Comparison · NCT01168908-sae
Revatio (Sildenafil) 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. Revatio (Sildenafil) vs Placebo: serious adverse events. Trial comparisons, record NCT01168908-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01168908-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 | 0.278 | 0.125 | 0.509 | wilson | |
| Risk in group 2 | 0.1 | 0.0179 | 0.404 | wilson | |
| Risk difference, group 1 minus group 2 | 0.178 | -0.163 | 0.423 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.78 | 0.375 | 20.6 | log | |
| Odds ratio, group 1 over group 2 | 3.46 | 0.344 | 34.8 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Revatio (Sildenafil) than on Placebo | 5.63 | 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 | Revatio (Sildenafil) | This arm will receive Revatio (sildenafil) for 12 months. During the first 6 months, the subject and investigator will be blinded to treatment. The second 6 months, will be open label treatment with Revatio.~Sildenafil: 20mg tablet three times daily | 5 | 18 | EG000 |
| Group 2 | Placebo | This arm will receive placebo (sugar pill) for 6 months and Revatio (sildenafil) for 6 months. During the first 6 months, the subject and investigator will be blinded to treatment. The second 6 months, will be open label treatment with Revatio.~Sildenafil: 20mg tablet three times daily | 1 | 10 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Revatio for Heart Disease in Duchenne Muscular Dystrophy and Becker Muscular Dystrophy
- NCT number
- NCT01168908
- Phases
- PHASE2
- Conditions
- Duchenne Muscular Dystrophy, Becker Muscular Dystrophy
- Interventions
- Sildenafil
- Lead sponsor
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
- Results first posted
- 2018-03-21
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01168908?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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