ID

38752

Descripción

Study ID: 111610 Clinical Study ID: 111610 Study Title: A randomised, double-blind, placebo-controlled study in healthy volunteers to examine the safety, tolerability and pharmacokinetics of a) single, ascending and b) twice-daily repeat doses of intranasal SB-705498. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00907933 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: SB705498, Placebo Study Indication: Rhinitis

Palabras clave

  1. 31/10/19 31/10/19 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

31 de octubre de 2019

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0

Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Comentarios de grupo de elementos para :

Comentarios del elemento para :

Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

Safety, tolerability and pharmacokinetics of single, ascending and twice-daily repeat doses of intranasal SB-705498 NCT00907933

Pharmacogenetic Research Consent; Pharmacogenetic Research Withdrawal of Consent

Pharmacogenetic Research Consent
Descripción

Pharmacogenetic Research Consent

Alias
UMLS CUI-1
C0021430
UMLS CUI-2
C2347500
Has informed consent been obtained for PGx-Pharmacogenetic research?
Descripción

Has informed consent been obtained for PGx-Pharmacogenetic research?

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2347500
Date informed consent obtained for GPx-Pharmacogenetic research
Descripción

Date informed consent obtained for GPx-Pharmacogenetic research

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2347500
UMLS CUI [1,3]
C0011008
If no informed consent obtained for Pharmacogenetic research, check reason
Descripción

If no informed consent obtained for Pharmacogenetic research, check reason

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2347500
UMLS CUI [1,3]
C0392360
If other reason for informed consent not been obtained, specify
Descripción

If other reason for informed consent not been obtained, specify

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2347500
UMLS CUI [1,3]
C0392360
UMLS CUI [1,4]
C2348235
UMLS CUI [1,5]
C2348235
Has a blood sample been collected for PGx-pharmacogenetic (DNA) research?
Descripción

Has a blood sample been collected for PGx-pharmacogenetic (DNA) research?

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C0005834
If a blood sample has been taken, record date sample taken
Descripción

If a blood sample has been taken, record date sample taken

Tipo de datos

date

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C0005834
UMLS CUI [1,3]
C0011008
Pharmacogenetic Research Withdrawal of Consent
Descripción

Pharmacogenetic Research Withdrawal of Consent

Alias
UMLS CUI-1
C1707492
UMLS CUI-2
C0031325
Has subject withdrawn consent for PGx research?
Descripción

Has subject withdrawn consent for PGx research?

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1707492
UMLS CUI [1,2]
C0031325
Date informed consent withdrawn
Descripción

Date informed consent withdrawn

Tipo de datos

date

Alias
UMLS CUI [1,1]
C1707492
UMLS CUI [1,2]
C0031325
UMLS CUI [1,3]
C0011008
Has a request been made for sample destruction?
Descripción

Has a request been made for sample destruction?

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1948029
UMLS CUI [1,2]
C0178913
UMLS CUI [1,3]
C1272683
If request for sample destruction has been made, check reason
Descripción

If request for sample destruction has been made, check reason

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1948029
UMLS CUI [1,2]
C0178913
UMLS CUI [1,3]
C1272683
UMLS CUI [1,4]
C0392360
If other reason for request for sample destruction, specify
Descripción

If other reason for request for sample destruction, specify

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1948029
UMLS CUI [1,2]
C0178913
UMLS CUI [1,3]
C1272683
UMLS CUI [1,4]
C0392360
UMLS CUI [1,5]
C0205394
UMLS CUI [1,6]
C2348235

Similar models

Pharmacogenetic Research Consent; Pharmacogenetic Research Withdrawal of Consent

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Pharmacogenetic Research Consent
C0021430 (UMLS CUI-1)
C2347500 (UMLS CUI-2)
Has informed consent been obtained for PGx-Pharmacogenetic research?
Item
Has informed consent been obtained for PGx-Pharmacogenetic research?
boolean
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
Date informed consent obtained for GPx-Pharmacogenetic research
Item
Date informed consent obtained for GPx-Pharmacogenetic research
date
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
If no informed consent obtained for Pharmacogenetic research, check reason
text
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Code List
If no informed consent obtained for Pharmacogenetic research, check reason
CL Item
Subject declined (1)
CL Item
Subject not asked by Investigator (2)
CL Item
Other, specify (Z)
If other reason for informed consent not been obtained, specify
Item
If other reason for informed consent not been obtained, specify
text
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C2348235 (UMLS CUI [1,5])
Has a blood sample been collected for PGx-pharmacogenetic (DNA) research?
Item
Has a blood sample been collected for PGx-pharmacogenetic (DNA) research?
boolean
C2347500 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
If a blood sample has been taken, record date sample taken
Item
If a blood sample has been taken, record date sample taken
date
C2347500 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item Group
Pharmacogenetic Research Withdrawal of Consent
C1707492 (UMLS CUI-1)
C0031325 (UMLS CUI-2)
Has subject withdrawn consent for PGx research?
Item
Has subject withdrawn consent for PGx research?
boolean
C1707492 (UMLS CUI [1,1])
C0031325 (UMLS CUI [1,2])
Date informed consent withdrawn
Item
Date informed consent withdrawn
date
C1707492 (UMLS CUI [1,1])
C0031325 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Has a request been made for sample destruction?
Item
Has a request been made for sample destruction?
boolean
C1948029 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C1272683 (UMLS CUI [1,3])
Item
If request for sample destruction has been made, check reason
text
C1948029 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C1272683 (UMLS CUI [1,3])
C0392360 (UMLS CUI [1,4])
Code List
If request for sample destruction has been made, check reason
CL Item
Subject withdrew consent for PGx (3)
CL Item
Screen failure (2)
CL Item
Other, specify (Z)
If other reason for request for sample destruction, specify
Item
If other reason for request for sample destruction, specify
text
C1948029 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C1272683 (UMLS CUI [1,3])
C0392360 (UMLS CUI [1,4])
C0205394 (UMLS CUI [1,5])
C2348235 (UMLS CUI [1,6])

Utilice este formulario para comentarios, preguntas y sugerencias.

Los campos marcados con * son obligatorios.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial