ID

20207

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. 13.02.17 13.02.17 -
Hochgeladen am

13. Februar 2017

DOI

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Radium-223 Dichloride (Alpharadin) DRKS00006460 NCT01618370 in Castration-Resistant (Hormone-Refractory) Prostate Cancer Patients With Bone Metastases

Englisch

Radium 223 Dichloride (Alpharadin) - Screening Visit

1 Formulare  
Demography
Beschreibung

Demography

Date of visit
Beschreibung

Visit date

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Year of birth
Beschreibung

Year of birth

Datentyp

integer

Alias
UMLS CUI [1]
C2826771
Age
Beschreibung

Age

Datentyp

integer

Alias
UMLS CUI [1]
C0001779
Age
Beschreibung

Age

Datentyp

integer

Alias
UMLS CUI [1]
C0001779
Gender: Male
Beschreibung

Gender

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
Date of first informed consent
Beschreibung

Date of informed consent

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0021430
Protocol amendment number in effect at time of first informed consent
Beschreibung

Protocol amendment number

Datentyp

integer

Alias
UMLS CUI [1,1]
C1507394
UMLS CUI [1,2]
C0237753
Ethnicity
Beschreibung

Check all that apply

Datentyp

text

Alias
UMLS CUI [1]
C0015031
White
Beschreibung

White (Caucasian)

Datentyp

boolean

Alias
UMLS CUI [1]
C0007457
Black ethnicity
Beschreibung

Black ethnicity

Datentyp

boolean

Alias
UMLS CUI [1]
C0005680
Asian
Beschreibung

Asian

Datentyp

boolean

Alias
UMLS CUI [1]
C0078988
American Indian or Alaska Native
Beschreibung

American Indian or Alaska Native

Datentyp

boolean

Alias
UMLS CUI [1]
C0683984
Native Hawaiian or Other Pacific Islander
Beschreibung

Native Hawaiian or Other Pacific Islander

Datentyp

boolean

Ethnicity not reported
Beschreibung

Ethnicity not reported

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0015031
UMLS CUI [1,2]
C1706613
Vital Signs
Beschreibung

Vital Signs

Date of vital signs
Beschreibung

Vital Signs Date

Datentyp

date

Alias
UMLS CUI [1]
C2826644
Weight
Beschreibung

Weight

Datentyp

float

Maßeinheiten
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Prostate Cancer Classification
Beschreibung

Prostate Cancer Classification

Date of initial diagnosis
Beschreibung

Date of initial diagnosis

Datentyp

date

Alias
UMLS CUI [1]
C2316983
Most recent progression/relapse date
Beschreibung

Disease Progression Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0011008
Type of assessment
Beschreibung

Laboratory proven should only be used in case the progression is proven via PSA increase

Datentyp

text

Alias
UMLS CUI [1]
C2911685
Date of diagnosis of bone metastases
Beschreibung

Date of diagnosis of bone metastases

Datentyp

date

Alias
UMLS CUI [1,1]
C2316983
UMLS CUI [1,2]
C0153690
Stage at initial diagnosis
Beschreibung

TNM Classification

Datentyp

text

Alias
UMLS CUI [1,1]
C0474935
UMLS CUI [1,2]
C4071762
Gleason score at initial diagnosis
Beschreibung

Gleason score at initial diagnosis

Datentyp

text

Alias
UMLS CUI [1,1]
C4071762
UMLS CUI [1,2]
C0332326
Stage at study entry
Beschreibung

TNM Classification

Datentyp

text

Alias
UMLS CUI [1,1]
C0474935
UMLS CUI [1,2]
C4041024
BPI-SF
Beschreibung

BPI-SF

Date of Assessment
Beschreibung

Assessment Date

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 every- day kinds of pain today?
Beschreibung

Brief pain inventory

Datentyp

text

Alias
UMLS CUI [1]
C1511326
Please rate your pain by circling the one number that best describes your pain at its worst in the last 24 hours.
Beschreibung

