ID

21392

Descrição

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: First Patch Test Medicine: abacavir, Condition: Infection, Human Immunodeficiency Virus, Phase: 4, Clinical Study ID: CNA106030, Sponsor: ViiV

Palavras-chave

Versões (1)
  1. 19/04/2017 19/04/2017 -
Transferido a

19 de abril de 2017

DOI

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Licença

Creative Commons BY-NC 3.0
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Genetic Screening For HLA-B*5701 in Patients with HIV First Patch Test NCT00340080

Inglês

Genetic Screening For HLA-B*5701 First Patch Test NCT00340080

1 Formulários  
First Patch Test, Visit 1, Baseline
Descrição

First Patch Test, Visit 1, Baseline

Alias
UMLS CUI-1
C0030646
UMLS CUI-2
C0220825
Subject Identifier
Descrição

Subject Identifier

Tipo de dados

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Descrição

Visit Date

Tipo de dados

date

Alias
UMLS CUI [1]
C1320303
Centre Number
Descrição

Centre Number

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Has a baseline digital photograph been taken after preparation of the back?
Descrição

baseline digital photograph

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0441468
UMLS CUI [1,2]
C0205095
At what time were patch test strips (Petrolatum Control, Excipient Control, 1% Abacavir, 10% Abacavir) applied to the prepared area of subject’s back (or upper arm, if applicable)
Descrição

time applied

Tipo de dados

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0030646
First Patch Test, Visit 2, 24hrs
Descrição

First Patch Test, Visit 2, 24hrs

Alias
UMLS CUI-1
C0030646
UMLS CUI-2
C0220825
Date of visit
Descrição

Date of visit

Tipo de dados

date

Alias
UMLS CUI [1]
C1320303
Are the two patch test strips intact?
Descrição

test strips intact

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0030646
UMLS CUI [1,2]
C0205266
If No, provide comments below
Descrição

Are the two patch test strips intact?

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0687118
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C0030646
Has a digital photograph been taken prior to removal of the first (LEFT) patch test strip?
Descrição

digital photograph

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0441468
UMLS CUI [1,2]
C0205091
Time LEFT patch test strip removed
Descrição

Time LEFT patch test strip removed

Tipo de dados

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0849355
UMLS CUI [2,1]
C0030646
UMLS CUI [2,2]
C0205091
Time digital photograph taken after removal of first (LEFT) patch test strip (within 5 minutes post removal of strip)
Descrição

Time digital photograph

Tipo de dados

time

Alias
UMLS CUI [1,1]
C0441468
UMLS CUI [1,2]
C0205091
Patch test interpretation, Petrolatum Control
Descrição

Assessment following removal of first (LEFT) patch Check one in each column and provide comments, if "other"

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C0440135
UMLS CUI [1,2]
C0030646
UMLS CUI [1,3]
C0420833
Petrolatum Control, provide comment
Descrição

Petrolatum Control

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0440135
UMLS CUI [1,2]
C0030646
UMLS CUI [1,3]
C0420833
Patch test interpretation, Excipient Control
Descrição

Assessment following removal of first (LEFT) patch Check one in each column and provide comments, if "other"

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C0015237
UMLS CUI [1,2]
C0030646
UMLS CUI [1,3]
C0420833
Excipient Control, provide comment
Descrição

Excipient Control

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0015237
UMLS CUI [1,2]
C0030646
UMLS CUI [1,3]
C0420833
Patch test interpretation, 1% Abacavir
Descrição

Assessment following removal of first (LEFT) patch Check one in each column and provide comments, if "other"

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C0663655
UMLS CUI [1,2]
C0030646
UMLS CUI [1,3]
C0420833
1% Abacavir, provide comment
Descrição

Abacavir

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0663655
UMLS CUI [1,2]
C0030646
UMLS CUI [1,3]
C0420833
Patch test interpretation, 10% Abacavir
Descrição

Assessment following removal of first (LEFT) patch Check one in each column and provide comments, if "other"

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C0663655
UMLS CUI [1,2]
C0030646
UMLS CUI [1,3]
C0420833
10% Abacavir, provide comment
Descrição

Abacavir

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0663655
UMLS CUI [1,2]
C0030646
UMLS CUI [1,3]
C0420833
First Patch Test, Visit 3, 48hrs
Descrição

