Comparison · NCT01376908-sae
Kuvan® + Phe-restricted Diet vs Phe-restricted Diet: 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. Kuvan® + Phe-restricted Diet vs Phe-restricted Diet: serious adverse events. Trial comparisons, record NCT01376908-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01376908-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 | 0.111 | 0.0385 | 0.281 | wilson | |
| Risk in group 2 | 0.037 | 0.00657 | 0.183 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0741 | -0.0888 | 0.246 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 3 | 0.333 | 27.1 | log | |
| Odds ratio, group 1 over group 2 | 3.25 | 0.316 | 33.4 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Kuvan® + Phe-restricted Diet than on Phe-restricted Diet | 13.5 | 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 | Kuvan® + Phe-restricted Diet | Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day). If after 4 weeks, there was less than 20 percent (%) increase in subject's Phe tolerance versus baseline, the dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria. | 3 | 27 | EG000 |
| Group 2 | Phe-restricted Diet | Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria. | 1 | 27 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From the first dose of study drug administration up to 31 days after the last dose of study drug administration
Source ClinicalTrials.gov
Trial
- Title
- Kuvan® in Phenylketonuria Patients Less Than 4 Years Old
- NCT number
- NCT01376908
- Phases
- PHASE3
- Conditions
- Phenylketonuria
- Interventions
- Kuvan®, Phenylalanine (Phe)-restricted diet
- Lead sponsor
- BioMarin Pharmaceutical
- Results first posted
- 2016-05-12
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01376908?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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