Comparison · NCT01774487-sae
Pentoxifylline - Group 1 (Treatment Starts 3-5 Days After Kasai Portoenterostomy) vs Pentoxifylline - Group 2 (Patient Diagnosed Too Late for Kasai Portoenterostomy): serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Pentoxifylline - Group 1 (Treatment Starts 3-5 Days After Kasai Portoenterostomy) vs Pentoxifylline - Group 2 (Patient Diagnosed Too Late for Kasai Portoenterostomy): serious adverse events. Trial comparisons, record NCT01774487-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01774487-sae
On this page
Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.75 | 0.409 | 0.929 | wilson | |
| Risk in group 2 | 1 | 0.207 | 1 | wilson | |
| Risk difference, group 1 minus group 2 | -0.25 | -0.591 | 0.563 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.75 | 0.503 | 1.12 | log | |
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
Number needed to treat, for one fewer participant with a serious adverse event on Pentoxifylline - Group 1 (Treatment Starts 3-5 Days After Kasai Portoenterostomy) than on Pentoxifylline - Group 2 (Patient Diagnosed Too Late for Kasai Portoenterostomy) | 4 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Pentoxifylline - 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 | 6 | 8 | EG000 |
| Group 2 | Pentoxifylline - 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 | 1 | 1 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- 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
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01774487?tab=results
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.
For software
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT01774487-sae