Comparison · NCT02004704-sae
Olipudase Alfa: Participants From DFI13412 (Adults) vs Olipudase Alfa: Participants From DFI13803 (Pediatrics): 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. Olipudase Alfa: Participants From DFI13412 (Adults) vs Olipudase Alfa: Participants From DFI13803 (Pediatrics): serious adverse events. Trial comparisons, record NCT02004704-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02004704-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 | 0.2 | 0.0362 | 0.624 | wilson | |
| Risk in group 2 | 0.5 | 0.299 | 0.701 | wilson | |
| Risk difference, group 1 minus group 2 | -0.3 | -0.559 | 0.17 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.4 | 0.0657 | 2.44 | log | |
| Odds ratio, group 1 over group 2 | 0.25 | 0.0236 | 2.65 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Olipudase Alfa: Participants From DFI13412 (Adults) than on Olipudase Alfa: Participants From DFI13803 (Pediatrics) | 3.33 | 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 | Olipudase Alfa: Participants From DFI13412 (Adults) | Participants continued to receive olipudase alfa at the same dose as at the completion of original study-DFI13412 (up to 3.0 mg/kg) via IV infusion every 2 weeks for 9 years, or until olipudase alfa was commercially accessible, whichever came first, unless the participant decided to enter another olipudase alfa clinical trial within the 9-year period prior to when olipudase alfa was commercially accessible. | 1 | 5 | EG000 |
| Group 2 | Olipudase Alfa: Participants From DFI13803 (Pediatrics) | Participants continued to receive olipudase alfa at the same dose as at the completion of original study-DFI13803 (up to 3.0 mg/kg) via IV infusion every 2 weeks for 9 years, or until olipudase alfa was commercially accessible, whichever came first, unless the participant decided to enter another olipudase alfa clinical trial within the 9-year period prior to when olipudase alfa was commercially accessible. During the study, pediatric participants who reached adult age (18 years old) received the adult infusion volume. | 10 | 20 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From the signature of informed consent up to 9 years or until olipudase alfa was commercially accessible, whichever came first
Source ClinicalTrials.gov
Trial
- Title
- A Long-Term Study of Olipudase Alfa in Patients With Acid Sphingomyelinase Deficiency
- NCT number
- NCT02004704
- Phases
- PHASE2
- Conditions
- Sphingomyelin Lipidosis
- Interventions
- GZ402665
- Lead sponsor
- Genzyme, a Sanofi Company
- Results first posted
- 2024-07-03
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02004704?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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