Comparison · NCT02246218-sae
RAVICTI: Age 2 Months to < 2 Years vs RAVICTI: Age 0 to <2 Months: 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. RAVICTI: Age 2 Months to < 2 Years vs RAVICTI: Age 0 to <2 Months: serious adverse events. Trial comparisons, record NCT02246218-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02246218-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 | 0.6 | 0.313 | 0.832 | wilson | |
| Risk in group 2 | 0.688 | 0.444 | 0.858 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0875 | -0.422 | 0.249 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.873 | 0.477 | 1.6 | log | |
| Odds ratio, group 1 over group 2 | 0.682 | 0.131 | 3.55 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on RAVICTI: Age 2 Months to < 2 Years than on RAVICTI: Age 0 to <2 Months | 11.4 | 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 | RAVICTI: Age 2 Months to < 2 Years | Participants age 2 months to \< 2 years received RAVICTI Oral Liquid administered just prior to breastfeeding or intake of formula or food. The recommended dosing regimen is 3-6 times per day depending on feeding schedule and at the discretion of the Investigator. | 6 | 10 | EG000 |
| Group 2 | RAVICTI: Age 0 to <2 Months | Participants age 0 to \< 2 months received RAVICTI Oral Liquid administered just prior to breastfeeding or intake of formula or food. The recommended dosing regimen is 3-6 times per day depending on feeding schedule and at the discretion of the Investigator. | 11 | 16 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
From the first dose of study treatment through 30 days after the final dose (mean [SD] duration of treatment was 9.13 [6.838] months for Cohort of 2 Months to <2 Years Participants and 10.67 [6.142] months for Cohort of 0 Months to <2 Months Participants).
Source ClinicalTrials.gov
Trial
- Title
- A Study of the Safety, Efficacy and Pharmacokinetics of Glycerol Phenylbutyrate in Pediatric Subjects Under 2 Years of Age With Urea Cycle Disorders
- NCT number
- NCT02246218
- Phases
- PHASE4
- Conditions
- Urea Cycle Disorder
- Interventions
- RAVICTI
- Lead sponsor
- Amgen
- Results first posted
- 2019-03-05
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02246218?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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