ID

20944

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

DOI

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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 (End of Active Follow-up)

English

Radium 223 Dichloride (Alpharadin) - End of Active Follow-up

1 forms  
Subject Visit
Description

Subject Visit

Visit Date
Description

Visit Date

Data type

date

Alias
UMLS CUI [1]
C1320303
ECOG Performance Status
Description

ECOG Performance Status

Date of performance status
Description

Date of performance status

Data type

date

Alias
UMLS CUI [1]
C2985720
Performance status
Description

Performance status

Data type

integer

Alias
UMLS CUI [1]
C1520224
Hematology (with DBC)
Description

Hematology (with DBC)

Date of specimen collection
Description

Date of specimen collection

Data type

date

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C0011008
Hematocrit
Description

Hematocrit

Data type

float

Alias
UMLS CUI [1]
C0518014
Hemoglobin
Description

Hemoglobin

Data type

float

Alias
UMLS CUI [1]
C0019046
RBC
Description

RBC

Data type

float

Alias
UMLS CUI [1]
C0014772
WBC
Description

WBC

Data type

float

Alias
UMLS CUI [1]
C0023508
Platelets
Description

Platelets

Data type

float

Alias
UMLS CUI [1]
C0005821
Neutrophils absolute count
Description

Neutrophils absolute count

Data type

integer

Alias
UMLS CUI [1]
C0948762
Lymphocytes absolute count
Description

Lymphocytes absolute count

Data type

float

Alias
UMLS CUI [1]
C3544087
Monocytes absolute count
Description

Monocytes absolute count

Data type

float

Alias
UMLS CUI [1]
C0200637
Eosinophils absolute count
Description

Eosinophils absolute count

Data type

float

Alias
UMLS CUI [1,1]
C0200638
UMLS CUI [1,2]
C1820736
Basophils absolute count
Description

Basophils absolute count

Data type

float

Alias
UMLS CUI [1,1]
C0200641
UMLS CUI [1,2]
C1820736
Neutrophils total
Description

Neutrophils total

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1]
C0200633
%
Lymphocytes
Description

Lymphocytes

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1]
C0024264
%
Monocytes
Description

Monocytes

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1]
C0026473
%
Eosinophils
Description

Eosinophils

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1]
C0945354
%
Basophils
Description

Basophils

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1]
C0200641
%
General Chemistry - Serum
Description

General Chemistry - Serum

Date of specimen collection
Description

Date of specimen collection

Data type

date

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C0011008
Sodium
Description

Sodium

Data type

float

Alias
UMLS CUI [1]
C0337443
Creatinine
Description

Creatinine

Data type

float

Alias
UMLS CUI [1]
C0201976
SGOT/AST
Description

SGOT/AST

Data type

integer

Alias
UMLS CUI [1]
C0201899
SGPT/ALT
Description

SGPT/ALT

Data type

integer

Alias
UMLS CUI [1]
C0201836
Alkaline Phosphatase
Description

Alkaline Phosphatase

Data type

float

Alias
UMLS CUI [1]
C0201850
Bilirubin, total
Description

Bilirubin, total

Data type

float

Alias
UMLS CUI [1]
C0201913
Prostate Specific Antigen
Description

Prostate Specific Antigen

Data type

integer

Alias
UMLS CUI [1]
C0201544
End of Active Follow-up
Description

End of Active Follow-up

Primary reason for discontinuation of active follow-up
Description

Primary reason for discontinuation of active follow-up

Data type

text

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C1549995
If primary reason is "Adverse Event(s) not associated with clinical disease progression", give number(s).
Description

Up to 3 AE numbers can be entered:

Data type

text

Alias
UMLS CUI [1,1]
C1444662
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C0877248
Dynamic search list contains: "Number - Term - Start Date"
Description

Dynamic search list

Data type

text

Alias
UMLS CUI [1,1]
C0557959
UMLS CUI [1,2]
C0745732
If primary reason is "Adverse Event(s) associated with clinical disease progression", give number(s).
Description

Up to 3 AE numbers can be entered:

Data type

text

Alias
UMLS CUI [1,1]
C1444662
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C0877248
Dynamic search list contains: "Number - Term - Start Date"
Description

Dynamic search list

Data type

text

Alias
UMLS CUI [1,1]
C0557959
UMLS CUI [1,2]
C0745732
If primary reason is `Withdrawal by subject (Consent withdrawn)`,specify
Description

primary reason Consent withdrawn

Data type

text

Alias
UMLS CUI [1,1]
C1549995
UMLS CUI [1,2]
C1707492
If primary reason is "Other", specify
Description

primary reason Other

Data type

text

Alias
UMLS CUI [1,1]
C1549995
UMLS CUI [1,2]
C0205394
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Similar models

