Comparison · NCT02377921-sae
Ace-ER 6 g/Day vs Placebo: 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. Ace-ER 6 g/Day vs Placebo: serious adverse events. Trial comparisons, record NCT02377921-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02377921-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 | 0.0444 | 0.0123 | 0.148 | wilson | |
| Risk in group 2 | 0.0227 | 0.00402 | 0.118 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0217 | -0.0789 | 0.127 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.96 | 0.184 | 20.8 | log | |
| Odds ratio, group 1 over group 2 | 2 | 0.175 | 22.9 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Ace-ER 6 g/Day than on Placebo | 46 | 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 | Ace-ER 6 g/Day | Ace-ER 6 g/day, divided TID for 48 weeks. | 2 | 45 | EG000 |
| Group 2 | Placebo | Matching placebo TID for 48 weeks. | 1 | 44 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Screening through Week 48 plus 28 days (+5 days). The mean (SD) duration of treatment was 340.2 (12.02) days and 332.9 (40.86) days for the Ace-ER and placebo groups, respectively.
Source ClinicalTrials.gov
Trial
- Title
- Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Sialic Acid in Patients With Glucosamine (UDP-N-acetyl)-2-epimerase Myopathy (GNEM) or Hereditary Inclusion Body Myopathy (HIBM)
- NCT number
- NCT02377921
- Phases
- PHASE3
- Conditions
- Hereditary Inclusion Body Myopathy, Distal Myopathy With Rimmed Vacuoles, Distal Myopathy, Nonaka Type, GNE Myopathy
- Interventions
- aceneuramic acid extended-release (Ace-ER), Placebo
- Lead sponsor
- Ultragenyx Pharmaceutical Inc
- Results first posted
- 2018-07-09
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02377921?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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