1=No pain 10=Pain as bad as you can imagine

Datentyp

integer

Alias
UMLS CUI [1]
C1511326
Please rate your pain by circling the one number that best describes your pain at its least in the last 24 hours.
Beschreibung

1=No Pain 10= Pain as bad as you can imagine

Datentyp

integer

Alias
UMLS CUI [1]
C1511326
Please rate your pain by circling the one number that best describes your pain on the average.
Beschreibung

1=No Pain 10= Pain as bad as you can imagine

Datentyp

integer

Alias
UMLS CUI [1]
C1511326
Please rate your pain by circling the one number that tells how much pain you have right now.
Beschreibung

1=No Pain 10= Pain as bad as you can imagine

Datentyp

integer

Alias
UMLS CUI [1]
C1511326
Circle the one number that describes how, during the past 24 hours, pain has interfered with your daily activities below
Beschreibung

1=No Pain 10= Pain as bad as you can imagine

Datentyp

text

Alias
UMLS CUI [1]
C1511326
General activity
Beschreibung

1=No Pain 10= Pain as bad as you can imagine

Datentyp

integer

Alias
UMLS CUI [1,1]
C1511326
UMLS CUI [1,2]
C0441655
Mood
Beschreibung

1=No Pain 10= Pain as bad as you can imagine

Datentyp

integer

Alias
UMLS CUI [1,1]
C1511326
UMLS CUI [1,2]
C0026516
Walking Ability
Beschreibung

1=No Pain 10= Pain as bad as you can imagine

Datentyp

integer

Alias
UMLS CUI [1,1]
C1511326
UMLS CUI [1,2]
C0559964
Normal Work (includes both work outside the home and housework)
Beschreibung

1=No Pain 10= Pain as bad as you can imagine

Datentyp

integer

Alias
UMLS CUI [1,1]
C1511326
UMLS CUI [1,2]
C3642250
Relations with other people
Beschreibung

1=No Pain 10= Pain as bad as you can imagine

Datentyp

integer

Alias
UMLS CUI [1,1]
C1511326
UMLS CUI [1,2]
C0021797
Sleep
Beschreibung

1=No Pain 10= Pain as bad as you can imagine

Datentyp

integer

Alias
UMLS CUI [1,1]
C1511326
UMLS CUI [1,2]
C0037313
Enjoyment of life
Beschreibung

1=No Pain 10= Pain as bad as you can imagine

Datentyp

integer

Alias
UMLS CUI [1,1]
C1511326
UMLS CUI [1,2]
C0424131
ECOG Performance Status
Beschreibung

ECOG Performance Status

Date of performance status
Beschreibung

Assessment date

Datentyp

date

Alias
UMLS CUI [1]
C2985720
Performance Status
Beschreibung

ECOG Performance Status

Datentyp

integer

Alias
UMLS CUI [1]
C1520224
Prior radiotherapy
Beschreibung

Prior radiotherapy

Has the subject received any prior radiotherapy associated with the cancer on study?
Beschreibung

Prior radiotherapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0279134
Regimen number
Beschreibung

Regimen number

Datentyp

text

Alias
UMLS CUI [1,1]
C0040808
UMLS CUI [1,2]
C0237753
Irradiated location 1
Beschreibung

Irradiation site

Datentyp

text

Alias
UMLS CUI [1]
C2169202
Irradiated location 2
Beschreibung

Irradiation site

Datentyp

text

Alias
UMLS CUI [1]
C2169202
Irradiated location 3
Beschreibung

Irradiation site

Datentyp

text

Alias
UMLS CUI [1]
C2169202
Intent
Beschreibung

Intent

Datentyp

text

Alias
UMLS CUI [1,1]
C1283828
UMLS CUI [1,2]
C1522449
Date of first fraction
Beschreibung

Date of first fraction

Datentyp

date

Alias
UMLS CUI [1,1]
C1279901
UMLS CUI [1,2]
C1522449
UMLS CUI [1,3]
C0011008
Date of last fraction
Beschreibung

