Comparison · NCT00146770-sae
Aldurazyme/|Aldurazyme***Check Title*** vs Placebo/|Aldurazyme***Check Title***: 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. Aldurazyme/|Aldurazyme***Check Title*** vs Placebo/|Aldurazyme***Check Title***: serious adverse events. Trial comparisons, record NCT00146770-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00146770-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 | 0.636 | 0.43 | 0.803 | wilson | |
| Risk in group 2 | 0.478 | 0.292 | 0.67 | wilson | |
| Risk difference, group 1 minus group 2 | 0.158 | -0.124 | 0.408 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.33 | 0.782 | 2.26 | log | |
| Odds ratio, group 1 over group 2 | 1.91 | 0.579 | 6.3 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Aldurazyme/|Aldurazyme***Check Title*** than on Placebo/|Aldurazyme***Check Title*** | 6.33 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Aldurazyme/|Aldurazyme***Check Title*** | Aldurazyme/\|Aldurazyme\*\*\*Check Description\*\*\* | 14 | 22 | EG001 |
| Group 2 | Placebo/|Aldurazyme***Check Title*** | Placebo/\|Aldurazyme\*\*\*Check Description\*\*\* | 11 | 23 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Phase 3 Extension Study of the Safety and Efficacy of Aldurazyme® (Laronidase) in Mucopolysaccharidosis I (MPS I) Patients
- NCT number
- NCT00146770
- Phases
- PHASE3
- Conditions
- Mucopolysaccharidosis I, Hurler's Syndrome, Hurler-Scheie Syndrome, Scheie Syndrome
- Interventions
- Aldurazyme, Aldurazyme, placebo
- Lead sponsor
- Genzyme, a Sanofi Company
- Results first posted
- 2009-06-16
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00146770?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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