ID

20953

Descrição

This study is a prospective, interventional, open-label, multi-center early access program for the use of Ra-223 Cl2 in HRPC/CRPC (Hormone refractory prostate cancer / Castrate resistant prostate cancer) patients diagnosed with bone metastasis and to collect additional short and long term safety data on the product. NCT01618370

Palavras-chave

Versões (1)
  1. 30/03/2017 30/03/2017 -
Transferido a

30 de março de 2017

DOI

Para um pedido faça login.

Licença

Creative Commons BY-NC 3.0
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.

Radium-223 Dichloride (Alpharadin) DRKS00006460 NCT01618370 in Castration-Resistant (Hormone-Refractory) Prostate Cancer Patients With Bone Metastases (Project Name: 16216)

Inglês

Radium 223 Dichloride (Alpharadin) - Project Name: 16216

1 Formulários  
Subject release
Descrição

Subject release

Date Subject released
Descrição

Date Subject released

Tipo de dados

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0391871
Section to be completed by Data Management only:
Descrição

Section to be completed by Data Management only:

Data Management release for investigator signature
Descrição

Data Management release for investigator signature

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0596404
UMLS CUI [1,2]
C0391871
UMLS CUI [1,3]
C2346576
Date signature requested
Descrição

Date signature requested

Tipo de dados

date

Alias
UMLS CUI [1,1]
C1519316
UMLS CUI [1,2]
C1272683
UMLS CUI [1,3]
C0011008
Investigator Signature
Descrição

Investigator Signature

I certify that all entries on the CRFs for this subject accurately and completely reflect the results of the examinations, tests, and evaluations performed on the dates specified
Descrição

Enter your password when you have entered all data for this subject including the End of Study Page and study level pages such as the Adverse Events page. You should also resolve all queries before 'signing' this page. If you change any data for this subject your 'Signature' will be revoked and you will need to return to this page to re-sign.

Tipo de dados

text

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0750484
Impact Interface
Descrição

Impact Interface

Trial Unit
Descrição

Trial Unit

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C0439148
Country
Descrição

Country

Tipo de dados

text

Alias
UMLS CUI [1]
C0454664
Date of birth
Descrição

Date of birth

Tipo de dados

date

Alias
UMLS CUI [1]
C0421451
Sex
Descrição

Sex

Tipo de dados

text

Alias
UMLS CUI [1]
C0079399
Randomization Number
Descrição

Randomization Number

Tipo de dados

integer

Date of start of screening (first visit)
Descrição

Date of start of screening

Tipo de dados

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C1710477
Date of the start of treatment (first treatment visit)
Descrição

Treatment start date

Tipo de dados

date

Alias
UMLS CUI [1]
C3173309
Date of the end of treatment (last treatment visit)
Descrição

Treatment end date

Tipo de dados

date

Alias
UMLS CUI [1]
C1531784
Date of end of study (if patient completes)
Descrição

End of study date

Tipo de dados

date

Alias
UMLS CUI [1]
C2983670
Date of last available screening visit
Descrição

Last screening visit date

Tipo de dados

date

Alias
UMLS CUI [1,1]
C2097637
UMLS CUI [1,2]
C0011008
Reason for withdrawal from screening
Descrição

Reason for withdrawal from screening

Tipo de dados

text

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0566251
UMLS CUI [1,3]
C1710477
Date of withdrawal from screening
Descrição

Date of withdrawal from screening

Tipo de dados

date

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C1710477
Date of withdrawal from treatment
Descrição

Date of withdrawal from treatment

Tipo de dados

date

Alias
UMLS CUI [1,1]
C1701941
UMLS CUI [1,2]
C0011008
Reason for withdrawal from treatment
Descrição

Reason for withdrawal from treatment

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1701941
UMLS CUI [1,2]
C0566251
Date of withdrawal from trial
Descrição

Date of withdrawal from trial

Tipo de dados

date

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0011008
Reason for withdrawal from Trial
Descrição

