ID

44846

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

  1. 2017-03-20 2017-03-20 -
  2. 2022-02-16 2022-02-16 - Martin Dugas
Rättsinnehavare

Bayer

Uppladdad den

16 februari 2022

DOI

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Licens

Creative Commons BY-NC 4.0

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

Radium 223 Dichloride (Alpharadin) - Subsequent Cycle

Subject Visit
Beskrivning

Subject Visit

Cycle number
Beskrivning

Cycle

Datatyp

integer

Alias
UMLS CUI [1]
C2045829
Visit Date
Beskrivning

Visit Date

Datatyp

date

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

Assessment of Disease Progression

Date of assessment
Beskrivning

Date of assessment

Datatyp

date

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

Disease progression

Datatyp

boolean

Alias
UMLS CUI [1]
C0242656
Vital Signs
Beskrivning

Vital Signs

Date of Vital Signs
Beskrivning

Date of Vital Signs

Datatyp

date

Alias
UMLS CUI [1]
C2826644
Weight
Beskrivning

Weight

Datatyp

float

Måttenheter
  • kg
Alias
UMLS CUI [1]
C0005910
kg
BPI-SF
Beskrivning

BPI-SF

Date of assessment
Beskrivning

Date of assessment

Datatyp

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?
Beskrivning

Current pain

Datatyp

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.
Beskrivning

BPI

Datatyp

integer

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.
Beskrivning

BPI

Datatyp

integer

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.
Beskrivning

BPI

Datatyp

integer

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.
Beskrivning

BPI

Datatyp

integer

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:
Beskrivning

BPI

Datatyp

integer

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

Pain interfered with General Activity

Datatyp

integer

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

Pain interfered with Mood

Datatyp

integer

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

Pain interfered with Walking Ability

Datatyp

integer

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)
Beskrivning

Pain interfered with Normal Work

Datatyp

integer

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

Pain interfered with Relations with other people

Datatyp

integer

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

Pain interfered with Sleep

Datatyp

integer

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

Pain interfered with Enjoyment of life

Datatyp

integer

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

ECOG Performance Status

Date of performance status
Beskrivning

Date of performance status

Datatyp

date

Alias
UMLS CUI [1]
C2985720
Performance status
Beskrivning

Performance status

Datatyp

integer

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

Hematology (with DBC)

Date of specimen collection
Beskrivning

Date of specimen collection

Datatyp

date

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

Hematocrit

Datatyp

float

Alias
UMLS CUI [1]
C0518014
Hemoglobin
Beskrivning

Hemoglobin

Datatyp

float

Alias
UMLS CUI [1]
C0019046
RBC
Beskrivning

RBC

Datatyp

float

Alias
UMLS CUI [1]
C0014772
WBC
Beskrivning

WBC

Datatyp

float

Alias
UMLS CUI [1]
C0023508
Platelets
Beskrivning

Platelets

Datatyp

float

Alias
UMLS CUI [1]
C0005821
Neutrophils absolute count
Beskrivning

Neutrophils absolute count

Datatyp

integer

Alias
UMLS CUI [1]
C0948762
Lymphocytes absolute count
Beskrivning

Lymphocytes absolute count

Datatyp

float

Alias
UMLS CUI [1]
C3544087
Monocytes absolute count
Beskrivning

Monocytes absolute count

Datatyp

float

Alias
UMLS CUI [1]
C0200637
Eosinophils absolute count
Beskrivning

Eosinophils absolute count

Datatyp

float

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

Basophils absolute count

Datatyp

float

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

Neutrophils total

Datatyp

float

Måttenheter
  • %
Alias
UMLS CUI [1]
C0200633
%
Lymphocytes
Beskrivning

Lymphocytes

Datatyp

float

Måttenheter
  • %
Alias
UMLS CUI [1]
C0024264
%
Monocytes
Beskrivning

Monocytes

Datatyp

float

Måttenheter
  • %
Alias
UMLS CUI [1]
C0026473
%
Eosinophils
Beskrivning

Eosinophils

Datatyp

float

Måttenheter
  • %
Alias
UMLS CUI [1]
C0945354
%
Basophils
Beskrivning

Basophils

Datatyp

float

Måttenheter
  • %
Alias
UMLS CUI [1]
C0200641
%
General Chemistry - Serum
Beskrivning

