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Trial · NCT03446612

Registered outcomes53

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

ListOutcomeTime frameDescription
OtherChange From Baseline in Hematology Parameter of MCHBaseline (Day 1) and at Days 42 and 59
Blood samples were collected for the analysis of hematology parameters including MCH. Baseline value (Day 1) is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value.
OtherAbsolute Values of the Hematology Parameter of Mean Corpuscular Volume (MCV)Days 1, 42 and 59Blood samples were collected for the analysis of hematology parameters including MCV.
OtherChange From Baseline in Hematology Parameter of MCVBaseline (Day 1) and at Days 42 and 59
Blood samples were collected for the analysis of hematology parameters including MCV. Baseline value (Day 1) is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value.
OtherAbsolute Values of Clinical Chemistry Parameters of Sodium, Potassium, Carbon-dioxide (Total), Chloride, Glucose and UreaDays 1, 42 and 59Blood samples will be collected for the analysis of clinical chemistry parameters including; sodium, potassium, carbon-dioxide (total), chloride, glucose and urea.
OtherChange From Baseline in Clinical Chemistry Parameter: Sodium, Potassium, Carbon-dioxide (Total), Chloride, Glucose and UreaBaseline (Day 1) and at Days 42 and 59
Blood samples will be collected for the analysis of clinical chemistry parameters including; sodium, potassium, carbon-dioxide (total), chloride, glucose and urea. Baseline value (Day 1) is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value.
OtherAbsolute Values of Clinical Chemistry Parameters of CreatinineDays 1, 42 and 59Blood samples will be collected for the analysis of clinical chemistry parameters including; creatinine.
OtherChange From Baseline in Clinical Chemistry Parameter: CreatinineBaseline (Day 1) and at Days 42 and 59
Blood samples will be collected for the analysis of clinical chemistry parameters including; creatinine. Baseline value (Day 1) is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value.
OtherAbsolute Values of Clinical Chemistry Parameters of Bilirubin (Direct/Indirect and Total)Days 1, 14, 28, 42 and 59Blood samples will be collected for the analysis of clinical chemistry parameters including; bilirubin (direct/indirect and total).
OtherChange From Baseline in Clinical Chemistry Parameter: Bilirubin (Direct/Indirect and Total)Baseline (Day 1) and at Days 14, 28, 42 and 59
Blood samples will be collected for the analysis of clinical chemistry parameters including; creatinine and bilirubin (direct/indirect and total). Baseline value (Day 1) is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value.
OtherAbsolute Values of Clinical Chemistry Parameters of Alanine Transaminase (ALT), Alkaline Phosphatase (ALP) and Aspartate Transaminase (AST)Days 1, 14, 28, 42 and 59Blood samples will be collected for the analysis of clinical chemistry parameters including; ALT, ALP and AST.
OtherChange From Baseline in Clinical Chemistry Parameter: ALT, ALP and ASTBaseline (Day 1) and at Days 14, 28, 42 and 59
Blood samples will be collected for the analysis of clinical chemistry parameters including; ALT, ALP and AST. Baseline value (Day 1) is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value.
OtherAbsolute Values of Clinical Chemistry Parameters of AlbuminDays 1, 14, 28, 42 and 59Blood samples will be collected for the analysis of clinical chemistry parameters including; Albumin.
OtherChange From Baseline in Clinical Chemistry Parameter: AlbuminBaseline (Day 1) and at Days 14, 28, 42 and 59
Blood samples will be collected for the analysis of clinical chemistry parameters including; Albumin. Baseline value (Day 1) is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value.

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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