Comparison · NCT01597596-7e7ae6be
Alglucosidase Alfa 4000 L Material (Non-US Participants) vs Alglucosidase Alfa 160 L Material (US Participants): Number of Participants With Invasive Ventilator-Free Survival
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. Alglucosidase Alfa 4000 L Material (Non-US Participants) vs Alglucosidase Alfa 160 L Material (US Participants): Number of Participants With Invasive Ventilator-Free Survival. Trial comparisons, record NCT01597596-7e7ae6be. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01597596-7e7ae6be
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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 | 1 | 0.207 | 1 | wilson | |
| Risk in group 2 | 0.667 | 0.208 | 0.939 | wilson | |
| Risk difference, group 1 minus group 2 | 0.333 | -0.505 | 0.792 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.5 | 0.674 | 3.34 | log | |
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat, for one more participant with the outcome on Alglucosidase Alfa 4000 L Material (Non-US Participants) than on Alglucosidase Alfa 160 L Material (US Participants) | 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 | Alglucosidase Alfa 4000 L Material (Non-US Participants) | Alglucosidase alfa (4000 L material) 20 mg/kg IV infusion QOW for 52 weeks. | 1 | 1 | OG000 |
| Group 2 | Alglucosidase Alfa 160 L Material (US Participants) | Alglucosidase alfa (160 L material) 20 mg/kg IV infusion QOW for 52 weeks. | 2 | 3 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Invasive Ventilator-Free Survival
- Description
Invasive ventilator-free survival was defined as the time during which the participant is alive and not invasively ventilated. Number of Participants with invasive ventilator-free survival were reported.
- Time frame
- Up to Week 52
- Population
- Full analysis population.
Source ClinicalTrials.gov
Trial
- Title
- A Noninferiority Study of Alglucosidase Alfa Manufactured at the 160 L and 4000 L Scales in Treatment Naïve Patients With Infantile-Onset Pompe Disease
- NCT number
- NCT01597596
- Phases
- PHASE4
- Conditions
- Pompe Disease (Infantile-Onset), Glycogen Storage Disease Type II (GSD II), Glycogenosis 2, Acid Maltase Deficiency
- Interventions
- alglucosidase alfa, alglucosidase alfa
- Lead sponsor
- Genzyme, a Sanofi Company
- Results first posted
- 2016-01-18
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01597596?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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