Comparison · NCT02058095-sae
Tadalafil 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. Tadalafil vs Placebo: serious adverse events. Trial comparisons, record NCT02058095-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02058095-sae
On this page
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 | 0.0667 | 0.0119 | 0.298 | wilson | |
| Risk in group 2 | 0 | 0.0000000000000000555 | 0.354 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0667 | -0.292 | 0.298 | 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 Tadalafil than on Placebo | 15 | 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 | Tadalafil | Subject received Tadalafil daily for a total of 12 weeks~Tadalafil: Tadalafil 5 mg tablet. Daily. Tadalafil dose varies from 5 mg to 20 mg for 12 weeks. If blood pressure is \>95 then subject dismissed from the Clinical Research Unit (CRU) on 2 (5 mg) tabs of tadalafil or placebo. If blood pressure is between 90 - 95 mmHg systolic, then dismiss on 1 (5 mg) tab of Tadalafil.~At 2 weeks (± 5 days) if blood pressure is\> 100 than add 1 (5 mg) tab of Tadalafil to make a total of 3 (5mg) tabs of Tadalafil.~At 4 weeks(± 5 days) if blood pressure is \> 100 add 1 (5 mg) tab to make a total of 4 (5 mg) tablets of Tadalafil. | 1 | 15 | EG000 |
| Group 2 | Placebo | Subject received Placebo daily for a total of 12 weeks~Placebo: Placebo tablet. Daily. Placebo tablets made to match appearance of 5mg Tadalafil tablets. Placebo dose varies from 5 mg to 20 mg (1 to 4 tablets) for 12 weeks. If blood pressure is \>95 then subject dismissed from CRU on 2 tabs of placebo. If blood pressure is between 90 - 95 mmHg systolic, then dismiss on 1 (5 mg) tablet of placebo.~At 2 weeks (± 5 days) if blood pressure is\> 100 than add 1 tab of placebo to make a total of 3 tablets of placebo.~At 4 weeks(± 5 days) if blood pressure is \> 100 add 1 (5 mg) tab to make a total of 4 tablets of placebo. | 0 | 7 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse Events were collected from baseline to end of study, approximately 13 weeks.
Source ClinicalTrials.gov
Trial
- Title
- Study to Determine How Cialis Effects the Renal Function in Response to Volume Expansion in Preclinical Diastolic Cardiomyopathy (Aim3)
- NCT number
- NCT02058095
- Phases
- PHASE1, PHASE2
- Conditions
- Cardiomyopathy, Renal Impairment
- Interventions
- Tadalafil, Placebo
- Lead sponsor
- Mayo Clinic
- Results first posted
- 2020-05-21
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02058095?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.
For software
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT02058095-sae