Comparison · NCT00853827-sae
Aliskiren 300 mg vs Placebo: 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. Aliskiren 300 mg vs Placebo: serious adverse events. Trial comparisons, record NCT00853827-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00853827-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 | 0.249 | 0.204 | 0.301 | wilson | |
| Risk in group 2 | 0.315 | 0.266 | 0.369 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0658 | -0.136 | 0.00553 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.791 | 0.613 | 1.02 | log | |
| Odds ratio, group 1 over group 2 | 0.722 | 0.507 | 1.03 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Aliskiren 300 mg than on Placebo | 15.2 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Aliskiren 300 mg | Visit 2 to 3, single blind for 1 week: patients received aliskiren 150 mg. visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets aliskiren 150 mg (force titration) | 76 | 305 | EG000 |
| Group 2 | Placebo | Period 1(Screening Period) visit 1(Day -42 to Day -1) eligibility for study participation was assessed. Period 2: visit 2 to 3, single blind for 1 week: patients received 1 tablet aliskiren 150 mg, 1 tablet placebo 150 mg. Period 3: visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets placebo 150 mg | 97 | 308 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Safety and Efficacy of Aliskiren on the Progression of Atherosclerosis in Coronary Artery Disease Patients
- NCT number
- NCT00853827
- Phases
- PHASE3
- Conditions
- Coronary Artery Disease (CAD), Coronary Atherosclerosis
- Interventions
- Placebo, Aliskiren
- Lead sponsor
- Novartis Pharmaceuticals
- Results first posted
- 2014-05-07
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00853827?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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