ID

25736

Descrição

PGX consent / withdrawal - GSK Study: GW679769 administered alone vs. with dexamethasone - Evaluation of safety, tolerability and pharmacokinetics NCT00291876 Study ID: 100789 Clinical Study ID: NKV100789 Study Title: A two-part, dose-rising study to evaluate the safety, tolerability and pharmacokinetics of single intravenous doses of GW679769 when administered alone and in combination with intravenous or oral doses of dexamethasone in healthy adult subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00291876 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: casopitant Trade Name: Rezonic,Zunrisa; Zunrisa,Rezonic Study Indication: Nausea and Vomiting, Chemotherapy-Induced

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Versões (1)
  1. 16/09/2017 16/09/2017 -
Titular dos direitos

glaxoSmithKline

Transferido a

16 septembre 2017

DOI

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Licença

Creative Commons BY-NC 3.0
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PGX consent / withdrawal - GSK Study: GW679769 administered alone vs. with dexamethasone - Evaluation of safety, tolerability and pharmacokinetics NCT00291876

Inglês

PGX consent / withdrawal - GSK Study: GW679769 administered alone vs. with dexamethasone - Evaluation of safety, tolerability and pharmacokinetics NCT00291876

1 Formulários  
PGX Consent
Descrição

PGX Consent

Alias
UMLS CUI-1
C0031325
UMLS CUI-2
C0021430
Has informed consent been obtained for PGx research?
Descrição

pharmacogenetics consent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0031325
UMLS CUI [1,2]
C0021430
If no, please specify whether subject declined, subject not asked by investigator or other.
Descrição

Reason for withdrawal

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C0031325
If yes, please specify date obtained.
Descrição

Date informed consent

Tipo de dados

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0009797
UMLS CUI [1,3]
C0031325
Record PGx sample collection date.
Descrição

Pharmacogenetics sample date

Tipo de dados

date

Alias
UMLS CUI [1,1]
C0031325
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C0011008
Pharmacogenetics withdraw consent
Descrição

Pharmacogenetics withdraw consent

Alias
UMLS CUI-1
C0031325
UMLS CUI-2
C2349954
UMLS CUI-3
C0021430
Has the subject withdrawn consent for PGx research?
Descrição

Pharmacogenetics withdraw consent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0031325
UMLS CUI [1,2]
C2349954
UMLS CUI [1,3]
C0021430
Did the subject request sample destruction?
Descrição

PGx sample destruction

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0031325
UMLS CUI [1,2]
C0370003
UMLS CUI [1,3]
C1948029
If yes, please specify whether subjects request, screen failure or other.
Descrição

Reson for PGx consent withdrawal

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C0031325
UMLS CUI [1,3]
C2349954
UMLS CUI [1,4]
C0021430
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Similar models

PGX consent / withdrawal - GSK Study: GW679769 administered alone vs. with dexamethasone - Evaluation of safety, tolerability and pharmacokinetics NCT00291876

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
PGX Consent
C0031325 (UMLS CUI-1)
C0021430 (UMLS CUI-2)
pharmacogenetics consent
Item
Has informed consent been obtained for PGx research?
boolean
C0031325 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
Item
If no, please specify whether subject declined, subject not asked by investigator or other.
integer
C2349954 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0031325 (UMLS CUI [1,3])
Reason for withdrawal
Code List
If no, please specify whether subject declined, subject not asked by investigator or other.
CL Item
Subject declined (1)
CL Item
Subject not asked by investigator (2)
CL Item
other (3)
Date informed consent
Item
If yes, please specify date obtained.
date
C0011008 (UMLS CUI [1,1])
C0009797 (UMLS CUI [1,2])
C0031325 (UMLS CUI [1,3])
Pharmacogenetics sample date
Item
Record PGx sample collection date.
date
C0031325 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item Group
Pharmacogenetics withdraw consent
C0031325 (UMLS CUI-1)
C2349954 (UMLS CUI-2)
C0021430 (UMLS CUI-3)
Pharmacogenetics withdraw consent
Item
Has the subject withdrawn consent for PGx research?
boolean
C0031325 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
PGx sample destruction
Item
Did the subject request sample destruction?
boolean
C0031325 (UMLS CUI [1,1])
C0370003 (UMLS CUI [1,2])
C1948029 (UMLS CUI [1,3])
Item
If yes, please specify whether subjects request, screen failure or other.
integer
C0566251 (UMLS CUI [1,1])
C0031325 (UMLS CUI [1,2])
C2349954 (UMLS CUI [1,3])
C0021430 (UMLS CUI [1,4])
Reson for PGx consent withdrawal
Code List
If yes, please specify whether subjects request, screen failure or other.
CL Item
subjects request (1)
CL Item
screen failure (2)
CL Item
other (3)
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