ID

4860

Description

ODM derived from http://clinicaltrials.gov/show/NCT00168051

Link

http://clinicaltrials.gov/show/NCT00168051

Keywords

  1. 12/5/11 12/5/11 -
  2. 4/13/14 4/13/14 - Julian Varghese
  3. 8/10/14 8/10/14 - Martin Dugas
  4. 9/20/21 9/20/21 -
Uploaded on

April 13, 2014

DOI

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License

Creative Commons BY-NC 3.0 Legacy

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Eligibility NCT00168051 Hemophilia A

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

18 Years to 64 Years
Description

Age

Data type

boolean

Male
Description

Gender

Data type

boolean

Severe hemophilia A
Description

Severe hemophilia A

Data type

boolean

Previously treated patients with at least 150 exposure days to any Factor VIII product
Description

Treatment with Factor VIII

Data type

boolean

Exclusion Criteria
Description

Exclusion Criteria

Hypersensitivity to any recombinant Factor VIII product
Description

Hypersensitivity Factor VIII

Data type

boolean

History of or current Factor VIII inhibitor
Description

Factor VIII inhibitor

Data type

boolean

Bleeding episode or other reason requiring Factor VIII treatment within 3 days of study
Description

Bleeding episode

Data type

boolean

Medical concepts
Description

Medical concepts

Age
Description

Age

Data type

string

Alias
UMLS CUI
C0001779
SNOMED CT 2010_0731
102518004
Gender
Description

Gender

Data type

string

Alias
UMLS CUI
C0024554
SNOMED CT 2010_0731
263495000
LOINC Version 232
MTHU002975
Diagnosis
Description

Diagnosis

Data type

string

Alias
UMLS CUI
C0011900
SNOMED CT 2010_0731
439401001
LOINC Version 232
MTHU008876
Hemophilia A
Description

Factor VIII deficiency

Data type

string

Alias
UMLS CUI
C0019069
SNOMED CT 2010_0731
234440005
MedDRA 13.1
10016080
ICD-10-CM Version 2010
D66
ICD-9-CM Version 2011
286.0
Medication
Description

Pharmaceutical Preparations

Data type

string

Alias
UMLS CUI
C0013227
Hypersensitivity
Description

Allergy

Data type

string

Alias
UMLS CUI
C0020517
SNOMED CT 2010_0731
257550005
ICD-10-CM Version 2010
T78.40
Factor VIII inhibitor
Description

Factor VIII antibody

Data type

string

Alias
UMLS CUI
C0368953
SNOMED CT 2010_0731
58730008
LOINC Version 232
MTHU014157
Bleeding tendency
Description

Bleeding diathesis

Data type

string

Alias
UMLS CUI
C0005779
SNOMED CT 2010_0731
248250000
MedDRA 13.1
10005134

Similar models

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
Age
Item
18 Years to 64 Years
boolean
Gender
Item
Male
boolean
Severe hemophilia A
Item
Severe hemophilia A
boolean
Treatment with Factor VIII
Item
Previously treated patients with at least 150 exposure days to any Factor VIII product
boolean
Item Group
Exclusion Criteria
Hypersensitivity Factor VIII
Item
Hypersensitivity to any recombinant Factor VIII product
boolean
Factor VIII inhibitor
Item
History of or current Factor VIII inhibitor
boolean
Bleeding episode
Item
Bleeding episode or other reason requiring Factor VIII treatment within 3 days of study
boolean
Item Group
Medical concepts
Age
Item
Age
string
C0001779 (UMLS CUI)
102518004 (SNOMED CT 2010_0731)
Gender
Item
Gender
string
C0024554 (UMLS CUI)
263495000 (SNOMED CT 2010_0731)
MTHU002975 (LOINC Version 232)
Diagnosis
Item
Diagnosis
string
C0011900 (UMLS CUI)
439401001 (SNOMED CT 2010_0731)
MTHU008876 (LOINC Version 232)
Factor VIII deficiency
Item
Hemophilia A
string
C0019069 (UMLS CUI)
234440005 (SNOMED CT 2010_0731)
10016080 (MedDRA 13.1)
D66 (ICD-10-CM Version 2010)
286.0 (ICD-9-CM Version 2011)
Pharmaceutical Preparations
Item
Medication
string
C0013227 (UMLS CUI)
Allergy
Item
Hypersensitivity
string
C0020517 (UMLS CUI)
257550005 (SNOMED CT 2010_0731)
T78.40 (ICD-10-CM Version 2010)
Factor VIII antibody
Item
Factor VIII inhibitor
string
C0368953 (UMLS CUI)
58730008 (SNOMED CT 2010_0731)
MTHU014157 (LOINC Version 232)
Bleeding diathesis
Item
Bleeding tendency
string
C0005779 (UMLS CUI)
248250000 (SNOMED CT 2010_0731)
10005134 (MedDRA 13.1)

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