Comparison · NCT01642056-sae
EPI-743 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. EPI-743 vs Placebo: serious adverse events. Trial comparisons, record NCT01642056-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01642056-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 | 0.15 | 0.0524 | 0.36 | wilson | |
| Risk in group 2 | 0.211 | 0.0851 | 0.433 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0605 | -0.304 | 0.184 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.713 | 0.183 | 2.77 | log | |
| Odds ratio, group 1 over group 2 | 0.662 | 0.127 | 3.45 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on EPI-743 than on Placebo | 16.5 | 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 | EPI-743 | Received EPI-743, 15mg/kg up to a maximum dose of 200 mg orally or via gastric tube three times daily with meals. EPI-743 is structurally related to Vitamin E and can be broadly classified as an antioxidant. | 3 | 20 | EG000 |
| Group 2 | Placebo | Received Placebo three times daily orally or via gastric tube with meals. | 4 | 19 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 14 Months
Source ClinicalTrials.gov
Trial
- Title
- EPI-743 for Metabolism or Mitochondrial Disorders
- NCT number
- NCT01642056
- Phases
- PHASE1, PHASE2
- Conditions
- Mitochondrial Disease, Neurology, Myopathy
- Interventions
- EPI-743, Placebo
- Lead sponsor
- National Human Genome Research Institute (NHGRI)
- Results first posted
- 2021-04-14
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01642056?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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