Trial · NCT01381094
Outcomes29
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 29
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Absolute Change From Baseline in Hemoglobin (Hgb) to End of Treatment (Week 6) | Baseline, Week 6 | Modified intent-to-treat (MITT) population: All randomized participants who received at least one dose of study medication and had a Baseline (both Screening and Baseline for Hgb and red blood cells \[RBC\] count) and at least one post-baseline measurement. Participants with available data were included in the analysis. | Grams per deciliter (g/dL) | MEAN |
| SECONDARY | Change From Baseline in Hgb at Week 1, Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8) | Baseline, Week 1, Week 2, Week 4, Week 6, Follow-up Visit (up to Week 8) | MITT population. Participants with available data were included in the analysis. | g/dL | MEAN |
| SECONDARY | Change From Baseline in Hematocrit (HCT) at Week 1, Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8) | Baseline, Week 1, Week 2, Week 4, Week 6, Follow-up Visit (up to Week 8) | MITT population. Participants with available data were included in the analysis. | Percentage of red blood cells in blood | MEAN |
| SECONDARY | Change From Baseline in Red Blood Cell (RBC) Count at Week 1, Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8) | Baseline, Week 1, Week 2, Week 4, Week 6, Follow-up Visit (up to Week 8) | MITT population. Participants with available data were included in the analysis. | 10^6 cells/microliter (10^6 cells/μL) | MEAN |
| SECONDARY | Change From Baseline in Absolute Reticulocyte Count at Week 1, Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8) | Baseline, Week 1, Week 2, Week 4, Week 6, Follow-up Visit (up to Week 8) | MITT population. Participants with available data were included in the analysis. | 10^6 cells/μL | MEAN |
| SECONDARY | Change From Baseline in Reticulocyte Hgb Content at Week 6 | Baseline, Week 6 | MITT population. Participants with available data were included in the analysis. | Picogram | MEAN |
| SECONDARY | Maximum Change From Baseline in Hgb | Baseline; up to Week 8 | MITT population. Participants with available data were included in the analysis. | g/dL | MEAN |
| SECONDARY | Maximum Change From Baseline in HCT | Baseline; up to Week 8 | MITT population. Participants with available data were included in the analysis. | Percentage of red blood cells | MEAN |
| SECONDARY | Maximum Change From Baseline in RBC Count | Baseline; up to Week 8 | MITT population. Participants with available data were included in the analysis. | 10^6 cells/μL | MEAN |
| SECONDARY | Maximum Change in Absolute Reticulocyte Count From Baseline | Baseline; up to Week 8 | MITT population. Participants with available data were included in the analysis. | 10^6 cells/μL | MEAN |
| SECONDARY | Number of Participants With Absolute Change From Baseline in Hgb ≥ 0.4, 0.6, 0.8, and 1.0 g/dL at the End of Dosing Period | Up to Week 6 (End of the Dosing Period) | MITT population. Participants with available data were included in the analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Change From Baseline in Hgb ≥5.0, 7.5, and 10.0% by the End of Dosing Period | Up to Week 6 (End of The Dosing Period) | MITT population. Participants with available data were included in the analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Change From Baseline in HCT ≥5.0, 7.5, and 10.0% by the End of Dosing Period | Up to Week 6 (End of The Dosing Period) | MITT population. Participants with available data were included in the analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Change From Baseline in RBC Count ≥5.0, 7.5, and 10.0% by the End of Dosing Period | Up to Week 6 (End of The Dosing Period) | MITT population. Participants with available data were included in the analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Change From Baseline in Reticulocyte Count ≥6000, 12000, and 18000 Cells/uL by the End of Dosing Period | Up to Week 6 (End of The Dosing Period) | MITT population. Participants with available data were included in the analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Total Iron at Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8) | Baseline, Week 2, Week 4, Week 6, Follow-up Visit (up to Week 8) | MITT population. Participants with available data were included in the analysis. | Micrograms per deciliter (µg/dL) | MEAN |
| SECONDARY | Change From Baseline in Unsaturated Iron Binding Capacity at Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8) | Baseline, Week 2, Week 4, Week 6, Follow-up Visit (up to Week 8) | MITT population. Participants with available data were included in the analysis. | µg/dL | MEAN |
| SECONDARY | Change From Baseline in Iron Saturation at Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8) | Baseline, Week 2, Week 4, Week 6, Follow-up Visit (up to Week 8) | MITT population. Participants with available data were included in the analysis. | Percentage of saturation | MEAN |
| SECONDARY | Change From Baseline in Total Iron Binding Capacity (TIBC) at Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8) | Baseline, Week 2, Week 4, Week 6, Follow-up Visit (up to Week 8) | MITT population. Participants with available data were included in the analysis. | µg/dL | MEAN |
| SECONDARY | Change From Baseline in Ferritin at Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8) | Baseline, Week 2, Week 4, Week 6, Follow-up (up to Week 8) | MITT population. Participants with available data were included in the analysis. | Nanograms per milliliter (ng/mL) | 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
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GET https://conductscience.org/api/trials/v1/NCT01381094/outcomes