ID

20953

Descrizione

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

Keywords

versioni (1)
  1. 30/03/17 30/03/17 -
Caricato su

30 marzo 2017

DOI

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Licenza

Creative Commons BY-NC 3.0
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Radium-223 Dichloride (Alpharadin) DRKS00006460 NCT01618370 in Castration-Resistant (Hormone-Refractory) Prostate Cancer Patients With Bone Metastases (Project Name: 16216)

Inglese

Radium 223 Dichloride (Alpharadin) - Project Name: 16216

1 moduli  
Subject release
Descrizione

Subject release

Date Subject released
Descrizione

Date Subject released

Tipo di dati

date

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

Section to be completed by Data Management only:

Data Management release for investigator signature
Descrizione

Data Management release for investigator signature

Tipo di dati

text

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

Date signature requested

Tipo di dati

date

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

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
Descrizione

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 di dati

text

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

Impact Interface

Trial Unit
Descrizione

Trial Unit

Tipo di dati

text

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

Country

Tipo di dati

text

Alias
UMLS CUI [1]
C0454664
Date of birth
Descrizione

Date of birth

Tipo di dati

date

Alias
UMLS CUI [1]
C0421451
Sex
Descrizione

Sex

Tipo di dati

text

Alias
UMLS CUI [1]
C0079399
Randomization Number
Descrizione

Randomization Number

Tipo di dati

integer

Date of start of screening (first visit)
Descrizione

Date of start of screening

Tipo di dati

date

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

Treatment start date

Tipo di dati

date

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

Treatment end date

Tipo di dati

date

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

End of study date

Tipo di dati

date

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

Last screening visit date

Tipo di dati

date

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

Reason for withdrawal from screening

Tipo di dati

text

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

Date of withdrawal from screening

Tipo di dati

date

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

Date of withdrawal from treatment

Tipo di dati

date

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

Reason for withdrawal from treatment

Tipo di dati

text

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

Date of withdrawal from trial

Tipo di dati

date

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

Reason for withdrawal from Trial

Tipo di dati

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
Descrizione

date of treatment phase visits

Tipo di dati

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
Descrizione

Comma-delimited list of names of regular visits

Tipo di dati

text

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

Comma-delimited list of names of regular visits

Tipo di dati

text

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

Most recent date of regular visits update

Tipo di dati

date

Alias
UMLS CUI [1,1]
C3899570
UMLS CUI [1,2]
C0011008
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Similar models

Radium 223 Dichloride (Alpharadin) - Project Name: 16216

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
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])
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