First Patch Test, Visit 3, 48hrs

Alias
UMLS CUI-1
C0030646
UMLS CUI-2
C0220825
Date of visit
Descrição

Date of visit

Tipo de dados

date

Alias
UMLS CUI [1]
C1320303
Patch test interpretation, Petrolatum Control
Descrição

Assessment following removal of first (LEFT) patch Check one in each column and provide comments, if "other"

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C0440135
UMLS CUI [1,2]
C0030646
UMLS CUI [1,3]
C0420833
Petrolatum Control, provide comment
Descrição

Petrolatum Control

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0440135
UMLS CUI [1,2]
C0030646
UMLS CUI [1,3]
C0420833
Patch test interpretation, Excipient Control
Descrição

Assessment following removal of first (LEFT) patch Check one in each column and provide comments, if "other"

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C0015237
UMLS CUI [1,2]
C0030646
UMLS CUI [1,3]
C0420833
Excipient Control, provide comment
Descrição

Excipient Control

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0015237
UMLS CUI [1,2]
C0030646
UMLS CUI [1,3]
C0420833
Patch test interpretation, 1% Abacavir
Descrição

Assessment following removal of first (LEFT) patch Check one in each column and provide comments, if "other"

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C0663655
UMLS CUI [1,2]
C0030646
UMLS CUI [1,3]
C0420833
1% Abacavir, provide comment
Descrição

Abacavir

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0663655
UMLS CUI [1,2]
C0030646
UMLS CUI [1,3]
C0420833
Patch test interpretation, 10% Abacavir
Descrição

Assessment following removal of first (LEFT) patch Check one in each column and provide comments, if "other"

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C0663655
UMLS CUI [1,2]
C0030646
UMLS CUI [1,3]
C0420833
10% Abacavir, provide comment
Descrição

Abacavir

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0663655
UMLS CUI [1,2]
C0030646
UMLS CUI [1,3]
C0420833
Is the patch test strip (RIGHT) intact?
Descrição

right test strips intact

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0030646
UMLS CUI [1,2]
C0205266
UMLS CUI [1,3]
C0205090
If No, provide comments below.
Descrição

Is the patch test strip (RIGHT) intact?

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0687118
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C0030646
UMLS CUI [1,4]
C0205090
Time RIGHT patch test strip removed
Descrição

Time RIGHT patch test strip removed

Tipo de dados

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0849355
UMLS CUI [2,1]
C0030646
UMLS CUI [2,2]
C0205090
Time digital photograph taken after removal of second (RIGHT) patch test strip (within 5 minutes post removal of strip)
Descrição

Time digital photograph

Tipo de dados

time

Alias
UMLS CUI [1,1]
C0441468
UMLS CUI [1,2]
C0205090
Patch test interpretation, Petrolatum Control
Descrição

48 hour assessment following removal of second (RIGHT) patch 􏰀Check one in each column and provide comments, if "other"

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C0440135
UMLS CUI [1,2]
C0030646
UMLS CUI [1,3]
C0420833
Petrolatum Control, provide comment
Descrição

Petrolatum Control

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0440135
UMLS CUI [1,2]
C0030646
UMLS CUI [1,3]
C0420833
Patch test interpretation, Excipient Control
Descrição

48 hour assessment following removal of second (RIGHT) patch 􏰀Check one in each column and provide comments, if "other"

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C0015237
UMLS CUI [1,2]
C0030646
UMLS CUI [1,3]
C0420833
Excipient Control, provide comment
Descrição

Excipient Control

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0015237
UMLS CUI [1,2]
C0030646
UMLS CUI [1,3]
C0420833
Patch test interpretation, 1% Abacavir
Descrição

48 hour assessment following removal of second (RIGHT) patch 􏰀Check one in each column and provide comments, if "other"

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C0663655
UMLS CUI [1,2]
C0030646
UMLS CUI [1,3]
C0420833
1% Abacavir, provide comment
Descrição

Abacavir

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0663655
UMLS CUI [1,2]
C0030646
UMLS CUI [1,3]
C0420833
Patch test interpretation, 10% Abacavir
Descrição

48 hour assessment following removal of second (RIGHT) patch 􏰀Check one in each column and provide comments, if "other"

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C0663655
UMLS CUI [1,2]
C0030646
UMLS CUI [1,3]
C0420833
10% Abacavir, provide comment
Descrição

