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Trial · NCT01587924

Outcomes23

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYModeled Hemoglobin (Hgb) Change From Baseline (Pre-dose on Day 1) at 4 Weeks of TreatmentBaseline (pre-dose on Day 1) and up to week 4ITT population. Only those participants available at the specified time points were analyzed.Grams per deciliter (g/dL)MEAN
SECONDARYHgb Variability Over 4 WeeksUp to 4 weeksITT population. Only those participants available at the specified time points were analyzed.g/dLMEAN
SECONDARYEvaluation of Change From Baseline in Hepcidin Over PeriodBaseline (pre-dose on Day 1) and up to 4 weeksITT population. Only those participants available at the specified time points were analyzed.Micrograms per liter (mcg/L)LEAST_SQUARES_MEAN
SECONDARYEvaluation of Change From Baseline (Pre-dose on Day 1) in High Sensitivity C-Reactive Protein (hsCRP) Over 4 WeeksBaseline (pre-dose on Day 1) and up to 4 weeksITT population. Only those participants available at the specified time points were analyzed.Milligrams per liter (mg/L)LEAST_SQUARES_MEAN
SECONDARYChange From Baseline for Erythropoeitin (EPO) Over PeriodBaseline (pre-dose on Day 1) and up to 4 weeksITT population. Only those participants available at the specified time points were analyzed.Units per liter (U/L)LEAST_SQUARES_MEAN
SECONDARYEvaluation of Change From Baseline (Pre-dose on Day 1) for Peak Vascular Endothelial Growth Factor (VEGF) Over 4 WeeksBaseline (pre-dose on Day 1) and up to 4 weeksITT population. Only those participants available at the specified time points were analyzed.Nanograms per liter (ng/L)LEAST_SQUARES_MEAN
SECONDARYEvaluation of Change From Baseline (Pre-dose on Day 1) for Hematocrit Over 4 WeeksBaseline (pre-dose on Day 1) and up to 4 weeksITT population. Only those participants available at the specified time points were analyzed.PercentageMEAN
SECONDARYResidual Standard Deviation in Hgb (From the Linear Regression)Up to 4 weeksITT population. Only those participants available at the specified time points were analyzed.g/LMEAN
SECONDARYNumber of Days Spent Within Hgb Range ( ±0.5 g/dL and ±1 g/dL ) From Baseline HgbBaseline (pre-dose on Day 1) and up to 4 weeksITT population. Only those participants available at the specified time points were analyzed.DaysMEDIAN
SECONDARYEvaluation of Change From Baseline (Pre-dose on Day 1) in Ferritin Over 4 WeeksBaseline (pre-dose on Day 1) and Week 4ITT population. Only those participants available at the specified time points were analyzed.Micrograms per literLEAST_SQUARES_MEAN
SECONDARYEvaluation of Change From Baseline (Pre-dose on Day 1) for Transferrin Over 4 WeeksBaseline (pre-dose on Day 1) and Week 4ITT population. Only those participants available at the specified time points were analyzed.Grams per literLEAST_SQUARES_MEAN
SECONDARYChange From Baseline (Pre-dose on Day 1) for Transferrin Saturation Over 4 WeeksBaseline (pre-dose on Day 1) and Week 4ITT population. Only those participants available at the specified time points were analyzed..RatioLEAST_SQUARES_MEAN
SECONDARYChange From Baseline (Pre-dose on Day 1) for Total Iron Over 4 WeeksBaseline (pre-dose on Day 1) and at Week 4ITT population. Only those participants available at the specified time points were analyzed.Micromoles per LiterLEAST_SQUARES_MEAN
SECONDARYChange From Baseline (Pre-dose on Day 1) in Total Iron Binding Capacity Over 4 WeeksBaseline (pre-dose on Day 1) and Week 4ITT population. Only those participants available at the specified time points were analyzed.Micromoles per LiterLEAST_SQUARES_MEAN
SECONDARYChange From Baseline (Pre-dose on Day 1) for Red Blood Cells (RBCs) Over 4 WeeksBaseline (pre-dose on Day 1) and up to 4 weeksITT population. Only those participants available at the specified time points were analyzed.10^12 cells per Liter (Giga cells per L)MEAN
SECONDARYChange From Baseline (Pre-dose on Day 1) for Reticulocytes Over 4 WeeksBaseline (pre-dose on Day 1) and up to 4 weeksITT population. Only those participants available at the specified time points were analyzed.Percentage changeMEAN
SECONDARYNumber of Participants Reaching Hgb Stopping CriteriaUp to 4 weeksITT population. Only those participants available at the time of assessment were analyzed.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)Up to 4 weeksSafety population.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants Discontinuing the Study Treatment Due to AEsUp to 4 weeksSafety populationParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYMean Plasma Concentration of GSK1278863 and GSK1278863 Metabolites Over 4 WeeksUp 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

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GET https://conductscience.org/api/trials/v1/NCT01587924/outcomes