Comparison · NCT02500641-sae
Febuxostat 80/120 mg/Day vs Allopurinol 100 up to 600 mg/Day: 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 80/120 mg/Day vs Allopurinol 100 up to 600 mg/Day: serious adverse events. Trial comparisons, record NCT02500641-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02500641-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 | 0.102 | 0.0564 | 0.178 | wilson | |
| Risk in group 2 | 0.0816 | 0.0419 | 0.153 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0204 | -0.0642 | 0.106 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.25 | 0.515 | 3.03 | log | |
| Odds ratio, group 1 over group 2 | 1.28 | 0.482 | 3.39 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Febuxostat 80/120 mg/Day than on Allopurinol 100 up to 600 mg/Day | 49 | 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 80/120 mg/Day | Febuxostat 80/120 mg film coated tablets.The initial daily dose is 80 mg given orally. In case a patient has serum urate level 6 mg/dl after 2 weeks of treatment the dose will be escalated to 120 mg and if tolerated will be maintained during the study treatment period.~To prevent flares in the initial stages of treatment, patients will be treated for at least 6 months with colchicine 0.5 - 1 mg quaque die (QD ) or in case of colchicine intolerance, Naproxen 550 mg bis in die (BID) with Omeprazole (20-40 mg once daily), if indicated to be used. | 10 | 98 | EG000 |
| Group 2 | Allopurinol 100 up to 600 mg/Day | Allopurinol 100/300 mg tablets.The initial daily allopurinol dose is 100 mg given orally, to be escalated of 100 mg every 2 weeks in patients with serum urate concentration \>6 mg/dl.~The maximum dose of allopurinol achievable in the study will depend on kidney function and tolerability, but will not exceed 600 mg daily.To prevent flares in the initial stages of treatment, patients will be treated for at least 6 months with colchicine 0.5 - 1 mg QD or in case of colchicine intolerance, Naproxen 550 mg BID with Omeprazole (20-40 mg once daily), if indicated to be used. | 8 | 98 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Source ClinicalTrials.gov
Trial
- Title
- Intensive Urate Lowering Therapy of Febuxostat Compared to Allopurinol on Cardiovascular Risk in Patients With Gout
- NCT number
- NCT02500641
- Phases
- PHASE4
- Conditions
- Gout
- Interventions
- Febuxostat 80/120mg/day, Allopurinol 100 up to 600mg/day, Colchicine, Naproxen, Omeprazole
- Lead sponsor
- Menarini International Operations Luxembourg SA
- Results first posted
- 2019-06-21
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02500641?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.
For software
Read this comparison from software.
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GET https://conductscience.org/api/comparisons/v1/NCT02500641-sae