Comparison · NCT00701701-deaths
Regimen A: Alglucosidase Alfa and Cyclophosphamide vs Regimen B: Alglucosidase Alfa, Rituximab and Methotrexate: deaths from any cause
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. Regimen A: Alglucosidase Alfa and Cyclophosphamide vs Regimen B: Alglucosidase Alfa, Rituximab and Methotrexate: deaths from any cause. Trial comparisons, record NCT00701701-deaths. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00701701-deaths
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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 | 0.793 | wilson | |
| Risk in group 2 | 0.333 | 0.0615 | 0.792 | wilson | |
| Risk difference, group 1 minus group 2 | -0.333 | -0.792 | 0.505 | 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 death from any cause on Regimen A: Alglucosidase Alfa and Cyclophosphamide than on Regimen B: Alglucosidase Alfa, Rituximab and Methotrexate | 3 | 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 | Regimen A: Alglucosidase Alfa and Cyclophosphamide | Participants exhibiting clinical decline since starting alglucosidase alfa (Myozyme®) therapy and having inhibitory antibodies and/or a sustained high rhGAA antibody titer (defined as at least 2 titers \>=25,600 obtained at least 1 month apart), regardless of their CRIM status, were assigned to Regimen A. In Regimen A, participants received alglucosidase alfa (Myozyme®) IV infusion of 20 mg/kg qow for a minimum of 18 months or, until the participant reached the age of 2 years (if the participant was \<6 months of age at the time of enrollment). In addition, cyclophosphamide 250 mg/m\^2 IV infusion was administered q4w after Myozyme® infusion for 6 months. | 0 | 1 | EG000 |
| Group 2 | Regimen B: Alglucosidase Alfa, Rituximab and Methotrexate | CRIM-negative participants were assigned to Regimen B if they either(1)exhibited clinical decline since starting alglucosidase alfa (Myozyme®)therapy and did not have inhibitory antibodies and/or a sustained rhGAA antibody titer(defined as at least 2 titers \>=25,600 obtained at least 1 month apart),or(2) did not exhibit clinical decline since starting alglucosidase alfa(Myozyme®) therapy, regardless of their anti-rhGAA or inhibitory antibody status. Regimen B participants with CRIM-negative status received alglucosidase alfa(Myozyme®) IV infusion of 20 mg/kg qow for a minimum of 18 months or,until participant reached the age of 2 years (if participant was \<6 months of age at time of enrollment). In addition,rituximab 375 mg/m\^2 IV was administered weekly beginning the day after Myozyme® infusion for 4 weeks(an optional 2nd cycle could be administered at the discretion of the investigator) and biweekly methotrexate 15 mg/m\^2 subcutaneous on the day after Myozyme® infusion for 6 months. | 1 | 3 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, all-cause mortality
- Time frame
- All Adverse Events (AEs) were collected from first IMP administration up to 18 months
Source ClinicalTrials.gov
Trial
- Title
- Immune Tolerance Induction Study
- NCT number
- NCT00701701
- Phases
- PHASE4
- Conditions
- Pompe Disease, Glycogen Storage Disease Type II (GSD-II), Glycogenesis 2 Acid Maltase Deficiency
- Interventions
- Myozyme® (alglucosidase alfa), Myozyme® (alglucosidase alfa)
- Lead sponsor
- Genzyme, a Sanofi Company
- Results first posted
- 2020-10-12
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00701701?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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