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Trial · NCT03446612

Outcomes53

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

TypeOutcomeTime framePopulationUnitsMeasured as
OTHER_PRE_SPECIFIEDChange From Baseline in Hematology Parameter of MCHBaseline (Day 1) and at Days 42 and 59Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).PicogramsMEAN
OTHER_PRE_SPECIFIEDAbsolute Values of the Hematology Parameter of Mean Corpuscular Volume (MCV)Days 1, 42 and 59Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).FemtolitersMEAN
OTHER_PRE_SPECIFIEDChange From Baseline in Hematology Parameter of MCVBaseline (Day 1) and at Days 42 and 59Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).FemtolitersMEAN
OTHER_PRE_SPECIFIEDAbsolute Values of Clinical Chemistry Parameters of Sodium, Potassium, Carbon-dioxide (Total), Chloride, Glucose and UreaDays 1, 42 and 59Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).Millimoles per LiterMEAN
OTHER_PRE_SPECIFIEDChange From Baseline in Clinical Chemistry Parameter: Sodium, Potassium, Carbon-dioxide (Total), Chloride, Glucose and UreaBaseline (Day 1) and at Days 42 and 59Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).Millimoles per LiterMEAN
OTHER_PRE_SPECIFIEDAbsolute Values of Clinical Chemistry Parameters of CreatinineDays 1, 42 and 59Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).Micromoles per LiterMEAN
OTHER_PRE_SPECIFIEDChange From Baseline in Clinical Chemistry Parameter: CreatinineBaseline (Day 1) and at Days 42 and 59Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).Micromoles per LiterMEAN
OTHER_PRE_SPECIFIEDAbsolute Values of Clinical Chemistry Parameters of Bilirubin (Direct/Indirect and Total)Days 1, 14, 28, 42 and 59Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).Micromoles per LiterMEAN
OTHER_PRE_SPECIFIEDChange From Baseline in Clinical Chemistry Parameter: Bilirubin (Direct/Indirect and Total)Baseline (Day 1) and at Days 14, 28, 42 and 59Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).Micromoles per LiterMEAN
OTHER_PRE_SPECIFIEDAbsolute Values of Clinical Chemistry Parameters of Alanine Transaminase (ALT), Alkaline Phosphatase (ALP) and Aspartate Transaminase (AST)Days 1, 14, 28, 42 and 59Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).International units per LiterMEAN
OTHER_PRE_SPECIFIEDChange From Baseline in Clinical Chemistry Parameter: ALT, ALP and ASTBaseline (Day 1) and at Days 14, 28, 42 and 59Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).International units per LiterMEAN
OTHER_PRE_SPECIFIEDAbsolute Values of Clinical Chemistry Parameters of AlbuminDays 1, 14, 28, 42 and 59Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).Grams per LiterMEAN
OTHER_PRE_SPECIFIEDChange From Baseline in Clinical Chemistry Parameter: AlbuminBaseline (Day 1) and at Days 14, 28, 42 and 59Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).Grams per LiterMEAN

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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