Information:
Fel:
ID
20207
Beskrivning
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
Nyckelord
Versioner (1)
- 2017-02-13 2017-02-13 -
Uppladdad den
13 februari 2017
DOI
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Licens
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
Radium 223 Dichloride (Alpharadin) - Screening Visit
- StudyEvent: ODM
Similar models
Radium 223 Dichloride (Alpharadin) - Screening Visit
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Visit date
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Year of birth
Item
Year of birth
integer
C2826771 (UMLS CUI [1])
Age
Item
Age
integer
C0001779 (UMLS CUI [1])
CL Item
Years (1)
CL Item
Months (2)
CL Item
Weeks (3)
CL Item
Days (4)
Gender
Item
Gender: Male
boolean
C0079399 (UMLS CUI [1])
Date of informed consent
Item
Date of first informed consent
date
C0011008 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,2])
Protocol amendment number
Item
Protocol amendment number in effect at time of first informed consent
integer
C1507394 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
Ethnicity
Item
Ethnicity
text
C0015031 (UMLS CUI [1])
White (Caucasian)
Item
White
boolean
C0007457 (UMLS CUI [1])
Black ethnicity
Item
Black ethnicity
boolean
C0005680 (UMLS CUI [1])
Asian
Item
Asian
boolean
C0078988 (UMLS CUI [1])
American Indian or Alaska Native
Item
American Indian or Alaska Native
boolean
C0683984 (UMLS CUI [1])
Native Hawaiian or Other Pacific Islander
Item
Native Hawaiian or Other Pacific Islander
boolean
Ethnicity not reported
Item
Ethnicity not reported
boolean
C0015031 (UMLS CUI [1,1])
C1706613 (UMLS CUI [1,2])
C1706613 (UMLS CUI [1,2])
Vital Signs Date
Item
Date of vital signs
date
C2826644 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Date of initial diagnosis
Item
Date of initial diagnosis
date
C2316983 (UMLS CUI [1])
Disease Progression Date
Item
Most recent progression/relapse date
date
C0012634 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Assessment type
Item
Type of assessment
text
C2911685 (UMLS CUI [1])
Date of diagnosis of bone metastases
Item
Date of diagnosis of bone metastases
date
C2316983 (UMLS CUI [1,1])
C0153690 (UMLS CUI [1,2])
C0153690 (UMLS CUI [1,2])
Stage at initial diagnosis
Item
Stage at initial diagnosis
text
C0474935 (UMLS CUI [1,1])
C4071762 (UMLS CUI [1,2])
C4071762 (UMLS CUI [1,2])
Gleason score at initial diagnosis
Item
Gleason score at initial diagnosis
text
C4071762 (UMLS CUI [1,1])
C0332326 (UMLS CUI [1,2])
C0332326 (UMLS CUI [1,2])
Stage at study entry
Item
Stage at study entry
text
C0474935 (UMLS CUI [1,1])
C4041024 (UMLS CUI [1,2])
C4041024 (UMLS CUI [1,2])
Assessment Date
Item
Date of Assessment
date
C2985720 (UMLS CUI [1])
Brief pain inventory
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 every- day kinds of pain today?
text
C1511326 (UMLS CUI [1])
Item
Please rate your pain by circling the one number that best describes your pain at its worst in the last 24 hours.
integer
C1511326 (UMLS CUI [1])
Code List
Please rate your pain by circling the one number that best describes your pain at its worst in the last 24 hours.
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CL Item
6 (6)
CL Item
7 (7)
CL Item
8 (8)
CL Item
9 (9)
CL Item
10 (10)
Item
Please rate your pain by circling the one number that best describes your pain at its least in the last 24 hours.
integer
C1511326 (UMLS CUI [1])
Code List
Please rate your pain by circling the one number that best describes your pain at its least in the last 24 hours.
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CL Item
6 (6)
CL Item
7 (7)
CL Item
8 (8)
CL Item
9 (9)
CL Item
10 (10)
Item
Please rate your pain by circling the one number that best describes your pain on the average.
integer
C1511326 (UMLS CUI [1])
Code List
Please rate your pain by circling the one number that best describes your pain on the average.
