Information:
Fel:
ID
21395
Beskrivning
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: Day 1 (Baseline) Medicine: abacavir, Condition: Infection, Human Immunodeficiency Virus, Phase: 4, Clinical Study ID: CNA106030, Sponsor: ViiV
Nyckelord
Versioner (1)
- 2017-04-19 2017-04-19 -
Uppladdad den
19 april 2017
DOI
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Licens
Creative Commons BY-NC 3.0
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Genetic Screening For HLA-B*5701 in Patients with HIV Day 1 NCT00340080
Genetic Screening For HLA-B*5701 Day 1 NCT00340080
- StudyEvent: ODM
Similar models
Genetic Screening For HLA-B*5701 Day 1 NCT00340080
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
CL Item
Yes (Y)
CL Item
No (N)
Item
Check the boxes corresponding to any of the exclusion criteria that disqualified the subject from entry.
integer
C0680251 (UMLS CUI [1])
Code List
Check the boxes corresponding to any of the exclusion criteria that disqualified the subject from entry.
CL Item
Did not meet treatment eligibility criteria (14)
CL Item
The investigational site does not receive written notification that it is appropriate to initiate ABC- containing HAART as part of this study. (15)
Item
Has the subject previously received and permanently stopped antiretroviral therapy prior to ABC-containing product initiation?
text
C1963724 (UMLS CUI [1])
Code List
Has the subject previously received and permanently stopped antiretroviral therapy prior to ABC-containing product initiation?
CL Item
Yes (Y)
CL Item
No (N)
Drug Name
Item
Drug Name (Trade name preferred)
text
C2360065 (UMLS CUI [1,1])
C1963724 (UMLS CUI [1,2])
C1963724 (UMLS CUI [1,2])
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1,1])
C1963724 (UMLS CUI [1,2])
C1963724 (UMLS CUI [1,2])
Stop Date
Item
Stop Date
date
C0806020 (UMLS CUI [1,1])
C1963724 (UMLS CUI [1,2])
C1963724 (UMLS CUI [1,2])
Item
Ongoing Medication?
text
C2826666 (UMLS CUI [1,1])
C1963724 (UMLS CUI [1,2])
C1963724 (UMLS CUI [1,2])
CL Item
Yes (Y)
CL Item
No (N)
Medical Conditions
Item
Medical Conditions
text
C0012634 (UMLS CUI [1])
Item
Record the subject’s Baseline CDC classification below, check one in Category A, B, or C
integer
C2319244 (UMLS CUI [1])
Code List
Record the subject’s Baseline CDC classification below, check one in Category A, B, or C
CL Item
Category A: Asymptomatic HIV infection/Persistent generalized lymphadenopathy/Acute (primary) HIV infection with accompanying illness or history of acute HIV (1)
CL Item
Category B: Symptomatic (non-AIDS) conditions (2)
CL Item
Category C: AIDS Indicator Conditions as defined by diagnostic or presumptive measures (3)
Blood pressure systolic
Item
Vital signs: Blood pressure systolic
integer
C0871470 (UMLS CUI [1])
Blood pressure diastolic
Item
Vital signs: Blood pressure diastolic
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Vital signs: Heart rate
integer
C0018810 (UMLS CUI [1])
Temperature
Item
Vital signs: Temperature
float
C0005903 (UMLS CUI [1])
Pregnancy test date
Item
Date sample taken
date
C0032976 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Item
Pregnancy test results
integer
C0032976 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,2])
CL Item
Positive (1)
CL Item
Negative (2)
CL Item
Not applicable (Not of childbearing potential) (3)