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Trial · NCT04896008

Outcomes13

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

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYTime to First Confirmed Morbidity or Mortality EventUp to approximately 31 monthsAll randomized participants who received at least one dose of study treatment.MonthsMEDIAN
SECONDARYOverall Survival (OS)Up to approximately 31 monthsAll randomized participants who received at least one dose of study treatment.MonthsMEDIAN
SECONDARYTransplant-free SurvivalUp to approximately 31 monthsAll randomized participants who received at least one dose of study treatment.MonthsMEDIAN
SECONDARYPercentage of Participants Who Experienced a Mortality EventUp to approximately 31 monthsAll randomized participants who received at least one dose of study treatment.Percentage of ParticipantsNUMBER
SECONDARYChange From Baseline in REVEAL Lite 2.0 Risk Score at Week 24Baseline and Week 24All randomized participants who received at least one dose of study treatment and who had REVEAL Lite 2.0 Risk Score available at both baseline and Week 24.Scores on a scaleMEDIAN
SECONDARYPercentage of Participants Achieving a Low or Intermediate (≤7) REVEAL Lite 2 Risk Score at Week 24Week 24
All randomized participants who received at least one dose of study treatment, who were randomized more than 24 weeks prior to the data cutoff, and who had a REVEAL Lite 2.0 risk score \>7 at baseline.
Percentage of ParticipantsNUMBER
SECONDARYChange From Baseline in NT-proBNP Levels at Week 24Baseline and Week 24All randomized participants who received at least one dose of study treatment and who had NT-proBNP levels available at both baseline and Week 24.pg/mLMEDIAN
SECONDARYChange From Baseline in Mean Pulmonary Artery Pressure (mPAP) at Week 24Baseline and Week 24All randomized participants who received at least one dose of study treatment and who had mPAP available at both baseline and Week 24.mmHgMEDIAN
SECONDARYChange From Baseline in Pulmonary Vascular Resistance (PVR)Baseline and Week 24All randomized participants who received at least one dose of study treatment and who had PVR available at both baseline and Week 24.Dynes*sec/cm^5MEDIAN
SECONDARYPercentage of Participants Who Improve in WHO FCBaseline and up to approximately 31 monthsAll randomized participants who received at least one dose of study treatment.Percentage of ParticipantsNUMBER
SECONDARYChange From Baseline in 6MWD at Week 24Baseline and Week 24All randomized participants who received at least one dose of study treatment and who had 6MWD available at both baseline and Week 24.MetersMEDIAN
SECONDARYChange From Baseline in Cardiac Output (CO) at Week 24Baseline and Week 24All randomized participants who received at least one dose of study treatment and who had CO available at both baseline and Week 24.Liters/minuteMEDIAN
SECONDARYChange From Baseline in European Quality of Life (EuroQoL)-5 Dimensions-5 Levels (EQ-5D-5L) Index Score at Week 24Baseline and Week 24
All randomized participants who received at least one dose of study treatment, who were randomized more than 24 weeks prior to the data cutoff, and who had data available from at least one baseline and post-baseline PRO assessment.
Scores on a ScaleMEDIAN

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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