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Trial · NCT03500549

Outcomes26

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

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYLeast Squares (LS) Mean Change From Baseline to Week 16 in Hemoglobin (Hb) Level During the RCPBaseline and Week 16The ITT set included all randomized subjects.Grams per deciliter (g/dL)LEAST_SQUARES_MEAN
SECONDARYPercentage of Subjects Who Did Not Require a Transfusion (Transfusion Avoidance) During the RCPDay 1 to Week 16The ITT set included all randomized subjects.Percentage of subjectsNUMBER
SECONDARYLS Mean Change From Baseline to Week 16 in Absolute Reticulocyte Count (ARC) During the RCPBaseline and Week 16The ITT set included all randomized subjects.10^9 cells/ liter (L)LEAST_SQUARES_MEAN
SECONDARYLS Mean Change From Baseline to Week 16 in Lactate Dehydrogenase (LDH) Level During the RCPBaseline and Week 16The ITT set included all randomized subjects.Units (U)/LLEAST_SQUARES_MEAN
SECONDARYLS Mean Change From Baseline to Week 16 in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Score During the RCPBaseline and Week 16The ITT set included all randomized subjects.Score on a scaleLEAST_SQUARES_MEAN
SECONDARYPercentage of Subjects Who Achieved a Hb Response in the Absence of Transfusions at Week 16Baseline and Week 16The ITT set included all randomized subjects.Percentage of subjectsNUMBER
SECONDARYPercentage of Subjects Who Achieved Reticulocyte Normalization in the Absence of Transfusions at Week 16Week 16The ITT set includes all randomized subjects.Percentage of subjectsNUMBER
SECONDARYPercentage of Subjects Who Achieved Hb Normalization in the Absence of Transfusions at Week 16Week 16The ITT set included all randomized subjects.Percentage of subjectsNUMBER
SECONDARYLS Mean Change From Baseline to Week 16 in Indirect Bilirubin Level During the RCPBaseline and Week 16The ITT set included all randomized subjects.Micromole (μmol)/LLEAST_SQUARES_MEAN
SECONDARYLS Mean Change From Baseline to Week 16 in Haptoglobin Level During the RCPBaseline and Week 16The ITT set included all randomized subjects.g/LLEAST_SQUARES_MEAN
SECONDARYLS Mean Change From Baseline to Week 16 in Linear Analog Scale Assessment (LASA) Scores During the RCPBaseline and Week 16The ITT set included all randomized subjects.Score on a scaleLEAST_SQUARES_MEAN
SECONDARYLS Mean Change From Baseline to Week 16 in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 Scale (QLQ-C30) Scores During the RCPBaseline and Week 16The ITT set included all randomized subjects.Score on a scaleLEAST_SQUARES_MEAN
SECONDARYTotal Number of PRBC Units Transfused During the RCPDay 1 to Week 16The ITT set included all randomized subjects.PRBC unitsNUMBER
SECONDARYMean Change From Baseline to Week 48 in Hb Level During the Treatment PeriodBaseline and Week 48The ITT set included all randomized subjects.g/dLMEAN
SECONDARYMean Change From Week 17 to Week 48 in Hb Level During the Open-label PeriodWeek 17 and Week 48The ITT set included all randomized subjects.g/dLMEAN
SECONDARYMean Change From Baseline to Week 48 in ARC During the Treatment PeriodBaseline and Week 48The ITT set included all randomized subjects.10^9 cells/LMEAN
SECONDARYMean Change From Week 17 to Week 48 in ARC During the Open-label PeriodWeek 17 and Week 48The ITT set included all randomized subjects.10^9 cells/LMEAN
SECONDARYMean Change From Baseline to Week 48 in LDH Level During the Treatment PeriodBaseline and Week 48The ITT set included all randomized subjects.U/LMEAN
SECONDARYMean Change From Week 17 to Week 48 in LDH Level During the Open-label PeriodWeek 17 and Week 48The ITT set included all randomized subjects.U/LMEAN
SECONDARYMean Change From Baseline to Week 48 in FACIT-Fatigue Scale Score During the Treatment PeriodBaseline and Week 48The ITT set included all randomized subjects.Score on a scaleMEAN

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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