Abacavir

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0663655
UMLS CUI [1,2]
C0030646
UMLS CUI [1,3]
C0420833
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Genetic Screening For HLA-B*5701 First Patch Test NCT00340080

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
First Patch Test, Visit 1, Baseline
C0030646 (UMLS CUI-1)
C0220825 (UMLS CUI-2)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Centre Number
Item
Centre Number
integer
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Item
Has a baseline digital photograph been taken after preparation of the back?
text
C0441468 (UMLS CUI [1,1])
C0205095 (UMLS CUI [1,2])
baseline digital photograph
Code List
Has a baseline digital photograph been taken after preparation of the back?
CL Item
Yes (Y)
CL Item
No (N)
time applied
Item
At what time were patch test strips (Petrolatum Control, Excipient Control, 1% Abacavir, 10% Abacavir) applied to the prepared area of subject’s back (or upper arm, if applicable)
time
C0040223 (UMLS CUI [1,1])
C0030646 (UMLS CUI [1,2])
Item Group
First Patch Test, Visit 2, 24hrs
C0030646 (UMLS CUI-1)
C0220825 (UMLS CUI-2)
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Item
Are the two patch test strips intact?
text
C0030646 (UMLS CUI [1,1])
C0205266 (UMLS CUI [1,2])
baseline digital photograph
Code List
Are the two patch test strips intact?
CL Item
Yes (Y)
CL Item
No (N)
test strips comments
Item
If No, provide comments below
text
C0687118 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0030646 (UMLS CUI [1,3])
Item
Has a digital photograph been taken prior to removal of the first (LEFT) patch test strip?
text
C0441468 (UMLS CUI [1,1])
C0205091 (UMLS CUI [1,2])
baseline digital photograph
Code List
Has a digital photograph been taken prior to removal of the first (LEFT) patch test strip?
CL Item
Yes (Y)
CL Item
No (N)
Time LEFT patch test strip removed
Item
Time LEFT patch test strip removed
time
C0040223 (UMLS CUI [1,1])
C0849355 (UMLS CUI [1,2])
C0030646 (UMLS CUI [2,1])
C0205091 (UMLS CUI [2,2])
Time digital photograph
Item
Time digital photograph taken after removal of first (LEFT) patch test strip (within 5 minutes post removal of strip)
time
C0441468 (UMLS CUI [1,1])
C0205091 (UMLS CUI [1,2])
Item
Patch test interpretation, Petrolatum Control
integer
C0440135 (UMLS CUI [1,1])
C0030646 (UMLS CUI [1,2])
C0420833 (UMLS CUI [1,3])
Petrolatum Control
Code List
Patch test interpretation, Petrolatum Control
CL Item
Doubtful Reaction (1)
CL Item
Weak Positive Reaction, 1+ (2)
CL Item
Strong Positive Reaction, 2+ (3)
CL Item
Extreme Positive Reaction, 3+ (4)
CL Item
Negative (5)
CL Item
Other (6)
Petrolatum Control
Item
Petrolatum Control, provide comment
text
C0440135 (UMLS CUI [1,1])
C0030646 (UMLS CUI [1,2])
C0420833 (UMLS CUI [1,3])
Item
Patch test interpretation, Excipient Control
integer
C0015237 (UMLS CUI [1,1])
C0030646 (UMLS CUI [1,2])
C0420833 (UMLS CUI [1,3])
Petrolatum Control
Code List
Patch test interpretation, Excipient Control
CL Item
Doubtful Reaction (1)
CL Item
Weak Positive Reaction, 1+ (2)
CL Item
Strong Positive Reaction, 2+ (3)
CL Item
Extreme Positive Reaction, 3+ (4)
CL Item
Negative (5)
CL Item
Other (6)
