Correlated Drug Terms (3)

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	Name (Synonyms)	Correlation
drug3411	placebo for risankizumab Wiki	1.00
drug3451	risankizumab Wiki	1.00
drug1004	Enoxaparin Wiki	0.29

Correlated MeSH Terms (3)

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	Name (Synonyms)	Correlation
D014456	Ulcer NIH	0.41
D003092	Colitis NIH	0.41
D003093	Colitis, Ulcerative NIH	0.41

Correlated HPO Terms (2)

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	Name (Synonyms)	Correlation
HP:0002583	Colitis HPO	0.41
HP:0100279	Ulcerative colitis HPO	0.41

Primary Outcomes

Description: Risk of arterial thromboembolic events (including myocardial infarction, stroke, systemic embolism), venous thromboembolism (including symptomatic deep vein thrombosis (DVT) of the upper or lower extremity, asymptomatic proximal DVT of the lower extremity, non-fatal pulmonary embolism (PE)), and all-cause mortality at Day 30 ± 2 days.

Measure: Composite outcome of arterial thromboembolic events, venous thromboembolic events and all-cause mortality at Day 30 ± 2 days.

Time: Day 30 ± 2 days

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Secondary Outcomes

Description: Risk of major bleeding defined using the International Society of Thrombosis and Haemostasis (ISTH) criteria

Measure: Major bleeding

Time: Day 30 ± 2 days

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Description: The composite of arterial thromboembolic events (including myocardial infarction, stroke, systemic embolism), venous thromboembolism (including symptomatic deep vein thrombosis (DVT) of the upper or lower extremity, asymptomatic proximal DVT of the lower extremity, non-fatal pulmonary embolism (PE)), and all-cause mortality at Hospital Day 10 + 4

Measure: Composite outcome of arterial thromboembolic events, venous thromboembolic events and all-cause mortality at Hospital Day 10 + 4

Time: Day 10 + 4

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Description: Sepsis-induced coagulopathy (SIC) score based on ISTH guidelines. Platelets, K/uL (thousands per microliter) [0-2] INR (International Normalized Ratio) [0-2] D-Dimer Levels, ng/mL [0-3] Fibrinogen, mg/dL [0-1] Calculated (SIC) scores greater or equal to 4 predicted higher mortality rates within 30 days and greater risk of pulmonary embolism.

Measure: Sepsis-induced coagulopathy (SIC) score

Time: Day 30 ± 2 days.

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Description: Progression to Acute Respiratory Distress Syndrome (ARDS) based on monitoring of patient conditions.

Measure: Progression to Acute Respiratory Distress Syndrome (ARDS)

Time: Day 30 ± 2 days.

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Description: Need for Intubation will be based on monitoring of patient conditions.

Measure: Need for Intubation

Time: Day 30 ± 2 days.

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Description: Need for Re-hospitalization will be based on monitoring of patient conditions.

Measure: Re-hospitalization

Time: Day 30 ± 2 days.

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