Comparison · NCT00120289-sae
ERN + Simvastatin vs Placebo + Simvastatin: 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. ERN + Simvastatin vs Placebo + Simvastatin: serious adverse events. Trial comparisons, record NCT00120289-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00120289-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 | 0.342 | 0.32 | 0.364 | wilson | |
| Risk in group 2 | 0.325 | 0.303 | 0.348 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0168 | -0.0148 | 0.0484 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.05 | 0.956 | 1.16 | log | |
| Odds ratio, group 1 over group 2 | 1.08 | 0.935 | 1.24 | log | |
| Number needed to harm, for one more participant with a serious adverse event on ERN + Simvastatin than on Placebo + Simvastatin | 59.5 | 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 | ERN + Simvastatin | Extended release niacin plus simvastatin~Extended release niacin: 2,000 mg/day or 1,500 mg/day if higher dose not tolerated~Simvastatin: Dose adjusted to achieve LDL-C 40 mg/dL - 80 mg/dL, adding ezetimibe (10 mg/day) if needed to achieve LDL-C target | 587 | 1,718 | EG000 |
| Group 2 | Placebo + Simvastatin | Simvastatin alone~Simvastatin: Dose adjusted to achieve LDL-C 40 mg/dL - 80 mg/dL, adding ezetimibe (10 mg/day) if needed to achieve LDL-C target | 551 | 1,696 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Randomization through final study visit after recommendation to curtail study (June - September 2011)
Source ClinicalTrials.gov
Trial
- Title
- Niacin Plus Statin to Prevent Vascular Events
- NCT number
- NCT00120289
- Phases
- PHASE3
- Conditions
- Cardiovascular Diseases, Heart Diseases, Cerebrovascular Accident, Coronary Disease, Atherosclerosis, Myocardial Infarction
- Interventions
- Extended release niacin, Simvastatin
- Lead sponsor
- Axio Research. LLC
- Results first posted
- 2015-06-17
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00120289?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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