ID

20951

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 (Unscheduled Procedures)

English

Radium 223 Dichloride (Alpharadin) - Unscheduled Procedures

1 forms  
Hematology (with DBC), unscheduled
Description

Hematology (with DBC), unscheduled

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, unscheduled
Description

General Chemistry - Serum, unscheduled

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
Vital Signs, unscheduled
Description

Vital Signs, unscheduled

Date of Vital Signs
Description

Date of Vital Signs

Data type

date

Alias
UMLS CUI [1]
C2826644
Weight
Description

Weight

Data type

text

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
BPI-SF, unscheduled
Description

BPI-SF, unscheduled

Date of assessment
Description

Date of assessment

Data type

date

Alias
UMLS CUI [1]
C2985720
Throughout our lives, most of us have had pain from time to time (such as minor headaches, sprains, and toothaches). Have you had pain other than these everyday kinds of pain today?
Description

Current pain

Data type

boolean

Alias
UMLS CUI [1]
C0030193
Please rate your pain by circling the one number that best describes your pain at its worst in the last 24 hours.
Description

BPI

Data type

text

Alias
UMLS CUI [1,1]
C2732532
UMLS CUI [1,2]
C3898741
Please rate your pain by circling the one number that best describes your pain at its least in the last 24 hours.
Description

BPI

Data type

text

Alias
UMLS CUI [1,1]
C2732532
UMLS CUI [1,2]
C3828673
Please rate your pain by circling the one number that best describes your pain on the average.
Description

BPI

Data type

text

Alias
UMLS CUI [1,1]
C0042815
UMLS CUI [1,2]
C3641836
Please rate your pain by circling the one number that tells how much pain you have right now.
Description

BPI

Data type

text

Alias
UMLS CUI [1,1]
C2732532
UMLS CUI [1,2]
C3840282
Circle the one number that describes how, during the past 24 hours, pain has interfered with your:
Description

BPI

Data type

text

Alias
UMLS CUI [1,1]
C2732532
UMLS CUI [1,2]
C0030193
UMLS CUI [1,3]
C0521102
General Activity
Description

Pain interfered with General Activity

Data type

text

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0441655
Mood
Description

Pain interfered with Mood

Data type

text

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0026516
Walking Ability
Description

Pain interfered with Walking Ability

Data type

text

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0559964
Normal Work (includes both work outside the home and housework)
Description

Pain interfered with Normal Work

Data type

text

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C3898033
Relations with other people
Description

Pain interfered with Relations with other people

Data type

text

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0021797
Sleep
Description

Pain interfered with Sleep

Data type

text

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0037313
Enjoyment of life
Description

Pain interfered with Enjoyment of life

Data type

text

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0424131
ECOG Performance Status, unscheduled
Description

ECOG Performance Status, unscheduled

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
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Similar models

Radium 223 Dichloride (Alpharadin) - Unscheduled Procedures

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Hematology (with DBC), unscheduled
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, unscheduled
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
Vital Signs, unscheduled
Date of Vital Signs
Item
Date of Vital Signs
date
C2826644 (UMLS CUI [1])
Weight
Item
Weight
text
C0005910 (UMLS CUI [1])
Item Group
BPI-SF, unscheduled
Date of assessment
Item
Date of assessment
date
C2985720 (UMLS CUI [1])
Current pain
Item
Throughout our lives, most of us have had pain from time to time (such as minor headaches, sprains, and toothaches). Have you had pain other than these everyday kinds of pain today?
boolean
C0030193 (UMLS CUI [1])
BPI
Item
Please rate your pain by circling the one number that best describes your pain at its worst in the last 24 hours.
text
C2732532 (UMLS CUI [1,1])
C3898741 (UMLS CUI [1,2])
BPI
Item
Please rate your pain by circling the one number that best describes your pain at its least in the last 24 hours.
text
C2732532 (UMLS CUI [1,1])
C3828673 (UMLS CUI [1,2])
BPI
Item
Please rate your pain by circling the one number that best describes your pain on the average.
text
C0042815 (UMLS CUI [1,1])
C3641836 (UMLS CUI [1,2])
BPI
Item
Please rate your pain by circling the one number that tells how much pain you have right now.
text
C2732532 (UMLS CUI [1,1])
C3840282 (UMLS CUI [1,2])
BPI
Item
Circle the one number that describes how, during the past 24 hours, pain has interfered with your:
text
C2732532 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
Pain interfered with General Activity
Item
General Activity
text
C0030193 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0441655 (UMLS CUI [1,3])
Pain interfered with Mood
Item
Mood
text
C0030193 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0026516 (UMLS CUI [1,3])
Pain interfered with Walking Ability
Item
Walking Ability
text
C0030193 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0559964 (UMLS CUI [1,3])
Pain interfered with Normal Work
Item
Normal Work (includes both work outside the home and housework)
text
C0030193 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C3898033 (UMLS CUI [1,3])
Pain interfered with Relations with other people
Item
Relations with other people
text
C0030193 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0021797 (UMLS CUI [1,3])
Pain interfered with Sleep
Item
Sleep
text
C0030193 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0037313 (UMLS CUI [1,3])
Pain interfered with Enjoyment of life
Item
Enjoyment of life
text
C0030193 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0424131 (UMLS CUI [1,3])
Item Group
ECOG Performance Status, unscheduled
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 )
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