ID

21161

Beschreibung

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: Day 2 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

Stichworte

Versionen (1)
  1. 12.04.17 12.04.17 -
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12. April 2017

DOI

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Lizenz

Creative Commons BY-NC 3.0
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HLA-B*5701 And Hypersensitivity To Abacavir Day 2 NCT00373945

Englisch

HLA-B*5701 And Hypersensitivity To Abacavir Day 2 NCT00373945

1 Formulare  
Date of Visit/Assessment
Beschreibung

Date of Visit/Assessment

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

Date of Visit

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Skin Patch Evaluation
Beschreibung

Skin Patch Evaluation

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

Date of visit

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Has the subject undergone tanning (artificial or natural UV rays) since last visit?
Beschreibung

tanning

Datentyp

text

Alias
UMLS CUI [1]
C0302595
Is the second (RIGHT) patch test strip intact?
Beschreibung

Is the second (RIGHT) patch test strip intact?

Datentyp

text

Alias
UMLS CUI [1,1]
C0030646
UMLS CUI [1,2]
C0205090
Check reason
Beschreibung

Please specify if "Is the second (RIGHT) patch test strip intact?"=No

Datentyp

integer

Alias
UMLS CUI [1,1]
C0687118
UMLS CUI [1,2]
C0392360
UMLS CUI [2,1]
C0030646
UMLS CUI [2,2]
C0205090
Time right patch test strip removed
Beschreibung

Time right patch test strip removed

Datentyp

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0849355
UMLS CUI [2,1]
C0030646
UMLS CUI [2,2]
C0205090
Did subject experience itching at the patch site?
Beschreibung

itching at the patch site

Datentyp

text

Alias
UMLS CUI [1]
C0030646
UMLS CUI [2]
C0033774
Itching Maximum Toxicity
Beschreibung

Please specify if "Did subject experience itching at the patch site?"=Yes

Datentyp

integer

Alias
UMLS CUI [1]
C0030646
UMLS CUI [2,1]
C0033774
UMLS CUI [2,2]
C0441800
Did subject experience pain/burning sensation at the patch site?
Beschreibung

pain/burning sensation at the patch site

Datentyp

text

Alias
UMLS CUI [1]
C0030646
UMLS CUI [2]
C0030193
UMLS CUI [3]
C0085624
Pain/burning sensation Maximum Toxicity
Beschreibung

Please specify if "Did subject experience pain/burning sensation at the patch site?"=Yes

Datentyp

integer

Alias
UMLS CUI [1]
C0030646
UMLS CUI [2]
C0030193
UMLS CUI [3]
C0085624
UMLS CUI [4]
C0441800
Skin Patch Interpretation - Erythema Present: Petrolatum Control
Beschreibung

Erythema Present: Petrolatum Control

Datentyp

text

Alias
UMLS CUI [1]
C0440135
UMLS CUI [2]
C0041834
UMLS CUI [3,1]
C0030646
UMLS CUI [3,2]
C0420833
Skin Patch Interpretation - Erythema Present: Excipient Control
Beschreibung

Erythema Present: Excipient Control

Datentyp

text

Alias
UMLS CUI [1]
C0015237
UMLS CUI [2]
C0041834
UMLS CUI [3,1]
C0030646
UMLS CUI [3,2]
C0420833
Skin Patch Interpretation - Erythema Present: Abacavir 1%
Beschreibung

Erythema Present: Abacavir 1%

Datentyp

text

Alias
UMLS CUI [1]
C0663655
UMLS CUI [2]
C0041834
UMLS CUI [3,1]
C0030646
UMLS CUI [3,2]
C0420833
Skin Patch Interpretation - Erythema Present: Abacavir 10%
Beschreibung

Erythema Present: Abacavir 10%

Datentyp

text

Alias
UMLS CUI [1]
C0663655
UMLS CUI [2]
C0041834
UMLS CUI [3,1]
C0030646
UMLS CUI [3,2]
C0420833
Skin Patch Interpretation - Induration Present: Petrolatum Control
Beschreibung

Induration Present: Petrolatum Control

Datentyp

text

Alias
UMLS CUI [1]
C0440135
UMLS CUI [2]
C0332534
UMLS CUI [3,1]
C0030646
UMLS CUI [3,2]
C0420833
Skin Patch Interpretation - Induration Present: Excipient Control
Beschreibung

