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Trial · NCT03136445

Outcomes18

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

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARY
The Proportion of Patients Who Die or Have Bleeding of WHO Grade 2 or Above by WHO Criteria During the First 30 Days From the First Dose of Trial Treatment, or Planned First Dose for Those Participants Who do Not Receive Treatment.
The first 30 days from first dose of trial treatmentParticipants with primary outcome data reportedpercentage of participantsNUMBER
SECONDARYMean (SD) Percentage of Days With WHO Grade 2 Bleeding or Above, Per Participant.The first 30 days from first dose of trial treatment .Participants with primary outcome data reportedpercentage of daysMEAN
SECONDARYTime to First Episode of Bleeding of WHO Grade 2 or Greater up to Study Day 30.The first 30 days from first dose of trial treatment.Participants with primary outcome data reportedLower quartile for number of daysMEDIAN
SECONDARYHighest Grade of Bleeding a Patient Experiences up to Study Day 30.The first 30 days from first dose of trial treatment.Data is only presented for participants who experienced at least one bleedParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Platelet Transfusions Per Patient up to Study Day 30.The first 30 days from first dose of trial treatment.Participants with primary outcome data reportedplatelet unitsMEDIAN
SECONDARYNumber of Red Cell Transfusions Per Patient up to Study Day 30.The first 30 days from first dose of trial treatment.Participants with primary outcome data reportedRed cell unitsMEDIAN
SECONDARYProportion of Patients Surviving at Least 30 Days Without a Platelet Transfusion.The first 30 days from first dose of trial treatment.Participants with primary outcome data reportedproportionNUMBER
SECONDARYProportion of Patients Surviving at Least 30 Days Without a Red Cell Transfusion.The first 30 days from first dose of trial treatment.Participants with primary outcome data reportedproportionNUMBER
SECONDARYNumber of Participants With a Thrombotic Event From First Administration of Trial Treatment up to and Including 120 Days After the First Dose of Trial Treatment is Received (N)Up to and including 120 days from the first administration of investigational medicinal product (IMP).ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Patients Developing Veno-occlusive Disease (VOD; Sinusoidal Obstructive Syndrome, SOS) Within 60 Days of First Administration of Trial Treatment.Up to and including 60 days from the first administration of IMP.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYAll-cause Mortality During the First 30 Days and 120 Days After the First Dose of Trial Treatment is Administered.Up to and including 120 days from the first administration of IMP.4 Participants were missing mortality data and so weren't analysdproportionNUMBER
SECONDARYDeath Due to Thrombosis During the First 120 Days After the First Dose of Trial Treatment is Administered.Up to and including 120 days from the first administration of IMP.percentNUMBER
SECONDARYDeath Due to Bleeding During the First 30 Days After the First Dose of Trial Treatment is Administered.Up to and including 30 days from the first administration of IMP.percentNUMBER
SECONDARYNumber of Serious Adverse Events (SAE) From First Administration of Trial Treatment Until 60 Days After the First Dose of Trial Treatment is Administered.Up to and including 60 days from the first administration of IMP.Serious adverse eventsNUMBER
OTHER_PRE_SPECIFIEDProportion of Days With Thrombocytopenia (≤10x10⁹/L, ≤30x10⁹L, ≤50x10⁹/L).Measured during first 30 days from first dose of IMP.Days platelet count count was recorded (so risk of thrombocytopenia could be detected)Days with thrombocytopeniaMEAN
OTHER_PRE_SPECIFIEDReasons for Platelet Transfusions.Measured during first 30 days from first dose of IMP.Participants with at least one platelet transfusionPlatelet transfusionsNUMBER
OTHER_PRE_SPECIFIEDReasons for Red Cell Transfusions.Measured during first 30 days from first dose of IMP.Participants with at least one red cell transfusionRed cell transfusionsNUMBER
OTHER_PRE_SPECIFIEDProportion of Days With FeverMeasured during first 30 days from first dose of IMP.Participants with fever data reportedDaysMEAN

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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