ID

20817

Beschreibung

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

Stichworte

Versionen (1)
  1. 20.03.17 20.03.17 -
Hochgeladen am

20. März 2017

DOI

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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 Treatment Visit)

Englisch

Radium 223 Dichloride (Alpharadin) - End of Treatment Visit

1 Formulare  
Subject Visit
Beschreibung

Subject Visit

Visit Date
Beschreibung

Visit Date

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Assessment of Disease Progression
Beschreibung

Assessment of Disease Progression

Date of assessment
Beschreibung

Date of assessment

Datentyp

date

Alias
UMLS CUI [1]
C2985720
Has the patient experienced Disease Progression per the local standard of care?
Beschreibung

Disease progression

Datentyp

boolean

Alias
UMLS CUI [1]
C0242656
Vital Signs
Beschreibung

Vital Signs

Date of Vital Signs
Beschreibung

Date of Vital Signs

Datentyp

date

Alias
UMLS CUI [1]
C2826644
Weight
Beschreibung

Weight

Datentyp

text

Maßeinheiten
  • kg
Alias
UMLS CUI [1]
C0005910
kg
BPI-SF
Beschreibung

BPI-SF

Date of assessment
Beschreibung

Date of assessment

Datentyp

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?
Beschreibung

Current pain

Datentyp

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.
Beschreibung

BPI

Datentyp

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.
Beschreibung

BPI

Datentyp

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.
Beschreibung

BPI

Datentyp

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.
Beschreibung

BPI

Datentyp

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:
Beschreibung

BPI

Datentyp

text

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

Pain interfered with General Activity

Datentyp

text

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

Pain interfered with Mood

Datentyp

text

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

Pain interfered with Walking Ability

Datentyp

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)
Beschreibung

Pain interfered with Normal Work

Datentyp

text

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

Pain interfered with Relations with other people

Datentyp

text

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

Pain interfered with Sleep

Datentyp

text

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

Pain interfered with Enjoyment of life

Datentyp

text

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

ECOG Performance Status

Date of performance status
Beschreibung

Date of performance status

Datentyp

date

Alias
UMLS CUI [1]
C2985720
Performance status
Beschreibung

Performance status

Datentyp

integer

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

Hematology (with DBC)

Date of specimen collection
Beschreibung

Date of specimen collection

Datentyp

date

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

Hematocrit

Datentyp

float

Alias
UMLS CUI [1]
C0518014
Hemoglobin
Beschreibung

Hemoglobin

Datentyp

float

Alias
UMLS CUI [1]
C0019046
RBC
Beschreibung

RBC

Datentyp

float

Alias
UMLS CUI [1]
C0014772
WBC
Beschreibung

WBC

Datentyp

float

Alias
UMLS CUI [1]
C0023508
Platelets
Beschreibung

Platelets

Datentyp

float

Alias
UMLS CUI [1]
C0005821
Neutrophils absolute count
Beschreibung

Neutrophils absolute count

Datentyp

integer

Alias
UMLS CUI [1]
C0948762
Lymphocytes absolute count
Beschreibung

Lymphocytes absolute count

Datentyp

float

Alias
UMLS CUI [1]
C3544087
Monocytes absolute count
Beschreibung

Monocytes absolute count

Datentyp

float

Alias
UMLS CUI [1]
C0200637
Eosinophils absolute count
Beschreibung

Eosinophils absolute count

Datentyp

float

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

Basophils absolute count

Datentyp

float

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

Neutrophils total

Datentyp

float

Maßeinheiten
  • %
Alias
UMLS CUI [1]
C0200633
%
Lymphocytes
Beschreibung

Lymphocytes

Datentyp

float

Maßeinheiten
  • %
Alias
UMLS CUI [1]
C0024264
%
Monocytes
Beschreibung

Monocytes

Datentyp

float

Maßeinheiten
  • %
Alias
UMLS CUI [1]
C0026473
%
Eosinophils
Beschreibung

Eosinophils

Datentyp

float

Maßeinheiten
  • %
Alias
UMLS CUI [1]
C0945354
%
Basophils
Beschreibung

Basophils

Datentyp

float

Maßeinheiten
  • %
Alias
UMLS CUI [1]
C0200641
%
General Chemistry - Serum
Beschreibung

General Chemistry - Serum

Date of specimen collection
Beschreibung

Date of specimen collection

Datentyp

date

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

Sodium

Datentyp

float

Alias
UMLS CUI [1]
C0337443
Creatinine
Beschreibung

Creatinine

Datentyp

float

Alias
UMLS CUI [1]
C0201976
SGOT/AST
Beschreibung

SGOT/AST

Datentyp

integer

Alias
UMLS CUI [1]
C0201899
SGPT/ALT
Beschreibung

SGPT/ALT

Datentyp

integer

Alias
UMLS CUI [1]
C0201836
Alkaline Phosphatase
Beschreibung

Alkaline Phosphatase

Datentyp

float

Alias
UMLS CUI [1]
C0201850
Bilirubin, total
Beschreibung

Bilirubin, total

Datentyp

float

Alias
UMLS CUI [1]
C0201913
Prostate Specific Antigen
Beschreibung

Prostate Specific Antigen

Datentyp

integer

Alias
UMLS CUI [1]
C0201544
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Ähnliche Modelle

Radium 223 Dichloride (Alpharadin) - End of Treatment Visit

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Subject Visit
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Assessment of Disease Progression
Date of assessment
Item
Date of assessment
date
C2985720 (UMLS CUI [1])
Disease progression
Item
Has the patient experienced Disease Progression per the local standard of care?
boolean
C0242656 (UMLS CUI [1])
Item Group
Vital Signs
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
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
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])
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