ID

21159

Description

A Retrospective Case-Control Study to Estimate the Sensitivity and Specificity of a Pharmacogenetic Marker (HLA-B*5701) in Subjects With and Without Hypersensitivity to Abacavir Assessment: Baseline NCT00373945 / VIIV-ABC107442 Annotated Design For Trial:abc442_lgm Protocol:ABC107442 Medicine: abacavir, Condition: Infection, Human Immunodeficiency Virus I, Phase: 4, Clinical Study ID: ABC107442, Sponsor: ViiV

Keywords

Versions (1)
  1. 4/12/17 4/12/17 -
Uploaded on

April 12, 2017

DOI

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License

Creative Commons BY-NC 3.0
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HLA-B*5701 And Hypersensitivity To Abacavir Baseline NCT00373945

English

HLA-B*5701 And Hypersensitivity To Abacavir Baseline NCT00373945

1 forms  
Date of Visit/Assessment
Description

Date of Visit/Assessment

Alias
UMLS CUI-1
C1320303
Date of Visit/Assessment
Description

DOV

Data type

date

Alias
UMLS CUI [1]
C1320303
Demography
Description

Demography

Alias
UMLS CUI-1
C0011298
Date of birth
Description

Date of birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Sex
Description

Sex

Data type

text

Alias
UMLS CUI [1]
C0079399
Ethnicity
Description

Ethnicity

Data type

integer

Alias
UMLS CUI [1]
C0015031
Self-reported Race
Description

Race

Data type

integer

Alias
UMLS CUI [1]
C0034510
Geographic Ancestry
Description

Check all that apply

Data type

integer

Alias
UMLS CUI [1,1]
C3841890
UMLS CUI [1,2]
C0034510
Subject Identification
Description

Subject Identification

Alias
UMLS CUI-1
C2348585
Subject number
Description

Subject number

Data type

integer

Alias
UMLS CUI [1]
C2348585
PGx-Pharmacogenetic Research Consent
Description

PGx-Pharmacogenetic Research Consent

Alias
UMLS CUI-1
C0008976
UMLS CUI-2
C0021430
Has informed consent been obtained for PGx-Pharmacogenetic Research?
Description

informed consent

Data type

text

Alias
UMLS CUI [1]
C0021430
Date informed consent obtained for PGx-Pharmacogenetic Research:
Description

Please specify if "Has informed consent been obtained for PGx-Pharmacogenetic Research?"=Yes

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0021430
Has blood sample been collected for PGx-Pharmacogenetic Research?
Description

Please specify if "Has informed consent been obtained for PGx-Pharmacogenetic Research?"=Yes

Data type

text

Alias
UMLS CUI [1]
C0005834
Record date sample taken
Description

Please specify if "Has blood sample been collected for PGx-Pharmacogenetic Research?"=Yes

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0005834
No, provide reason below
Description

Please specify if "Has informed consent been obtained for PGx-Pharmacogenetic Research?"=No

Data type

integer

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1705116
UMLS CUI [1,3]
C0392360
reason informed consent was not obtained
Description

If other, please specify

Data type

text

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1705116
UMLS CUI [1,3]
C0392360
Sample type
Description

hidden

Data type

text

Alias
UMLS CUI [1]
C2347029
Genetics Type
Description

hidden

Data type

text

Alias
UMLS CUI [1]
C0017399
Eligibility Question
Description

Eligibility Question

Alias
UMLS CUI-1
C1516637
Did the subject meet all the entry criteria?
Description

entry criteria

Data type

text

Alias
UMLS CUI [1]
C1516637
Please select all boxes corresponding to violations of any inclusion/exclusion criteria
Description

Please specify if "Did the subject meet all the entry criteria?"=No

Data type

text

Alias
UMLS CUI [1]
C1516637
Please clarify exception(s) below
Description

Do not admit the subject into the study if any Inclusion/Exclusion criteria is checked unless an exception has been granted by the GSK Medical Monitor and subject is continuing in the study