Induration Present: Excipient Control

Datentyp

text

Alias
UMLS CUI [1]
C0015237
UMLS CUI [2]
C0332534
UMLS CUI [3,1]
C0030646
UMLS CUI [3,2]
C0420833
Skin Patch Interpretation - Induration Present: Abacavir 1%
Beschreibung

Induration Present: Abacavir 1%

Datentyp

text

Alias
UMLS CUI [1]
C0663655
UMLS CUI [2]
C0332534
UMLS CUI [3,1]
C0030646
UMLS CUI [3,2]
C0420833
Skin Patch Interpretation - Induration Present: Abacavir 10%
Beschreibung

Induration Present: Abacavir 10%

Datentyp

text

Alias
UMLS CUI [1]
C0663655
UMLS CUI [2]
C0332534
UMLS CUI [3,1]
C0030646
UMLS CUI [3,2]
C0420833
Skin Patch Interpretation - Papules Present: Petrolatum Control
Beschreibung

Papules Present: Petrolatum Control

Datentyp

text

Alias
UMLS CUI [1]
C0440135
UMLS CUI [2]
C0332563
UMLS CUI [3,1]
C0030646
UMLS CUI [3,2]
C0420833
Skin Patch Interpretation - Papules Present: Excipient Control
Beschreibung

Papules Present: Excipient Control

Datentyp

text

Alias
UMLS CUI [1]
C0015237
UMLS CUI [2]
C0332563
UMLS CUI [3,1]
C0030646
UMLS CUI [3,2]
C0420833
Skin Patch Interpretation - Papules Present: Abacavir 1%
Beschreibung

Papules Present: Abacavir 1%

Datentyp

text

Alias
UMLS CUI [1]
C0663655
UMLS CUI [2]
C0332563
UMLS CUI [3,1]
C0030646
UMLS CUI [3,2]
C0420833
Skin Patch Interpretation - Papules Present: Abacavir 10%
Beschreibung

Papules Present: Abacavir 10%

Datentyp

text

Alias
UMLS CUI [1]
C0663655
UMLS CUI [2]
C0332563
UMLS CUI [3,1]
C0030646
UMLS CUI [3,2]
C0420833
Skin Patch Interpretation - Vesicles Present: Petrolatum Control
Beschreibung

Vesicles Present: Petrolatum Control

Datentyp

text

Alias
UMLS CUI [1]
C0440135
UMLS CUI [2]
C0333262
UMLS CUI [3,1]
C0030646
UMLS CUI [3,2]
C0420833
Skin Patch Interpretation - Vesicles Present: Excipient Control
Beschreibung

Vesicles Present: Excipient Control

Datentyp

text

Alias
UMLS CUI [1]
C0015237
UMLS CUI [2]
C0333262
UMLS CUI [3,1]
C0030646
UMLS CUI [3,2]
C0420833
Skin Patch Interpretation - Vesicles Present: Abacavir 1%
Beschreibung

Vesicles Present: Abacavir 1%

Datentyp

text

Alias
UMLS CUI [1]
C0663655
UMLS CUI [2]
C0333262
UMLS CUI [3,1]
C0030646
UMLS CUI [3,2]
C0420833
Skin Patch Interpretation - Vesicles Present: Abacavir 10%
Beschreibung

Vesicles Present: Abacavir 10%

Datentyp

text

Alias
UMLS CUI [1]
C0663655
UMLS CUI [2]
C0333262
UMLS CUI [3,1]
C0030646
UMLS CUI [3,2]
C0420833
Skin Patch Interpretation - Entire well vesiculated or blistered: Petrolatum Control
Beschreibung

Entire well vesiculated or blistered: Petrolatum Control

Datentyp

text

Alias
UMLS CUI [1]
C0440135
UMLS CUI [2]
C2220104
UMLS CUI [3,1]
C0030646
UMLS CUI [3,2]
C0420833
Skin Patch Interpretation - Entire well vesiculated or blistered: Excipient Control
Beschreibung

Entire well vesiculated or blistered: Excipient Control

Datentyp

text

Alias
UMLS CUI [1]
C0015237
UMLS CUI [2]
C2220104
UMLS CUI [3,1]
C0030646
UMLS CUI [3,2]
C0420833
Skin Patch Interpretation - Entire well vesiculated or blistered: Abacavir 1%
Beschreibung

