ID

37603

Beschrijving

BAY 59-7939 (Xarelto, SPAF), Non Interventional Studies; ODM derived from: https://clinicaltrials.gov/show/NCT02090543

Link

https://clinicaltrials.gov/show/NCT02090543

Trefwoorden

  1. 10-08-19 10-08-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

10 augustus 2019

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Atrial Fibrillation NCT02090543

Eligibility Atrial Fibrillation NCT02090543

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
a.general criteria (group 1and group2):
Beschrijving

Criteria General

Datatype

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C0205246
diagnosed non-valvular af
Beschrijving

Atrial Fibrillation

Datatype

boolean

Alias
UMLS CUI [1]
C0004238
older than 18 years
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
general capability and willingness to perform a structured patient interview in german
Beschrijving

Patient interview German language

Datatype

boolean

Alias
UMLS CUI [1,1]
C0683518
UMLS CUI [1,2]
C0017477
no participation in any other clinical or observational study over the last 3 month
Beschrijving

Participation Absent Clinical Trial Other | Participation Absent Observational Study Other

Datatype

boolean

Alias
UMLS CUI [1,1]
C0679823
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0008976
UMLS CUI [1,4]
C0205394
UMLS CUI [2,1]
C0679823
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C1518527
UMLS CUI [2,4]
C0205394
additional criteria for group1 (vka-experienced):
Beschrijving

Criteria Additional | Group Number

Datatype

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1524062
UMLS CUI [2,1]
C0441833
UMLS CUI [2,2]
C0237753
active vka-therapy for at least 3 month without significant interruptions
Beschrijving

Vitamin K antagonists

Datatype

boolean

Alias
UMLS CUI [1]
C3653316
in case of perioperative interruption vka treatment should not have been hold for more than two weeks.
Beschrijving

Interruption perioperative | Vitamin K antagonists To be stopped

Datatype

boolean

Alias
UMLS CUI [1,1]
C1512900
UMLS CUI [1,2]
C1518988
UMLS CUI [2,1]
C3653316
UMLS CUI [2,2]
C1272691
additional criteria for group2 (rivaroxaban-experienced patients):
Beschrijving

Criteria Additional | Group Number

Datatype

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1524062
UMLS CUI [2,1]
C0441833
UMLS CUI [2,2]
C0237753
active rivaroxaban-therapy for at least 3 month without significant interruptions
Beschrijving

rivaroxaban

Datatype

boolean

Alias
UMLS CUI [1]
C1739768
in case of perioperative interruption vka treatment should not have been hold for more than two weeks.
Beschrijving

Interruption perioperative | Vitamin K antagonists To be stopped

Datatype

boolean

Alias
UMLS CUI [1,1]
C1512900
UMLS CUI [1,2]
C1518988
UMLS CUI [2,1]
C3653316
UMLS CUI [2,2]
C1272691
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
participation in any other clinical or observational study over the last 3 month
Beschrijving

Study Subject Participation Status | Clinical Trial | Observational Study

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0008976
UMLS CUI [3]
C1518527

Similar models

Eligibility Atrial Fibrillation NCT02090543

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Criteria General
Item
a.general criteria (group 1and group2):
boolean
C0243161 (UMLS CUI [1,1])
C0205246 (UMLS CUI [1,2])
Atrial Fibrillation
Item
diagnosed non-valvular af
boolean
C0004238 (UMLS CUI [1])
Age
Item
older than 18 years
boolean
C0001779 (UMLS CUI [1])
Patient interview German language
Item
general capability and willingness to perform a structured patient interview in german
boolean
C0683518 (UMLS CUI [1,1])
C0017477 (UMLS CUI [1,2])
Participation Absent Clinical Trial Other | Participation Absent Observational Study Other
Item
no participation in any other clinical or observational study over the last 3 month
boolean
C0679823 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C0679823 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1518527 (UMLS CUI [2,3])
C0205394 (UMLS CUI [2,4])
Criteria Additional | Group Number
Item
additional criteria for group1 (vka-experienced):
boolean
C0243161 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
C0441833 (UMLS CUI [2,1])
C0237753 (UMLS CUI [2,2])
Vitamin K antagonists
Item
active vka-therapy for at least 3 month without significant interruptions
boolean
C3653316 (UMLS CUI [1])
Interruption perioperative | Vitamin K antagonists To be stopped
Item
in case of perioperative interruption vka treatment should not have been hold for more than two weeks.
boolean
C1512900 (UMLS CUI [1,1])
C1518988 (UMLS CUI [1,2])
C3653316 (UMLS CUI [2,1])
C1272691 (UMLS CUI [2,2])
Criteria Additional | Group Number
Item
additional criteria for group2 (rivaroxaban-experienced patients):
boolean
C0243161 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
C0441833 (UMLS CUI [2,1])
C0237753 (UMLS CUI [2,2])
rivaroxaban
Item
active rivaroxaban-therapy for at least 3 month without significant interruptions
boolean
C1739768 (UMLS CUI [1])
Interruption perioperative | Vitamin K antagonists To be stopped
Item
in case of perioperative interruption vka treatment should not have been hold for more than two weeks.
boolean
C1512900 (UMLS CUI [1,1])
C1518988 (UMLS CUI [1,2])
C3653316 (UMLS CUI [2,1])
C1272691 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Study Subject Participation Status | Clinical Trial | Observational Study
Item
participation in any other clinical or observational study over the last 3 month
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2])
C1518527 (UMLS CUI [3])

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