ID

20953

Description

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

Versions (1)
  1. 3/30/17 3/30/17 -
Uploaded on

March 30, 2017

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License

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)

English

Radium 223 Dichloride (Alpharadin) - Project Name: 16216

1 forms  
Subject release
Description

Subject release

Date Subject released
Description

Date Subject released

Data type

date

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

Section to be completed by Data Management only:

Data Management release for investigator signature
Description

Data Management release for investigator signature

Data type

text

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

Date signature requested

Data type

date

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

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
Description

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.

Data type

text

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

Impact Interface

Trial Unit
Description

Trial Unit

Data type

text

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

Country

Data type

text

Alias
UMLS CUI [1]
C0454664
Date of birth
Description

Date of birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Sex
Description

Sex

Data type

text

Alias
UMLS CUI [1]
C0079399
Randomization Number
Description

Randomization Number

Data type

integer

Date of start of screening (first visit)
Description

Date of start of screening

Data type

date

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

Treatment start date

Data type

date

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

Treatment end date

Data type

date

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

End of study date

Data type

date

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

Last screening visit date

Data type

date

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

Reason for withdrawal from screening

Data type

text

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

Date of withdrawal from screening

Data type

date

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

Date of withdrawal from treatment

Data type

date

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

Reason for withdrawal from treatment

Data type

text

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

Date of withdrawal from trial

Data type

date

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

Reason for withdrawal from Trial

Data type

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
Description

date of treatment phase visits

Data type

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
Description

Comma-delimited list of names of regular visits

Data type

text

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

Comma-delimited list of names of regular visits

Data type

text

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

Most recent date of regular visits update

Data type

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 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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