Comparison · NCT01063855-sae
PDE5I + PLACEBO vs PDE5I + DPX: 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. PDE5I + PLACEBO vs PDE5I + DPX: serious adverse events. Trial comparisons, record NCT01063855-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01063855-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 | 0.0163 | 0.00637 | 0.0412 | wilson | |
| Risk in group 2 | 0.012 | 0.00409 | 0.0347 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00433 | -0.0204 | 0.0304 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.36 | 0.308 | 6.02 | log | |
| Odds ratio, group 1 over group 2 | 1.37 | 0.303 | 6.17 | log | |
| Number needed to harm, for one more participant with a serious adverse event on PDE5I + PLACEBO than on PDE5I + DPX | 231 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | PDE5I + PLACEBO | Placebo tablets identical in appearance to dapoxetine taken 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction. | 4 | 245 | EG000 |
| Group 2 | PDE5I + DPX | Dapoxetine 30 mg to 60 mg tablets 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction. | 3 | 250 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse events were reported for the duration of the study; each patient participated in the study for approximately 18 weeks.
Source ClinicalTrials.gov
Trial
- Title
- Concomitant Use of PriLigy in Men Treated for Erectile Dysfunction
- NCT number
- NCT01063855
- Phases
- PHASE3
- Conditions
- Erectile Dysfunction, Sexual Dysfunction
- Interventions
- Placebo, Dapoxetine, PDE5I (phosphodiesterase-5 inhibitor)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Results first posted
- 2012-11-05
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01063855?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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