ID

21399

Beschrijving

NCT00340080 / VIIV-CNA106030 A phase IV, randomised, multicentre, double-blind, study to evaluate the clinical utility of prospective genetic screening (HLA-B*5701) for susceptibility to abacavir hypersensitivity Assessment: HIV risk factors/Mode of Transmission Medicine: abacavir, Condition: Infection, Human Immunodeficiency Virus, Phase: 4, Clinical Study ID: CNA106030, Sponsor: ViiV

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Versies (1)
  1. 19-04-17 19-04-17 -
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19 april 2017

DOI

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Creative Commons BY-NC 3.0
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Genetic Screening For HLA-B*5701 in Patients with HIV HIV risk factors NCT00340080

Engels

Genetic Screening For HLA-B*5701 HIV risk factors NCT00340080

1 Formulieren  
HIV risk factors/Mode of Transmission
Beschrijving

HIV risk factors/Mode of Transmission

Alias
UMLS CUI-1
C0019682
UMLS CUI-2
C0035648
UMLS CUI-3
C1443844
Subject Identifier
Beschrijving

Subject Identifier

Datatype

text

Alias
UMLS CUI [1]
C2348585
Are there any risk factors or is the mode of transmission known that could have resulted in this subject acquiring HIV?
Beschrijving

HIV risk factors or mode of transmission

Datatype

text

Alias
UMLS CUI [1,1]
C0019682
UMLS CUI [1,2]
C0035648
UMLS CUI [1,3]
C1443844
If Yes, check all that apply
Beschrijving

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

Datatype

integer

Alias
UMLS CUI [1,1]
C0019682
UMLS CUI [1,2]
C0035648
UMLS CUI [1,3]
C1443844
If other, please specify
Beschrijving

HIV risk factors or mode of transmission

Datatype

text

Alias
UMLS CUI [1,1]
C0019682
UMLS CUI [1,2]
C0035648
UMLS CUI [1,3]
C1443844
Category B: Symptomatic (non-AIDS) Conditions, check􏰀 all that apply:
Beschrijving

Indicate if the subject has experienced any of the following CDC-defined HIV-associated conditions at any time up to and including Baseline below:

Datatype

text

Alias
UMLS CUI [1,1]
C3888530
UMLS CUI [1,2]
C0012634
Category B: Symptomatic (non-AIDS) Conditions, if other please specify
Beschrijving

Symptomatic (non-AIDS) Conditions

Datatype

text

Alias
UMLS CUI [1,1]
C3888530
UMLS CUI [1,2]
C0012634
Category C: AIDS Indicator Conditions as defined by diagnostic or presumptive measures, check􏰀 all that apply:
Beschrijving

Category C includes the clinical conditions listed in the AIDS surveillance case definition.

Datatype

text

Alias
UMLS CUI [1,1]
C3888531
UMLS CUI [1,2]
C0012634
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Similar models

Genetic Screening For HLA-B*5701 HIV risk factors NCT00340080

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
HIV risk factors/Mode of Transmission
C0019682 (UMLS CUI-1)
C0035648 (UMLS CUI-2)
C1443844 (UMLS CUI-3)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Item
Are there any risk factors or is the mode of transmission known that could have resulted in this subject acquiring HIV?
text
C0019682 (UMLS CUI [1,1])
C0035648 (UMLS CUI [1,2])
C1443844 (UMLS CUI [1,3])
HIV risk factors or mode of transmission
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
Yes (Y)
CL Item
No (N)
Item
If Yes, check all that apply
integer
C0019682 (UMLS CUI [1,1])
C0035648 (UMLS CUI [1,2])
C1443844 (UMLS CUI [1,3])
HIV risk factors or mode of transmission
Code List
If Yes, check 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
Vertical/Perinatal transmission (7)
CL Item
Other (8)
HIV risk factors or mode of transmission
Item
If other, please specify
text
C0019682 (UMLS CUI [1,1])
C0035648 (UMLS CUI [1,2])
C1443844 (UMLS CUI [1,3])
Item
Category B: Symptomatic (non-AIDS) Conditions, check􏰀 all that apply:
text
C3888530 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
Symptomatic (non-AIDS) Conditions
Code List
Category B: Symptomatic (non-AIDS) Conditions, check􏰀 all that apply:
CL Item
Bacillary angiomatosis (B1)
CL Item
Candidiasis, oropharyngeal (thrush) (B2)
CL Item
Candidiasis, vulvovaginal; persistent, frequent or poorly responsive to therapy (B3)
CL Item
Cervical dysplasia (moderate or severe)/cervical carcinoma in situ (B4)
CL Item
Constitutional symptoms, such as fever (38.5 C) or diarrhea lasting greater than 1 month (B26)
CL Item
Hairy leukoplakia, oral (B7)
CL Item
Herpes zoster (shingles), involving at least two distinct episodes or more than one dermatome (B8)
CL Item
Idiopathic thrombocytopenic purpura (B9)
CL Item
Listeriosis (B10)
CL Item
Pelvic inflammatory disease, particularly if complicated by tubo-ovarian abscess (B11)
CL Item
Peripheral neuropathy (B12)
CL Item
Other (BOT)
Symptomatic (non-AIDS) Conditions
Item
Category B: Symptomatic (non-AIDS) Conditions, if other please specify
text
C3888530 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
Item
Category C: AIDS Indicator Conditions as defined by diagnostic or presumptive measures, check􏰀 all that apply:
text
C3888531 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
AIDS Indicator Conditions
Code List
Category C: AIDS Indicator Conditions as defined by diagnostic or presumptive measures, check􏰀 all that apply:
CL Item
Candidiasis of bronchi, trachea, or lungs (C1)
CL Item
Candidiasis, esophageal (C2)
CL Item
Cervical cancer, invasive (C3)
CL Item
Coccidioidomycosis, disseminated or extrapulmonary (C4)
CL Item
Cryptococcosis, extrapulmonary (C5)
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