ID

25736

Beschrijving

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

Trefwoorden

Versies (1)
  1. 16-09-17 16-09-17 -
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glaxoSmithKline

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16 september 2017

DOI

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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

Engels

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

1 Formulieren  
PGX Consent
Beschrijving

PGX Consent

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

pharmacogenetics consent

Datatype

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.
Beschrijving

Reason for withdrawal

Datatype

integer

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

Date informed consent

Datatype

date

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

Pharmacogenetics sample date

Datatype

date

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

Pharmacogenetics withdraw consent

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Has the subject withdrawn consent for PGx research?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

Pharmacogenetics withdraw consent

Datatype

boolean

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

PGx sample destruction

Datatype

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.
Beschrijving

Reson for PGx consent withdrawal

Datatype

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 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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