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Trial · NCT02476916

Registered outcomes34

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryPercentage of Participants Experiencing at Least One Adverse Event (AEs) in the Core PeriodUp to Week 24An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered study drug-related.
SecondaryPercentage of Participants Experiencing at Least One AE up to Month 102Up to Month 102
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered study drug-related. Safety data for cumulative period (Core period and Extension period) has been reported in this outcome measure.
SecondaryChange From Baseline in Hemoglobin (Hb) Value at Week 24Baseline and Week 24Change (absolute change) from baseline was calculated as post-baseline value - baseline value. Increased Hb values indicate improvement.
SecondaryChange From Baseline Hb Value up to Month 102Baseline, Months 12, 36, 60, 84, and 102Change (absolute change) from baseline was calculated as post-baseline value - baseline value. Increased Hb values indicate improvement.
SecondaryChange From Baseline in Hematocrit at Week 24Baseline and Week 24Change (absolute change) from baseline was calculated as post-baseline value - baseline value. Increased hematocrit values indicate improvement.
SecondaryChange From Baseline in Hematocrit up to Month 102Baseline, Months 12, 36, 60, 84, and 102Change (absolute change) from baseline was calculated as post-baseline value - baseline value. Increased hematocrit values indicate improvement.
SecondaryChange From Baseline in Reticulocyte Count at Week 24Baseline and Week 24Change (absolute change) from baseline was calculated as post-baseline value - baseline value. Decreased reticulocyte count values indicate improvement.
SecondaryChange From Baseline in Reticulocyte Count up to Month 102Baseline, Months 12, 36, 60, 84, and 102Change (absolute change) from baseline will be calculated as post-baseline value - baseline value. Decreased reticulocyte count values indicate improvement.
SecondaryChange From Baseline in Haptoglobin at Week 24Baseline and Week 24Change (absolute change) from baseline was calculated as post-baseline value - baseline value. Increased haptoglobin values indicate improvement.
SecondaryChange From Baseline in Haptoglobin up to Month 102Baseline, Months 12, 36, 60, 84, and 102Change (absolute change) from baseline was calculated as post-baseline value - baseline value. Increased haptoglobin values indicate improvement.
SecondaryChange From Baseline in Carboxyhemoglobin (COHb) at Week 24Baseline and Week 24Change (absolute change) from baseline was calculated as post-baseline value - baseline value. Decreased COHb values indicate improvement.
SecondaryChange From Baseline in COHb up to Month 30Baseline, Months 12, 18, 24, and 30Change (absolute change) from baseline was calculated as post-baseline value - baseline value. Decreased COHb values indicate improvement.
SecondaryChange From Baseline in Lactate Dehydrogenase (LDH) at Week 24Baseline and Week 24Change (absolute change) from baseline was calculated as post-baseline value - baseline value. Decreased LDH values indicate improvement.
SecondaryChange From Baseline in LDH up to Month 30Baseline, Months 12, 18, 24, and 30Change (absolute change) from baseline was calculated as post-baseline value - baseline value. Decreased LDH values indicate improvement.
SecondaryChange From Baseline in Total Bilirubin at Week 24Baseline and Week 24Change (absolute change) from baseline was calculated as post-baseline value - baseline value. Decreased total bilirubin values indicate improvement.
SecondaryChange From Baseline in Total Bilirubin up to Month 102Baseline, Months 12, 36, 60, 84, and 102Change (absolute change) from baseline was calculated as post-baseline value - baseline value. Decreased total bilirubin values indicate improvement.
SecondaryChange From Baseline in Indirect Bilirubin at Week 24Baseline and Week 24Change (absolute change) from baseline was calculated as post-baseline value - baseline value. Decreased indirect bilirubin values indicate improvement.
SecondaryChange From Baseline in Indirect Bilirubin up to Month 102Baseline, Months 12, 36, 60, 84, and 102Change (absolute change) from baseline was calculated as post-baseline value - baseline value. Decreased indirect bilirubin values indicate improvement.
SecondaryChange From Baseline in Erythropoietin (EPO) at Week 24Baseline and Week 24Change (absolute change) from baseline was calculated as post-baseline value - baseline value. Decreased EPO values indicate improvement.
SecondaryChange From Baseline in (EPO) up to Month 30Baseline, Months 12, 18, 24, and 30Change (absolute change) from baseline was calculated as post-baseline value - baseline value. Decreased EPO values indicate improvement.

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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