ID

41825

Descrição

Study ID: 111582 Clinical Study ID: 111582 Study Title: An Open Label Study to Examine the Effects of Low-fat and High-fat Meals on the Pharmacokinetics of Orally Administered Lapatinib in Metastatic ErbB2 Positive Breast Cancer Patients. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00821054 https://clinicaltrials.gov/ct2/show/NCT00821054 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Lapatinib Trade Name: N/A Study Indication: Neoplasms, Breast The study consists of a screening, four study visits at day-1, week 1, 2 and 3 and a follow-up visit. This document documents if a consent for PGx-Pharmacogenetic Research has been given and/or withdrawn.

Link

https://clinicaltrials.gov/ct2/show/NCT00821054

Palavras-chave

Versões (1)
  1. 23/01/2021 23/01/2021 -
Titular dos direitos

GlaxoSmithKline

Transferido a

23 de janeiro de 2021

DOI

Para um pedido faça login.

Licença

Creative Commons BY-NC 4.0
Comentários do modelo :

Aqui pode comentar o modelo. Pode comentá-lo especificamente através dos balões de texto nos grupos de itens e itens.

Voltar para os comentários do modelo
Comentários do grupo de itens para :

Comentários do item para :

Para descarregar formulários, precisa de ter uma sessão iniciada. Por favor faça login ou registe-se gratuitamente.

Effects of Low-fat and high-fat meals on the Pharmacokinetics of Lapatinib in ErB2+ Breast Cancer patients, NCT00821054

Inglês

Pharmacogenetic Research

1 Formulários  
Administrative Data
Descrição

Administrative Data

Alias
UMLS CUI-1
C1320722
subject ID
Descrição

subject ID

Tipo de dados

text

Alias
UMLS CUI [1]
C2348585
date of visit
Descrição

date of visit

Tipo de dados

date

Alias
UMLS CUI [1]
C1320303
PGx-Pharmacogenetic Research Consent
Descrição

PGx-Pharmacogenetic Research Consent

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

informed consent for pharmacogenetic research

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2347500
if yes, please provide the date informed consent obtained for PGx-Pharmacogenetic research
Descrição

pharmacogenetic research consent, date

Tipo de dados

date

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2347500
UMLS CUI [1,3]
C0011008
if yes, has a blood sample been collected for PGx-pharmacogenetic (DNA) research?
Descrição

pharmacogenetic research, blood sample

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1277698
UMLS CUI [1,2]
C2347500
if blood sample taken, please record date
Descrição

date blood sample taken, pharmacogenetic test

Tipo de dados

date

Alias
UMLS CUI [1,1]
C1277698
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C2347500
if no, please check reason:
Descrição

pharmacogenetic tests, no consent, reason

Tipo de dados

text

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C0332197
UMLS CUI [1,4]
C0566251
if other, please specify:
Descrição

pharmacogenetic tests, no consent, other reason

Tipo de dados

text

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C0332197
UMLS CUI [1,4]
C3840932
PGx-Pharmacogenetic Research Withdrawal of Consent
Descrição

PGx-Pharmacogenetic Research Withdrawal of Consent

Alias
UMLS CUI-1
C2347500
UMLS CUI-2
C0021430
UMLS CUI-3
C2349954
has subject withdrawn consent for PGx-Pharmacogenetic research?
Descrição

withdrawn consent for PGx-Pharmacogenetic research

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C2349954
if yes, please record the date the informed consent has been withdrawn
Descrição

pharmacogenetic tests, date informed consent has been withdrawn

Tipo de dados

date

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C2349954
UMLS CUI [1,4]
C0011008
has a request been made for sample destruction?
Descrição

pharmacogenetic research, request for sample destruction

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C1948029
UMLS CUI [1,3]
C1272683
if yes, please check reason:
Descrição

pharmacogenetic research, request for sample destruction, reason

Tipo de dados

text

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C1948029
UMLS CUI [1,3]
C1272683
UMLS CUI [1,4]
C0566251
if other, please specify:
Descrição

pharmacogenetic research, request for sample destruction, other reason

Tipo de dados

text

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C1948029
UMLS CUI [1,3]
C1272683
UMLS CUI [1,4]
C3840932
Voltar ao início da página

Similar models

Pharmacogenetic Research

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
subject ID
Item
subject ID
text
C2348585 (UMLS CUI [1])
date of visit
Item
date of visit
date
C1320303 (UMLS CUI [1])
Item Group
PGx-Pharmacogenetic Research Consent
C2347500 (UMLS CUI-1)
C0021430 (UMLS CUI-2)
informed consent for pharmacogenetic research
Item
has informed consent been obtained for PGx-Pharmacogenetic research?
boolean
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
pharmacogenetic research consent, date
Item
if yes, please provide the date informed consent obtained for PGx-Pharmacogenetic research
date
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
pharmacogenetic research, blood sample
Item
if yes, has a blood sample been collected for PGx-pharmacogenetic (DNA) research?
boolean
C1277698 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
date blood sample taken, pharmacogenetic test
Item
if blood sample taken, please record date
date
C1277698 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C2347500 (UMLS CUI [1,3])
Item
if no, please check reason:
text
C2347500 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])
pharmacogenetic research, no consent, reason
Code List
if no, please check reason:
CL Item
subject declined (1)
CL Item
subject not asked by Investigator (2)
CL Item
other (z)
pharmacogenetic tests, no consent, other reason
Item
if other, please specify:
text
C2347500 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C3840932 (UMLS CUI [1,4])
Item Group
PGx-Pharmacogenetic Research Withdrawal of Consent
C2347500 (UMLS CUI-1)
C0021430 (UMLS CUI-2)
C2349954 (UMLS CUI-3)
withdrawn consent for PGx-Pharmacogenetic research
Item
has subject withdrawn consent for PGx-Pharmacogenetic research?
boolean
C2347500 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C2349954 (UMLS CUI [1,3])
pharmacogenetic tests, date informed consent has been withdrawn
Item
if yes, please record the date the informed consent has been withdrawn
date
C2347500 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C2349954 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
pharmacogenetic research, request for sample destruction
Item
has a request been made for sample destruction?
boolean
C2347500 (UMLS CUI [1,1])
C1948029 (UMLS CUI [1,2])
C1272683 (UMLS CUI [1,3])
Item
if yes, please check reason:
text
C2347500 (UMLS CUI [1,1])
C1948029 (UMLS CUI [1,2])
C1272683 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])
pharmacogenetic research, request for sample destruction, reason
Code List
if yes, please check reason:
CL Item
subject withdrew consent for PGx (3)
CL Item
other (Z)
pharmacogenetic research, request for sample destruction, other reason
Item
if other, please specify:
text
C2347500 (UMLS CUI [1,1])
C1948029 (UMLS CUI [1,2])
C1272683 (UMLS CUI [1,3])
C3840932 (UMLS CUI [1,4])
Voltar ao início da página 

Contacto

Use este formulário para feedback, perguntas e sugestões de aperfeiçoamento.

Campos marcados com * são obrigatórios.

Ajuda

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