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CL Item
6 (6)
CL Item
7 (7)
CL Item
8 (8)
CL Item
9 (9)
CL Item
10 (10)
Item
Please rate your pain by circling the one number that tells how much pain you have right now.
integer
C1511326 (UMLS CUI [1])
Code List
Please rate your pain by circling the one number that tells how much pain you have right now.
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CL Item
6 (6)
CL Item
7 (7)
CL Item
8 (8)
CL Item
9 (9)
CL Item
10 (10)
Item
Circle the one number that describes how, during the past 24 hours, pain has interfered with your daily activities below
text
C1511326 (UMLS CUI [1])
Code List
Circle the one number that describes how, during the past 24 hours, pain has interfered with your daily activities below
Item
General activity
integer
C1511326 (UMLS CUI [1,1])
C0441655 (UMLS CUI [1,2])
C0441655 (UMLS CUI [1,2])
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CL Item
6 (6)
CL Item
7 (7)
CL Item
8 (8)
CL Item
9 (9)
CL Item
10 (10)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CL Item
6 (6)
CL Item
7 (7)
CL Item
8 (8)
CL Item
9 (9)
CL Item
10 (10)
Item
Walking Ability
integer
C1511326 (UMLS CUI [1,1])
C0559964 (UMLS CUI [1,2])
C0559964 (UMLS CUI [1,2])
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CL Item
6 (6)
CL Item
7 (7)
CL Item
8 (8)
CL Item
9 (9)
CL Item
10 (10)
Item
Normal Work (includes both work outside the home and housework)
integer
C1511326 (UMLS CUI [1,1])
C3642250 (UMLS CUI [1,2])
C3642250 (UMLS CUI [1,2])
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CL Item
6 (6)
CL Item
7 (7)
CL Item
8 (8)
CL Item
9 (9)
CL Item
10 (10)
Item
Relations with other people
integer
C1511326 (UMLS CUI [1,1])
C0021797 (UMLS CUI [1,2])
C0021797 (UMLS CUI [1,2])
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CL Item
6 (6)
CL Item
7 (7)
CL Item
8 (8)
CL Item
9 (9)
CL Item
10 (10)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CL Item
6 (6)
CL Item
7 (7)
CL Item
8 (8)
CL Item
9 (9)
CL Item
10 (10)
Item
Enjoyment of life
integer
C1511326 (UMLS CUI [1,1])
C0424131 (UMLS CUI [1,2])
C0424131 (UMLS CUI [1,2])
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CL Item
6 (6)
CL Item
7 (7)
CL Item
8 (8)
CL Item
9 (9)
CL Item
10 (10)
Assessment date
Item
Date of performance status
date
C2985720 (UMLS CUI [1])
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, E.g., Light Housework, Office Work. (1)
CL Item
Ambulatory And Capable Of All Selfcare But Unable To Carry Out Any Work Activities. Up And About More Than 50% Of Waking Hours. (2)
CL Item
Capable Of Only Limited Selfcare, Confined To Bed Or Chair More Than 50% Of Waking Hours. (3)
CL Item
Completely Disabled. Cannot Carry On Any Selfcare. Totally Confined To Bed Or Chair. (4)
Prior radiotherapy
Item
Has the subject received any prior radiotherapy associated with the cancer on study?
boolean
C0279134 (UMLS CUI [1])
Regimen number
Item
Regimen number
text
C0040808 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
Irradiation site
Item
Irradiated location 1
text
C2169202 (UMLS CUI [1])
Irradiation site
Item
Irradiated location 2
text
C2169202 (UMLS CUI [1])
Irradiation site
Item
Irradiated location 3
text
C2169202 (UMLS CUI [1])
Intent
Item
Intent
text
C1283828 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
C1522449 (UMLS CUI [1,2])
Date of first fraction
Item
Date of first fraction
date
C1279901 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C1522449 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Date of last fraction
Item
Date of last fraction
date
C1517741 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C1522449 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Total cumulative dose
Item
Total cumulative dose
text
C2986497 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
C1522449 (UMLS CUI [1,2])
Best response
Item
Best response
text
C2986560 (UMLS CUI [1])
Item Group
Prior diagnostic and therapeutic procedures for prostate cancer
Prior diagnostic or therapeutic procedure
Item
Has the subject undergone any prior diagnostic or therapeutic procedure associated with the cancer under study?