Entire well vesiculated or blistered: Abacavir 1%

Datentyp

text

Alias
UMLS CUI [1]
C0663655
UMLS CUI [2]
C2220104
UMLS CUI [3,1]
C0030646
UMLS CUI [3,2]
C0420833
Skin Patch Interpretation - Entire well vesiculated or blistered: Abacavir 10%
Beschreibung

Entire well vesiculated or blistered: Abacavir 10%

Datentyp

text

Alias
UMLS CUI [1]
C0663655
UMLS CUI [2]
C2220104
UMLS CUI [3,1]
C0030646
UMLS CUI [3,2]
C0420833
Investigator's overall interpretation of the skin test result is
Beschreibung

If you are unable to make a determination on whether the test was positive or negative, please call or page Dr. ..., as soon as possible and preferably while the subject is still in the clinic

Datentyp

text

Alias
UMLS CUI [1,1]
C0030646
UMLS CUI [1,2]
C0220825
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Ähnliche Modelle

HLA-B*5701 And Hypersensitivity To Abacavir Day 2 NCT00373945

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Date of Visit/Assessment
C1320303 (UMLS CUI-1)
Date of Visit
Item
Date of Visit/Assessment
date
C1320303 (UMLS CUI [1])
Item Group
Skin Patch Evaluation
C0030646 (UMLS CUI-1)
C0220825 (UMLS CUI-2)
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Item
Has the subject undergone tanning (artificial or natural UV rays) since last visit?
text
C0302595 (UMLS CUI [1])
Has the subject undergone (artificial or natural UV rays) since the last visit?
Code List
Has the subject undergone tanning (artificial or natural UV rays) since last visit?
CL Item
Yes (Y)
CL Item
No (N)
Item
Is the second (RIGHT) patch test strip intact?
text
C0030646 (UMLS CUI [1,1])
C0205090 (UMLS CUI [1,2])
Are the two patch test strips intact?
Code List
Is the second (RIGHT) patch test strip intact?
CL Item
Yes (Y)
CL Item
No (N)
Item
Check reason
integer
C0687118 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0030646 (UMLS CUI [2,1])
C0205090 (UMLS CUI [2,2])
reason
Code List
Check reason
CL Item
Adverse Event (1)
CL Item
Shower/bath (2)
CL Item
Exercise/sweat (3)
CL Item
Other, specify (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])
Item
Did subject experience itching at the patch site?
text
C0030646 (UMLS CUI [1])
C0033774 (UMLS CUI [2])
itching at the patch site
Code List
Did subject experience itching at the patch site?
CL Item
No (N)
CL Item
Yes (Y)
Item
Itching Maximum Toxicity
integer
C0030646 (UMLS CUI [1])
C0033774 (UMLS CUI [2,1])
C0441800 (UMLS CUI [2,2])
Itching Maximum Toxicity
Code List
Itching Maximum Toxicity
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
Item
Did subject experience pain/burning sensation at the patch site?
text
C0030646 (UMLS CUI [1])
C0030193 (UMLS CUI [2])
C0085624 (UMLS CUI [3])
pain/burning sensation at the patch site
Code List
Did subject experience pain/burning sensation at the patch site?
CL Item
No (N)
CL Item
Yes (Y)
Item
Pain/burning sensation Maximum Toxicity
integer
C0030646 (UMLS CUI [1])
C0030193 (UMLS CUI [2])
C0085624 (UMLS CUI [3])
C0441800 (UMLS CUI [4])
Pain/burning sensation Maximum Toxicity
Code List
Pain/burning sensation Maximum Toxicity
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
Item
Skin Patch Interpretation - Erythema Present: Petrolatum Control
text
C0440135 (UMLS CUI [1])
C0041834 (UMLS CUI [2])
C0030646 (UMLS CUI [3,1])
C0420833 (UMLS CUI [3,2])
Has the subject undergone (artificial or natural UV rays) since the last visit?
Code List
Skin Patch Interpretation - Erythema Present: Petrolatum Control
CL Item
Yes (Y)
CL Item
No (N)
Item
Skin Patch Interpretation - Erythema Present: Excipient Control
text
