Comparison · NCT03918447-sae
Bardoxolone Methyl vs Placebo: 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. Bardoxolone Methyl vs Placebo: serious adverse events. Trial comparisons, record NCT03918447-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03918447-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 | 0.113 | 0.0838 | 0.152 | wilson | |
| Risk in group 2 | 0.0785 | 0.0542 | 0.113 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0349 | -0.0103 | 0.0804 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.44 | 0.898 | 2.32 | log | |
| Odds ratio, group 1 over group 2 | 1.5 | 0.889 | 2.53 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Bardoxolone Methyl than on Placebo | 28.7 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Bardoxolone Methyl | During the treatment period, the participants received bardoxolone methyl capsules, QD at a starting dose of 5 mg, followed by dose-escalation to 10 mg at Week 2, and to 20 mg at Week 4. If the eligibility UACR was \>300 mg/g, the dose was increased to 30 mg starting from Week 6 until Week 100. Participants continued to be assessed during the off-treatment period up to Week 112. | 38 | 335 | EG000 |
| Group 2 | Placebo | During the treatment period, participants received bardoxolone methyl matching-placebo capsules, orally, QD up to Week 100, with sham titration to maintain the blinding. Participants did not receive a bardoxolone methyl matching placebo capsule during the off-treatment period between Weeks 100 and 112. | 26 | 331 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From first dose of the study drug up to end of follow-up (up to Week 112)
Source ClinicalTrials.gov
Trial
- Title
- A Trial of Bardoxolone Methyl in Patients With ADPKD - FALCON
- NCT number
- NCT03918447
- Phases
- PHASE3
- Conditions
- Autosomal Dominant Polycystic Kidney, ADPKD
- Interventions
- Bardoxolone methyl oral capsule, Placebo oral capsule
- Lead sponsor
- Biogen
- Results first posted
- 2024-06-11
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03918447?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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