Comparison · NCT03518034-a3e4cd4b
AndroGel 1.62% vs Placebo: Incidence of High-Grade Prostate Cancer
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. AndroGel 1.62% vs Placebo: Incidence of High-Grade Prostate Cancer. Trial comparisons, record NCT03518034-a3e4cd4b. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03518034-a3e4cd4b
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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 | 0.00193 | 0.000823 | 0.0045 | wilson | |
| Risk in group 2 | 0.00115 | 0.000392 | 0.00338 | wilson | |
| Risk difference, group 1 minus group 2 | 0.000773 | -0.00172 | 0.00346 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.67 | 0.4 | 6.98 | log | |
| Odds ratio, group 1 over group 2 | 1.67 | 0.399 | 7 | log | |
| Number needed to treat, for one more participant with the outcome on AndroGel 1.62% than on Placebo | 1,290 | 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 | AndroGel 1.62% | Participants received topical testosterone starting with a 40.5 mg dose (2 pump actuations) of the study drug OD. Participants may have received a dose in the range of 20.25 mg (1 actuation) to 101.25 mg (5 actuations) in 20.25 mg increments during the course of the study if titrations were necessary. | 5 | 2,596 | OG000 |
| Group 2 | Placebo | Participants received matching placebo OD. | 3 | 2,602 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Incidence of High-Grade Prostate Cancer
- Description
Presented as the number and percentage of participants with any high grade prostate cancer, defined as Gleason grade of 4 + 3 or higher, as adjudicated by Prostate Safety Events Committee (PAC). This grade is based on how abnormal prostate cells appear. Grade 1: cells look almost like normal prostate cells; Grade 5; cells look very different from normal prostate cells. Since most prostate cancers contain cells of different grades, the 2 most common grades are used. Gleason score is determined by adding the 2 most common grades. Higher numbers indicate a faster growing cancer that is more likely to spread. Currently the lowest score assigned to a tumor is grade 3. Grades below 3 show normal to near normal cells. Most cancers have a Gleason score (the sum of the 2 most common grades) of 6 (Gleason scores of 3+3) or 7 (Gleason scores of 3+4 or 4+3).
- Time frame
- Randomization to event or last known date if no event (up to approximately 52 months).
- Population
- TRAVERSE Main Study Safety Set: all randomized participants who received at least one dose of study drug and have no duplicate/triplicate participant IDs.
Source ClinicalTrials.gov
Trial
- Title
- A Study to Evaluate the Effect of Testosterone Replacement Therapy (TRT) on the Incidence of Major Adverse Cardiovascular Events (MACE) and Efficacy Measures in Hypogonadal Men
- NCT number
- NCT03518034
- Phases
- PHASE4
- Conditions
- Hypogonadism, Cardiovascular Diseases
- Interventions
- AndroGel®, Placebo
- Lead sponsor
- AbbVie
- Results first posted
- 2024-03-13
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03518034?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.govNone 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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