C0015237 (UMLS CUI [1])
C0041834 (UMLS CUI [2])
C0030646 (UMLS CUI [3,1])
C0420833 (UMLS CUI [3,2])
Has the subject undergone (artificial or natural UV rays) since the last visit?
Code List
Skin Patch Interpretation - Erythema Present: Excipient Control
CL Item
Yes (Y)
CL Item
No (N)
Item
Skin Patch Interpretation - Erythema Present: Abacavir 1%
text
C0663655 (UMLS CUI [1])
C0041834 (UMLS CUI [2])
C0030646 (UMLS CUI [3,1])
C0420833 (UMLS CUI [3,2])
Has the subject undergone (artificial or natural UV rays) since the last visit?
Code List
Skin Patch Interpretation - Erythema Present: Abacavir 1%
CL Item
Yes (Y)
CL Item
No (N)
Item
Skin Patch Interpretation - Erythema Present: Abacavir 10%
text
C0663655 (UMLS CUI [1])
C0041834 (UMLS CUI [2])
C0030646 (UMLS CUI [3,1])
C0420833 (UMLS CUI [3,2])
Has the subject undergone (artificial or natural UV rays) since the last visit?
Code List
Skin Patch Interpretation - Erythema Present: Abacavir 10%
CL Item
Yes (Y)
CL Item
No (N)
Item
Skin Patch Interpretation - Induration Present: Petrolatum Control
text
C0440135 (UMLS CUI [1])
C0332534 (UMLS CUI [2])
C0030646 (UMLS CUI [3,1])
C0420833 (UMLS CUI [3,2])
Has the subject undergone (artificial or natural UV rays) since the last visit?
Code List
Skin Patch Interpretation - Induration Present: Petrolatum Control
CL Item
Yes (Y)
CL Item
No (N)
Item
Skin Patch Interpretation - Induration Present: Excipient Control
text
C0015237 (UMLS CUI [1])
C0332534 (UMLS CUI [2])
C0030646 (UMLS CUI [3,1])
C0420833 (UMLS CUI [3,2])
Has the subject undergone (artificial or natural UV rays) since the last visit?
Code List
Skin Patch Interpretation - Induration Present: Excipient Control
CL Item
Yes (Y)
CL Item
No (N)
Item
Skin Patch Interpretation - Induration Present: Abacavir 1%
text
C0663655 (UMLS CUI [1])
C0332534 (UMLS CUI [2])
C0030646 (UMLS CUI [3,1])
C0420833 (UMLS CUI [3,2])
Has the subject undergone (artificial or natural UV rays) since the last visit?
Code List
Skin Patch Interpretation - Induration Present: Abacavir 1%
CL Item
Yes (Y)
CL Item
No (N)
Item
Skin Patch Interpretation - Induration Present: Abacavir 10%
text
C0663655 (UMLS CUI [1])
C0332534 (UMLS CUI [2])
C0030646 (UMLS CUI [3,1])
C0420833 (UMLS CUI [3,2])
Has the subject undergone (artificial or natural UV rays) since the last visit?
Code List
Skin Patch Interpretation - Induration Present: Abacavir 10%
CL Item
Yes (Y)
CL Item
No (N)
Item
Skin Patch Interpretation - Papules Present: Petrolatum Control
text
C0440135 (UMLS CUI [1])
C0332563 (UMLS CUI [2])
C0030646 (UMLS CUI [3,1])
C0420833 (UMLS CUI [3,2])
Has the subject undergone (artificial or natural UV rays) since the last visit?
Code List
Skin Patch Interpretation - Papules Present: Petrolatum Control
CL Item
Yes (Y)
CL Item
No (N)
Item
Skin Patch Interpretation - Papules Present: Excipient Control
text
C0015237 (UMLS CUI [1])
C0332563 (UMLS CUI [2])
C0030646 (UMLS CUI [3,1])
C0420833 (UMLS CUI [3,2])
Has the subject undergone (artificial or natural UV rays) since the last visit?
Code List
Skin Patch Interpretation - Papules Present: Excipient Control
CL Item
Yes (Y)
CL Item
No (N)
Item
Skin Patch Interpretation - Papules Present: Abacavir 1%
text
C0663655 (UMLS CUI [1])
C0332563 (UMLS CUI [2])
C0030646 (UMLS CUI [3,1])
C0420833 (UMLS CUI [3,2])
Has the subject undergone (artificial or natural UV rays) since the last visit?
Code List
Skin Patch Interpretation - Papules Present: Abacavir 1%
CL Item
Yes (Y)
CL Item
No (N)
Item
Skin Patch Interpretation - Papules Present: Abacavir 10%
text
C0663655 (UMLS CUI [1])
C0332563 (UMLS CUI [2])
