Comparison · NCT05543187-sae
Primary Cohort: TAK-625 vs Supplemental Cohort: TAK-625: 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. Primary Cohort: TAK-625 vs Supplemental Cohort: TAK-625: serious adverse events. Trial comparisons, record NCT05543187-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT05543187-sae
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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 | 0.0000000000000000555 | 0.561 | wilson | |
| Risk in group 2 | 0 | 0 | 0.658 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.658 | 0.561 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to harm | from the risk difference interval | the two groups' risks are equal |
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 | Primary Cohort: TAK-625 | Participants diagnosed with PFIC2 due to ABCB11 mutation that predicted residual BSEP function received TAK-625 orally, BID. In dose escalation period, dose was increased weekly, 150 mcg/kg, 300 mcg/kg, 450 mcg/kg, and 600 mcg/kg for up to 4 weeks (Weeks 1 to 4) or extended to 6 weeks depending on the safety or tolerability concerns. After the dose escalation period, each participant continued dosing with TAK-625 600 mcg/kg, orally, BID dose level in the stable dosing period, a follow-up dosing period after Week 48, and a safety follow-up period. | 0 | 3 | EG000 |
| Group 2 | Supplemental Cohort: TAK-625 | Participants diagnosed with other PFIC subtypes or post-surgical received TAK-625 orally, BID. In dose escalation period, dose was increased weekly, 150 mcg/kg, 300 mcg/kg, 450 mcg/kg, and 600 mcg/kg for up to 4 weeks (Weeks 1 to 4) or extended to 6 weeks depending on the safety or tolerability concerns. After the dose escalation period, each participant continued dosing with TAK-625 600 mcg/kg, orally, BID dose level in the stable dosing period, a follow-up dosing period after Week 48, and a safety follow-up period. | 0 | 2 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From start of study drug administration up to follow-up (up to Week 133)
Source ClinicalTrials.gov
Trial
- Title
- A Study of TAK-625 for the Treatment of Progressive Familial Intrahepatic Cholestasis (PFIC)
- NCT number
- NCT05543187
- Phases
- PHASE3
- Conditions
- Progressive Familial Intrahepatic Cholestasis (PFIC)
- Interventions
- TAK-625
- Lead sponsor
- Takeda
- Results first posted
- 2024-09-24
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT05543187?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.
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