Comparison · NCT02684591-sae
Aramchol 600 mg Orally Daily 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. Aramchol 600 mg Orally Daily vs Placebo: serious adverse events. Trial comparisons, record NCT02684591-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02684591-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 | 0.0000000000000000139 | 0.133 | wilson | |
| Risk in group 2 | 0 | 0.0000000000000000139 | 0.133 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.133 | 0.133 | 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 | from the risk difference interval | the two groups' risks are equal |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Aramchol 600 mg Orally Daily | Total 600 mg Aramchol (200 mg/tablet and 400 mg/tablet) per day once a day orally for 12 weeks.~Intervention: Aramchol~Aramchol: Aramchol, a conjugate of Cholic acid and Arachidic acid, is a first in class member of a novel family of synthetic Fatty-Acid / Bile-Acid Conjugates (FABACs). FABACs are composed of endogenic compounds, orally administrated with potentially good safety and tolerability parameters | 0 | 25 | EG000 |
| Group 2 | Placebo | Placebo in the form of a tablet; Two bottles will be given to patient and they will take two pills, once a day orally for 12 weeks.~Placebo: Placebo | 0 | 25 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 12 Weeks
Source ClinicalTrials.gov
Trial
- Title
- Aramchol for HIV-associated Nonalcoholic Fatty Liver Disease and Lipodystrophy
- NCT number
- NCT02684591
- Phases
- PHASE2
- Conditions
- Nonalcoholic Fatty Liver Disease, HIV
- Interventions
- Aramchol, Placebo
- Lead sponsor
- University of California, San Diego
- Results first posted
- 2019-08-21
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02684591?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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