Trial · NCT01414075
Outcomes26
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 26
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum Change From Baseline in Hb During Weeks 3-13 | Baseline, Weeks 3-13 | EE population included participants who received study treatment for 6 weeks or longer and had valid corresponding Hb measurements. | grams/deciliter (g/dL) | MEAN |
| 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 | EE population included participants who received study treatment for 6 weeks or longer and had valid corresponding Hb measurements. LOCF method was used to impute missing values. | g/dL | MEAN |
| 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 | EE population included participants who received study treatment for 6 weeks or longer and had valid corresponding Hb measurements. LOCF method was used to impute missing values. | Participants | COUNT_OF_PARTICIPANTS |
| 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 | EE population included participants who received study treatment for 6 weeks or longer and had valid corresponding Hb measurements. LOCF method was used to impute missing values. | Participants | COUNT_OF_PARTICIPANTS |
| 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 | EE population included participants who received study treatment for 6 weeks or longer and had valid corresponding Hb measurements. LOCF method was used to impute missing values. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Achieved Maximum Hb During Weeks 3-13 | Weeks 3-13 | EE population included participants who received study treatment for 6 weeks or longer and had valid corresponding Hb measurements. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With a Maximum Change From Baseline in Hb During Weeks 3-13 | Baseline, Weeks 3-13 | EE population included participants who received study treatment for 6 weeks or longer and had valid corresponding Hb measurements. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Median Time to Hb Response (Increase in Hb by ≥1.0 g/dL From Baseline) | Baseline up to Week 13 | EE population included participants who received study treatment for 6 weeks or longer and had valid corresponding Hb measurements. LOCF method was used to impute missing values. | weeks | MEDIAN |
| SECONDARY | Weekly Dose at First Hb Response (Increase in Hb by ≥1.0 g/dL From Baseline) | Baseline up to Week 13 | EE population included participants who received study treatment for 6 weeks or longer and had valid corresponding Hb measurements. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure. LOCF method was used to impute missing values. | mg/kg | MEAN |
| SECONDARY | Number of Participants Requiring Dose Increase at Weeks 5 and 9 | Weeks 5 and 9 | Safety population included all participants who received any dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Requiring Dose Reduction or Dose Discontinuation Due to Excessive Erythropoiesis | Weeks 5 and 9 | Safety population included all participants who received any dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Ferritin at Week 13 | Baseline, Week 13 | EE population included participants who received study treatment for 6 weeks or longer and had valid corresponding Hb measurements. LOCF method was used to impute missing values. | micrograms/liter (µg/L) | MEAN |
| SECONDARY | Change From Baseline in Transferrin Saturation (TSAT) at Week 13 | Baseline, Week 13 | EE population included participants who received study treatment for 6 weeks or longer and had valid corresponding Hb measurements. LOCF method was used to impute missing values. | percentage of transferrin | MEAN |
| SECONDARY | Change From Baseline in Reticulocyte Hemoglobin Content at Week 13 | Baseline, Week 13 | EE population included participants who received study treatment for 6 weeks or longer and had valid corresponding Hb measurements. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure. LOCF method was used to impute missing values. | picogram (pg) | MEAN |
| 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 | EE population included participants who received study treatment for 6 weeks or longer and had valid corresponding Hb measurements. LOCF method was used to impute missing values. | Participants | COUNT_OF_PARTICIPANTS |
| 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 | EE population included participants who received study treatment for 6 weeks or longer and had valid corresponding Hb measurements. Here, 'Overall number of participants analyzed' signifies participants with maximum Hb ≥11 g/dL and change of Hb ≥1 g/dL during Weeks 10-13. LOCF method was used to impute missing values. | Participants | COUNT_OF_PARTICIPANTS |
| 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 | EE population included participants who received study treatment for 6 weeks or longer and had valid corresponding Hb measurements. Here, 'Overall number of participants analyzed' signifies participants with maximum Hb ≥10 g/dL and change of Hb ≥1 g/dL during Weeks 10-13. LOCF method was used to impute missing values. | Participants | COUNT_OF_PARTICIPANTS |
| 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 | EE population included participants who received study treatment for 6 weeks or longer and had valid corresponding Hb measurements. LOCF method was used to impute missing values. | Participants | COUNT_OF_PARTICIPANTS |
| 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 | EE population included participants who received study treatment for 6 weeks or longer and had valid corresponding Hb measurements. LOCF method was used to impute missing values. | Participants | COUNT_OF_PARTICIPANTS |
| 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 | Safety population included all participants who received any dose of study drug. Here 'Number analyzed' signifies participants evaluable for specified category. | Participants | COUNT_OF_PARTICIPANTS |
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.
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GET https://conductscience.org/api/trials/v1/NCT01414075/outcomes