ID
20810
Beschrijving
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
Trefwoorden
Versies (2)
- 20-03-17 20-03-17 -
- 16-02-22 16-02-22 - Martin Dugas
Geüploaded op
20 maart 2017
DOI
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Licentie
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 (Subsequent Cycle)
Radium 223 Dichloride (Alpharadin) - Subsequent Cycle
- StudyEvent: ODM
Beschrijving
Assessment of Disease Progression
Beschrijving
Vital Signs
Beschrijving
BPI-SF
Beschrijving
Date of assessment
Datatype
date
Alias
- UMLS CUI [1]
- C2985720
Beschrijving
Current pain
Datatype
boolean
Alias
- UMLS CUI [1]
- C0030193
Beschrijving
BPI
Datatype
text
Alias
- UMLS CUI [1,1]
- C2732532
- UMLS CUI [1,2]
- C3898741
Beschrijving
BPI
Datatype
text
Alias
- UMLS CUI [1,1]
- C2732532
- UMLS CUI [1,2]
- C3828673
Beschrijving
BPI
Datatype
text
Alias
- UMLS CUI [1,1]
- C0042815
- UMLS CUI [1,2]
- C3641836
Beschrijving
BPI
Datatype
text
Alias
- UMLS CUI [1,1]
- C2732532
- UMLS CUI [1,2]
- C3840282
Beschrijving
BPI
Datatype
text
Alias
- UMLS CUI [1,1]
- C2732532
- UMLS CUI [1,2]
- C0030193
- UMLS CUI [1,3]
- C0521102
Beschrijving
Pain interfered with General Activity
Datatype
text
Alias
- UMLS CUI [1,1]
- C0030193
- UMLS CUI [1,2]
- C0521102
- UMLS CUI [1,3]
- C0441655
Beschrijving
Pain interfered with Mood
Datatype
text
Alias
- UMLS CUI [1,1]
- C0030193
- UMLS CUI [1,2]
- C0521102
- UMLS CUI [1,3]
- C0026516
Beschrijving
Pain interfered with Walking Ability
Datatype
text
Alias
- UMLS CUI [1,1]
- C0030193
- UMLS CUI [1,2]
- C0521102
- UMLS CUI [1,3]
- C0559964
Beschrijving
Pain interfered with Normal Work
Datatype
text
Alias
- UMLS CUI [1,1]
- C0030193
- UMLS CUI [1,2]
- C0521102
- UMLS CUI [1,3]
- C3898033
Beschrijving
Pain interfered with Relations with other people
Datatype
text
Alias
- UMLS CUI [1,1]
- C0030193
- UMLS CUI [1,2]
- C0521102
- UMLS CUI [1,3]
- C0021797
Beschrijving
Pain interfered with Sleep
Datatype
text
Alias
- UMLS CUI [1,1]
- C0030193
- UMLS CUI [1,2]
- C0521102
- UMLS CUI [1,3]
- C0037313
Beschrijving
Pain interfered with Enjoyment of life
Datatype
text
Alias
- UMLS CUI [1,1]
- C0030193
- UMLS CUI [1,2]
- C0521102
- UMLS CUI [1,3]
- C0424131
Beschrijving
ECOG Performance Status
Beschrijving
Hematology (with DBC)
Beschrijving
Date of specimen collection
Datatype
date
Alias
- UMLS CUI [1,1]
- C0032976
- UMLS CUI [1,2]
- C0011008
Beschrijving
Hematocrit
Datatype
float
Alias
- UMLS CUI [1]
- C0518014
Beschrijving
Hemoglobin
Datatype
float
Alias
- UMLS CUI [1]
- C0019046
Beschrijving
RBC
Datatype
float
Alias
- UMLS CUI [1]
- C0014772
Beschrijving
WBC
Datatype
float
Alias
- UMLS CUI [1]
- C0023508
Beschrijving
Platelets
Datatype
float
Alias
- UMLS CUI [1]
- C0005821
Beschrijving
Neutrophils absolute count
Datatype
integer
Alias
- UMLS CUI [1]
- C0948762
Beschrijving
Lymphocytes absolute count
Datatype
float
Alias
- UMLS CUI [1]
- C3544087
Beschrijving
Monocytes absolute count
Datatype
float
Alias
- UMLS CUI [1]
- C0200637
Beschrijving
Eosinophils absolute count
Datatype
float
Alias
- UMLS CUI [1,1]
- C0200638
- UMLS CUI [1,2]
- C1820736
Beschrijving
Basophils absolute count
Datatype
float
Alias
- UMLS CUI [1,1]
- C0200641
- UMLS CUI [1,2]
- C1820736
Beschrijving
Neutrophils total
Datatype
float
Maateenheden
- %
Alias
- UMLS CUI [1]
