Registered outcomes18

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

1 to 18 of 18

List	Outcome	Time frame	Description
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 treatment	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. A time-to-event analysis will be used to determine this proportion to ensure that all patients are included in the primary outcome analysis, not just those who are followed up for the full 30 days. Any patients lost to follow-up will be included in the analysis and censored at the time that they were lost.
Secondary	Mean (SD) Percentage of Days With WHO Grade 2 Bleeding or Above, Per Participant.	The first 30 days from first dose of trial treatment .	Number of days where WHO grade 2 or above bleeding has been recorded bleeding using WHO bleeding criteria.
Secondary	Time 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.	Bleeding assessed using WHO bleeding criteria. Time to first episode of bleeding of WHO grade 2 or above was estimated using a cumulative incidence function, with death as a competing risk. The lower quartile for the time is reported as the median was not estimable.
Secondary	Highest Grade of Bleeding a Patient Experiences up to Study Day 30.	The first 30 days from first dose of trial treatment.	Measured using WHO bleeding criteria (The higher the grade, the most severe the bleed). Grade 0: no bleeding Grade 1: petechial bleeding Grade 2: mild blood loss (clinically significant) Grade 3: gross blood loss, requires transfusion(severe) Grade 4: debilitating blood loss, retinal or cerebral associated with fatality
Secondary	Number of Platelet Transfusions Per Patient up to Study Day 30.	The first 30 days from first dose of trial treatment.	Measured by number of recorded platelet transfusions per patient.
Secondary	Number of Red Cell Transfusions Per Patient up to Study Day 30.	The first 30 days from first dose of trial treatment.	Measured by number of recorded red cell transfusions per patient.
Secondary	Proportion of Patients Surviving at Least 30 Days Without a Platelet Transfusion.	The first 30 days from first dose of trial treatment.	Measured by calculating number of patients surviving at least 30 days without a platelet transfusion.
Secondary	Proportion of Patients Surviving at Least 30 Days Without a Red Cell Transfusion.	The first 30 days from first dose of trial treatment.	Measured by calculating the number of patients surviving at least 30 days without a red cell transfusion.
Secondary	Number 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).	Measured by calculating number of patients developing clinically diagnosed thrombotic events within 120 days of Treatment Day 1 i.e the first day that the IMP is administered.
Secondary	Number 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.	Measured by calculating number of patients developing Veno-occlusive Disease (VOD; Sinusoidal obstructive syndrome, SOS) within 60 days of Treatment Day 1 i.e the first day that the IMP is administered.
Secondary	All-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.	Measured by calculating number of deaths in first 30 days and 120 days after Treatment Day 1 i.e the first day that the IMP is administered.
Secondary	Death 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.	Measured by calculating number of deaths due to thrombosis during the first 120 days after Treatment Day 1 i.e the first day that the IMP is administered.
Secondary	Death 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.	Measured by calculating number of deaths due to bleeding during the first 30 days
Secondary	Number 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.	Measured by calculating the total number of SAE's reported from first administration of IMP.
Other	Proportion of Days With Thrombocytopenia (≤10x10⁹/L, ≤30x10⁹L, ≤50x10⁹/L).	Measured during first 30 days from first dose of IMP.	Measured by number of days that the patient's laboratory results indicate that the patient is thrombocytopenic.
Other	Reasons for Platelet Transfusions.	Measured during first 30 days from first dose of IMP.	Reasons for platelet transfusions as documented by clinician.
Other	Reasons for Red Cell Transfusions.	Measured during first 30 days from first dose of IMP.	Reasons for red cell transfusions as documented by clinician.
Other	Proportion of Days With Fever	Measured during first 30 days from first dose of IMP.	Highest daily temperature ≥ 38.1°C

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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