Comparison · NCT00064792-sae
OraPlus vs Simvastatin Susp: 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. OraPlus vs Simvastatin Susp: serious adverse events. Trial comparisons, record NCT00064792-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00064792-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 | 0.0435 | 0.00772 | 0.21 | wilson | |
| Risk in group 2 | 0 | 0 | 0.143 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0435 | -0.104 | 0.21 | 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 OraPlus than on Simvastatin Susp | 23 | 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 | OraPlus | During the placebo phase, subjects were given a daily dose of an oral suspension not containing active drug. All subjects continued taking cholesterol suspension at 150mg/kg/day. | 1 | 23 | EG000 |
| Group 2 | Simvastatin Susp | Subjects began this phase by taking 0.5mg/kg/day of an oral suspension with active drug for 6 weeks followed by a daily dose of 1mg/kg/day. Subjects continued taking 150mg/kg/day of cholesterol suspension. | 0 | 23 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 6 weeks
Source ClinicalTrials.gov
Trial
- Title
- Simvastatin Therapy in Smith-Lemli-Opitz Syndrome
- NCT number
- NCT00064792
- Phases
- PHASE2
- Conditions
- Smith-Lemli-Opitz Syndrome
- Interventions
- Simvastatin Susp., OraPlus
- Lead sponsor
- Forbes Porter, M.D.
- Results first posted
- 2014-06-06
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00064792?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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