Trial · NCT03518034
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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) | MACE is a composite endpoint including non-fatal myocardial infraction (MI), non-fatal stroke and cardiovascular (CV) death as adjudicated by Clinical Events Committee (CEC). |
| 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) | MACE is a composite endpoint including non-fatal MI, non-fatal stroke and CV death as adjudicated by CEC. |
| 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). | The CV safety endpoint is a composite endpoint including non-fatal MI, non-fatal stroke, CV death, and coronary revascularization procedures/cardiac percutaneous coronary intervention (PCI), or coronary artery bypass graft (CABG) as adjudicated by CEC. |
| 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). | The CV safety endpoint is a composite endpoint including non-fatal MI, non-fatal stroke, CV death, and coronary revascularization procedures/cardiac PCI, or CABG as adjudicated by CEC. |
| Secondary | Incidence of High-Grade Prostate Cancer | Randomization to event or last known date if no event (up to approximately 52 months). | 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). |
| Other | 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 | PDQ-Q4 asks 12 yes/no questions about sexual activity. Scores on the PDQ-Q4 range from 0 to 12, with higher scores indicating more activity. |
| Other | Number and Percentage of Participants Whose Persistent Depressive Disorder (PDD) Remits During Intervention Per Remission Definition | Months 6, 12, 24 | The remission of low-grade, late-onset PDD was defined as: a) Patient Health Questionnaire (PHQ-9) score less than 4 and Geriatric Depression Scale-15 (GDS-15) score \<5, and b) answer "no" to the question "Give your best guess: Over the past 6 months, have you been feeling sad or depressed more days than not, even if you felt okay sometimes?" The PHQ-9 is a 9-item depression scale. Total scores can range from 0 to 27, with higher scores indicating a worse outcome. A total score of 0-4 indicates minimal depression severity. The GDS-15 is a series of 15 yes/no questions asking how the participant felt in the past week. A score greater that 5 indicates depression; a higher score indicates a worse outcome. |
| Other | 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). | Clinical fracture is defined as a clinical spine or non-spine fracture, documented by imaging or surgery, and confirmed by the Fracture Adjudication Committee (FAC). Fractures of the sternum, fingers, toes, facial bones and skull were excluded. |
| Other | Time From Randomization to First Clinical Fracture | Randomization to event or maximum follow-up (up to approximately 52 months). | Clinical fracture is defined as a clinical spine or non-spine fracture, documented by imaging or surgery, and confirmed by the FAC. Fractures of the sternum, fingers, toes, facial bones and skull were excluded. |
| Other | Number and Percentage of Anemic Participants Whose Baseline Anemia Was Corrected During the Intervention Period | Baseline, Months 6, 12, 24, 36 and 48 | The correction of anemia was defined as an increase in hemoglobin level \>12.7 g/dL during the intervention period (at Months 6, 12, 24, 36 and 48) for participants in TRAVERSE main study with anemia at baseline. |
| Other | 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 | Number and percentage of participants in each arm who had prediabetes at baseline progressing to diabetes, defined as hemoglobin A1C (HbA1C) equal to or higher than 6.5%, initiation of diabetes medication, or two consecutive fasting glucose levels \>125 mg/dL, assessed at all available time points after baseline. |
| Other | Tertiary Endpoint: Incidence Rate of All Cause Mortality | Randomization to event or last known date if no date (up to approximately 52 months). | Presented as the number and percentage of participants who died, regardless of cause. |
| Other | Tertiary Endpoint: Incidence Rate of Heart Failure | Randomization to event or last known date if no date (up to approximately 52 months). | Presented as the number and percentage of participants with heart failure events (requiring hospitalization and/or urgent visit), as adjudicated by CEC. |
| Other | Tertiary Endpoint: Incidence Rate of Venous Thromboembolic Events | Randomization to event or last known date if no date (up to approximately 52 months). | Presented as the number and percentage of participants with venous thromboembolic events, as adjudicated by CEC. Events include deep vein thrombosis, pulmonary embolism, venous thromboembolism (excluding superficial thrombophlebitis). |
| Other | Tertiary Endpoint: Incidence Rate of Peripheral Arterial Revascularization | Randomization to event or last known date if no event (up to approximately 52 months). | Presented as the number and percentage of participants with peripheral arterial revascularization, as adjudicated by CEC. |
| Other | Tertiary Endpoint: Incidence Rate of Prostate Biopsy | Randomization to event or last known date if no event (up to approximately 52 months). | Presented as the number and percentage of participants who underwent prostate biopsy. |
| Other | Tertiary Endpoint: Incidence Rate of Prostate Cancer | Randomization to event or last known date if no event (up to approximately 52 months). | Presented as the number and percentage of participants who with prostate cancer, as adjudicated by Prostate Safety Events Committee (PAC). |
| Other | Tertiary Endpoint: Incidence Rate of Acute Urinary Retention | Randomization to event or last known date if no event (up to approximately 52 months). | Presented as the number and percentage of participants with acute urinary retention, as adjudicated by PAC. |
| Other | 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). | Presented as the number and percentage of participants who started pharmacologic treatment for lower urinary tract symptoms. |
| Other | 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). | Presented as the number and percentage of participants who underwent invasive prostate surgical procedures for benign prostate hyperplasia, as adjudicated by Prostate Safety Events Committee (PAC). Invasive prostate surgical procedures include prostatectomy, transurethral prostate resection, brachytherapy or other prostate surgical procedure. |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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.
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GET https://conductscience.org/api/trials/v1/NCT03518034/registered