ID

33295

Description

Effectiveness Study of Atrial Fibrillation; ODM derived from: https://clinicaltrials.gov/show/NCT01856075

Link

https://clinicaltrials.gov/show/NCT01856075

Keywords

Versions (1)
  1. 12/4/18 12/4/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

December 4, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT01856075

English

Eligibility Atrial Fibrillation NCT01856075

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient 18 years old or above
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
patient with paroxysmal or persistent atrial fibrillation
Description

Paroxysmal atrial fibrillation | Persistent atrial fibrillation

Data type

boolean

Alias
UMLS CUI [1]
C0235480
UMLS CUI [2]
C2585653
patient using an aai (antiarrhythmic drug of interest) or dronedarone (index drug)
Description

Anti-Arrhythmia Agents | dronedarone

Data type

boolean

Alias
UMLS CUI [1]
C0003195
UMLS CUI [2]
C0766326
patient's treatment changed from one aai to another aai or dronedarone or from no antiarrhythmic therapy to the start of aai or dronedarone therapy during previous 6 months before the date of recruitment
Description

Anti-Arrhythmia Agents | dronedarone | Anti-Arrhythmia Agents Absent

Data type

boolean

Alias
UMLS CUI [1]
C0003195
UMLS CUI [2]
C0766326
UMLS CUI [3,1]
C0003195
UMLS CUI [3,2]
C0332197
patient with at least 6 months of medical and treatment information prior to the start of the index drug
Description

Patient has Information Medical | Patient has Treatment information

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C3539897
UMLS CUI [1,3]
C1533716
UMLS CUI [1,4]
C0205476
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C3539897
UMLS CUI [2,3]
C2708735
patient able to answer the telephone interview in a language of the participating country: english, german, italian or spanish (with or without proxy).
Description

Telephone Interview Answer English Language | Telephone Interview Answer German language | Telephone Interview Answer Italian language | Telephone Interview Answer Spanish Language | Proxy Present | Proxy Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0021823
UMLS CUI [1,2]
C0508431
UMLS CUI [1,3]
C0376245
UMLS CUI [2,1]
C0021823
UMLS CUI [2,2]
C0508431
UMLS CUI [2,3]
C0017477
UMLS CUI [3,1]
C0021823
UMLS CUI [3,2]
C0508431
UMLS CUI [3,3]
C0022275
UMLS CUI [4,1]
C0021823
UMLS CUI [4,2]
C0508431
UMLS CUI [4,3]
C0037750
UMLS CUI [5,1]
C0600420
UMLS CUI [5,2]
C0150312
UMLS CUI [6,1]
C0600420
UMLS CUI [6,2]
C0332197
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient with heart failure (nyha class iv)
Description

Heart failure New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1275491
patient with permanent atrial fibrillation
Description

Permanent atrial fibrillation

Data type

boolean

Alias
UMLS CUI [1]
C2586056
patient with psychiatric conditions preventing the participation to the study according to the physician
Description

Mental condition Study Subject Participation Status Excluded

Data type

boolean

Alias
UMLS CUI [1,1]
C3840291
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C0332196
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Similar models

Eligibility Atrial Fibrillation NCT01856075

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
patient 18 years old or above
boolean
C0001779 (UMLS CUI [1])
Paroxysmal atrial fibrillation | Persistent atrial fibrillation
Item
patient with paroxysmal or persistent atrial fibrillation
boolean
C0235480 (UMLS CUI [1])
C2585653 (UMLS CUI [2])
Anti-Arrhythmia Agents | dronedarone
Item
patient using an aai (antiarrhythmic drug of interest) or dronedarone (index drug)
boolean
C0003195 (UMLS CUI [1])
C0766326 (UMLS CUI [2])
Anti-Arrhythmia Agents | dronedarone | Anti-Arrhythmia Agents Absent
Item
patient's treatment changed from one aai to another aai or dronedarone or from no antiarrhythmic therapy to the start of aai or dronedarone therapy during previous 6 months before the date of recruitment
boolean
C0003195 (UMLS CUI [1])
C0766326 (UMLS CUI [2])
C0003195 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Patient has Information Medical | Patient has Treatment information
Item
patient with at least 6 months of medical and treatment information prior to the start of the index drug
boolean
C0030705 (UMLS CUI [1,1])
C3539897 (UMLS CUI [1,2])
C1533716 (UMLS CUI [1,3])
C0205476 (UMLS CUI [1,4])
C0030705 (UMLS CUI [2,1])
C3539897 (UMLS CUI [2,2])
C2708735 (UMLS CUI [2,3])
Telephone Interview Answer English Language | Telephone Interview Answer German language | Telephone Interview Answer Italian language | Telephone Interview Answer Spanish Language | Proxy Present | Proxy Absent
Item
patient able to answer the telephone interview in a language of the participating country: english, german, italian or spanish (with or without proxy).
boolean
C0021823 (UMLS CUI [1,1])
C0508431 (UMLS CUI [1,2])
C0376245 (UMLS CUI [1,3])
C0021823 (UMLS CUI [2,1])
C0508431 (UMLS CUI [2,2])
C0017477 (UMLS CUI [2,3])
C0021823 (UMLS CUI [3,1])
C0508431 (UMLS CUI [3,2])
C0022275 (UMLS CUI [3,3])
C0021823 (UMLS CUI [4,1])
C0508431 (UMLS CUI [4,2])
C0037750 (UMLS CUI [4,3])
C0600420 (UMLS CUI [5,1])
C0150312 (UMLS CUI [5,2])
C0600420 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
Item Group
C0680251 (UMLS CUI)
Heart failure New York Heart Association Classification
Item
patient with heart failure (nyha class iv)
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Permanent atrial fibrillation
Item
patient with permanent atrial fibrillation
boolean
C2586056 (UMLS CUI [1])
Mental condition Study Subject Participation Status Excluded
Item
patient with psychiatric conditions preventing the participation to the study according to the physician
boolean
C3840291 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0332196 (UMLS CUI [1,3])
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