ID

21157

Beschrijving

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: End of Study 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

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Versies (1)
  1. 12-04-17 12-04-17 -
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12 april 2017

DOI

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Licentie

Creative Commons BY-NC 3.0
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HLA-B*5701 And Hypersensitivity To Abacavir End of Study NCT00373945

Engels

HLA-B*5701 And Hypersensitivity To Abacavir End of Study NCT00373945

1 Formulieren  
Date of Visit/Assessment
Beschrijving

Date of Visit/Assessment

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

Date of Visit/Assessment

Datatype

date

Alias
UMLS CUI [1]
C1320303
Study Conclusion
Beschrijving

Study Conclusion

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008972
Date of subject completion or date of subject withdrawal
Beschrijving

Date of subject completion or date of subject withdrawal

Datatype

date

Alias
UMLS CUI [1,1]
C2983670
UMLS CUI [1,2]
C0422727
Was the subject withdrawn from the study?
Beschrijving

Was the subject withdrawn from the study?

Datatype

text

Alias
UMLS CUI [1]
C0422727
Primary reason for withdrawal
Beschrijving

Please specify if "Was the subject withdrawn from the study?"=Yes

Datatype

integer

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0392360
Did the subject experience any non-serious adverse events during the study?
Beschrijving

Did the subject experience any non-serious adverse events during the study?

Datatype

text

Alias
UMLS CUI [1]
C1518404
Did the subject experience any serious adverse events during the study?
Beschrijving

Did the subject experience any serious adverse events during the study?

Datatype

text

Alias
UMLS CUI [1]
C1519255
Were any concomitant medications taken by the subject during the study?
Beschrijving

Were any concomitant medications taken by the subject during the study?

Datatype

text

Alias
UMLS CUI [1]
C2347852
Case book ready for signature
Beschrijving

CRA should check the box when data cleaning is complete

Datatype

text

Alias
UMLS CUI [1]
C1519316
Q1
Beschrijving

Q1

Datatype

text

Q2
Beschrijving

Q2

Datatype

text

Pregnancy Information
Beschrijving

Pregnancy Information

Alias
UMLS CUI-1
C0032961
UMLS CUI-2
C1533716
Did the subject become pregnant during the study?
Beschrijving

If Yes, complete the paper Pregnancy Notification form

Datatype

text

Alias
UMLS CUI [1]
C0032961
PGx-Pharmacogenetic Research Withdrawal of Consent
Beschrijving

PGx-Pharmacogenetic Research Withdrawal of Consent

Alias
UMLS CUI-1
C1707492
UMLS CUI-2
C0021430
Has subject withdrawn consent for PGx-Pharmacogenetic Research?
Beschrijving

Has subject withdrawn consent for PGx-Pharmacogenetic Research?

Datatype

text

Alias
UMLS CUI [1,1]
C1707492
UMLS CUI [1,2]
C0021430
Has a request been made for sample destruction?
Beschrijving

Has a request been made for sample destruction?

Datatype

text

Alias
UMLS CUI [1,1]
C1948029
UMLS CUI [1,2]
C0370003
UMLS CUI [1,3]
C1272683
Reason for sample destruction
Beschrijving

Please specify if "Has a request been made for sample destruction?"=Yes

Datatype

integer

Alias
UMLS CUI [1,1]
C1948029
UMLS CUI [1,2]
C0370003
UMLS CUI [1,3]
C0392360
Sample type
Beschrijving

Sample type

Datatype

text

Alias
UMLS CUI [1]
C2347029
Genetics Type
Beschrijving

Genetics Type

Datatype

text

Alias
UMLS CUI [1]
C0017399
Investigator Signature
Beschrijving

Investigator Signature

Alias
UMLS CUI-1
C2346576
Is this casebook ready to sign?
Beschrijving

Is this casebook ready to sign?

