Comparison · NCT01078389-sae
Febuxostat 40 mg or 80 mg 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. Febuxostat 40 mg or 80 mg vs Placebo: serious adverse events. Trial comparisons, record NCT01078389-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01078389-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 | 0.0828 | 0.049 | 0.137 | wilson | |
| Risk in group 2 | 0.0701 | 0.0396 | 0.121 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0127 | -0.0485 | 0.0745 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.18 | 0.546 | 2.56 | log | |
| Odds ratio, group 1 over group 2 | 1.2 | 0.52 | 2.76 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Febuxostat 40 mg or 80 mg than on Placebo | 78.5 | 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 | Febuxostat 40 mg or 80 mg | Febuxostat 40 mg or 80 mg (based on serum urate levels at Day 14), capsules, orally, once daily for up to 24 Months. | 13 | 157 | EG000 |
| Group 2 | Placebo | Febuxostat placebo-matching capsules, orally, once daily for up to 24 Months. | 11 | 157 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Treatment-emergent adverse events are adverse events, regardless of relationship to study drug, that started on or after the first dose of study drug and no more than 30 days after last dose of study drug (Up to 25 months)
Source ClinicalTrials.gov
Trial
- Title
- Effect of Febuxostat on Joint Damage in Hyperuricemic Subjects With Early Gout
- NCT number
- NCT01078389
- Phases
- PHASE2
- Conditions
- Joint Damage
- Interventions
- Febuxostat, Placebo for Febuxostat
- Lead sponsor
- Takeda
- Results first posted
- 2014-09-10
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01078389?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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