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Trial · NCT03446612

Outcomes53

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

TypeOutcomeTime framePopulationUnitsMeasured as
SECONDARYNumber of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)Up to 59 daysSafety Population includes all randomised participants who received at least one dose of study treatment.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants With Any AE of Special Interest (AESI)Up to 59 daysSafety PopulationParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants Discontinuing the Randomized Study TreatmentUp to Day 42Safety PopulationParticipantsCOUNT_OF_PARTICIPANTS
OTHER_PRE_SPECIFIEDAbsolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)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).millimeters of mercury (mmHg)MEAN
OTHER_PRE_SPECIFIEDChange From Baseline in DBP and SBPBaseline (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).mmHgMEAN
OTHER_PRE_SPECIFIEDAbsolute Values of Electrocardiogram (ECG) Mean Heart RateDays 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).Beats per minuteMEAN
OTHER_PRE_SPECIFIEDChange From Baseline in ECG Mean Heart RateBaseline (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).Beats per minuteMEAN
OTHER_PRE_SPECIFIEDAbsolute Values of ECG Parameters- PR Interval, QRS Interval, and QT Interval and QT Interval Corrected for Heart Rate Using Bazett's Formula (QTcB)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).MillisecondsMEAN
OTHER_PRE_SPECIFIEDChange From Baseline in ECG Parameters- PR Interval, QRS Duration, and QT Interval and QTcBBaseline (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).MillisecondsMEAN
OTHER_PRE_SPECIFIEDAbsolute Values of the Hematology Parameters of Platelet Count, White Blood Cell (WBC) Count (Absolute), Basophils, Eosinophils, Lymphocytes, Monocytes and NeutrophilsDays 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).Giga cells per LiterMEAN
OTHER_PRE_SPECIFIEDChange From Baseline in Hematology Parameters of Platelet Count, Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and NeutrophilsBaseline (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).Giga cells per LiterMEAN
OTHER_PRE_SPECIFIEDAbsolute Values of the Hematology Parameter of Red Blood Cell (RBC) Count and Reticulocyte Count (RC)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).Trillion cells per literMEAN
OTHER_PRE_SPECIFIEDChange From Baseline in Hematology Parameters of RBC Count and RCBaseline (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).Trillion cells per literMEAN
OTHER_PRE_SPECIFIEDAbsolute Values of the Hematology Parameters of Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC)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).Grams per deciliterMEAN
OTHER_PRE_SPECIFIEDChange From Baseline in Hematology Parameters- Hemoglobin and MCHCBaseline (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).Grams per deciliterMEAN
OTHER_PRE_SPECIFIEDAbsolute Values of Hematology Parameter: HematocritDays 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).Proportion of red blood cells in bloodMEAN
OTHER_PRE_SPECIFIEDChange From Baseline in Hematology Parameter: HematocritBaseline (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).Proportion of red blood cells in bloodMEAN
OTHER_PRE_SPECIFIEDAbsolute Values of Hematology Parameter of Red Blood Cell Distribution Width (RDW)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).Percentage of widthMEAN
OTHER_PRE_SPECIFIEDChange From Baseline in RDWBaseline (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).Percentage of widthMEAN
OTHER_PRE_SPECIFIEDAbsolute Values of the Hematology Parameter of Mean Corpuscular Hemoglobin (MCH)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).PicogramsMEAN

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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