Date of last fraction

Datentyp

date

Alias
UMLS CUI [1,1]
C1517741
UMLS CUI [1,2]
C1522449
UMLS CUI [1,3]
C0011008
Total cumulative dose
Beschreibung

Include units

Datentyp

text

Alias
UMLS CUI [1,1]
C2986497
UMLS CUI [1,2]
C1522449
Best response
Beschreibung

Best response

Datentyp

text

Alias
UMLS CUI [1]
C2986560
Prior diagnostic and therapeutic procedures for prostate cancer
Beschreibung

Prior diagnostic and therapeutic procedures for prostate cancer

Has the subject undergone any prior diagnostic or therapeutic procedure associated with the cancer under study?
Beschreibung

Including surgery and biopsy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0430022
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0332152
Procedure Name
Beschreibung

Procedure

Datentyp

text

Alias
UMLS CUI [1]
C0184661
Other procedure: please specify
Beschreibung

Other procedure

Datentyp

text

Alias
UMLS CUI [1]
C0393107
Location
Beschreibung

Location

Datentyp

text

Alias
UMLS CUI [1]
C0450429
Other location: please specify
Beschreibung

Other location

Datentyp

text

Alias
UMLS CUI [1,1]
C0450429
UMLS CUI [1,2]
C0205394
Date of procedure
Beschreibung

Date of procedure

Datentyp

date

Alias
UMLS CUI [1]
C2584899
Purpose of procedure
Beschreibung

Purpose of procedure

Datentyp

text

Alias
UMLS CUI [1]
C0517852
Therapeutic intent
Beschreibung

Therapeutic intent

Datentyp

text

Alias
UMLS CUI [1]
C1292734
Procedure established diagnosis
Beschreibung

Procedure established diagnosis

Datentyp

text

Alias
UMLS CUI [1,1]
C0332139
UMLS CUI [1,2]
C1948041
Surgical margins
Beschreibung

Surgical margins

Datentyp

text

Alias
UMLS CUI [1]
C0229985
Hematology (with DBC)
Beschreibung

Hematology (with DBC)

Lab Name
Beschreibung

Local lab range must be set to `new standarts´ in the local lab reference section

Datentyp

text

Alias
UMLS CUI [1]
C1882331
Date of specimen collection
Beschreibung

Date of collection

Datentyp

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
Hematocrit
Beschreibung

Hematocrit

Datentyp

float

Maßeinheiten
  • %
Alias
UMLS CUI [1]
C0518014
%
Hemoglobin
Beschreibung

Hemoglobin

Datentyp

float

Alias
UMLS CUI [1]
C0019046
RBC
Beschreibung

Red Blood Count

Datentyp

float

Alias
UMLS CUI [1]
C1287262
WBC
Beschreibung

White Blood Count

Datentyp

float

Alias
UMLS CUI [1]
C0023508
Platelets
Beschreibung

Platelets

Datentyp

float

Alias
UMLS CUI [1]
C0005821
Differential blood count
Beschreibung

reported as absolute count

Datentyp

text

Alias
UMLS CUI [1]
C0545131
Neutrophils absolute count
Beschreibung

Absolute neutrophils

Datentyp

integer

Alias
UMLS CUI [1]
C0948762
Lymphocytes absolute count
Beschreibung

Lymphocytes count

Datentyp

float

Alias
UMLS CUI [1]
C3544087
Monocytes absolute count
Beschreibung

Monocytes count

Datentyp

float

Alias
UMLS CUI [1]
C0200637
Eosinophils absolute count
Beschreibung

Eosinophils count

Datentyp

float

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

Basophils count

Datentyp

float

Alias
UMLS CUI [1,1]
C0200641
UMLS CUI [1,2]
C1820736
Differential blood count
Beschreibung

