Trial · NCT02865850
Outcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Hemoglobin (Hb) to the Average Over the Primary Efficacy Period (Weeks 24 to 36) | Baseline; Weeks 24 to 36 | Randomized Population: All participants randomized. Analyses of this population were based on the randomized treatment. | Grams per deciliter (g/dL) | LEAST_SQUARES_MEAN |
| PRIMARY | Median Time to First Major Adverse Cardiovascular Event (MACE) | Up to 176 weeks | Safety Population (INNO2VATE): All participants from the INNO2VATE population who received 1 or more doses of study drug. Only those participants with MACE events were analyzed for this outcome measure. | Weeks | MEDIAN |
| SECONDARY | Change From Baseline in Hb to the Average Over the Secondary Efficacy Period (Weeks 40 to 52) | Baseline; Weeks 40 to 52 | Randomized Population. Analyses of this population were based on the randomized treatment. | g/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Median Time to First MACE Plus Hospitalization for Heart Failure or Thromboembolic Event Excluding Vascular Access Thrombosis | Up to 176 weeks | Safety Population (INNO2VATE). Only those participants with MACE plus hospitalization for heart failure or thromboembolic event excluding vascular access thrombosis were analyzed for this outcome measure. | Weeks | MEDIAN |
| SECONDARY | Median Time to First Cardiovascular MACE | Up to 176 weeks | Safety Population (INNO2VATE). Only those participants with cardiovascular MACE events were analyzed for this outcome measure. | Weeks | MEDIAN |
| SECONDARY | Median Time to First Cardiovascular Death | Up to 176 weeks | Safety Population (INNO2VATE). Only those participants with cardiovascular death were analyzed for this outcome measure. | Weeks | MEDIAN |
| SECONDARY | Median Time to First All-cause Mortality | Up to 176 weeks | Safety Population (INNO2VATE). Only those participants with all-cause mortality were analyzed for this outcome measure. | Weeks | MEDIAN |
| OTHER_PRE_SPECIFIED | Exploratory - Proportion of Participants With Hb Values Within the Target Range During the Primary Evaluation Period (Weeks 24 to 36) | Weeks 24 to 36 | |||
| OTHER_PRE_SPECIFIED | Exploratory - Proportion of Time With Hb Values Within the Target Range During the Primary Evaluation Period (Weeks 24 to 36) | Weeks 24 to 36 | |||
| OTHER_PRE_SPECIFIED | Exploratory - Proportion of Time With Hb Values Within the Target Range During the Secondary Evaluation Period (Weeks 40 to 52) | Weeks 40 to 52 | |||
| OTHER_PRE_SPECIFIED | Exploratory - Proportion of Participants With Hb Values Within the Target Range During the Secondary Evaluation Period (Weeks 40 to 52) | Weeks 40 to 52 | |||
| OTHER_PRE_SPECIFIED | Exploratory - Proportion of Participants With an Hb Increase of >1.0 g/dL From Baseline Visit | Baseline; up to Week 52 | |||
| OTHER_PRE_SPECIFIED | Exploratory - Time to Achieve Hb Increase of >1.0 g/dL From Baseline Visit | Baseline; up to Week 52 | |||
| OTHER_PRE_SPECIFIED | Exploratory - Mean Change in Hb Between Baseline (Mean Pretreatment Hb) and the Primary Evaluation Period (Mean Hb From Weeks 24 to 36) Stratified by Pre-baseline Erythropoiesis-stimulating Agent (ESA) Exposure | Baseline; Weeks 24 to 36 | |||
| OTHER_PRE_SPECIFIED | Exploratory - Mean Monthly Dose of Intravenous (IV) Elemental Iron Administered in Participants Who Have Received IV Iron | Up to Week 52 | |||
| OTHER_PRE_SPECIFIED | Exploratory - Proportion of Participants Receiving IV Iron Therapy | Up to Week 52 | |||
| OTHER_PRE_SPECIFIED | Exploratory - Proportion of Participants Receiving Red Blood Cells (RBCs) Transfusion(s) | Up to Week 52 |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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
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GET https://conductscience.org/api/trials/v1/NCT02865850/outcomes