Trial · NCT01414075
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 26
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Change From Baseline in Hb During Weeks 3-13 | Baseline, Weeks 3-13 | Baseline Hb was defined as the mean of the last 3 central laboratory Hb values prior to the first dose administration. This outcome measure is derived from the maximum change from baseline during Weeks 3-13, without last observation carried forward (LOCF) imputation. |
| Secondary | Mean Change From Baseline in Hb During Weeks 2-5, 6-9, and 10-13 | Baseline, Weeks 2-5, 6-9, and 10-13 | Baseline Hb was defined as the mean of the last 3 central laboratory Hb values prior to the first dose administration. |
| Secondary | Number of Participants Whose Maximum Hb Achieved During Treatment Was at Least 1.0 g/dL Increase From Baseline and Was ≥11.0 g/dL | Week 3 to 13 | Baseline Hb was defined as the mean of the last 3 central laboratory Hb values prior to the first dose administration. |
| Secondary | Number of Participants Whose Maximum Hb Achieved During Treatment Was at Least 1.0 g/dL Increase From Baseline and Was ≥10.0 g/dL | Week 3 to 13 | Baseline Hb was defined as the mean of the last 3 central laboratory Hb values prior to the first dose administration. |
| Secondary | Number of Participants With a Hb Response, Defined as an Increase in Hb by ≥1.0 g/dL From Baseline, by Weeks 5, 9, and 13 | Weeks 5, 9, and 13 | Baseline Hb was defined as the mean of the last 3 central laboratory Hb values prior to the first dose administration. |
| Secondary | Number of Participants Who Achieved Maximum Hb During Weeks 3-13 | Weeks 3-13 | |
| Secondary | Number of Participants With a Maximum Change From Baseline in Hb During Weeks 3-13 | Baseline, Weeks 3-13 | Baseline Hb was defined as the mean of the last 3 central laboratory Hb values prior to the first dose administration. The number of participants who fall within the following categories of maximum change are reported: \<1 g/dL, ≥1 g/dL, 1 to \<2 g/dL, 2 to \<3 g/dL, \>3 to \<4 g/dL, ≥4 g/dL. |
| Secondary | Median Time to Hb Response (Increase in Hb by ≥1.0 g/dL From Baseline) | Baseline up to Week 13 | Baseline Hb was defined as the mean of the last 3 central laboratory Hb values prior to the first dose administration. |
| Secondary | Weekly Dose at First Hb Response (Increase in Hb by ≥1.0 g/dL From Baseline) | Baseline up to Week 13 | Baseline Hb was defined as the mean of the last 3 central laboratory Hb values prior to the first dose administration. |
| Secondary | Number of Participants Requiring Dose Increase at Weeks 5 and 9 | Weeks 5 and 9 | Number of participants requiring dose increase due to any reasons is reported. |
| Secondary | Number of Participants Requiring Dose Reduction or Dose Discontinuation Due to Excessive Erythropoiesis | Weeks 5 and 9 | Number of participants requiring dose reduction or dose discontinuation due to excessive erythropoiesis is reported. |
| Secondary | Change From Baseline in Ferritin at Week 13 | Baseline, Week 13 | Baseline was defined as the average of the last 2 values prior to the first dose administration. |
| Secondary | Change From Baseline in Transferrin Saturation (TSAT) at Week 13 | Baseline, Week 13 | |
| Secondary | Change From Baseline in Reticulocyte Hemoglobin Content at Week 13 | Baseline, Week 13 | |
| Secondary | Number of Participants With Mean Hb Values 11.0-13.0 g/dL at Weeks 6-9 and 10-13 | Weeks 6-9 and 10-13 | |
| Secondary | Number of Participants With Mean Hb Values Within 11.0-13.0 g/dL During Weeks 10-13 Among Those With Maximum Hb ≥11.0 g/dL and Change of Hb ≥1 g/dL | Weeks 10-13 | |
| Secondary | Number of Participants With Mean Hb Values Within 10.0-13.0 g/dL During Weeks 10-13 Among Those With Maximum Hb ≥10.0 g/dL and Change of Hb ≥1 g/dL | Weeks 10-13 | |
| Secondary | Number of Participants With Mean Hb Values in Excess of 13.0 and 14.0 g/dL at Weeks 6-9 and 10-13 | Weeks 6-9 and 10-13 | |
| Secondary | Number of Participants With Mean Hb Values <10.0 g/dL at Weeks 6-9 and 10-13 | Weeks 6-9 and 10-13 | |
| Secondary | Number of Participants Requiring Rescue Treatment With an Erythropoiesis-Stimulating Agent (ESA), Red Blood Cells (RBC) Transfusion, or IV Iron (Excluding Arm C) | Baseline up to Week 13 | Number of participants requiring rescue treatment with an ESA, RBC transfusion, or IV Iron (Excluding Arm C) was reported. |
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/NCT01414075/registered