General Chemistry - Serum

Date of specimen collection
Beskrivning

Date of specimen collection

Datatyp

date

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

Sodium

Datatyp

float

Alias
UMLS CUI [1]
C0337443
Creatinine
Beskrivning

Creatinine

Datatyp

float

Alias
UMLS CUI [1]
C0201976
SGOT/AST
Beskrivning

SGOT/AST

Datatyp

integer

Alias
UMLS CUI [1]
C0201899
SGPT/ALT
Beskrivning

SGPT/ALT

Datatyp

integer

Alias
UMLS CUI [1]
C0201836
Alkaline Phosphatase
Beskrivning

Alkaline Phosphatase

Datatyp

float

Alias
UMLS CUI [1]
C0201850
Bilirubin, total
Beskrivning

Bilirubin, total

Datatyp

float

Alias
UMLS CUI [1]
C0201913
Prostate Specific Antigen
Beskrivning

Prostate Specific Antigen

Datatyp

integer

Alias
UMLS CUI [1]
C0201544
Skeletal Related Events
Beskrivning

Skeletal Related Events

Has the subject received any external beam radiotherapy to relieve skeletal symptoms (bone pain)?
Beskrivning

external beam radiotherapy

Datatyp

boolean

Alias
UMLS CUI [1]
C1517033
Has the subject received any external beam radiotherapy to relieve skeletal symptoms (bone pain)? If yes: select related therapy
Beskrivning

external beam radiotherapy

Datatyp

text

Alias
UMLS CUI [1]
C1517033
select up to 3 most important related skeletal symptoms (bone pain)
Beskrivning

skeletal symptoms (bone pain)

Datatyp

text

Alias
UMLS CUI [1,1]
C0037088
UMLS CUI [1,2]
C0151825
Has the subject experienced any new symptomatic pathological bone fractures (vertebral or non-vertebral)?
Beskrivning

pathological bone fractures

Datatyp

boolean

Alias
UMLS CUI [1]
C0016663
Has the subject experienced any new symptomatic pathological bone fractures (vertebral or non-vertebral)? If yes: select up to 3 new symptomatic pathological bone fractures
Beskrivning

pathological bone fractures

Datatyp

text

Alias
UMLS CUI [1]
C0016663
Has the subject undergone any tumor-related orthopedic surgical intervention?
Beskrivning

tumor-related orthopedic surgical intervention

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0549433
UMLS CUI [1,2]
C0162439
UMLS CUI [1,3]
C1868739
Has the subject undergone any tumor-related orthopedic surgical intervention?
Beskrivning

tumor-related orthopedic surgical intervention

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0549433
UMLS CUI [1,2]
C0162439
UMLS CUI [1,3]
C1868739
Has the subject undergone any tumor-related orthopedic surgical intervention? If yes: select up to 3 tumor-related orthopedic surgical interventions
Beskrivning

tumor-related orthopedic surgical intervention

Datatyp

text

Alias
UMLS CUI [1,1]
C0549433
UMLS CUI [1,2]
C0162439
UMLS CUI [1,3]
C1868739
Has the subject experienced any spinal cord compression?
Beskrivning

spinal cord compression

Datatyp

boolean

Alias
UMLS CUI [1]
C0037926
Has the subject experienced any spinal cord compression? If yes: Date of diagnosis
Beskrivning

spinal cord compression: Date of diagnosis

Datatyp

date

Alias
UMLS CUI [1,1]
C0037926
UMLS CUI [1,2]
C2316983
Has the subject experienced any spinal cord compression? If yes: select up to 3 most relevant symptoms associated with this diagnosis
Beskrivning