boolean
C0430022 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
Procedure
Item
Procedure Name
text
C0184661 (UMLS CUI [1])
Other procedure
Item
Other procedure: please specify
text
C0393107 (UMLS CUI [1])
Location
Item
Location
text
C0450429 (UMLS CUI [1])
Other location
Item
Other location: please specify
text
C0450429 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
Date of procedure
Item
Date of procedure
date
C2584899 (UMLS CUI [1])
Purpose of procedure
Item
Purpose of procedure
text
C0517852 (UMLS CUI [1])
Therapeutic intent
Item
Therapeutic intent
text
C1292734 (UMLS CUI [1])
Procedure established diagnosis
Item
Procedure established diagnosis
text
C0332139 (UMLS CUI [1,1])
C1948041 (UMLS CUI [1,2])
C1948041 (UMLS CUI [1,2])
Surgical margins
Item
Surgical margins
text
C0229985 (UMLS CUI [1])
Laboratory Name
Item
Lab Name
text
C1882331 (UMLS CUI [1])
Date of collection
Item
Date of specimen collection
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Hematocrit
Item
Hematocrit
float
C0518014 (UMLS CUI [1])
Hemoglobin
Item
Hemoglobin
float
C0019046 (UMLS CUI [1])
Red Blood Count
Item
RBC
float
C1287262 (UMLS CUI [1])
White Blood Count
Item
WBC
float
C0023508 (UMLS CUI [1])
Platelets
Item
Platelets
float
C0005821 (UMLS CUI [1])
Differential blood count
Item
Differential blood count
text
C0545131 (UMLS CUI [1])
Absolute neutrophils
Item
Neutrophils absolute count
integer
C0948762 (UMLS CUI [1])
Lymphocytes count
Item
Lymphocytes absolute count
float
C3544087 (UMLS CUI [1])
Monocytes count
Item
Monocytes absolute count
float
C0200637 (UMLS CUI [1])
Eosinophils count
Item
Eosinophils absolute count
float
C0200638 (UMLS CUI [1,1])
C1820736 (UMLS CUI [1,2])
C1820736 (UMLS CUI [1,2])
Basophils count
Item
Basophils absolute count
float
C0200641 (UMLS CUI [1,1])
C1820736 (UMLS CUI [1,2])
C1820736 (UMLS CUI [1,2])
Differential blood count
Item
Differential blood count
text
C0545131 (UMLS CUI [1])
Neutrophils total
Item
Neutrophils total
float
C0200633 (UMLS CUI [1])
Lymphocytes count
Item
Lymphocytes
float
C0200635 (UMLS CUI [1])
Monocytes count
Item
Monocytes
float
C0200637 (UMLS CUI [1])
Eosinophils count
Item
Eosinophils
float
C0200638 (UMLS CUI [1])
Basophils count
Item
Basophils
float
C0200641 (UMLS CUI [1])
Laboratory Name
Item
Lab Name
text
C1882331 (UMLS CUI [1])
Date of collection
Item
Date of specimen collection
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Sodium
Item
Sodium
float
C0337443 (UMLS CUI [1])
Albumin
Item
Albumin
float
C0201838 (UMLS CUI [1])
Creatinine, Serum
Item
Creatinine
float
C0201976 (UMLS CUI [1])
SGOT (AST)
Item
SGOT
float
C0201899 (UMLS CUI [1])
SGPT (ALT)
Item
SGPT
float
C0201836 (UMLS CUI [1])
Alkaline Phosphatase
Item
Alkaline Phosphatase
float
C0201850 (UMLS CUI [1])
Bilirubin
Item
Bilirubin, total
float
C1278039 (UMLS CUI [1])
PSA
Item
Prostate-Specific Antigen
float
C0138741 (UMLS CUI [1])
Testosterone
Item
Testosterone
float
C0039601 (UMLS CUI [1])