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Trial · NCT05791708

Registered outcomes13

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

ListOutcomeTime frameDescription
PrimaryPatterns of CAD and CAS disease characteristicsUp to 6 yearsCAD or CAS characteristics at diagnosis, enrollment, and during follow up (e.g., criteria used for diagnosis, symptoms, laboratory results) will be described.
PrimaryNumber of participants with CAD or CAS complicationsUp to 6 years
Thromboembolic events (venous, arterial or cerebral), deaths related to CAD or CAS, other CAD/CAS complications (e.g., acute hemolytic crisis, hemolysis-related complications), and other comorbid conditions occurring before enrollment, at enrollment, and during follow up will be described.
PrimaryPatterns of use of CAD and CAS treatmentsUp to 6 years
CAD or CAS treatments received before enrollment, at enrollment, and during the follow up period will be summarized. CAD or CAS symptoms and complications, autoimmune disorders or lymphoproliferative disorders, physician assessment of treatment status, and changes in laboratory results will be described by CAD or CAS treatments.
PrimaryNumber of participants with health-resource utilizationUp to 6 years
Health resource utilization may include hospitalizations (including length of stay), outpatient visits, emergency room visits, specific transfusion visits, nursing home/rehabilitation center stays, and home healthcare visits during registry follow-up period
PrimaryCold Agglutinin Disease Symptoms and Impact Questionnaire (CAD-SIQ)Up to 6 years
PrimaryFunctional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)Up to 6 years
Primary36-Item Short Form Survey Instrument (SF-36) v2Up to 6 years
PrimarySutimlimab cohort: Sutimlimab treatment patternsUp to 6 yearsSutimlimab dosing information, reasons for dose adjustments, reasons for discontinuation will be described.
PrimarySutimlimab cohort: Number of participants with adverse events, serious adverse events, adverse events of special interests (AESIs), other events of interests (e.g., Treatment emergent)Up to 6 years
PrimarySutimlimab cohort: change from baseline in hemoglobinFrom baseline up to 6 years
PrimarySutimlimab cohort: change from baseline in bilirubinFrom baseline up to 6 years
PrimarySutimlimab cohort: change from baseline in Lactate dehydrogenase (LDH)From baseline up to 6 years
PrimarySutimlimab cohort: number of blood cells transfusionsUp to 6 years

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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