ID

21502

Beschrijving

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: Non-serious Adverse Events Medicine: abacavir, Condition: Infection, Human Immunodeficiency Virus, Phase: 4, Clinical Study ID: CNA106030, Sponsor: ViiV

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Versies (1)
  1. 25-04-17 25-04-17 -
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25 april 2017

DOI

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Creative Commons BY-NC 3.0
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Genetic Screening For HLA-B*5701 in Patients with HIV Non-serious Adverse Events NCT00340080

Engels

Genetic Screening For HLA-B*5701 Non-serious Adverse Events NCT00340080

1 Formulieren  
Non-serious Adverse Events
Beschrijving

Non-serious Adverse Events

Alias
UMLS CUI-1
C1518404
Subject Identifier
Beschrijving

Subject Identifier

Datatype

text

Alias
UMLS CUI [1]
C2348585
Did the subject experience any non-serious adverse events during the study?
Beschrijving

Note: If this is a Serious Adverse Event (SAE), do not complete this form, go to the SAE section and complete the SAE form.

Datatype

text

Alias
UMLS CUI [1]
C1518404
Event, Diagnosis Only (if known) Otherwise Sign/Symptom
Beschrijving

If Yes, record details below.

Datatype

text

Alias
UMLS CUI [1]
C1518404
Start Date
Beschrijving

Start Date

Datatype

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C1518404
Outcome
Beschrijving

Outcome

Datatype

integer

Alias
UMLS CUI [1,1]
C1705586
UMLS CUI [1,2]
C1518404
End Date
Beschrijving

End Date

Datatype

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C1518404
Maximum Toxicity or Intensity
Beschrijving

Maximum Toxicity or Intensity

Datatype

integer

Alias
UMLS CUI [1,1]
C1710066
UMLS CUI [1,2]
C1518404
Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
Beschrijving

Action Taken with Investigational Product

Datatype

integer

Alias
UMLS CUI [1]
C1704758
UMLS CUI [2]
C1518404
Did the subject withdraw from study as a result of this AE?
Beschrijving

Withdrawal

Datatype

text

Alias
UMLS CUI [1]
C1710677
UMLS CUI [2]
C1518404
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Beschrijving

Relationship to Investigational Product(s)

Datatype

text

Alias
UMLS CUI [1,1]
C0085978
UMLS CUI [1,2]
C1518404
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Similar models

Genetic Screening For HLA-B*5701 Non-serious Adverse Events NCT00340080

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Non-serious Adverse Events
C1518404 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Item
Did the subject experience any non-serious adverse events during the study?
text
C1518404 (UMLS CUI [1])
non-serious adverse events
Code List
Did the subject experience any non-serious adverse events during the study?
CL Item
Yes (Y)
CL Item
No (N)
Non-serious Adverse Event
Item
Event, Diagnosis Only (if known) Otherwise Sign/Symptom
text
C1518404 (UMLS CUI [1])
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Item
Outcome
integer
C1705586 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Outcome
Code List
Outcome
CL Item
Recovered/ Resolved (1)
CL Item
Recovering/ Resolving (2)
CL Item
Not recovered/ Not resolved (3)
CL Item
Recovered/ Resolved with sequelae (4)
End Date
Item
End Date
date
C0806020 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Item
Maximum Toxicity or Intensity
integer
C1710066 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Maximum Toxicity or Intensity
Code List
Maximum Toxicity or Intensity
CL Item
Mild or Grade 1 (1)
CL Item
Moderate or Grade 2 (2)
CL Item
Severe or Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Not applicable (5)
Item
Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
integer
C1704758 (UMLS CUI [1])
C1518404 (UMLS CUI [2])
Action Taken with Investigational Product
Code List
Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
CL Item
Investigational products withdrawn (1)
CL Item
Dose reduced (2)
CL Item
Dose increased (3)
CL Item
Dose not changed (4)
CL Item
Dose interrupted (5)
CL Item
Not applicable (6)
Item
Did the subject withdraw from study as a result of this AE?
text
C1710677 (UMLS CUI [1])
C1518404 (UMLS CUI [2])
non-serious adverse events
Code List
Did the subject withdraw from study as a result of this AE?
CL Item
Yes (Y)
CL Item
No (N)
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
text
C0085978 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
non-serious adverse events
Code List
Is there a reasonable possibility that the AE may have been caused by the investigational product?
CL Item
Yes (Y)
CL Item
No (N)
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