Comparison · NCT03583697-sae
Vosoritide vs Placebo: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Vosoritide vs Placebo: serious adverse events. Trial comparisons, record NCT03583697-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03583697-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 | 0.0698 | 0.024 | 0.186 | wilson | |
| Risk in group 2 | 0.188 | 0.0889 | 0.353 | wilson | |
| Risk difference, group 1 minus group 2 | -0.118 | -0.29 | 0.0348 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.372 | 0.101 | 1.38 | log | |
| Odds ratio, group 1 over group 2 | 0.325 | 0.0746 | 1.42 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Vosoritide than on Placebo | 8.49 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Vosoritide | All Vosoritide : 11 sentinel + 32 randomized participants who received vosoritide 15 µg/kg/day or 30 µg/kg/day, single daily subcutaneous injection. | 3 | 43 | EG001 |
| Group 2 | Placebo | Placebo: Participants who received placebo single daily subcutaneous injection. | 6 | 32 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to Week 56 Safety Follow-Up.
Source ClinicalTrials.gov
Trial
- Title
- A Clinical Trial to Evaluate the Safety and Efficacy of BMN 111 in Infants and Young Children With Achondroplasia
- NCT number
- NCT03583697
- Phases
- PHASE2
- Conditions
- Achondroplasia
- Interventions
- BMN 111, Placebo
- Lead sponsor
- BioMarin Pharmaceutical
- Results first posted
- 2024-06-13
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03583697?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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