Comparison · NCT00221104-sae
Pravastatin Group vs Control Group: 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. Pravastatin Group vs Control Group: serious adverse events. Trial comparisons, record NCT00221104-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00221104-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 | 0.241 | 0.212 | 0.272 | wilson | |
| Risk in group 2 | 0.209 | 0.182 | 0.239 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0321 | -0.00928 | 0.0734 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.15 | 0.959 | 1.39 | log | |
| Odds ratio, group 1 over group 2 | 1.2 | 0.948 | 1.53 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Pravastatin Group than on Control Group | 31.1 | 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 | Pravastatin Group | The administration was initiated within 1 month after randomization, and the treatment was continued until final observation. Diet and exercise therapies were reinforced when the total cholesterol levels consistently exceeded 6·21 mmol/L (240 mg/dL) at routine clinical visits. Increase of pravastatin dose or addition of other non-statin drugs (such as ion exchange resin, eicosapentaenoic acid and ezetimibe) was allowed only when such reinforcements were insufficient. Even under such conditions, use of other statins (such as simvastatin and atorvastatin) was prohibited. | 188 | 780 | EG000 |
| Group 2 | Control Group | The administration of any statin was prohibited, although use of other non-statin drugs was allowed when necessary. | 164 | 785 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Mean length of follow-up was 4.89 years.
Source ClinicalTrials.gov
Trial
- Title
- Japan Statin Treatment Against Recurrent Stroke (J-STARS)
- NCT number
- NCT00221104
- Phases
- PHASE3
- Conditions
- Ischemic Stroke
- Interventions
- Pravastatin
- Lead sponsor
- Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
- Results first posted
- 2018-01-25
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00221104?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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