ID

21388

Description

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: ABC-Containing Product Discontinuation Medicine: abacavir, Condition: Infection, Human Immunodeficiency Virus, Phase: 4, Clinical Study ID: CNA106030, Sponsor: ViiV

Keywords

Versions (1)
  1. 4/19/17 4/19/17 -
Uploaded on

April 19, 2017

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License

Creative Commons BY-NC 3.0
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Genetic Screening For HLA-B*5701 in Patients with HIV ABC-Containing Product Discontinuation NCT00340080

English

Genetic Screening For HLA-B*5701 ABC-Containing Product Discontinuation NCT00340080

1 forms  
ABC-Containing Product Discontinuation
Description

ABC-Containing Product Discontinuation

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C0663655
UMLS CUI-3
C0850893
Subject Identifier
Description

Subject Identifier

Data type

text

Alias
UMLS CUI [1]
C2348585
Was the ABC-Containing product stopped permanently before the end of the scheduled treatment period? Ziagen:
Description

Ziagen stopped

Data type

text

Alias
UMLS CUI [1,1]
C0724476
UMLS CUI [1,2]
C0850893
Primary reason the ABC-Containing Product was stopped, Ziagen:
Description

If Yes, 􏰀check the primary reason the ABC-Containing Product was stopped

Data type

integer

Alias
UMLS CUI [1,1]
C0850893
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C0724476
Primary reason the ABC-Containing Product was stopped, Ziagen:
Description

If Other, please specify

Data type

text

Alias
UMLS CUI [1,1]
C0850893
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C0724476
Was the ABC-Containing product stopped permanently before the end of the scheduled treatment period? Trizivir:
Description

Trizivir stopped

Data type

text

Alias
UMLS CUI [1,1]
C0939514
UMLS CUI [1,2]
C0850893
Primary reason the ABC-Containing Product was stopped, Trizivir:
Description

primary reason Trizivir was stopped

Data type

integer

Alias
UMLS CUI [1,1]
C0850893
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C0939514
Primary reason the ABC-Containing Product was stopped, Trizivir:
Description

If Other, please specify

Data type

text

Alias
UMLS CUI [1,1]
C0850893
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C0939514
Was the ABC-Containing product stopped permanently before the end of the scheduled treatment period? Kivexa:
Description

Kivexa stopped

Data type

text

Alias
UMLS CUI [1,1]
C1567988
UMLS CUI [1,2]
C0850893
Primary reason the ABC-Containing Product was stopped, Kivexa:
Description

primary reason Kivexa was stopped

Data type

integer

Alias
UMLS CUI [1,1]
C0850893
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C1567988
Primary reason the ABC-Containing Product was stopped, Kivexa:
Description

If Other, please specify

Data type

text

Alias
UMLS CUI [1,1]
C0850893
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C1567988
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Similar models

Genetic Screening For HLA-B*5701 ABC-Containing Product Discontinuation NCT00340080

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
ABC-Containing Product Discontinuation
C0013227 (UMLS CUI-1)
C0663655 (UMLS CUI-2)
C0850893 (UMLS CUI-3)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Item
Was the ABC-Containing product stopped permanently before the end of the scheduled treatment period? Ziagen:
text
C0724476 (UMLS CUI [1,1])
C0850893 (UMLS CUI [1,2])
ABC-Containing product stopped
Code List
Was the ABC-Containing product stopped permanently before the end of the scheduled treatment period? Ziagen:
CL Item
Yes (Y)
CL Item
No (N)
Item
Primary reason the ABC-Containing Product was stopped, Ziagen:
integer
C0850893 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0724476 (UMLS CUI [1,3])
primary reason the ABC-Containing Product was stopped
Code List
Primary reason the ABC-Containing Product was stopped, Ziagen:
CL Item
Adverse event (Record details on the Non-Serious Adverse Events or Serious Adverse Event (1)
CL Item
Lost to follow-up (2)
CL Item
Lost to follow-up (2)
CL Item
Protocol violation (3)
CL Item
Subject decided to withdraw from the study (4)
CL Item
Lack of efficacy (5)
CL Item
Sponsor terminated study (6)
CL Item
Non-compliance (17)
CL Item
Investigator Decision (26)
CL Item
Other, specify (0)
primary reason Ziagen was stopped
Item
Primary reason the ABC-Containing Product was stopped, Ziagen:
text
C0850893 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0724476 (UMLS CUI [1,3])
Item
Was the ABC-Containing product stopped permanently before the end of the scheduled treatment period? Trizivir:
text
C0939514 (UMLS CUI [1,1])
C0850893 (UMLS CUI [1,2])
ABC-Containing product stopped
Code List
Was the ABC-Containing product stopped permanently before the end of the scheduled treatment period? Trizivir:
CL Item
Yes (Y)
CL Item
No (N)
Item
Primary reason the ABC-Containing Product was stopped, Trizivir:
integer
C0850893 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0939514 (UMLS CUI [1,3])
primary reason the ABC-Containing Product was stopped
Code List
Primary reason the ABC-Containing Product was stopped, Trizivir:
CL Item
Adverse event (Record details on the Non-Serious Adverse Events or Serious Adverse Event (1)
CL Item
Lost to follow-up (2)
CL Item
Lost to follow-up (2)
CL Item
Protocol violation (3)
CL Item
Subject decided to withdraw from the study (4)
CL Item
Lack of efficacy (5)
CL Item
Sponsor terminated study (6)
CL Item
Non-compliance (17)
CL Item
Investigator Decision (26)
CL Item
Other, specify (0)
primary reason Trizivir was stopped
Item
Primary reason the ABC-Containing Product was stopped, Trizivir:
text
C0850893 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0939514 (UMLS CUI [1,3])
Item
Was the ABC-Containing product stopped permanently before the end of the scheduled treatment period? Kivexa:
text
C1567988 (UMLS CUI [1,1])
C0850893 (UMLS CUI [1,2])
ABC-Containing product stopped
Code List
Was the ABC-Containing product stopped permanently before the end of the scheduled treatment period? Kivexa:
CL Item
Yes (Y)
CL Item
No (N)
Item
Primary reason the ABC-Containing Product was stopped, Kivexa:
integer
C0850893 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C1567988 (UMLS CUI [1,3])
primary reason the ABC-Containing Product was stopped
Code List
Primary reason the ABC-Containing Product was stopped, Kivexa:
CL Item
Adverse event (Record details on the Non-Serious Adverse Events or Serious Adverse Event (1)
CL Item
Lost to follow-up (2)
CL Item
Lost to follow-up (2)
CL Item
Protocol violation (3)
CL Item
Subject decided to withdraw from the study (4)
CL Item
Lack of efficacy (5)
CL Item
Sponsor terminated study (6)
CL Item
Non-compliance (17)
CL Item
Investigator Decision (26)
CL Item
Other, specify (0)
primary reason Kivexa was stopped
Item
Primary reason the ABC-Containing Product was stopped, Kivexa:
text
C0850893 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C1567988 (UMLS CUI [1,3])
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