Values reported in %

Datentyp

text

Alias
UMLS CUI [1]
C0545131
Neutrophils total
Beschreibung

Neutrophils total

Datentyp

float

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

Lymphocytes count

Datentyp

float

Maßeinheiten
  • %
Alias
UMLS CUI [1]
C0200635
%
Monocytes
Beschreibung

Monocytes count

Datentyp

float

Maßeinheiten
  • %
Alias
UMLS CUI [1]
C0200637
%
Eosinophils
Beschreibung

Eosinophils count

Datentyp

float

Maßeinheiten
  • %
Alias
UMLS CUI [1]
C0200638
%
Basophils
Beschreibung

Basophils count

Datentyp

float

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

General chemistry - Serum

Lab Name
Beschreibung

Local Lab Range Type must be set to "New standards" in the Local Lab Reference Section

Datentyp

text

Alias
UMLS CUI [1]
C1882331
Date of specimen collection
Beschreibung

Date of collection

Datentyp

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
Sodium
Beschreibung

Sodium

Datentyp

float

Alias
UMLS CUI [1]
C0337443
Albumin
Beschreibung

Albumin

Datentyp

float

Alias
UMLS CUI [1]
C0201838
Creatinine
Beschreibung

Creatinine, Serum

Datentyp

float

Alias
UMLS CUI [1]
C0201976
SGOT
Beschreibung

SGOT (AST)

Datentyp

float

Alias
UMLS CUI [1]
C0201899
SGPT
Beschreibung

SGPT (ALT)

Datentyp

float

Alias
UMLS CUI [1]
C0201836
Alkaline Phosphatase
Beschreibung

Alkaline Phosphatase

Datentyp

float

Alias
UMLS CUI [1]
C0201850
Bilirubin, total
Beschreibung

Bilirubin

Datentyp

float

Alias
UMLS CUI [1]
C1278039
Prostate-Specific Antigen
Beschreibung

PSA

Datentyp

float

Alias
UMLS CUI [1]
C0138741
Testosterone
Beschreibung

Testosterone

Datentyp

float

Alias
UMLS CUI [1]
C0039601
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Ähnliche Modelle

Radium 223 Dichloride (Alpharadin) - Screening Visit

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Demography
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])
Item
Age
integer
C0001779 (UMLS CUI [1])
Age
Code List
Age
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])
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])
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])
Item Group
Vital Signs
Vital Signs Date
Item
Date of vital signs
date
C2826644 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Item Group
Prostate Cancer Classification
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])
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])
Stage at initial diagnosis
Item
Stage at initial diagnosis
text
C0474935 (UMLS CUI [1,1])
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])
Stage at study entry
Item
Stage at study entry
text
C0474935 (UMLS CUI [1,1])
C4041024 (UMLS CUI [1,2])
Item Group
BPI-SF
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])
Brief pain inventory
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])
Brief pain inventory
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])
Brief pain inventory
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])
Brief pain inventory
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])
Brief pain inventory
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])
Brief pain inventory
Code List
General activity
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
Mood
integer
C1511326 (UMLS CUI [1,1])
C0026516 (UMLS CUI [1,2])
Brief pain inventory
Code List
Mood
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])
Brief pain inventory
Code List
Walking Ability
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])
Brief pain inventory
Code List
Normal Work (includes both work outside the home and housework)
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])
Brief pain inventory
Code List
Relations with other people
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
Sleep
integer
C1511326 (UMLS CUI [1,1])
C0037313 (UMLS CUI [1,2])
Brief pain inventory
Code List
Sleep
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])
Brief pain inventory
Code List
Enjoyment of life
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 Group
ECOG Performance Status
Assessment date
Item
Date of performance status
date
C2985720 (UMLS CUI [1])
Item
Performance Status
integer
C1520224 (UMLS CUI [1])
ECOG 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, 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)
Item Group
Prior radiotherapy
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])
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])
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])
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])
Total cumulative dose
Item
Total cumulative dose
text
C2986497 (UMLS CUI [1,1])
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])
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])
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])
Surgical margins
Item
Surgical margins
text
C0229985 (UMLS CUI [1])
Item Group
Hematology (with DBC)
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])
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])
Basophils count
Item
Basophils absolute count
float
C0200641 (UMLS CUI [1,1])
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])
Item Group
General chemistry - Serum
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])
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])
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