Comparison · NCT00084084-sae
Safety Population RB vs Transition Safety Population: 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. Safety Population RB vs Transition Safety Population: serious adverse events. Trial comparisons, record NCT00084084-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00084084-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 | 0.118 | 0.0329 | 0.343 | wilson | |
| Risk in group 2 | 0.182 | 0.0514 | 0.477 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0642 | -0.371 | 0.197 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.647 | 0.106 | 3.94 | log | |
| Odds ratio, group 1 over group 2 | 0.6 | 0.0715 | 5.03 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Safety Population RB than on Transition Safety Population | 15.6 | 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 | Safety Population RB | Patients in Cohort 1 who received at least 1 dose of Replagal RB in Phase 1 - no data from Phase 2 (Replagal AF) included. | 2 | 17 | EG000 |
| Group 2 | Transition Safety Population | A subset of patients from the Safety Population RB who additionally received at least 1 dose of Replagal AF in Phase 2. | 2 | 11 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 362 weeks
Source ClinicalTrials.gov
Trial
- Title
- Replagal Enzyme Replacement Therapy for Children With Fabry Disease
- NCT number
- NCT00084084
- Phases
- PHASE2
- Conditions
- Fabry Disease
- Interventions
- Agalsidase alfa
- Lead sponsor
- Shire
- Results first posted
- 2013-10-10
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00084084?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.
For software
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GET https://conductscience.org/api/comparisons/v1/NCT00084084-sae