Trial · NCT01977482
Outcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Hemoglobin (Hgb) at Week 4 | Baseline (Week -4, Week-2 and Day 1) and Week 4 | ITT Population. Only participants with data available at specific time point were analyzed. | grams (g)/deciliter (dL) | MEAN |
| SECONDARY | Hgb Concentration at Week 24 | Week 24 | ITT Population. Only participants with data available at specific time point were analyzed. | g/dL | MEAN |
| SECONDARY | Percentage of Time Within, Below, and Above Hgb Target Range Between Weeks 20 and 24 | Week 20 to Week 24 | ITT population. Only participants with data available at specific timepoint were analyzed. | Percentage of days | MEAN |
| SECONDARY | Number of Participants With Hgb in the Target Range at Week 24 | Week 24 | ITT Population. Only participants with data available at specific time point were analyzed. | Participants | NUMBER |
| SECONDARY | Number of Participants Reaching Pre-defined Hgb Stopping Criteria | Up to 24 weeks | ITT Population | Participants | NUMBER |
| SECONDARY | Maximum Observed Change From Baseline in Erythropoietin (EPO) | Baseline (Day 1) to Week 28 | ITT Population. Only participants with data available at specific time point were analyzed. | international units(IU)/Liter (L) | MEAN |
| SECONDARY | Maximum Observed Percent Change From Baseline in Vascular Endothelial Growth Factor (VEGF) | Baseline (Day 1) to Week 28 | ITT Population. Only participants with data available at specific time point were analyzed. | Percent change | GEOMETRIC_MEAN |
| SECONDARY | Population Plasma PK Parameters of GSK1278863 and Metabolites | Day 1, Week 4, and Week 20 | Pharmacokinetic Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points; thus, the overall number of participants analyzed reflects everyone in the pharmacokinetic population | nanograms (ng)/milliliter (mL) | MEAN |
| SECONDARY | Percent Change From Baseline in Hepcidin at Week 24 | Baseline (Day 1) and Week 24 | ITT Population. Only participants with data available at specific time point were analyzed. | Percent change | GEOMETRIC_MEAN |
| SECONDARY | Change From Baseline in Ferritin at Week 24 | Baseline (Day 1) and Week 24 | ITT Population. Only participants with data available at specific time point were analyzed. | Micrograms/Liter | MEAN |
| SECONDARY | Change From Baseline in Transferrin at Week 24 | Baseline (Day 1) and Week 24 | ITT Population. Only participants with data available at specific time point were analyzed. | grams (g)/Liter (L) | MEAN |
| SECONDARY | Percent Change From Baseline in Transferrin Saturation at Week 24 | Baseline (Day 1) and Week 24 | ITT Population. Only participants with data available at specific time point were analyzed. | Percent change | GEOMETRIC_MEAN |
| SECONDARY | Change From Baseline in Total Iron at Week 24 | Baseline (Day 1) and Week 24 | ITT Population. Only participants with data available at specific time point were analyzed. | Micromoles/Liter | MEAN |
| SECONDARY | Change From Baseline in Total Iron Binding Capacity at Week 24 | Baseline (Day 1) and Week 24 | ITT Population. Only participants with data available at specific time point were analyzed. | Micromoles/Liter | MEAN |
| SECONDARY | Change From Baseline in Reticulocyte Hemoglobin at Week 24 | Baseline (Day 1) and Week 24 | ITT Population. Only participants with data available at specific time point were analyzed. | Picogram | MEAN |
| SECONDARY | Change From Baseline in Hematocrit at Week 24 | Baseline (Day 1) and Week 24 | ITT Population. Only participants with data available at specific time point were analyzed. | Ratio | MEAN |
| SECONDARY | Change From Baseline in Red Blood Cells at Week 24 | Baseline (Day 1) and Week 24 | ITT Population. Only participants with data available at specific time point were analyzed. | 10^12 cells/Liter | MEAN |
| SECONDARY | Change From Baseline in Reticulocyte Count at Week 24 | Baseline (Day 1) and Week 24 | ITT Population. Only participants with data available at specific time point were analyzed. | Percentage of reticulocytes in blood | 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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