Comparison · NCT02795676-sae
PRX-102 (Pegunigalsidase Alfa) vs Agalsidase Beta: 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. PRX-102 (Pegunigalsidase Alfa) vs Agalsidase Beta: serious adverse events. Trial comparisons, record NCT02795676-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02795676-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 | 0.154 | 0.0801 | 0.275 | wilson | |
| Risk in group 2 | 0.24 | 0.115 | 0.434 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0862 | -0.294 | 0.0881 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.641 | 0.249 | 1.65 | log | |
| Odds ratio, group 1 over group 2 | 0.576 | 0.176 | 1.89 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on PRX-102 (Pegunigalsidase Alfa) than on Agalsidase Beta | 11.6 | 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 | PRX-102 (Pegunigalsidase Alfa) | Pegunigalsidase alfa administered as an intravenous infusion every 2 weeks, at a dosage of 1 mg/kg | 8 | 52 | EG000 |
| Group 2 | Agalsidase Beta | Agalsidase beta administered as an intravenous infusion every 2 weeks, at a dosage of 1 mg/kg | 6 | 25 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 24 months
Source ClinicalTrials.gov
Trial
- Title
- Study of the Safety and Efficacy of PRX-102 Compared to Agalsidase Beta on Renal Function
- NCT number
- NCT02795676
- Phases
- PHASE3
- Conditions
- Fabry Disease
- Interventions
- PRX-102 (pegunigalsidase alfa), agalsidase beta
- Lead sponsor
- Protalix
- Results first posted
- 2023-08-02
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02795676?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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