Comparison · NCT02353312-sae
On Kuvan vs Off Kuvan: 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. On Kuvan vs Off Kuvan: serious adverse events. Trial comparisons, record NCT02353312-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02353312-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 | 0.143 | 0.057 | 0.315 | wilson | |
| Risk in group 2 | 0.214 | 0.102 | 0.395 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0714 | -0.272 | 0.134 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.667 | 0.211 | 2.11 | log | |
| Odds ratio, group 1 over group 2 | 0.611 | 0.152 | 2.46 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on On Kuvan than on Off Kuvan | 14 | 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 | On Kuvan | Kuvan® supplementation in addition to standard care for heart failure for three months. At the end of three months, stop Kuvan®, patients will only receive Standard care for heart failure for another 3 months~Kuvan: Kuvan® (sapropterin dihydrochloride) will be initiated at 10mg/kg/day with meals for one week. After telephone contact on day 7, assuming no adverse effects are noted, the patient will be instructed to increase their daily dose to 20mg/kg/day with meals for the remainder of the 3 months. | 4 | 28 | EG000 |
| Group 2 | Off Kuvan | Standard care for heart failure for three months. At the end of three months, Starting Kuvan® supplementation in addition to Standard care for heart failure for another 3 months | 6 | 28 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 6 months
Source ClinicalTrials.gov
Trial
- Title
- Rhode Island Diastolic Dysfunction - Heart Failure
- NCT number
- NCT02353312
- Phases
- NA
- Conditions
- Heart Failure, Cardiovascular Disease
- Interventions
- Kuvan
- Lead sponsor
- Providence VA Medical Center
- Results first posted
- 2025-07-03
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02353312?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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