ID

33295

Beschreibung

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

Link

https://clinicaltrials.gov/show/NCT01856075

Stichworte

Versionen (1)
  1. 04.12.18 04.12.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

4. Dezember 2018

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT01856075

Englisch

Eligibility Atrial Fibrillation NCT01856075

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient 18 years old or above
Beschreibung

Age

Datentyp

boolean

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

Paroxysmal atrial fibrillation | Persistent atrial fibrillation

Datentyp

boolean

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

Anti-Arrhythmia Agents | dronedarone

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

Patient has Information Medical | Patient has Treatment information

Datentyp

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).
Beschreibung

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

Datentyp

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
Beschreibung

Exclusion Criteria

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

Heart failure New York Heart Association Classification

Datentyp

boolean

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

Permanent atrial fibrillation

Datentyp

boolean

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

Mental condition Study Subject Participation Status Excluded

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3840291
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C0332196
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Ähnliche Modelle

Eligibility Atrial Fibrillation NCT01856075

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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