- C0200633
Beschrijving
Lymphocytes
Datatype
float
Maateenheden
- %
Alias
- UMLS CUI [1]
- C0024264
Beschrijving
Monocytes
Datatype
float
Maateenheden
- %
Alias
- UMLS CUI [1]
- C0026473
Beschrijving
Eosinophils
Datatype
float
Maateenheden
- %
Alias
- UMLS CUI [1]
- C0945354
Beschrijving
Basophils
Datatype
float
Maateenheden
- %
Alias
- UMLS CUI [1]
- C0200641
Beschrijving
General Chemistry - Serum
Beschrijving
Date of specimen collection
Datatype
date
Alias
- UMLS CUI [1,1]
- C0032976
- UMLS CUI [1,2]
- C0011008
Beschrijving
Sodium
Datatype
float
Alias
- UMLS CUI [1]
- C0337443
Beschrijving
Creatinine
Datatype
float
Alias
- UMLS CUI [1]
- C0201976
Beschrijving
SGOT/AST
Datatype
integer
Alias
- UMLS CUI [1]
- C0201899
Beschrijving
SGPT/ALT
Datatype
integer
Alias
- UMLS CUI [1]
- C0201836
Beschrijving
Alkaline Phosphatase
Datatype
float
Alias
- UMLS CUI [1]
- C0201850
Beschrijving
Bilirubin, total
Datatype
float
Alias
- UMLS CUI [1]
- C0201913
Beschrijving
Prostate Specific Antigen
Datatype
integer
Alias
- UMLS CUI [1]
- C0201544
Beschrijving
Skeletal Related Events
Beschrijving
external beam radiotherapy
Datatype
boolean
Alias
- UMLS CUI [1]
- C1517033
Beschrijving
external beam radiotherapy
Datatype
text
Alias
- UMLS CUI [1]
- C1517033
Beschrijving
skeletal symptoms (bone pain)
Datatype
text
Alias
- UMLS CUI [1,1]
- C0037088
- UMLS CUI [1,2]
- C0151825
Beschrijving
pathological bone fractures
Datatype
boolean
Alias
- UMLS CUI [1]
- C0016663
Beschrijving
pathological bone fractures
Datatype
text
Alias
- UMLS CUI [1]
- C0016663
Beschrijving
tumor-related orthopedic surgical intervention
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0549433
- UMLS CUI [1,2]
- C0162439
- UMLS CUI [1,3]
- C1868739
Beschrijving
tumor-related orthopedic surgical intervention
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0549433
- UMLS CUI [1,2]
- C0162439
- UMLS CUI [1,3]
- C1868739
Beschrijving
tumor-related orthopedic surgical intervention
Datatype
text
Alias
- UMLS CUI [1,1]
- C0549433
- UMLS CUI [1,2]
- C0162439
- UMLS CUI [1,3]
- C1868739
Beschrijving
spinal cord compression
Datatype
boolean
Alias
- UMLS CUI [1]
- C0037926
Beschrijving
spinal cord compression: Date of diagnosis
Datatype
date
Alias
- UMLS CUI [1,1]
- C0037926
- UMLS CUI [1,2]
- C2316983
Beschrijving
spinal cord compression
Datatype
text
Alias
- UMLS CUI [1]
- C0037926
Similar models
Radium 223 Dichloride (Alpharadin) - Subsequent Cycle
- StudyEvent: ODM
C3898741 (UMLS CUI [1,2])
C3828673 (UMLS CUI [1,2])
C3641836 (UMLS CUI [1,2])
C3840282 (UMLS CUI [1,2])
C0030193 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C0521102 (UMLS CUI [1,2])
C0441655 (UMLS CUI [1,3])
C0521102 (UMLS CUI [1,2])
C0026516 (UMLS CUI [1,3])
C0521102 (UMLS CUI [1,2])
C0559964 (UMLS CUI [1,3])
C0521102 (UMLS CUI [1,2])
C3898033 (UMLS CUI [1,3])
C0521102 (UMLS CUI [1,2])
C0021797 (UMLS CUI [1,3])
C0521102 (UMLS CUI [1,2])
C0037313 (UMLS CUI [1,3])
C0521102 (UMLS CUI [1,2])
C0424131 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C1820736 (UMLS CUI [1,2])
C1820736 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0151825 (UMLS CUI [1,2])
C0162439 (UMLS CUI [1,2])
C1868739 (UMLS CUI [1,3])
C0162439 (UMLS CUI [1,2])
C1868739 (UMLS CUI [1,3])
C0162439 (UMLS CUI [1,2])
C1868739 (UMLS CUI [1,3])
C2316983 (UMLS CUI [1,2])