Registered outcomes41

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

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List	Outcome	Time frame	Description
Primary	Rate of success	At 6 months	Defined as absence of deep venous thrombosis relapse and of major bleeding event, without introduction of additional immunosuppressive medication for BS activity other than thrombotic events at 6 months.
Secondary	Cumulative incidence of deep venous thrombosis and superficial venous thrombosis relapse	At 12 months
Secondary	Cumulative incidence of major venous thrombosis	At 12 months	pulmonary embolism, vena cava , Budd Chiari syndrome , intra-cardiac relapse
Secondary	Cumulative incidence of venous repermeabilization	At 6 months	assessed by vascular imaging
Secondary	Proportion of patients with a dose ≤ 5 mg/day of prednisone	At 6 months	(prednisone or equivalent prednisone dose only if prednisone is out of stock in the market)
Secondary	Proportion of patients with a dose ≤ 5 mg/day of prednisone	At 12 months	(prednisone or equivalent prednisone dose only if prednisone is out of stock in the market)
Secondary	Dose of prednisone	At 3 months	(prednisone or equivalent prednisone dose only if prednisone is out of stock in the market)
Secondary	Dose of prednisone	At 6 months	(prednisone or equivalent prednisone dose only if prednisone is out of stock in the market)
Secondary	Dose of prednisone	At 12 months	(prednisone or equivalent prednisone dose only if prednisone is out of stock in the market)
Secondary	Cumulative dose of prednisone	At 3 months	(prednisone or equivalent prednisone dose only if prednisone is out of stock in the market)
Secondary	Cumulative dose of prednisone	At 6 months	(prednisone or equivalent prednisone dose only if prednisone is out of stock in the market)
Secondary	Cumulative dose of prednisone	At 12 months	(prednisone or equivalent prednisone dose only if prednisone is out of stock in the market)
Secondary	Cumulative incidence of major bleeding event	At 12 months
Secondary	Cumulative incidence of bleeding event	At 12 months
Secondary	Number of adverse events	At 3 months
Secondary	Number of adverse events	At 6 months
Secondary	Number of adverse events	At 12 months
Secondary	Change in SF-36 quality-of-life	At 3 months	The Short Form (36) Health Survey is a 36-item measure if health status. The score obtained varies between 0 and 100. The higher the score the less disability.
Secondary	Change in SF-36 quality-of-life	At 6 months	The Short Form (36) Health Survey is a 36-item measure if health status. The score obtained varies between 0 and 100. The higher the score the less disability.
Secondary	Change in SF-36 quality-of-life	At 12 months	The Short Form (36) Health Survey is a 36-item measure if health status. The score obtained varies between 0 and 100. The higher the score the less disability.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

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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Registered outcomes41

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