Comparison · NCT01027143-sae
Omega-3 Fatty Acids vs Control: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Omega-3 Fatty Acids vs Control: serious adverse events. Trial comparisons, record NCT01027143-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01027143-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 | 0.039 | 0.0133 | 0.108 | wilson | |
| Risk in group 2 | 0 | 0 | 0.155 | wilson | |
| Risk difference, group 1 minus group 2 | 0.039 | -0.118 | 0.108 | 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 harm, for one more participant with a serious adverse event on Omega-3 Fatty Acids than on Control | 25.7 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: control.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Omega-3 Fatty Acids | 3 softgels (EPA, DHA) twice daily~omega-3 polyunsaturated fatty acids: ProEPA Xtra 1000mg softgels: 3 softgels twice daily | 3 | 77 | EG000 |
| Group 2 | Control | Soybean oil: 3 matched softgel caps twice daily~Omega-3 Fatty Acid: Soybean oil: 3(age 12-25) matched softgel caps twice daily | 0 | 21 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Over the course of the study post randomization (24 weeks)
Source ClinicalTrials.gov
Trial
- Title
- Obesity and Asthma: Nutrigenetic Response to Omega-3 Fatty Acids
- NCT number
- NCT01027143
- Phases
- PHASE2, PHASE3
- Conditions
- Asthma, Obesity
- Interventions
- omega-3 polyunsaturated fatty acids, Omega-3 Fatty Acid
- Lead sponsor
- Nemours Children's Clinic
- Results first posted
- 2023-09-08
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01027143?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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