Data type

text

Alias
UMLS CUI [1]
C1516637
HIV Risk Factors / Mode of Transmission
Description

HIV Risk Factors / Mode of Transmission

Alias
UMLS CUI-1
C0019682
UMLS CUI-2
C0035648
UMLS CUI-3
C1443844
Are there any risk factors or is the mode of transmission known that could have resulted in this subject acquiring HIV?
Description

risk factors or transmission of HIV

Data type

text

Alias
UMLS CUI [1,1]
C0035648
UMLS CUI [1,2]
C1443844
Yes, tick all that apply
Description

Please specify if "Are there any risk factors or is the mode of transmission known that could have resulted in this subject acquiring HIV?"=Yes

Data type

integer

Alias
UMLS CUI [1,1]
C0035648
UMLS CUI [1,2]
C1443844
risk factors / transmission of HIV
Description

If other, please specify

Data type

text

Alias
UMLS CUI [1,1]
C0035648
UMLS CUI [1,2]
C1443844
Skin Patch Application
Description

Skin Patch Application

Alias
UMLS CUI-1
C0030646
UMLS CUI-2
C0185125
Date of visit
Description

Date of visit

Data type

date

Alias
UMLS CUI [1,1]
C1320303
UMLS CUI [1,2]
C0185125
Has the subject undergone tanning (artificial or natural UV rays) in the past 14 days?
Description

tanning

Data type

text

Alias
UMLS CUI [1]
C0302595
At what time were the two patches applied to the prepared area of the subject's back (or upper arm, if applicable)?
Description

time of application

Data type

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0185125
UMLS CUI [1,3]
C0030646
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Similar models

