Comparison · NCT02058368-sae
Placebo + Tam 0.2mg vs Dut 0.5 mg + Tam 0.2 mg: 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. Placebo + Tam 0.2mg vs Dut 0.5 mg + Tam 0.2 mg: serious adverse events. Trial comparisons, record NCT02058368-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02058368-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 | 0.172 | 0.134 | 0.219 | wilson | |
| Risk in group 2 | 0.161 | 0.124 | 0.206 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0115 | -0.0479 | 0.071 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.07 | 0.751 | 1.53 | log | |
| Odds ratio, group 1 over group 2 | 1.09 | 0.709 | 1.67 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Placebo + Tam 0.2mg than on Dut 0.5 mg + Tam 0.2 mg | 86.7 | 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 | Placebo + Tam 0.2mg | Participants were randomized in a ratio of 1:1 to receive Dut placebo QD plus Tam 0.2 mg QD for 104 Weeks. | 52 | 302 | EG000 |
| Group 2 | Dut 0.5 mg + Tam 0.2 mg | Participants were randomized in a ratio of 1:1 to receive Dut 0.5 mg QD plus Tam 0.2 mg QD for 104 Weeks. | 49 | 305 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to 24 months
Source ClinicalTrials.gov
Trial
- Title
- Study to Compare the Efficacy and Safety of Combination Treatment With Dutasteride and Tamsulosin With Tamsulosin Monotherapy, in Men With Moderate to Severe Benign Prostatic Hyperplasia
- NCT number
- NCT02058368
- Phases
- PHASE3
- Conditions
- Prostatic Hyperplasia
- Interventions
- Dutasteride 0.5mg capsules, Dutasteride placebo capsules, Tamsulosin 0.2mg tablets, Disintegrating placebo tamsulosin tablet
- Lead sponsor
- GlaxoSmithKline
- Results first posted
- 2019-04-05
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02058368?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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GET https://conductscience.org/api/comparisons/v1/NCT02058368-sae