Excipient Control
Item
Excipient Control, provide comment
text
C0015237 (UMLS CUI [1,1])
C0030646 (UMLS CUI [1,2])
C0420833 (UMLS CUI [1,3])
Item
Patch test interpretation, 1% Abacavir
integer
C0663655 (UMLS CUI [1,1])
C0030646 (UMLS CUI [1,2])
C0420833 (UMLS CUI [1,3])
Petrolatum Control
Code List
Patch test interpretation, 1% Abacavir
CL Item
Doubtful Reaction (1)
CL Item
Weak Positive Reaction, 1+ (2)
CL Item
Strong Positive Reaction, 2+ (3)
CL Item
Extreme Positive Reaction, 3+ (4)
CL Item
Negative (5)
CL Item
Other (6)
Abacavir
Item
1% Abacavir, provide comment
text
C0663655 (UMLS CUI [1,1])
C0030646 (UMLS CUI [1,2])
C0420833 (UMLS CUI [1,3])
Item
Patch test interpretation, 10% Abacavir
integer
C0663655 (UMLS CUI [1,1])
C0030646 (UMLS CUI [1,2])
C0420833 (UMLS CUI [1,3])
Petrolatum Control
Code List
Patch test interpretation, 10% Abacavir
CL Item
Doubtful Reaction (1)
CL Item
Weak Positive Reaction, 1+ (2)
CL Item
Strong Positive Reaction, 2+ (3)
CL Item
Extreme Positive Reaction, 3+ (4)
CL Item
Negative (5)
CL Item
Other (6)
Abacavir
Item
10% Abacavir, provide comment
text
C0663655 (UMLS CUI [1,1])
C0030646 (UMLS CUI [1,2])
C0420833 (UMLS CUI [1,3])
Item Group
First Patch Test, Visit 3, 48hrs
C0030646 (UMLS CUI-1)
C0220825 (UMLS CUI-2)
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Item
Patch test interpretation, Petrolatum Control
integer
C0440135 (UMLS CUI [1,1])
C0030646 (UMLS CUI [1,2])
C0420833 (UMLS CUI [1,3])
Petrolatum Control
Code List
Patch test interpretation, Petrolatum Control
CL Item
Doubtful Reaction (1)
CL Item
Weak Positive Reaction, 1+ (2)
CL Item
Strong Positive Reaction, 2+ (3)
CL Item
Extreme Positive Reaction, 3+ (4)
CL Item
Negative (5)
CL Item
Other (6)
Petrolatum Control
Item
Petrolatum Control, provide comment
text
C0440135 (UMLS CUI [1,1])
C0030646 (UMLS CUI [1,2])
C0420833 (UMLS CUI [1,3])
Item
Patch test interpretation, Excipient Control
integer
C0015237 (UMLS CUI [1,1])
C0030646 (UMLS CUI [1,2])
C0420833 (UMLS CUI [1,3])
Petrolatum Control
Code List
Patch test interpretation, Excipient Control
CL Item
Doubtful Reaction (1)
CL Item
Weak Positive Reaction, 1+ (2)
CL Item
Strong Positive Reaction, 2+ (3)
CL Item
Extreme Positive Reaction, 3+ (4)
CL Item
Negative (5)
CL Item
Other (6)
Excipient Control
Item
Excipient Control, provide comment
text
C0015237 (UMLS CUI [1,1])
C0030646 (UMLS CUI [1,2])
C0420833 (UMLS CUI [1,3])
Item
Patch test interpretation, 1% Abacavir
integer
C0663655 (UMLS CUI [1,1])
C0030646 (UMLS CUI [1,2])
C0420833 (UMLS CUI [1,3])
Petrolatum Control
Code List
Patch test interpretation, 1% Abacavir
CL Item
Doubtful Reaction (1)
CL Item
Weak Positive Reaction, 1+ (2)
CL Item
Strong Positive Reaction, 2+ (3)
CL Item
Extreme Positive Reaction, 3+ (4)
CL Item
Negative (5)
CL Item
Other (6)
Abacavir
Item
1% Abacavir, provide comment
text
C0663655 (UMLS CUI [1,1])
C0030646 (UMLS CUI [1,2])
C0420833 (UMLS CUI [1,3])
Item
Patch test interpretation, 10% Abacavir
integer
C0663655 (UMLS CUI [1,1])
C0030646 (UMLS CUI [1,2])
C0420833 (UMLS CUI [1,3])
Petrolatum Control
Code List
Patch test interpretation, 10% Abacavir
CL Item
Doubtful Reaction (1)
CL Item
Weak Positive Reaction, 1+ (2)
CL Item
Strong Positive Reaction, 2+ (3)
