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 harm, for one more participant with a serious adverse event on Cutaneous LP than on Dose Escalation Extension Group12from the risk difference intervalthe interval includes no difference

Groups2

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

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Cutaneous LPSubjects with a diagnosis of cutaneous LP will receive Baricitinib (LY3009104) for a 16 weeks treatment period~Baricitinib (LY3009104) 2 mg: 2 mg orally administered once daily for 16 weeks112EG000
Group 2Dose Escalation Extension Group
Subject that demonstrate a response to the 16 weeks of treatment with 2 mg of Baricitinib (LY3009104), but have not achieved a PGA 0 will receive 4 mg of Baricitinib (LY3009104) for 12 weeks~Baricitinib (LY3009104) 4 mg: 4 mg orally administered once daily for 12 weeks
05EG001

Harm

What it counts
Total, serious adverse events
Time frame
Adverse events were collected for each participant from baseline to 30 days following the last administration of the study product. The Baricitinib 2mg group was followed for a total of approximately 5 months. The participants who continued in the Baricitinib 4mg extension group were followed for a total of approximately 9 months.

Source ClinicalTrials.gov

Trial

Title
Baricitinib (LY3009104) in the Treatment of Cutaneous Lichen Planus
NCT number
NCT05188521
Phases
PHASE2
Conditions
Cutaneous Lichen Planus
Interventions
Baricitinib (LY3009104) 2 mg, Baricitinib (LY3009104) 4 mg
Lead sponsor
Aaron R. Mangold
Results first posted
2024-06-11

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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