Comparison · NCT03198728-sae
SOV2012-F1-Treated vs Andro-Gel Treated: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. SOV2012-F1-Treated vs Andro-Gel Treated: serious adverse events. Trial comparisons, record NCT03198728-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03198728-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 | 0.0421 | 0.0223 | 0.078 | wilson | |
| Risk in group 2 | 0.01 | 0.00177 | 0.0545 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0321 | -0.0166 | 0.0689 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 4.21 | 0.54 | 32.7 | log | |
| Odds ratio, group 1 over group 2 | 4.35 | 0.543 | 34.8 | log | |
| Number needed to harm, for one more participant with a serious adverse event on SOV2012-F1-Treated than on Andro-Gel Treated | 31.2 | 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 | SOV2012-F1-Treated | 200 patients treated with SOV2012-F1, starting dose of 600 mg - (400 mg with morning meal and 200 mg with evening meal). Dose titrated up to a maximum of 600 mg TU in the morning and 400 mg in the evening or down to 200 mg TU in the morning based on plasma T at Days 14 and 42.~SOV2012-F1: oral preparation of testosterone undecanoate (TU) | 9 | 214 | EG000 |
| Group 2 | Andro-Gel Treated | 100 patients treated with AndroGel, according to label, using samples on Days 14 and 42 with dose adjustment on Days 28 and 56.~AndroGel: topical testosterone gel, 1.62% | 1 | 100 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 365 days
Source ClinicalTrials.gov
Trial
- Title
- Efficacy and Safety of Oral Testosterone Undecanoate in Hypogonadal Men
- NCT number
- NCT03198728
- Phases
- PHASE3
- Conditions
- Hypogonadism, Male
- Interventions
- SOV2012-F1, AndroGel
- Lead sponsor
- Marius Pharmaceuticals
- Results first posted
- 2023-06-28
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03198728?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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