Comparison · NCT05007392-sae
Febuxostat vs Dotinurad: 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. Febuxostat vs Dotinurad: serious adverse events. Trial comparisons, record NCT05007392-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT05007392-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 | 0.0178 | 0.00693 | 0.0448 | wilson | |
| Risk in group 2 | 0.0135 | 0.00459 | 0.0388 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00432 | -0.0232 | 0.0328 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.32 | 0.299 | 5.84 | log | |
| Odds ratio, group 1 over group 2 | 1.33 | 0.294 | 6 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Febuxostat than on Dotinurad | 231 | 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 | Febuxostat | Participants received febuxostat 20 mg tablet, orally, once daily for first 4 weeks; followed febuxostat 40 mg tablet, orally, once daily for 20 weeks. To maintain blinding, participants also received the dotinurad matching placebo up to Week 24. | 4 | 225 | EG000 |
| Group 2 | Dotinurad | Participants received dotinurad 1 mg tablet, orally, once daily for first 4 weeks; followed by dotinurad 2 mg tablet, orally, once daily for 8 weeks; further followed by dotinurad 4 mg tablet, orally, once daily for 12 weeks. To maintain blinding, participants also received the febuxostat matching placebo up to Week 24. | 3 | 223 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From first dose of study drug up to Week 24
Source ClinicalTrials.gov
Trial
- Title
- A Study to Evaluate Efficacy of Dotinurad and Febuxostat for the Treatment of Participants With Gout
- NCT number
- NCT05007392
- Phases
- PHASE3
- Conditions
- Gout
- Interventions
- Dotinurad, Febuxostat, Dotinurad Matched Placebo, Febuxostat Matched Placebo
- Lead sponsor
- Eisai Co., Ltd.
- Results first posted
- 2025-07-30
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT05007392?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.govNone 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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