Comparison · NCT01062763-sae
Addition of 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
Cite this record
ConductScience Library. Addition of Spironolactone vs Placebo: serious adverse events. Trial comparisons, record NCT01062763-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01062763-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 | 0.0164 | 0.0029 | 0.0872 | wilson | |
| Risk in group 2 | 0 | 0 | 0.0621 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0164 | -0.0472 | 0.0872 | 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 Addition of Spironolactone than on Placebo | 61 | 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 | Addition of Spironolactone | spironolactone is added to previous antihypertensive treatment~spironolactone : 25 uptrated if necessary to 50 mg once daily | 1 | 61 | EG000 |
| Group 2 | Placebo | 1tablet of matching placebo uptrated to 2 if neccessary | 0 | 58 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 4 months
Source ClinicalTrials.gov
Trial
- Title
- The Effect of Spironolactone on Blood Pressure in Type-2 Diabetics With Resistant Hypertension
- NCT number
- NCT01062763
- Phases
- PHASE3
- Conditions
- Arterial Hypertension, Hypertension, Resistant to Conventional Therapy, Diabetes Mellitus
- Interventions
- spironolactone, placebo
- Lead sponsor
- Ib Abildgaard Jacobsen
- Results first posted
- 2014-05-08
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01062763?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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