spinal cord compression

Datatyp

text

Alias
UMLS CUI [1]
C0037926

Similar models

Radium 223 Dichloride (Alpharadin) - Subsequent Cycle

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Subject Visit
Cycle
Item
Cycle number
integer
C2045829 (UMLS CUI [1])
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
float
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])
Item
Please rate your pain by circling the one number that best describes your pain at its worst in the last 24 hours.
integer
C2732532 (UMLS CUI [1,1])
C3898741 (UMLS CUI [1,2])
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
0: No Pain (0)
C0234225 (UMLS CUI-1)
(Comment:en)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CL Item
6 (6)
(Comment:en)
CL Item
7 (7)
(Comment:en)
CL Item
8 (8)
(Comment:en)
CL Item
9 (9)
(Comment:en)
CL Item
10: Pain as bad as you can imagine (10)
C3642228 (UMLS CUI-1)
(Comment:en)
Item
Please rate your pain by circling the one number that best describes your pain at its least in the last 24 hours.
integer
C2732532 (UMLS CUI [1,1])
C3828673 (UMLS CUI [1,2])
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
0: No Pain (0)
C0234225 (UMLS CUI-1)
(Comment:en)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CL Item
6 (6)
(Comment:en)
CL Item
7 (7)
(Comment:en)
CL Item
8 (8)
(Comment:en)
CL Item
9 (9)
(Comment:en)
CL Item
10: Pain as bad as you can imagine (10)
C3642228 (UMLS CUI-1)
(Comment:en)
Item
Please rate your pain by circling the one number that best describes your pain on the average.
integer
C0042815 (UMLS CUI [1,1])
C3641836 (UMLS CUI [1,2])
Code List
Please rate your pain by circling the one number that best describes your pain on the average.
CL Item
0: No Pain (0)
C0234225 (UMLS CUI-1)
(Comment:en)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CL Item
6 (6)
(Comment:en)
CL Item
7 (7)
(Comment:en)
CL Item
8 (8)
(Comment:en)
CL Item
9 (9)
(Comment:en)
CL Item
10: Pain as bad as you can imagine (10)
C3642228 (UMLS CUI-1)
(Comment:en)
Item
Please rate your pain by circling the one number that tells how much pain you have right now.
integer
C2732532 (UMLS CUI [1,1])
C3840282 (UMLS CUI [1,2])
Code List
Please rate your pain by circling the one number that tells how much pain you have right now.
CL Item
0: No Pain (0)
C0234225 (UMLS CUI-1)
(Comment:en)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CL Item
6 (6)
(Comment:en)
CL Item
7 (7)
(Comment:en)
CL Item
8 (8)
(Comment:en)
CL Item
9 (9)
(Comment:en)
CL Item
10: Pain as bad as you can imagine (10)
C3642228 (UMLS CUI-1)
(Comment:en)
Item
Circle the one number that describes how, during the past 24 hours, pain has interfered with your:
integer
C2732532 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
Code List
Circle the one number that describes how, during the past 24 hours, pain has interfered with your:
CL Item
0: No Pain (0)
C0234225 (UMLS CUI-1)
(Comment:en)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CL Item
6 (6)
(Comment:en)
CL Item
7 (7)
(Comment:en)
CL Item
8 (8)
(Comment:en)
CL Item
9 (9)
(Comment:en)
CL Item
10: Pain as bad as you can imagine (10)
C3642228 (UMLS CUI-1)
(Comment:en)
Item
General Activity
integer
C0030193 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0441655 (UMLS CUI [1,3])
Code List
General Activity
CL Item
0: Does not interfere (0)
C0521103 (UMLS CUI-1)
(Comment:en)
CL Item
1 (1)
(Comment:en)
CL Item
2 (2)
(Comment:en)
CL Item
3 (3)
(Comment:en)
CL Item
4 (4)
(Comment:en)
CL Item
5 (5)
(Comment:en)
CL Item
6 (6)
(Comment:en)
CL Item
7 (7)
(Comment:en)
CL Item
8 (8)
(Comment:en)
CL Item
9 (9)
(Comment:en)
CL Item
10: Completely Interferes (10)
C3899517 (UMLS CUI-1)
(Comment:en)
Item
Mood
integer
C0030193 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0026516 (UMLS CUI [1,3])
CL Item
0: Does not interfere (0)
C0521103 (UMLS CUI-1)
(Comment:en)
CL Item
1 (1)
(Comment:en)
CL Item
2 (2)
(Comment:en)
CL Item
3 (3)
(Comment:en)
CL Item
4 (4)
(Comment:en)
CL Item
5 (5)
(Comment:en)
CL Item
6 (6)
(Comment:en)
CL Item
7 (7)
(Comment:en)
CL Item
8 (8)
(Comment:en)
CL Item
9 (9)
(Comment:en)
CL Item
10: Completely Interferes (10)
C3899517 (UMLS CUI-1)
(Comment:en)
Item
Walking Ability
integer
C0030193 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0559964 (UMLS CUI [1,3])
Code List
Walking Ability
CL Item
0: Does not interfere (0)
C0521103 (UMLS CUI-1)
(Comment:en)
CL Item
1 (1)
(Comment:en)
CL Item
2 (2)
(Comment:en)
CL Item
3 (3)
(Comment:en)
CL Item
4 (4)
(Comment:en)
CL Item
5 (5)
(Comment:en)
CL Item
6 (6)
(Comment:en)
CL Item
7 (7)
(Comment:en)
CL Item
8 (8)
(Comment:en)
CL Item
9 (9)
