Comparison · NCT01426438-sae
Arm A: Extended-release Niacin With Aspirin vs Arm B: Fenofibrate: 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. Arm A: Extended-release Niacin With Aspirin vs Arm B: Fenofibrate: serious adverse events. Trial comparisons, record NCT01426438-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01426438-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 | 0.02 | 0.00354 | 0.105 | wilson | |
| Risk in group 2 | 0 | 0.00000000000000000694 | 0.0727 | wilson | |
| Risk difference, group 1 minus group 2 | 0.02 | -0.0545 | 0.105 | 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 Arm A: Extended-release Niacin With Aspirin than on Arm B: Fenofibrate | 50 | 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 | Arm A: Extended-release Niacin With Aspirin | Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24) Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24. | 1 | 50 | EG000 |
| Group 2 | Arm B: Fenofibrate | Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks. | 0 | 49 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse event data were collected from randomization to the date the participant went off study.
Source ClinicalTrials.gov
Trial
- Title
- Endothelial Function, Lipoproteins, and Inflammation With Low HDL Cholesterol in HIV: ER Niacin Versus Fenofibrate
- NCT number
- NCT01426438
- Phases
- PHASE2
- Conditions
- HIV-1 Infection
- Interventions
- Niacin, Aspirin, Fenofibrate
- Lead sponsor
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
- Results first posted
- 2014-10-21
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01426438?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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