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Comparison · NCT01774487-deaths

Pentoxifylline - Group 1 (Treatment Starts 3-5 Days After Kasai Portoenterostomy) vs Pentoxifylline - Group 2 (Patient Diagnosed Too Late for Kasai Portoenterostomy): deaths from any cause

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. Pentoxifylline - Group 1 (Treatment Starts 3-5 Days After Kasai Portoenterostomy) vs Pentoxifylline - Group 2 (Patient Diagnosed Too Late for Kasai Portoenterostomy): deaths from any cause. Trial comparisons, record NCT01774487-deaths. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01774487-deaths

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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 1000.324wilson
Risk in group 2000.793wilson
Risk difference, group 1 minus group 20-0.7930.324newcombe 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 harmfrom 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 1Pentoxifylline - Group 1 (Treatment Starts 3-5 Days After Kasai Portoenterostomy)
All newly-diagnosed biliary atresia patients fulfilling the study's inclusion criteria will receive oral pentoxifylline, 20 mg/kg/day divided in three doses for a total of 90 days.~The hospital pharmacy will create a 20 mg/ml oral pentoxifylline solution using 400 mg pentoxifylline tablets and established compounding recipes.~Pentoxifylline: 20 mg/kg/day divided in 3 doses, given orally for 90 days
08EG000
Group 2Pentoxifylline - Group 2 (Patient Diagnosed Too Late for Kasai Portoenterostomy)
All newly-diagnosed biliary atresia patients fulfilling the study's inclusion criteria will receive oral pentoxifylline, 20 mg/kg/day divided in three doses for a total of 90 days.~The hospital pharmacy will create a 20 mg/ml oral pentoxifylline solution using 400 mg pentoxifylline tablets and established compounding recipes.~Pentoxifylline: 20 mg/kg/day divided in 3 doses, given orally for 90 days
01EG001

Harm

What it counts
Total, all-cause mortality
Time frame
Adverse event (AE) data was collected for 12 weeks after the Kasai portoenterostomy (duration of time when patient received medication during the study). Note: Some secondary outcomes were collected at age 2 years, but AEs (included all-cause mortality) were collected for 12 weeks after Kasai portoenterostomy to capture those AEs that could possibly be related to treatment.

Source ClinicalTrials.gov

Trial

Title
Pentoxifylline Therapy in Biliary Atresia
NCT number
NCT01774487
Phases
PHASE2
Conditions
Biliary Atresia
Interventions
Pentoxifylline
Lead sponsor
Baylor College of Medicine
Results first posted
2023-10-12

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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