Comparison · NCT00701415-sae
Fabrazyme 0.5 mg/kg vs Fabrazyme 1.0 mg/kg: 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. Fabrazyme 0.5 mg/kg vs Fabrazyme 1.0 mg/kg: serious adverse events. Trial comparisons, record NCT00701415-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00701415-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 | 0.375 | 0.185 | 0.614 | wilson | |
| Risk in group 2 | 0.333 | 0.152 | 0.583 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0417 | -0.272 | 0.341 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.13 | 0.433 | 2.92 | log | |
| Odds ratio, group 1 over group 2 | 1.2 | 0.274 | 5.25 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Fabrazyme 0.5 mg/kg than on Fabrazyme 1.0 mg/kg | 24 | 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 | Fabrazyme 0.5 mg/kg | Fabrazyme 0.5 mg/kg was administered every 2 weeks (up to 131 infusion) up to 260 weeks, the total infusion time was not less than 45 minutes. In case of significant progression of Fabry disease, the dose was increased to 1.0 mg/kg every 2 weeks. | 6 | 16 | EG000 |
| Group 2 | Fabrazyme 1.0 mg/kg | Fabrazyme 1.0 mg/kg was administered every 4 weeks (up to 66 infusion) up to 260 weeks, the total infusion time was not less than 90 minutes. In case of significant progression of Fabry disease, the dose was increased to 1.0 mg/kg every 2 weeks. | 5 | 15 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 264) regardless of seriousness or relationship to investigational product.
Source ClinicalTrials.gov
Trial
- Title
- A Study of Two Fabrazyme (Agalsidase Beta) Dosing Regimens in Treatment-naïve, Male Pediatric Patients Without Severe Symptoms
- NCT number
- NCT00701415
- Phases
- PHASE3
- Conditions
- Fabry Disease
- Interventions
- Agalsidase beta, Agalsidase beta
- Lead sponsor
- Genzyme, a Sanofi Company
- Results first posted
- 2016-06-29
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00701415?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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