Comparison · NCT00858637-sae
MCI-196 (Active) + Simvastatin (Placebo)/ Comparison Phase vs Simvastatin (Active) + MCI-196 (Placebo)/ Comparion Phase: 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. MCI-196 (Active) + Simvastatin (Placebo)/ Comparison Phase vs Simvastatin (Active) + MCI-196 (Placebo)/ Comparion Phase: serious adverse events. Trial comparisons, record NCT00858637-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00858637-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 | 0.125 | 0.0784 | 0.193 | wilson | |
| Risk in group 2 | 0.0916 | 0.0532 | 0.153 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0334 | -0.0439 | 0.112 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.36 | 0.672 | 2.77 | log | |
| Odds ratio, group 1 over group 2 | 1.42 | 0.642 | 3.13 | log | |
Number needed to harm, for one more participant with a serious adverse event on MCI-196 (Active) + Simvastatin (Placebo)/ Comparison Phase than on Simvastatin (Active) + MCI-196 (Placebo)/ Comparion Phase | 29.9 | 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 | MCI-196 (Active) + Simvastatin (Placebo)/ Comparison Phase | Active Comparison Phase: 3, 6, 9, 12g of MCI-196 / day as titrated | 16 | 128 | EG000 |
| Group 2 | Simvastatin (Active) + MCI-196 (Placebo)/ Comparion Phase | Active Comparison Phase: 10 mg to 40 mg of Simvastatin / day as titrated | 12 | 131 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 16 weeks (Baseline - 16 weeks)
Source ClinicalTrials.gov
Trial
- Title
- Efficacy and Safety Study of MCI-196 Versus Simvastatin for Dyslipidaemia in Chronic Kidney Disease (CKD) Subjects on Dialysis
- NCT number
- NCT00858637
- Phases
- PHASE3
- Conditions
- Chronic Kidney Disease
- Interventions
- MCI-196, Placebo of Simvastatin, Simvastatin, Placebo of MCI-196
- Lead sponsor
- Tanabe Pharma Corporation
- Results first posted
- 2014-10-17
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00858637?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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