Trial · NCT01906489
Outcomes47
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 47
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Achieving a Successful Hemoglobin Response | Weeks 19 and 20 | Per Protocol (PP) Population: participants in modified intent-to-treat (MITT) Population who had completed the study and had efficacy data through Week 20, had a study medication compliance of ≥ 80%, and did not have any protocol deviations. Only participants with available data were analyzed. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Hemoglobin Value ≥13.0 g/dL at Any Time During the Study | Up to 20 Weeks | Modified Intent-to-Treat (MITT) Population: all randomized participants who received at least one dose of study medication and had a Baseline (either screening or Baseline for both Hgb and RBC count) and at least one post-Baseline measurement for both Hgb and RBC. Only participants with available data were analyzed. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving a Successful Hemoglobin Response, Determined Solely Based on the Hemoglobin Value | Weeks 19 and 20 | MITT Population. Only participants with available data were analyzed. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving a Successful Hemoglobin Response in ESA Treatment naïve Group | Weeks 19 and 20 | MITT Population. Only participants with available data were analyzed. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving a Successful Hemoglobin Response in ESA Previously Treated Group | Weeks 19 and 20 | MITT Population. Only participants with available data were analyzed. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving a Successful Hemoglobin Response in ESA Actively Treated Group | Weeks 19 and 20 | MITT Population. Only participants with available data were analyzed. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving a Successful Hemoglobin Response, Analyzed in mITT Population | Weeks 19 and 20 | MITT Population. Only participants with available data were analyzed. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Hemoglobin | Baseline, Week 2, Week 4, Week 6, Week 8, Week 12, Week 16, Week 19 and Week 20 | MITT Population. Only participants with available data were analyzed. | g/dL | MEAN |
| SECONDARY | Absolute Values of Hemoglobin | Baseline, Week 2, Week 4, Week 6, Week 8, Week 12, Week 16, Week 19 and Week 20 | MITT Population. Only participants with available data were analyzed. | g/dL | MEAN |
| SECONDARY | Change From Baseline in Hematocrit | Baseline, Week 2, Week 4, Week 6, Week 8, Week 12, Week 16, Week 19 and Week 20 | MITT Population. Only participants with available data were analyzed. | Percentage of red blood cells in blood | MEAN |
| SECONDARY | Absolute Values of Hematocrit | Baseline, Week 2, Week 4, Week 6, Week 8, Week 12, Week 16, Week 19 and Week 20 | MITT Population. Only participants with available data were analyzed. | Percentage of red blood cells in blood | MEAN |
| SECONDARY | Change From Baseline in Red Blood Cell Count | Baseline, Week 2, Week 4, Week 6, Week 8, Week 12, Week 16, Week 19 and Week 20 | MITT Population. Only participants with available data were analyzed. | 10^6 cells per microliter | MEAN |
| SECONDARY | Absolute Values of Red Blood Cell Count | Baseline, Week 2, Week 4, Week 6, Week 8, Week 12, Week 16, Week 19 and Week 20 | MITT Population. Only participants with available data were analyzed. | 10^6 cells per microliter | MEAN |
| SECONDARY | Change From Baseline in Reticulocyte Count | Baseline, Week 2, Week 4, Week 6, Week 8, Week 12, Week 16, Week 19 and Week 20 | MITT Population. Only participants with available data were analyzed. | 10^6 cells per microliter | MEAN |
| SECONDARY | Absolute Values of Reticulocyte Count | Baseline, Week 2, Week 4, Week 6, Week 8, Week 12, Week 16, Week 19 and Week 20 | MITT Population. Only participants with available data were analyzed. | 10^6 cells per microliter | MEAN |
| SECONDARY | Percentage of Participants Who Received ESA Rescue | Up to 20 Weeks | MITT Population. Only participants with available data were analyzed. | Percentage of participants | NUMBER |
| SECONDARY | Mean Number of ESA Rescue Doses Administered Per Participant | Up to 20 Weeks | MITT Population. Only participants with available data were analyzed. | Doses/participants | MEAN |
| SECONDARY | Percentage of Participants Who Received Packed Red Blood Cell Transfusion Rescue | Up to 20 Weeks | MITT Population. Only participants with available data were analyzed. | Percentage of participants | NUMBER |
| SECONDARY | Number of Packed Red Blood Cell Transfusion Administered Per Participant | Up to 20 Weeks | MITT Population. Only participants who received transfusion rescue were analyzed. | Units of blood per participant | MEDIAN |
| SECONDARY | Time to First Transfusion or ESA Rescue Medication Intake | Up to 20 Weeks | MITT Population. Only participants with available data were analyzed. | Weeks | MEAN |
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
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT01906489/outcomes