(Comment:en)
CL Item
10: Completely Interferes (10)
C3899517 (UMLS CUI-1)
(Comment:en)
Item
Normal Work (includes both work outside the home and housework)
integer
C0030193 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C3898033 (UMLS CUI [1,3])
Code List
Normal Work (includes both work outside the home and housework)
CL Item
0: Does not interfere (0)
C0521103 (UMLS CUI-1)
(Comment:en)
CL Item
1 (1)
(Comment:en)
CL Item
2 (2)
(Comment:en)
CL Item
3 (3)
(Comment:en)
CL Item
4 (4)
(Comment:en)
CL Item
5 (5)
(Comment:en)
CL Item
6 (6)
(Comment:en)
CL Item
7 (7)
(Comment:en)
CL Item
8 (8)
(Comment:en)
CL Item
9 (9)
(Comment:en)
CL Item
10: Completely Interferes (10)
C3899517 (UMLS CUI-1)
(Comment:en)
Item
Relations with other people
integer
C0030193 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0021797 (UMLS CUI [1,3])
Code List
Relations with other people
CL Item
0: Does not interfere (0)
C0521103 (UMLS CUI-1)
(Comment:en)
CL Item
1 (1)
(Comment:en)
CL Item
2 (2)
(Comment:en)
CL Item
3 (3)
(Comment:en)
CL Item
4 (4)
(Comment:en)
CL Item
5 (5)
(Comment:en)
CL Item
6 (6)
(Comment:en)
CL Item
7 (7)
(Comment:en)
CL Item
8 (8)
(Comment:en)
CL Item
9 (9)
(Comment:en)
CL Item
10: Completely Interferes (10)
C3899517 (UMLS CUI-1)
(Comment:en)
Item
Sleep
integer
C0030193 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0037313 (UMLS CUI [1,3])
CL Item
0: Does not interfere (0)
C0521103 (UMLS CUI-1)
(Comment:en)
CL Item
1 (1)
(Comment:en)
CL Item
2 (2)
(Comment:en)
CL Item
3 (3)
(Comment:en)
CL Item
4 (4)
(Comment:en)
CL Item
5 (5)
(Comment:en)
CL Item
6 (6)
(Comment:en)
CL Item
7 (7)
(Comment:en)
CL Item
8 (8)
(Comment:en)
CL Item
9 (9)
(Comment:en)
CL Item
10: Completely Interferes (10)
C3899517 (UMLS CUI-1)
(Comment:en)
Item
Enjoyment of life
integer
C0030193 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0424131 (UMLS CUI [1,3])
Code List
Enjoyment of life
CL Item
0: Does not interfere (0)
C0521103 (UMLS CUI-1)
(Comment:en)
CL Item
1 (1)
(Comment:en)
CL Item
2 (2)
(Comment:en)
CL Item
3 (3)
(Comment:en)
CL Item
4 (4)
(Comment:en)
CL Item
5 (5)
(Comment:en)
CL Item
6 (6)
(Comment:en)
CL Item
7 (7)
(Comment:en)
CL Item
8 (8)
(Comment:en)
CL Item
9 (9)
(Comment:en)
CL Item
10: Completely Interferes (10)
C3899517 (UMLS CUI-1)
(Comment:en)
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])
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
Skeletal Related Events
external beam radiotherapy
Item
Has the subject received any external beam radiotherapy to relieve skeletal symptoms (bone pain)?
boolean
C1517033 (UMLS CUI [1])
external beam radiotherapy
Item
Has the subject received any external beam radiotherapy to relieve skeletal symptoms (bone pain)? If yes: select related therapy
text
C1517033 (UMLS CUI [1])
skeletal symptoms (bone pain)
Item
select up to 3 most important related skeletal symptoms (bone pain)
text
C0037088 (UMLS CUI [1,1])
C0151825 (UMLS CUI [1,2])
pathological bone fractures
Item
Has the subject experienced any new symptomatic pathological bone fractures (vertebral or non-vertebral)?
boolean
C0016663 (UMLS CUI [1])
pathological bone fractures
Item
Has the subject experienced any new symptomatic pathological bone fractures (vertebral or non-vertebral)? If yes: select up to 3 new symptomatic pathological bone fractures
text
C0016663 (UMLS CUI [1])
tumor-related orthopedic surgical intervention
Item
Has the subject undergone any tumor-related orthopedic surgical intervention?
boolean
C0549433 (UMLS CUI [1,1])
C0162439 (UMLS CUI [1,2])
C1868739 (UMLS CUI [1,3])
tumor-related orthopedic surgical intervention
Item
Has the subject undergone any tumor-related orthopedic surgical intervention?
boolean
C0549433 (UMLS CUI [1,1])
C0162439 (UMLS CUI [1,2])
C1868739 (UMLS CUI [1,3])
tumor-related orthopedic surgical intervention
Item
Has the subject undergone any tumor-related orthopedic surgical intervention? If yes: select up to 3 tumor-related orthopedic surgical interventions
text
C0549433 (UMLS CUI [1,1])
C0162439 (UMLS CUI [1,2])
C1868739 (UMLS CUI [1,3])
spinal cord compression
Item
Has the subject experienced any spinal cord compression?
boolean
C0037926 (UMLS CUI [1])
spinal cord compression: Date of diagnosis
Item
Has the subject experienced any spinal cord compression? If yes: Date of diagnosis
date
C0037926 (UMLS CUI [1,1])
C2316983 (UMLS CUI [1,2])
spinal cord compression
Item
Has the subject experienced any spinal cord compression? If yes: select up to 3 most relevant symptoms associated with this diagnosis
text
C0037926 (UMLS CUI [1])

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