Comparison · NCT05843916-sae
Lead-in Period (Fabrazyme) vs Treatment Period (AGA BETA BS): 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. Lead-in Period (Fabrazyme) vs Treatment Period (AGA BETA BS): serious adverse events. Trial comparisons, record NCT05843916-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT05843916-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 | 0 | 0.161 | wilson | |
| Risk in group 2 | 0.263 | 0.118 | 0.488 | wilson | |
| Risk difference, group 1 minus group 2 | -0.263 | -0.488 | -0.0463 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat, for one fewer participant with a serious adverse event on Lead-in Period (Fabrazyme) than on Treatment Period (AGA BETA BS) | 3.8 | 2.05 | 21.6 | from the risk difference interval |
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 | Lead-in Period (Fabrazyme) | This is a single-arm study design where participants will serve as their own controls. First, all participants will receive 2 doses of Fabrazyme® with approximately 14 days between them.~Recombinant human alpha galactosidase A (agalsidase beta): All participants will receive 2 doses of Fabrazyme® with approximately 14 days between them. The dose will be 1 mg/kg of body mass every 2 weeks. | 0 | 20 | EG000 |
| Group 2 | Treatment Period (AGA BETA BS) | After completing Lead-in period, all participants will switch treatment and receive AGA BETA BS for 54 weeks.~Recombinant human alpha-galactosidase A (agalsidase beta): All participants will receive AGA BETA BS for 54 weeks. The dose will be 1 mg/kg of body mass every 2 weeks. | 5 | 19 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 13 months
Source ClinicalTrials.gov
Trial
- Title
- Switch Over Study of Biosimilar Agalsidase Beta for Fabry Disease
- NCT number
- NCT05843916
- Phases
- PHASE3
- Conditions
- Fabry Disease
- Interventions
- Recombinant human alpha galactosidase A (agalsidase beta), Recombinant human alpha-galactosidase A (agalsidase beta)
- Lead sponsor
- Bio Sidus SA
- Results first posted
- 2026-02-18
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT05843916?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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