ID

43022

Descrição

Satisfaction/Quality of Life With Rivaroxaban in SPAF (Stroke Prevention in Atrial Fibrillation) Indication; ODM derived from: https://clinicaltrials.gov/show/NCT01805531

Link

https://clinicaltrials.gov/show/NCT01805531

Palavras-chave

Versões (2)
  1. 07/08/2019 07/08/2019 -
  2. 17/09/2021 17/09/2021 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

17 de setembro de 2021

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT01805531

Inglês

Eligibility Atrial Fibrillation NCT01805531

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
female and male subjects ≥ 18 years of age with a diagnosis of non-valvular atrial fibrillation
Descrição

Age | Atrial Fibrillation

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0004238
who are treated with vitamin k antagonists (vka) with issues for at least the 4 previous weeks (issues are assessed on medical judgment)
Descrição

Treatment with Vitamin K antagonist | Problem Duration

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1096489
UMLS CUI [2,1]
C0033213
UMLS CUI [2,2]
C0449238
who start treatment with rivaroxaban to prevent stroke or non-cns (central nervous system) systemic embolism
Descrição

rivaroxaban | Treatment Preventing Cerebrovascular accident | Treatment Preventing SYSTEMIC ARTERIAL EMBOLISM | Exception Central Nervous System

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1739768
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C1292733
UMLS CUI [2,3]
C0038454
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C1292733
UMLS CUI [3,3]
C0149876
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C3714787
with anticoagulation therapy planned for at least 6 months
Descrição

Anticoagulation Therapy Planned

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0003281
UMLS CUI [1,2]
C1301732
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
contra indication to the use of xarelto as described in the summary of product characteristics (smpc); key contra indications are:
Descrição

Medical contraindication Xarelto

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C3159309
hypersensitivity to the active substance or to any of the excipients listed in smpc section 6.1.
Descrição

Hypersensitivity Xarelto | Hypersensitivity Xarelto Excipient

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C3159309
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C3159309
UMLS CUI [2,3]
C0015237
lesion or condition at significant risk of major bleeding
Descrição

Lesion At risk Hemorrhage Major | Condition At risk Hemorrhage Major

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C0019080
UMLS CUI [1,4]
C0205164
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C1444641
UMLS CUI [2,3]
C0019080
UMLS CUI [2,4]
C0205164
concomitant treatment with any other anticoagulant agent
Descrição

Anticoagulants Other

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0003280
UMLS CUI [1,2]
C0205394
clinically significant active bleeding
Descrição

Hemorrhage

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0019080
hepatic disease associated with coagulopathy and clinically relevant bleeding risk including cirrhotic patients with child pugh b and c
Descrição

Liver disease Associated with Blood Coagulation Disorders | Bleeding risk | Patients Cirrhotic Child-Pugh Classification

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C0005779
UMLS CUI [2]
C3251812
UMLS CUI [3,1]
C0030705
UMLS CUI [3,2]
C0439686
UMLS CUI [3,3]
C4050412
pregnancy and breast feeding
Descrição

Pregnancy | Breast Feeding

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Atrial Fibrillation NCT01805531

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Age | Atrial Fibrillation
Item
female and male subjects ≥ 18 years of age with a diagnosis of non-valvular atrial fibrillation
boolean
C0001779 (UMLS CUI [1])
C0004238 (UMLS CUI [2])
Treatment with Vitamin K antagonist | Problem Duration
Item
who are treated with vitamin k antagonists (vka) with issues for at least the 4 previous weeks (issues are assessed on medical judgment)
boolean
C1096489 (UMLS CUI [1])
C0033213 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
rivaroxaban | Treatment Preventing Cerebrovascular accident | Treatment Preventing SYSTEMIC ARTERIAL EMBOLISM | Exception Central Nervous System
Item
who start treatment with rivaroxaban to prevent stroke or non-cns (central nervous system) systemic embolism
boolean
C1739768 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C0038454 (UMLS CUI [2,3])
C0087111 (UMLS CUI [3,1])
C1292733 (UMLS CUI [3,2])
C0149876 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C3714787 (UMLS CUI [4,2])
Anticoagulation Therapy Planned
Item
with anticoagulation therapy planned for at least 6 months
boolean
C0003281 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Medical contraindication Xarelto
Item
contra indication to the use of xarelto as described in the summary of product characteristics (smpc); key contra indications are:
boolean
C1301624 (UMLS CUI [1,1])
C3159309 (UMLS CUI [1,2])
Hypersensitivity Xarelto | Hypersensitivity Xarelto Excipient
Item
hypersensitivity to the active substance or to any of the excipients listed in smpc section 6.1.
boolean
C0020517 (UMLS CUI [1,1])
C3159309 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C3159309 (UMLS CUI [2,2])
C0015237 (UMLS CUI [2,3])
Lesion At risk Hemorrhage Major | Condition At risk Hemorrhage Major
Item
lesion or condition at significant risk of major bleeding
boolean
C0221198 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C0019080 (UMLS CUI [1,3])
C0205164 (UMLS CUI [1,4])
C0348080 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C0019080 (UMLS CUI [2,3])
C0205164 (UMLS CUI [2,4])
Anticoagulants Other
Item
concomitant treatment with any other anticoagulant agent
boolean
C0003280 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Hemorrhage
Item
clinically significant active bleeding
boolean
C0019080 (UMLS CUI [1])
Liver disease Associated with Blood Coagulation Disorders | Bleeding risk | Patients Cirrhotic Child-Pugh Classification
Item
hepatic disease associated with coagulopathy and clinically relevant bleeding risk including cirrhotic patients with child pugh b and c
boolean
C0023895 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0005779 (UMLS CUI [1,3])
C3251812 (UMLS CUI [2])
C0030705 (UMLS CUI [3,1])
C0439686 (UMLS CUI [3,2])
C4050412 (UMLS CUI [3,3])
Pregnancy | Breast Feeding
Item
pregnancy and breast feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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