Reason for withdrawal from Trial

Tipo de dados

text

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0566251
UMLS CUI [1,3]
C0008976
Most recent date of treatment phase visits update
Descrição

date of treatment phase visits

Tipo de dados

date

Alias
UMLS CUI [1,1]
C0814495
UMLS CUI [1,2]
C3899570
UMLS CUI [1,3]
C0011008
Comma-delimited list of names of regular visits
Descrição

Comma-delimited list of names of regular visits

Tipo de dados

text

Alias
UMLS CUI [1]
C3899570
Comma-delimited list of names of regular visits
Descrição

Comma-delimited list of names of regular visits

Tipo de dados

text

Alias
UMLS CUI [1]
C3899570
Most recent date of regular visits update
Descrição

Most recent date of regular visits update

Tipo de dados

date

Alias
UMLS CUI [1,1]
C3899570
UMLS CUI [1,2]
C0011008
Voltar ao início da página

Similar models

Radium 223 Dichloride (Alpharadin) - Project Name: 16216

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Subject release
Date Subject released
Item
Date Subject released
date
C0011008 (UMLS CUI [1,1])
C0391871 (UMLS CUI [1,2])
Item Group
Section to be completed by Data Management only:
Data Management release for investigator signature
Item
Data Management release for investigator signature
text
C0596404 (UMLS CUI [1,1])
C0391871 (UMLS CUI [1,2])
C2346576 (UMLS CUI [1,3])
Date signature requested
Item
Date signature requested
date
C1519316 (UMLS CUI [1,1])
C1272683 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item Group
Investigator Signature
Confirmation
Item
I certify that all entries on the CRFs for this subject accurately and completely reflect the results of the examinations, tests, and evaluations performed on the dates specified
text
C2346576 (UMLS CUI [1,1])
C0750484 (UMLS CUI [1,2])
Item Group
Impact Interface
Trial Unit
Item
Trial Unit
text
C0008976 (UMLS CUI [1,1])
C0439148 (UMLS CUI [1,2])
Country
Item
Country
text
C0454664 (UMLS CUI [1])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Sex
Item
Sex
text
C0079399 (UMLS CUI [1])
Randomization Number
Item
Randomization Number
integer
Date of start of screening
Item
Date of start of screening (first visit)
date
C0808070 (UMLS CUI [1,1])
C1710477 (UMLS CUI [1,2])
Treatment start date
Item
Date of the start of treatment (first treatment visit)
date
C3173309 (UMLS CUI [1])
Treatment end date
Item
Date of the end of treatment (last treatment visit)
date
C1531784 (UMLS CUI [1])
End of study date
Item
Date of end of study (if patient completes)
date
C2983670 (UMLS CUI [1])
Last screening visit date
Item
Date of last available screening visit
date
C2097637 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Reason for withdrawal from screening
Item
Reason for withdrawal from screening
text
C2349954 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C1710477 (UMLS CUI [1,3])
Date of withdrawal from screening
Item
Date of withdrawal from screening
date
C2349954 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C1710477 (UMLS CUI [1,3])
Date of withdrawal from treatment
Item
Date of withdrawal from treatment
date
C1701941 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Reason for withdrawal from treatment
Item
Reason for withdrawal from treatment
text
C1701941 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
Date of withdrawal from trial
Item
Date of withdrawal from trial
date
C2349954 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Reason for withdrawal from Trial
Item
Reason for withdrawal from Trial
text
C2349954 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
date of treatment phase visits
Item
Most recent date of treatment phase visits update
date
C0814495 (UMLS CUI [1,1])
C3899570 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Comma-delimited list of names of regular visits
Item
Comma-delimited list of names of regular visits
text
C3899570 (UMLS CUI [1])
Comma-delimited list of names of regular visits
Item
Comma-delimited list of names of regular visits
text
C3899570 (UMLS CUI [1])
Most recent date of regular visits update
Item
Most recent date of regular visits update
date
C3899570 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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