ID
20810
Description
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
Mots-clés
Versions (2)
- 20/03/2017 20/03/2017 -
- 16/02/2022 16/02/2022 - Martin Dugas
Téléchargé le
20 mars 2017
DOI
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Licence
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
Description
Assessment of Disease Progression
Description
Vital Signs
Description
BPI-SF
Description
Date of assessment
Type de données
date
Alias
- UMLS CUI [1]
- C2985720
Description
Current pain
Type de données
boolean
Alias
- UMLS CUI [1]
- C0030193
Description
BPI
Type de données
text
Alias
- UMLS CUI [1,1]
- C2732532
- UMLS CUI [1,2]
- C3898741
Description
BPI
Type de données
text
Alias
- UMLS CUI [1,1]
- C2732532
- UMLS CUI [1,2]
- C3828673
Description
BPI
Type de données
text
Alias
- UMLS CUI [1,1]
- C0042815
- UMLS CUI [1,2]
- C3641836
Description
BPI
Type de données
text
Alias
- UMLS CUI [1,1]
- C2732532
- UMLS CUI [1,2]
- C3840282
Description
BPI
Type de données
text
Alias
- UMLS CUI [1,1]
- C2732532
- UMLS CUI [1,2]
- C0030193
- UMLS CUI [1,3]
- C0521102
Description
Pain interfered with General Activity
Type de données
text
Alias
- UMLS CUI [1,1]
- C0030193
- UMLS CUI [1,2]
- C0521102
- UMLS CUI [1,3]
- C0441655
Description
Pain interfered with Mood
Type de données
text
Alias
- UMLS CUI [1,1]
- C0030193
- UMLS CUI [1,2]
- C0521102
- UMLS CUI [1,3]
- C0026516
Description
Pain interfered with Walking Ability
Type de données
text
Alias
- UMLS CUI [1,1]
- C0030193
- UMLS CUI [1,2]
- C0521102
- UMLS CUI [1,3]
- C0559964
Description
Pain interfered with Normal Work
Type de données
text
Alias
- UMLS CUI [1,1]
- C0030193
- UMLS CUI [1,2]
- C0521102
- UMLS CUI [1,3]
- C3898033
Description
Pain interfered with Relations with other people
Type de données
text
Alias
- UMLS CUI [1,1]
- C0030193
- UMLS CUI [1,2]
- C0521102
- UMLS CUI [1,3]
- C0021797
Description
Pain interfered with Sleep
Type de données
text
Alias
- UMLS CUI [1,1]
- C0030193
- UMLS CUI [1,2]
- C0521102
- UMLS CUI [1,3]
- C0037313
Description
Pain interfered with Enjoyment of life
Type de données
text
Alias
- UMLS CUI [1,1]
- C0030193
- UMLS CUI [1,2]
- C0521102
- UMLS CUI [1,3]
- C0424131
Description
ECOG Performance Status
Description
Hematology (with DBC)
Description
Date of specimen collection
Type de données
date
Alias
- UMLS CUI [1,1]
- C0032976
- UMLS CUI [1,2]
- C0011008
Description
Hematocrit
Type de données
float
Alias
- UMLS CUI [1]
- C0518014
Description
Hemoglobin
Type de données
float
Alias
- UMLS CUI [1]
- C0019046
Description
RBC
Type de données
float
Alias
- UMLS CUI [1]
- C0014772
Description
WBC
Type de données
float
Alias
- UMLS CUI [1]
- C0023508
Description
Platelets
Type de données
float
Alias
- UMLS CUI [1]
- C0005821
Description
Neutrophils absolute count
Type de données
integer
Alias
- UMLS CUI [1]
- C0948762
Description
Lymphocytes absolute count
Type de données
float
Alias
- UMLS CUI [1]
- C3544087
Description
Monocytes absolute count
Type de données
float
Alias
- UMLS CUI [1]
- C0200637
Description
Eosinophils absolute count
Type de données
float
Alias
- UMLS CUI [1,1]
- C0200638
- UMLS CUI [1,2]
- C1820736
Description
Basophils absolute count
Type de données
float
Alias
- UMLS CUI [1,1]
- C0200641
- UMLS CUI [1,2]
- C1820736
Description
Neutrophils total
Type de données
float
Unités de mesure
- %
Alias
- UMLS CUI [1]
- C0200633
Description
Lymphocytes
Type de données
float
Unités de mesure
- %
Alias
- UMLS CUI [1]
- C0024264
Description
Monocytes
Type de données
float
Unités de mesure
- %
Alias
- UMLS CUI [1]
- C0026473
Description
Eosinophils
Type de données
float
Unités de mesure
- %
Alias
- UMLS CUI [1]
- C0945354
Description
Basophils
Type de données
float
Unités de mesure
- %
Alias
- UMLS CUI [1]
- C0200641
Description
General Chemistry - Serum
Description
Date of specimen collection
Type de données
date
Alias
- UMLS CUI [1,1]
- C0032976
- UMLS CUI [1,2]
- C0011008
Description
Sodium
Type de données
float
Alias
- UMLS CUI [1]
- C0337443
Description
Creatinine
Type de données
float
Alias
- UMLS CUI [1]
- C0201976
Description
SGOT/AST
Type de données
integer
Alias
- UMLS CUI [1]
- C0201899
Description
SGPT/ALT
Type de données
integer
Alias
- UMLS CUI [1]
- C0201836
Description
Alkaline Phosphatase
Type de données
float
Alias
- UMLS CUI [1]
- C0201850
Description
Bilirubin, total
Type de données
float
Alias
- UMLS CUI [1]
- C0201913
Description
Prostate Specific Antigen
Type de données
integer
Alias
- UMLS CUI [1]
- C0201544
Description
Skeletal Related Events
Description
external beam radiotherapy
Type de données
boolean
Alias
- UMLS CUI [1]
- C1517033
Description
external beam radiotherapy
Type de données
text
Alias
- UMLS CUI [1]
- C1517033
Description
skeletal symptoms (bone pain)
Type de données
text
Alias
- UMLS CUI [1,1]
- C0037088
- UMLS CUI [1,2]
- C0151825
Description
pathological bone fractures
Type de données
boolean
Alias
- UMLS CUI [1]
- C0016663
Description
pathological bone fractures
Type de données
text
Alias
- UMLS CUI [1]
- C0016663
Description
tumor-related orthopedic surgical intervention
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0549433
- UMLS CUI [1,2]
- C0162439
- UMLS CUI [1,3]
- C1868739
Description
tumor-related orthopedic surgical intervention
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0549433
- UMLS CUI [1,2]
- C0162439
- UMLS CUI [1,3]
- C1868739
Description
tumor-related orthopedic surgical intervention
Type de données
text
Alias
- UMLS CUI [1,1]
- C0549433
- UMLS CUI [1,2]
- C0162439
- UMLS CUI [1,3]
- C1868739
Description
spinal cord compression
Type de données
boolean
Alias
- UMLS CUI [1]
- C0037926
Description
spinal cord compression: Date of diagnosis
Type de données
date
Alias
- UMLS CUI [1,1]
- C0037926
- UMLS CUI [1,2]
- C2316983
Description
spinal cord compression
Type de données
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])