CL Item
Extreme Positive Reaction, 3+ (4)
CL Item
Negative (5)
CL Item
Other (6)
Abacavir
Item
10% Abacavir, provide comment
text
C0663655 (UMLS CUI [1,1])
C0030646 (UMLS CUI [1,2])
C0420833 (UMLS CUI [1,3])
Item
Is the patch test strip (RIGHT) intact?
text
C0030646 (UMLS CUI [1,1])
C0205266 (UMLS CUI [1,2])
C0205090 (UMLS CUI [1,3])
baseline digital photograph
Code List
Is the patch test strip (RIGHT) intact?
CL Item
Yes (Y)
CL Item
No (N)
right patch test strip
Item
If No, provide comments below.
text
C0687118 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0030646 (UMLS CUI [1,3])
C0205090 (UMLS CUI [1,4])
Time RIGHT patch test strip removed
Item
Time RIGHT patch test strip removed
time
C0040223 (UMLS CUI [1,1])
C0849355 (UMLS CUI [1,2])
C0030646 (UMLS CUI [2,1])
C0205090 (UMLS CUI [2,2])
Time digital photograph
Item
Time digital photograph taken after removal of second (RIGHT) patch test strip (within 5 minutes post removal of strip)
time
C0441468 (UMLS CUI [1,1])
C0205090 (UMLS CUI [1,2])
Item
Patch test interpretation, Petrolatum Control
integer
C0440135 (UMLS CUI [1,1])
C0030646 (UMLS CUI [1,2])
C0420833 (UMLS CUI [1,3])
Petrolatum Control
Code List
Patch test interpretation, Petrolatum Control
CL Item
Doubtful Reaction (1)
CL Item
Weak Positive Reaction, 1+ (2)
CL Item
Strong Positive Reaction, 2+ (3)
CL Item
Extreme Positive Reaction, 3+ (4)
CL Item
Negative (5)
CL Item
Other (6)
Petrolatum Control
Item
Petrolatum Control, provide comment
text
C0440135 (UMLS CUI [1,1])
C0030646 (UMLS CUI [1,2])
C0420833 (UMLS CUI [1,3])
Item
Patch test interpretation, Excipient Control
integer
C0015237 (UMLS CUI [1,1])
C0030646 (UMLS CUI [1,2])
C0420833 (UMLS CUI [1,3])
Petrolatum Control
Code List
Patch test interpretation, Excipient Control
CL Item
Doubtful Reaction (1)
CL Item
Weak Positive Reaction, 1+ (2)
CL Item
Strong Positive Reaction, 2+ (3)
CL Item
Extreme Positive Reaction, 3+ (4)
CL Item
Negative (5)
CL Item
Other (6)
Excipient Control
Item
Excipient Control, provide comment
text
C0015237 (UMLS CUI [1,1])
C0030646 (UMLS CUI [1,2])
C0420833 (UMLS CUI [1,3])
Item
Patch test interpretation, 1% Abacavir
integer
C0663655 (UMLS CUI [1,1])
C0030646 (UMLS CUI [1,2])
C0420833 (UMLS CUI [1,3])
Petrolatum Control
Code List
Patch test interpretation, 1% Abacavir
CL Item
Doubtful Reaction (1)
CL Item
Weak Positive Reaction, 1+ (2)
CL Item
Strong Positive Reaction, 2+ (3)
CL Item
Extreme Positive Reaction, 3+ (4)
CL Item
Negative (5)
CL Item
Other (6)
Abacavir
Item
1% Abacavir, provide comment
text
C0663655 (UMLS CUI [1,1])
C0030646 (UMLS CUI [1,2])
C0420833 (UMLS CUI [1,3])
Item
Patch test interpretation, 10% Abacavir
integer
C0663655 (UMLS CUI [1,1])
C0030646 (UMLS CUI [1,2])
C0420833 (UMLS CUI [1,3])
Petrolatum Control
Code List
Patch test interpretation, 10% Abacavir
CL Item
Doubtful Reaction (1)
CL Item
Weak Positive Reaction, 1+ (2)
CL Item
Strong Positive Reaction, 2+ (3)
CL Item
Extreme Positive Reaction, 3+ (4)
CL Item
Negative (5)
CL Item
Other (6)
Abacavir
Item
10% Abacavir, provide comment
text
C0663655 (UMLS CUI [1,1])
C0030646 (UMLS CUI [1,2])
C0420833 (UMLS CUI [1,3])
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