Comparison · NCT01257737-sae
HPN-100- Pediatric vs HPN-100 - Adult: 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. HPN-100- Pediatric vs HPN-100 - Adult: serious adverse events. Trial comparisons, record NCT01257737-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01257737-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 | 0.267 | 0.16 | 0.41 | wilson | |
| Risk in group 2 | 0.442 | 0.304 | 0.589 | wilson | |
| Risk difference, group 1 minus group 2 | -0.175 | -0.357 | 0.0237 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.604 | 0.335 | 1.09 | log | |
| Odds ratio, group 1 over group 2 | 0.459 | 0.188 | 1.12 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on HPN-100- Pediatric than on HPN-100 - Adult | 5.71 | 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 | HPN-100- Pediatric | Pediatric participants (age 1-17) continued HPN-100 treatment after completion of HPN-100-005SE, HPN-100-007, or HPN-100-012SE. | 12 | 45 | EG000 |
| Group 2 | HPN-100 - Adult | Adult participants (age 19-61) continued HPN-100 treatment after completion of HPN-100-005SE, HPN-100-007, or HPN-100-012SE. | 19 | 43 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From the time of informed consent until 7 days after the last dose of study drug, up to 66 months
Source ClinicalTrials.gov
Trial
- Title
- To Evaluate the Safety of Long-term Use of HPN-100 in the Management of Urea Cycle Disorders (UCDs)
- NCT number
- NCT01257737
- Phases
- PHASE4
- Conditions
- Urea Cycle Disorders
- Interventions
- HPN-100
- Lead sponsor
- Amgen
- Results first posted
- 2018-05-04
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01257737?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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