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Trial · NCT07465029

Registered outcomes25

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

ListOutcomeTime frameDescription
PrimaryIncidence of transfusion dependent lower-risk myelodysplastic syndromes (TD LR-MDS)Up to 5-years
PrimaryPrevalence of transfusion dependent lower-risk myelodysplastic syndromes (TD LR-MDS)Up to 5-years
SecondaryProportion of participants receiving each first-line treatment categoryUp to 5-years
Treatment categories include: * Erythropoiesis-stimulating agents (ESA) * Luspateracept * Hypomethylating agents (HMAs) * Lenalidomide * Conservative management (red-blood cell (RBC) transfusions without disease modifying therapy)
SecondaryProportion of participants by treatment category at each line of therapyUp to 5-years
Treatment category received at each line of therapy (first line, second line, third line and beyond), categorized as erythropoiesis-stimulating agents (ESA), luspatercept, hypomethylating agents (HMA), lenalidomide, or conservative management (red blood cell transfusions without disease-modifying therapy). Treatment sequences will be derived from retrospective medical chart abstraction of documented treatment start and stop dates.
SecondaryTreatment duration (time from initiation to discontinuation) of first-line treatmentUp to 5-years
SecondaryDefined as number of RBC units received per participant per 8-weeksUp to 5-years
SecondaryNumber and Rate of Healthcare Resource Utilization EventsUp to 5-years
Healthcare resource utilization events, including primary care visits, specialist visits, outpatient visits all-cause hospitalizations, transfusion-related hospitalizations, general laboratory tests, number of prescriptions related to transfusion-dependent lower-risk myelodysplastic syndromes, red blood cell transfusions, use of concomitant medicines related to other comorbidities as documented in participant medical records.
SecondaryNumber of participants that achieve hematologic improvement-erythroid (HI-E)Up to 5-years
SecondaryNumber of participants that achieve red-blood cell (RBC) transfusion independence (TI)Up to 5-years
SecondaryNumber of participants that experience a change in transfusion burden (change in number of red-blood cell units received per 8-weeks)Up to 5-years
SecondaryNumber of participants that progress to higher-risk myelodysplastic syndromes (MDS)Up to 5-years
SecondaryNumber of participants that progress to acute myeloid leukemia (AML)Up to 5-years
SecondaryNumber of participants that do not respond to first-line treatmentUp to 5-years
SecondaryNumber of participants that experience loss of response/secondary failure after an initial hematologic responseUp to 5-years
SecondaryCause of deathUp to 5-years
SecondarySerious adverse events (SAEs)Up to 5-years
SecondaryNumber of serious cardiovascular events requiring emergency room visit or hospitalizationUp to 5-years
Cardiovascular events include: will include acute myocardial infarction or acute coronary syndrome, heart failure decompensation, clinically significant arrhythmias (including atrial fibrillation/flutter and ventricular arrhythmia), stroke or transient ischemic attack, and venous thromboembolism.
SecondaryParticipant ageBaseline
SecondaryParticipant sexBaseline
SecondaryYear of first-line treatment initiationBaseline

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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