Radium 223 Dichloride (Alpharadin) - End of Active Follow-up

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Subject Visit
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
ECOG Performance Status
Date of performance status
Item
Date of performance status
date
C2985720 (UMLS CUI [1])
Item
Performance status
integer
C1520224 (UMLS CUI [1])
Performance status
Code List
Performance status
CL Item
Fully active, able to carry on all pre-disease performance without restriction. (0 )
CL Item
Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature ( eg light housework, office work). (1 )
CL Item
Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours. (2 )
CL Item
Capable of only limited self-care, confined to bed or chair more than 50% ofwaking hours. (3 )
CL Item
Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. (4 )
Item Group
Hematology (with DBC)
Date of specimen collection
Item
Date of specimen collection
date
C0032976 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Hematocrit
Item
Hematocrit
float
C0518014 (UMLS CUI [1])
Hemoglobin
Item
Hemoglobin
float
C0019046 (UMLS CUI [1])
RBC
Item
RBC
float
C0014772 (UMLS CUI [1])
WBC
Item
WBC
float
C0023508 (UMLS CUI [1])
Platelets
Item
Platelets
float
C0005821 (UMLS CUI [1])
Neutrophils absolute count
Item
Neutrophils absolute count
integer
C0948762 (UMLS CUI [1])
Lymphocytes absolute count
Item
Lymphocytes absolute count
float
C3544087 (UMLS CUI [1])
Monocytes absolute count
Item
Monocytes absolute count
float
C0200637 (UMLS CUI [1])
Eosinophils absolute count
Item
Eosinophils absolute count
float
C0200638 (UMLS CUI [1,1])
C1820736 (UMLS CUI [1,2])
Basophils absolute count
Item
Basophils absolute count
float
C0200641 (UMLS CUI [1,1])
C1820736 (UMLS CUI [1,2])
Neutrophils total
Item
Neutrophils total
float
C0200633 (UMLS CUI [1])
Lymphocytes
Item
Lymphocytes
float
C0024264 (UMLS CUI [1])
Monocytes
Item
Monocytes
float
C0026473 (UMLS CUI [1])
Eosinophils
Item
Eosinophils
float
C0945354 (UMLS CUI [1])
Basophils
Item
Basophils
float
C0200641 (UMLS CUI [1])
Item Group
General Chemistry - Serum
Date of specimen collection
Item
Date of specimen collection
date
C0032976 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Sodium
Item
Sodium
float
C0337443 (UMLS CUI [1])
Creatinine
Item
Creatinine
float
C0201976 (UMLS CUI [1])
SGOT/AST
Item
SGOT/AST
integer
C0201899 (UMLS CUI [1])
SGPT/ALT
Item
SGPT/ALT
integer
C0201836 (UMLS CUI [1])
Alkaline Phosphatase
Item
Alkaline Phosphatase
float
C0201850 (UMLS CUI [1])
Bilirubin, total
Item
Bilirubin, total
float
C0201913 (UMLS CUI [1])
Prostate Specific Antigen
Item
Prostate Specific Antigen
integer
C0201544 (UMLS CUI [1])
Item Group
End of Active Follow-up
Primary reason for discontinuation of active follow-up
Item
Primary reason for discontinuation of active follow-up
text
C0008976 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C1549995 (UMLS CUI [1,3])
primary reason
Item
If primary reason is "Adverse Event(s) not associated with clinical disease progression", give number(s).
text
C1444662 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
Dynamic search list
Item
Dynamic search list contains: "Number - Term - Start Date"
text
C0557959 (UMLS CUI [1,1])
C0745732 (UMLS CUI [1,2])
primary reason
Item
If primary reason is "Adverse Event(s) associated with clinical disease progression", give number(s).
text
C1444662 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
Dynamic search list
Item
Dynamic search list contains: "Number - Term - Start Date"
text
C0557959 (UMLS CUI [1,1])
C0745732 (UMLS CUI [1,2])
primary reason Consent withdrawn
Item
If primary reason is `Withdrawal by subject (Consent withdrawn)`,specify
text
C1549995 (UMLS CUI [1,1])
C1707492 (UMLS CUI [1,2])
primary reason Other
Item
If primary reason is "Other", specify
text
C1549995 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
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