Comparison · NCT04138277-sae
Treatment Continued Group vs Treatment Switched Group: 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. Treatment Continued Group vs Treatment Switched Group: serious adverse events. Trial comparisons, record NCT04138277-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04138277-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 | 0.21 | 0.135 | 0.311 | wilson | |
| Risk in group 2 | 0.27 | 0.154 | 0.43 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0604 | -0.236 | 0.0935 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.777 | 0.394 | 1.53 | log | |
| Odds ratio, group 1 over group 2 | 0.717 | 0.291 | 1.77 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Treatment Continued Group than on Treatment Switched Group | 16.6 | 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 | Treatment Continued Group | Participants who received ATB200 (20 mg/kg) co-administered with AT2221 (260 mg) in the feeder study who continued on that dose in this long-term extension | 17 | 81 | EG000 |
| Group 2 | Treatment Switched Group | Participants who received alglucosidase alfa/placebo in the feeder study who were switched to ATB200 (20 mg/kg) co-administered with AT2221 (260 mg) in this long-term extension | 10 | 37 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1 to 58 months).
Source ClinicalTrials.gov
Trial
- Title
- A Study to Assess the Long-term Safety and Efficacy of ATB200/AT2221 in Adult Subjects With Late-Onset Pompe Disease (LOPD)
- NCT number
- NCT04138277
- Phases
- PHASE3
- Conditions
- Pompe Disease (Late-onset)
- Interventions
- AT2221, ATB200
- Lead sponsor
- Amicus Therapeutics
- Results first posted
- 2026-01-12
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04138277?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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