Datatype

text

Alias
UMLS CUI [1]
C2346576
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Similar models

HLA-B*5701 And Hypersensitivity To Abacavir End of Study NCT00373945

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Date of Visit/Assessment
C1320303 (UMLS CUI-1)
Date of Visit/Assessment
Item
Date of Visit/Assessment
date
C1320303 (UMLS CUI [1])
Item Group
Study Conclusion
C1707478 (UMLS CUI-1)
C0008972 (UMLS CUI-2)
Date of subject completion or date of subject withdrawal
Item
Date of subject completion or date of subject withdrawal
date
C2983670 (UMLS CUI [1,1])
C0422727 (UMLS CUI [1,2])
Item
Was the subject withdrawn from the study?
text
C0422727 (UMLS CUI [1])
Was the subject withdrawn from the study?
Code List
Was the subject withdrawn from the study?
CL Item
No (N)
CL Item
Yes (Y)
Item
Primary reason for withdrawal
integer
C0422727 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Primary reason for withdrawal
Code List
Primary reason for withdrawal
CL Item
Adverse Event, Record details on the Non-Serious Adverse Event or Serious Adverse Events forms as appropriate (1)
CL Item
Lost to follow-up (2)
CL Item
Protocol violation (3)
CL Item
Subject decided to withdraw from the study (4)
CL Item
Sponsor terminated study (5)
CL Item
Other, specify (6)
Item
Did the subject experience any non-serious adverse events during the study?
text
C1518404 (UMLS CUI [1])
Was the subject withdrawn from the study?
Code List
Did the subject experience any non-serious adverse events during the study?
CL Item
No (N)
CL Item
Yes (Y)
Item
Did the subject experience any serious adverse events during the study?
text
C1519255 (UMLS CUI [1])
Was the subject withdrawn from the study?
Code List
Did the subject experience any serious adverse events during the study?
CL Item
No (N)
CL Item
Yes (Y)
Item
Were any concomitant medications taken by the subject during the study?
text
C2347852 (UMLS CUI [1])
Was the subject withdrawn from the study?
Code List
Were any concomitant medications taken by the subject during the study?
CL Item
No (N)
CL Item
Yes (Y)
Item
Case book ready for signature
text
C1519316 (UMLS CUI [1])
Case book ready for signature
Code List
Case book ready for signature
CL Item
Yes (Y)
Item
Q1
text
Was the subject withdrawn from the study?
Code List
Q1
CL Item
No (N)
CL Item
Yes (Y)
Q2
Item
Q2
text
Item Group
Pregnancy Information
C0032961 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
Item
Did the subject become pregnant during the study?
text
C0032961 (UMLS CUI [1])
Was the subject withdrawn from the study?
Code List
Did the subject become pregnant during the study?
CL Item
No (N)
CL Item
Yes (Y)
Item Group
PGx-Pharmacogenetic Research Withdrawal of Consent
C1707492 (UMLS CUI-1)
C0021430 (UMLS CUI-2)
Item
Has subject withdrawn consent for PGx-Pharmacogenetic Research?
text
C1707492 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
Was the subject withdrawn from the study?
Code List
Has subject withdrawn consent for PGx-Pharmacogenetic Research?
CL Item
No (N)
CL Item
Yes (Y)
Item
Has a request been made for sample destruction?
text
C1948029 (UMLS CUI [1,1])
C0370003 (UMLS CUI [1,2])
C1272683 (UMLS CUI [1,3])
Was the subject withdrawn from the study?
Code List
Has a request been made for sample destruction?
CL Item
No (N)
CL Item
Yes (Y)
Item
Reason for sample destruction
integer
C1948029 (UMLS CUI [1,1])
C0370003 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Reason for sample destruction
Code List
Reason for sample destruction
CL Item
Subject requested (1)
CL Item
Screen failure (2)
CL Item
Other, specify (3)
Sample type
Item
Sample type
text
C2347029 (UMLS CUI [1])
Genetics Type
Item
Genetics Type
text
C0017399 (UMLS CUI [1])
Item Group
Investigator Signature
C2346576 (UMLS CUI-1)
Item
Is this casebook ready to sign?
text
C2346576 (UMLS CUI [1])
Case book ready for signature
Code List
Is this casebook ready to sign?
CL Item
Yes (Y)
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