Comparison · NCT00639158-sae
ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe vs Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe: 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. ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe vs Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe: serious adverse events. Trial comparisons, record NCT00639158-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00639158-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 | 0.011 | 0.00376 | 0.0319 | wilson | |
| Risk in group 2 | 0.0185 | 0.00794 | 0.0426 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00749 | -0.0327 | 0.0159 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.596 | 0.144 | 2.47 | log | |
| Odds ratio, group 1 over group 2 | 0.591 | 0.14 | 2.5 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe than on Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe | 134 | 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 | ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe | 3 | 272 | EG000 | |
| Group 2 | Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe | 5 | 270 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
Safety and Efficacy Study Comparing ABT-335 Coadministered With Atorvastatin and Ezetimibe to Atorvastatin Coadministered With Ezetimibe in Subjects With Multiple Abnormal Lipid (Fat) Levels in the Blood
- NCT number
- NCT00639158
- Phases
- PHASE3
- Conditions
- Dyslipidemias, Coronary Heart Disease, Combined (Atherogenic) Dyslipidemia, Mixed Dyslipidemia
- Interventions
- ABT-335, placebo, atorvastatin, ezetimibe
- Lead sponsor
- Abbott
- Results first posted
- 2009-11-05
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00639158?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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