Trial · NCT03518034
Outcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time From Randomization to the First Component Event of Major Adverse Cardiac Event (MACE): Number and Percentage of Participants With an Event | Randomization to event or last known date if no event (up to approximately 52 months) | TRAVERSE Main Study Safety Set: all randomized participants who received at least one dose of study drug and have no duplicate/triplicate participant IDs. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Time From Randomization to the First Component Event of MACE | Randomization to event or last known date if no event (up to approximately 52 months) | TRAVERSE Main Study Safety Set: all randomized participants who received at least one dose of study drug and have no duplicate/triplicate participant IDs. | months | MEDIAN |
| SECONDARY | Time From Randomization to the First Component Event of CV Safety Endpoint: Number and Percentage of Participants With an Event | Randomization to event or last known date if no event (up to approximately 52 months). | TRAVERSE Main Study Safety Set: all randomized participants who received at least one dose of study drug and have no duplicate/triplicate participant IDs. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time From Randomization to the First Component Event of CV Safety Endpoint | Randomization to event or last known date if no event (up to approximately 52 months). | TRAVERSE Main Study Safety Set: all randomized participants who received at least one dose of study drug and have no duplicate/triplicate participant IDs. | months | MEDIAN |
| SECONDARY | Incidence of High-Grade Prostate Cancer | Randomization to event or last known date if no event (up to approximately 52 months). | TRAVERSE Main Study Safety Set: all randomized participants who received at least one dose of study drug and have no duplicate/triplicate participant IDs. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Change in Psychosexual Daily Questionnaire Question 4 (PDQ-Q4) From Baseline to Months 6, 12 and 24 | From Baseline to Months 6, 12, and 24 | TRAVERSE Sexual Function Sub-Study: participants in the TRAVERSE main study full analysis set (i.e., randomized, no duplicate/triplicate participant IDs) who were eligible for the sexual function sub-study. | score on a scale | LEAST_SQUARES_MEAN |
| OTHER_PRE_SPECIFIED | Number and Percentage of Participants Whose Persistent Depressive Disorder (PDD) Remits During Intervention Per Remission Definition | Months 6, 12, 24 | PDD Sub-Study participants (those included TRAVERSE main study full analysis set participants \[i.e., randomized, no duplicate/triplicate participant IDs\] who met the criteria for low-grade PDD) with an assessment at given time point. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Time From Randomization to First Clinical Fracture: Number and Percentage of Participants With an Event | Randomization to event or last known date if no event (up to approximately 52 months). | TRAVERSE Main Study Full Analysis Set: all randomized participants without duplicate/triplicate participant IDs. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Time From Randomization to First Clinical Fracture | Randomization to event or maximum follow-up (up to approximately 52 months). | TRAVERSE Main Study Full Analysis Set: all randomized participants without duplicate/triplicate participant IDs. | months | MEDIAN |
| OTHER_PRE_SPECIFIED | Number and Percentage of Anemic Participants Whose Baseline Anemia Was Corrected During the Intervention Period | Baseline, Months 6, 12, 24, 36 and 48 | All randomized participants in TRAVERSE main study who had anemia at baseline; participants with an assessment at given time point. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Number and Percentage of Participants With Pre-Diabetes at Baseline Who Progressed to Diabetes at Months 6, 12, 24, 36 and 48 | Baseline, Months 6, 12, 24, 36 and 48 | All randomized participants in TRAVERSE main study who had prediabetes at baseline; participants with an assessment at given time point. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Tertiary Endpoint: Incidence Rate of All Cause Mortality | Randomization to event or last known date if no date (up to approximately 52 months). | TRAVERSE Main Study Safety Set: all randomized participants who received at least one dose of study drug and have no duplicate/triplicate participant IDs. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Tertiary Endpoint: Incidence Rate of Heart Failure | Randomization to event or last known date if no date (up to approximately 52 months). | TRAVERSE Main Study Safety Set: all randomized participants who received at least one dose of study drug and have no duplicate/triplicate participant IDs. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Tertiary Endpoint: Incidence Rate of Venous Thromboembolic Events | Randomization to event or last known date if no date (up to approximately 52 months). | TRAVERSE Main Study Safety Set: all randomized participants who received at least one dose of study drug and have no duplicate/triplicate participant IDs. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Tertiary Endpoint: Incidence Rate of Peripheral Arterial Revascularization | Randomization to event or last known date if no event (up to approximately 52 months). | TRAVERSE Main Study Safety Set: all randomized participants who received at least one dose of study drug and have no duplicate/triplicate participant IDs. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Tertiary Endpoint: Incidence Rate of Prostate Biopsy | Randomization to event or last known date if no event (up to approximately 52 months). | TRAVERSE Main Study Safety Set: all randomized participants who received at least one dose of study drug and have no duplicate/triplicate participant IDs. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Tertiary Endpoint: Incidence Rate of Prostate Cancer | Randomization to event or last known date if no event (up to approximately 52 months). | TRAVERSE Main Study Safety Set: all randomized participants who received at least one dose of study drug and have no duplicate/triplicate participant IDs. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Tertiary Endpoint: Incidence Rate of Acute Urinary Retention | Randomization to event or last known date if no event (up to approximately 52 months). | TRAVERSE Main Study Safety Set: all randomized participants who received at least one dose of study drug and have no duplicate/triplicate participant IDs. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Tertiary Endpoint: Incidence Rate of Pharmacologic Treatment for Lower Urinary Tract Symptoms | Randomization to event or last known date if no event (up to approximately 52 months). | TRAVERSE Main Study Safety Set: all randomized participants who received at least one dose of study drug and have no duplicate/triplicate participant IDs. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Tertiary Endpoint: Incidence Rate of Invasive Prostate Surgical Procedures for Benign Prostatic Hyperplasia | Randomization to event or last known date if no event (up to approximately 52 months). | TRAVERSE Main Study Safety Set: all randomized participants who received at least one dose of study drug and have no duplicate/triplicate participant IDs. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT03518034/outcomes