Trial · NCT01587924
Outcomes23
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 23
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Modeled Hemoglobin (Hgb) Change From Baseline (Pre-dose on Day 1) at 4 Weeks of Treatment | Baseline (pre-dose on Day 1) and up to week 4 | ITT population. Only those participants available at the specified time points were analyzed. | Grams per deciliter (g/dL) | MEAN |
| SECONDARY | Hgb Variability Over 4 Weeks | Up to 4 weeks | ITT population. Only those participants available at the specified time points were analyzed. | g/dL | MEAN |
| SECONDARY | Evaluation of Change From Baseline in Hepcidin Over Period | Baseline (pre-dose on Day 1) and up to 4 weeks | ITT population. Only those participants available at the specified time points were analyzed. | Micrograms per liter (mcg/L) | LEAST_SQUARES_MEAN |
| SECONDARY | Evaluation of Change From Baseline (Pre-dose on Day 1) in High Sensitivity C-Reactive Protein (hsCRP) Over 4 Weeks | Baseline (pre-dose on Day 1) and up to 4 weeks | ITT population. Only those participants available at the specified time points were analyzed. | Milligrams per liter (mg/L) | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline for Erythropoeitin (EPO) Over Period | Baseline (pre-dose on Day 1) and up to 4 weeks | ITT population. Only those participants available at the specified time points were analyzed. | Units per liter (U/L) | LEAST_SQUARES_MEAN |
| SECONDARY | Evaluation of Change From Baseline (Pre-dose on Day 1) for Peak Vascular Endothelial Growth Factor (VEGF) Over 4 Weeks | Baseline (pre-dose on Day 1) and up to 4 weeks | ITT population. Only those participants available at the specified time points were analyzed. | Nanograms per liter (ng/L) | LEAST_SQUARES_MEAN |
| SECONDARY | Evaluation of Change From Baseline (Pre-dose on Day 1) for Hematocrit Over 4 Weeks | Baseline (pre-dose on Day 1) and up to 4 weeks | ITT population. Only those participants available at the specified time points were analyzed. | Percentage | MEAN |
| SECONDARY | Residual Standard Deviation in Hgb (From the Linear Regression) | Up to 4 weeks | ITT population. Only those participants available at the specified time points were analyzed. | g/L | MEAN |
| SECONDARY | Number of Days Spent Within Hgb Range ( ±0.5 g/dL and ±1 g/dL ) From Baseline Hgb | Baseline (pre-dose on Day 1) and up to 4 weeks | ITT population. Only those participants available at the specified time points were analyzed. | Days | MEDIAN |
| SECONDARY | Evaluation of Change From Baseline (Pre-dose on Day 1) in Ferritin Over 4 Weeks | Baseline (pre-dose on Day 1) and Week 4 | ITT population. Only those participants available at the specified time points were analyzed. | Micrograms per liter | LEAST_SQUARES_MEAN |
| SECONDARY | Evaluation of Change From Baseline (Pre-dose on Day 1) for Transferrin Over 4 Weeks | Baseline (pre-dose on Day 1) and Week 4 | ITT population. Only those participants available at the specified time points were analyzed. | Grams per liter | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline (Pre-dose on Day 1) for Transferrin Saturation Over 4 Weeks | Baseline (pre-dose on Day 1) and Week 4 | ITT population. Only those participants available at the specified time points were analyzed.. | Ratio | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline (Pre-dose on Day 1) for Total Iron Over 4 Weeks | Baseline (pre-dose on Day 1) and at Week 4 | ITT population. Only those participants available at the specified time points were analyzed. | Micromoles per Liter | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline (Pre-dose on Day 1) in Total Iron Binding Capacity Over 4 Weeks | Baseline (pre-dose on Day 1) and Week 4 | ITT population. Only those participants available at the specified time points were analyzed. | Micromoles per Liter | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline (Pre-dose on Day 1) for Red Blood Cells (RBCs) Over 4 Weeks | Baseline (pre-dose on Day 1) and up to 4 weeks | ITT population. Only those participants available at the specified time points were analyzed. | 10^12 cells per Liter (Giga cells per L) | MEAN |
| SECONDARY | Change From Baseline (Pre-dose on Day 1) for Reticulocytes Over 4 Weeks | Baseline (pre-dose on Day 1) and up to 4 weeks | ITT population. Only those participants available at the specified time points were analyzed. | Percentage change | MEAN |
| SECONDARY | Number of Participants Reaching Hgb Stopping Criteria | Up to 4 weeks | ITT population. Only those participants available at the time of assessment were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to 4 weeks | Safety population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Discontinuing the Study Treatment Due to AEs | Up to 4 weeks | Safety population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Mean Plasma Concentration of GSK1278863 and GSK1278863 Metabolites Over 4 Weeks | Up to 4 weeks | Pharmacokinetic (PK) population included all the participants who received at least one dose of the study drug and from whom at least one sample was withdrawn for PK analysis. Only those participants available at the specified time points were analyzed. | 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
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT01587924/outcomes