HLA-B*5701 And Hypersensitivity To Abacavir Baseline NCT00373945

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Date of Visit/Assessment
C1320303 (UMLS CUI-1)
DOV
Item
Date of Visit/Assessment
date
C1320303 (UMLS CUI [1])
Item Group
Demography
C0011298 (UMLS CUI-1)
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Sex
text
C0079399 (UMLS CUI [1])
Sex
Code List
Sex
CL Item
Male (M)
CL Item
Female (F)
Item
Ethnicity
integer
C0015031 (UMLS CUI [1])
Ethnicity
Code List
Ethnicity
CL Item
Hispanic or Latino (1)
CL Item
Not Hispanic or Latino (2)
Item
Self-reported Race
integer
C0034510 (UMLS CUI [1])
Race
Code List
Self-reported Race
CL Item
White (1)
CL Item
Black (2)
CL Item
Other (OT)
Item
Geographic Ancestry
integer
C3841890 (UMLS CUI [1,1])
C0034510 (UMLS CUI [1,2])
Geographic Ancestry
Code List
Geographic Ancestry
CL Item
African American/African Heritage (11)
CL Item
American Indian or Alaskan Native (12)
CL Item
Asian - Central/South Asian Heritage (13)
CL Item
Asian - East Asian Heritage (14)
CL Item
Asian - Japanese Heritage (15)
CL Item
Asian - South East Asian Heritage (16)
CL Item
Native Hawaiian or Other Pacific Islander (17)
CL Item
White - Arabic/North African Heritage (18)
CL Item
White - White/Caucasian/European Heritage (19)
Item Group
Subject Identification
C2348585 (UMLS CUI-1)
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item Group
PGx-Pharmacogenetic Research Consent
C0008976 (UMLS CUI-1)
C0021430 (UMLS CUI-2)
Item
Has informed consent been obtained for PGx-Pharmacogenetic Research?
text
C0021430 (UMLS CUI [1])
informed consent
Code List
Has informed consent been obtained for PGx-Pharmacogenetic Research?
CL Item
Yes (Y)
CL Item
No (N)
date of informed consent
Item
Date informed consent obtained for PGx-Pharmacogenetic Research:
date
C0011008 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
Item
Has blood sample been collected for PGx-Pharmacogenetic Research?
text
C0005834 (UMLS CUI [1])
undefined item
Code List
Has blood sample been collected for PGx-Pharmacogenetic Research?
CL Item
Yes (Y)
CL Item
No (N)
date sample taken
Item
Record date sample taken
date
C0011008 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
Item
No, provide reason below
integer
C0021430 (UMLS CUI [1,1])
C1705116 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
reason informed consent was not obtained
Code List
No, provide reason below
CL Item
Subject declined (1)
CL Item
Subject not asked by Investigator (2)
CL Item
Other, specify (Z)
reason informed consent was not obtained
Item
reason informed consent was not obtained
text
C0021430 (UMLS CUI [1,1])
C1705116 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Sample type
Item
Sample type
text
C2347029 (UMLS CUI [1])
Genetics Type
Item
Genetics Type
text
C0017399 (UMLS CUI [1])
Item Group
Eligibility Question
C1516637 (UMLS CUI-1)
Item
Did the subject meet all the entry criteria?
text
C1516637 (UMLS CUI [1])
entry criteria
Code List
Did the subject meet all the entry criteria?
CL Item
Yes (Y)
CL Item
No (N)
Item
Please select all boxes corresponding to violations of any inclusion/exclusion criteria
text
C1516637 (UMLS CUI [1])
violations of inclusion/exclusion criteria
Code List
Please select all boxes corresponding to violations of any inclusion/exclusion criteria
CL Item
Inclusion Criteria 1 (I01)
CL Item
Inclusion Criteria 2 (I02)
CL Item
Inclusion Criteria 3 (I03)
CL Item
Inclusion Criteria 4 (I04)
CL Item
Inclusion Criteria 5 (I05)
CL Item
Exclusion Criteria 1 (E01)
CL Item
Exclusion Criteria 2 (E02)
CL Item
Exclusion Criteria 3 (E03)
exception
Item
Please clarify exception(s) below
text
C1516637 (UMLS CUI [1])
Item Group
HIV Risk Factors / Mode of Transmission
C0019682 (UMLS CUI-1)
C0035648 (UMLS CUI-2)
C1443844 (UMLS CUI-3)
Item
Are there any risk factors or is the mode of transmission known that could have resulted in this subject acquiring HIV?
text
C0035648 (UMLS CUI [1,1])
C1443844 (UMLS CUI [1,2])
risk factors or transmission of HIV
Code List
Are there any risk factors or is the mode of transmission known that could have resulted in this subject acquiring HIV?
CL Item
No (N)
CL Item
Yes (Y)
Item
Yes, tick all that apply
integer
C0035648 (UMLS CUI [1,1])
C1443844 (UMLS CUI [1,2])
risk factors / transmission of HIV
Code List
Yes, tick all that apply
CL Item
Homosexual contact (1)
CL Item
Heterosexual contact (2)
CL Item
Injectable drug use (3)
CL Item
Transfusion (4)
CL Item
Hemophilia-associated injections (5)
CL Item
Occupational exposure (6)
CL Item
Other, specify (OT)
risk factors / transmission of HIV
Item
risk factors / transmission of HIV
text
C0035648 (UMLS CUI [1,1])
C1443844 (UMLS CUI [1,2])
Item Group
Skin Patch Application
C0030646 (UMLS CUI-1)
C0185125 (UMLS CUI-2)
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1,1])
C0185125 (UMLS CUI [1,2])
Item
Has the subject undergone tanning (artificial or natural UV rays) in the past 14 days?
text
C0302595 (UMLS CUI [1])
tanning
Code List
Has the subject undergone tanning (artificial or natural UV rays) in the past 14 days?
CL Item
Yes (Y)
CL Item
No (N)
time of application
Item
At what time were the two patches applied to the prepared area of the subject's back (or upper arm, if applicable)?
time
C0040223 (UMLS CUI [1,1])
C0185125 (UMLS CUI [1,2])
C0030646 (UMLS CUI [1,3])
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