Trial · NCT02879305
Outcomes36
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 36
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to First Occurrence of Adjudicated Major Adverse Cardiovascular Event (MACE) During Cardiovascular (CV) Events Follow-up Time Period: Non-inferiority Analysis | Up to 3.9 person-years for CV follow-up time period | All Randomized (Intent-to-treat \[ITT\]) Population comprised of all randomized participants. Participants were analyzed according to the treatment to which they were randomized. | Events per 100 person years | NUMBER |
| PRIMARY | Mean Change From Baseline in Hemoglobin (Hgb) Levels During Evaluation Period (Week 28 to Week 52) | Baseline (Pre-dose on Day 1) and evaluation period (Week 28 to Week 52) | All Randomized (ITT) Population. | Grams per deciliter | LEAST_SQUARES_MEAN |
| SECONDARY | Time to First Occurrence of Adjudicated MACE During CV Events Follow-up Time Period: Superiority Analysis | Up to 3.9 person-years for CV follow-up time period | All Randomized (ITT) Population. | Events per 100 person years | NUMBER |
| SECONDARY | Time to First Occurrence of Adjudicated MACE or Thromboembolic Event During CV Events Follow-up Time Period | Up to 3.9 person-years for CV follow-up time period | All Randomized (ITT) Population. | Events per 100 person years | NUMBER |
| SECONDARY | Time to First Occurrence of Adjudicated MACE or Hospitalization for Heart Failure During CV Events Follow-up Time Period | Up to 3.9 person-years for CV follow-up time period | All Randomized (ITT) Population. | Events per 100 person years | NUMBER |
| SECONDARY | Mean Average Monthly On-treatment IV Iron Dose Per Participant | Day 1 to Week 52 | All Randomized (ITT) Population. Only those participants with data available at the indicated time points were analyzed. | Milligrams | LEAST_SQUARES_MEAN |
| SECONDARY | Time to First Occurrence of Adjudicated All-Cause Mortality During Vital Status for Follow-up Time Period | Up to 3.9 person-years for vital status follow-up time period | All Randomized (ITT) Population. | Events per 100 person years | NUMBER |
| SECONDARY | Time to First Occurrence of Adjudicated CV Mortality During CV Events Follow-up Time Period | Up to 3.9 person-years for CV follow-up time period | All Randomized (ITT) Population. | Events per 100 person years | NUMBER |
| SECONDARY | Time to First Occurrence of Adjudicated Myocardial Infarction (MI) (Fatal and Non-Fatal) During CV Events Follow-up Time Period | Up to 3.9 person-years for CV follow-up time period | All Randomized (ITT) Population. | Events per 100 person years | NUMBER |
| SECONDARY | Time to First Occurrence of Adjudicated Stroke (Fatal and Non-Fatal) During CV Events Follow-up Time Period | Up to 3.9 person-years for CV follow-up time period | All Randomized (ITT) Population. | Events per 100 person years | NUMBER |
| SECONDARY | Number of Participants With Adjudicated MACE or Hospitalization for Heart Failure (Recurrent Events Analysis) | Up to 3.9 person-years for CV follow-up time period | All Randomized (ITT) Population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to First Occurrence of Adjudicated CV Mortality or Non-Fatal MI During CV Events Follow-up Time Period | Up to 3.9 person-years for CV follow-up time period | All Randomized (ITT) Population. | Events per 100 person years | NUMBER |
| SECONDARY | Time to First Occurrence of All-Cause Hospitalization During CV Events Follow-up Time Period | Up to 3.9 person-years for CV follow-up time period | All Randomized (ITT) Population. | Events per 100 person years | NUMBER |
| SECONDARY | Time to First Occurrence of All-Cause Hospital Re-admission Within 30 Days During CV Events Follow-up Time Period | Up to 3.9 person-years for CV follow-up time period | All Randomized (ITT) Population. | Events per 100 person years | NUMBER |
| SECONDARY | Time to First Occurrence of Adjudicated MACE or Hospitalization for Heart Failure or Thromboembolic Events During CV Events Follow-up Time Period | Up to 3.9 person-years for CV follow-up time period | All Randomized (ITT) Population. | Events per 100 person years | NUMBER |
| SECONDARY | Time to First Occurrence of Adjudicated Hospitalization for Heart Failure During CV Events Follow-up Time Period | Up to 3.9 person-years for CV follow-up time period | All Randomized (ITT) Population. | Events per 100 person years | NUMBER |
| SECONDARY | Time to First Occurrence of Adjudicated Thromboembolic Events During CV Events Follow-up Time Period | Up to 3.9 person-years for CV follow-up time period | All Randomized (ITT) Population. | Events per 100 person years | NUMBER |
| SECONDARY | Change From Baseline in Post-randomization Hemoglobin Levels at Week 52 | Baseline (Pre-dose on Day 1) and Week 52 | All Randomized (ITT) Population. Only those participants with data available at the indicated time points were analyzed. | Grams per deciliter | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Hgb Responders in the Hgb Analysis Range (10 to 11.5 Grams/Deciliter) During Evaluation Period (Week 28 to Week 52) | Week 28 to Week 52 | All Randomized (ITT) Population. Only those participants with data available at the indicated time points were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Time With Hemoglobin in the Analysis Range (10 to 11.5 Grams/Deciliter) During Evaluation Period (Week 28 to Week 52): Non-inferiority Analysis | Week 28 to Week 52 | All Randomized (ITT) Population. Only those participants with data available at the indicated time points were analyzed. | Percentage of days | MEDIAN |
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/NCT02879305/outcomes