C0030646 (UMLS CUI [3,1])
C0420833 (UMLS CUI [3,2])
Has the subject undergone (artificial or natural UV rays) since the last visit?
Code List
Skin Patch Interpretation - Papules Present: Abacavir 10%
CL Item
Yes (Y)
CL Item
No (N)
Item
Skin Patch Interpretation - Vesicles Present: Petrolatum Control
text
C0440135 (UMLS CUI [1])
C0333262 (UMLS CUI [2])
C0030646 (UMLS CUI [3,1])
C0420833 (UMLS CUI [3,2])
Has the subject undergone (artificial or natural UV rays) since the last visit?
Code List
Skin Patch Interpretation - Vesicles Present: Petrolatum Control
CL Item
Yes (Y)
CL Item
No (N)
Item
Skin Patch Interpretation - Vesicles Present: Excipient Control
text
C0015237 (UMLS CUI [1])
C0333262 (UMLS CUI [2])
C0030646 (UMLS CUI [3,1])
C0420833 (UMLS CUI [3,2])
Has the subject undergone (artificial or natural UV rays) since the last visit?
Code List
Skin Patch Interpretation - Vesicles Present: Excipient Control
CL Item
Yes (Y)
CL Item
No (N)
Item
Skin Patch Interpretation - Vesicles Present: Abacavir 1%
text
C0663655 (UMLS CUI [1])
C0333262 (UMLS CUI [2])
C0030646 (UMLS CUI [3,1])
C0420833 (UMLS CUI [3,2])
Has the subject undergone (artificial or natural UV rays) since the last visit?
Code List
Skin Patch Interpretation - Vesicles Present: Abacavir 1%
CL Item
Yes (Y)
CL Item
No (N)
Item
Skin Patch Interpretation - Vesicles Present: Abacavir 10%
text
C0663655 (UMLS CUI [1])
C0333262 (UMLS CUI [2])
C0030646 (UMLS CUI [3,1])
C0420833 (UMLS CUI [3,2])
Has the subject undergone (artificial or natural UV rays) since the last visit?
Code List
Skin Patch Interpretation - Vesicles Present: Abacavir 10%
CL Item
Yes (Y)
CL Item
No (N)
Item
Skin Patch Interpretation - Entire well vesiculated or blistered: Petrolatum Control
text
C0440135 (UMLS CUI [1])
C2220104 (UMLS CUI [2])
C0030646 (UMLS CUI [3,1])
C0420833 (UMLS CUI [3,2])
Has the subject undergone (artificial or natural UV rays) since the last visit?
Code List
Skin Patch Interpretation - Entire well vesiculated or blistered: Petrolatum Control
CL Item
Yes (Y)
CL Item
No (N)
Item
Skin Patch Interpretation - Entire well vesiculated or blistered: Excipient Control
text
C0015237 (UMLS CUI [1])
C2220104 (UMLS CUI [2])
C0030646 (UMLS CUI [3,1])
C0420833 (UMLS CUI [3,2])
Has the subject undergone (artificial or natural UV rays) since the last visit?
Code List
Skin Patch Interpretation - Entire well vesiculated or blistered: Excipient Control
CL Item
Yes (Y)
CL Item
No (N)
Item
Skin Patch Interpretation - Entire well vesiculated or blistered: Abacavir 1%
text
C0663655 (UMLS CUI [1])
C2220104 (UMLS CUI [2])
C0030646 (UMLS CUI [3,1])
C0420833 (UMLS CUI [3,2])
Has the subject undergone (artificial or natural UV rays) since the last visit?
Code List
Skin Patch Interpretation - Entire well vesiculated or blistered: Abacavir 1%
CL Item
Yes (Y)
CL Item
No (N)
Item
Skin Patch Interpretation - Entire well vesiculated or blistered: Abacavir 10%
text
C0663655 (UMLS CUI [1])
C2220104 (UMLS CUI [2])
C0030646 (UMLS CUI [3,1])
C0420833 (UMLS CUI [3,2])
Has the subject undergone (artificial or natural UV rays) since the last visit?
Code List
Skin Patch Interpretation - Entire well vesiculated or blistered: Abacavir 10%
CL Item
Yes (Y)
CL Item
No (N)
Item
Investigator's overall interpretation of the skin test result is
text
C0030646 (UMLS CUI [1,1])
C0220825 (UMLS CUI [1,2])
undefined item
Code List
Investigator's overall interpretation of the skin test result is
CL Item
Positive (1)
CL Item
Negative (2)
CL Item
Consultation (3)
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