Comparison · NCT00094302-sae
Spironolactone 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
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ConductScience Library. Spironolactone vs Placebo: serious adverse events. Trial comparisons, record NCT00094302-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00094302-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 | 0.485 | 0.461 | 0.509 | wilson | |
| Risk in group 2 | 0.496 | 0.473 | 0.52 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0113 | -0.0447 | 0.022 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.977 | 0.913 | 1.05 | log | |
| Odds ratio, group 1 over group 2 | 0.956 | 0.836 | 1.09 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Spironolactone than on Placebo | 88.3 | 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 | Spironolactone | Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial. | 835 | 1,722 | EG001 |
| Group 2 | Placebo | Placebo of spironolactone | 855 | 1,723 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject.
Source ClinicalTrials.gov
Trial
- Title
- Aldosterone Antagonist Therapy for Adults With Heart Failure and Preserved Systolic Function
- NCT number
- NCT00094302
- Phases
- PHASE3
- Conditions
- Cardiovascular Diseases, Heart Diseases, Heart Failure, Congestive
- Interventions
- Spironolactone, Placebo
- Lead sponsor
- Carelon Research
- Results first posted
- 2015-03-02
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00094302?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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