Informações:
Falhas:
ID
21502
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: Non-serious Adverse Events Medicine: abacavir, Condition: Infection, Human Immunodeficiency Virus, Phase: 4, Clinical Study ID: CNA106030, Sponsor: ViiV
Palavras-chave
Versões (1)
- 25/04/2017 25/04/2017 -
Transferido a
25 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 Non-serious Adverse Events NCT00340080
Genetic Screening For HLA-B*5701 Non-serious Adverse Events NCT00340080
Similar models
Genetic Screening For HLA-B*5701 Non-serious Adverse Events NCT00340080
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
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])
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])
C1518404 (UMLS CUI [1,2])
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])
C1518404 (UMLS CUI [1,2])
Item
Maximum Toxicity or Intensity
integer
C1710066 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,2])
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])
C1518404 (UMLS CUI [2])
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Investigational products withdrawn (1)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])
C1518404 (UMLS CUI [2])
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])
C1518404 (UMLS CUI [1,2])
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)