ID
44846
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 (2)
- 20.03.17 20.03.17 -
- 16.02.22 16.02.22 - Martin Dugas
Rechteinhaber
Bayer
Hochgeladen am
16. Februar 2022
DOI
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Lizenz
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
- StudyEvent: ODM
Beschreibung
Assessment of Disease Progression
Beschreibung
Vital Signs
Beschreibung
BPI-SF
Beschreibung
Date of assessment
Datentyp
date
Alias
- UMLS CUI [1]
- C2985720
Beschreibung
Current pain
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0030193
Beschreibung
BPI
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C2732532
- UMLS CUI [1,2]
- C3898741
Beschreibung
BPI
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C2732532
- UMLS CUI [1,2]
- C3828673
Beschreibung
BPI
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0042815
- UMLS CUI [1,2]
- C3641836
Beschreibung
BPI
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C2732532
- UMLS CUI [1,2]
- C3840282
Beschreibung
BPI
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C2732532
- UMLS CUI [1,2]
- C0030193
- UMLS CUI [1,3]
- C0521102
Beschreibung
Pain interfered with General Activity
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0030193
- UMLS CUI [1,2]
- C0521102
- UMLS CUI [1,3]
- C0441655
Beschreibung
Pain interfered with Mood
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0030193
- UMLS CUI [1,2]
- C0521102
- UMLS CUI [1,3]
- C0026516
Beschreibung
Pain interfered with Walking Ability
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0030193
- UMLS CUI [1,2]
- C0521102
- UMLS CUI [1,3]
- C0559964
Beschreibung
Pain interfered with Normal Work
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0030193
- UMLS CUI [1,2]
- C0521102
- UMLS CUI [1,3]
- C3898033
Beschreibung
Pain interfered with Relations with other people
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0030193
- UMLS CUI [1,2]
- C0521102
- UMLS CUI [1,3]
- C0021797
Beschreibung
Pain interfered with Sleep
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0030193
- UMLS CUI [1,2]
- C0521102
- UMLS CUI [1,3]
- C0037313
Beschreibung
Pain interfered with Enjoyment of life
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0030193
- UMLS CUI [1,2]
- C0521102
- UMLS CUI [1,3]
- C0424131
Beschreibung
ECOG Performance Status
Beschreibung
Hematology (with DBC)
Beschreibung
Date of specimen collection
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0032976
- UMLS CUI [1,2]
- C0011008
Beschreibung
Hematocrit
Datentyp
float
Alias
- UMLS CUI [1]
- C0518014
Beschreibung
Hemoglobin
Datentyp
float
Alias
- UMLS CUI [1]
- C0019046
Beschreibung
RBC
Datentyp
float
Alias
- UMLS CUI [1]
- C0014772
Beschreibung
WBC
Datentyp
float
Alias
- UMLS CUI [1]
- C0023508
Beschreibung
Platelets
Datentyp
float
Alias
- UMLS CUI [1]
- C0005821
Beschreibung
Neutrophils absolute count
Datentyp
integer
Alias
- UMLS CUI [1]
- C0948762
Beschreibung
Lymphocytes absolute count
Datentyp
float
Alias
- UMLS CUI [1]
- C3544087
Beschreibung
Monocytes absolute count
Datentyp
float
Alias
- UMLS CUI [1]
- C0200637
Beschreibung
Eosinophils absolute count
Datentyp
float
Alias
- UMLS CUI [1,1]
- C0200638
- UMLS CUI [1,2]
- C1820736
Beschreibung
Basophils absolute count
Datentyp
float
Alias
- UMLS CUI [1,1]
- C0200641
- UMLS CUI [1,2]
- C1820736
Beschreibung
Neutrophils total
Datentyp
float
Maßeinheiten
- %
Alias
- UMLS CUI [1]
- C0200633
Beschreibung
Lymphocytes
Datentyp
float
Maßeinheiten
- %
Alias
- UMLS CUI [1]
- C0024264
Beschreibung
Monocytes
Datentyp
float
Maßeinheiten
- %
Alias
- UMLS CUI [1]
- C0026473
Beschreibung
Eosinophils
Datentyp
float
Maßeinheiten
- %
Alias
- UMLS CUI [1]
- C0945354
Beschreibung
Basophils
Datentyp
float
Maßeinheiten
- %
Alias
- UMLS CUI [1]
- C0200641
Beschreibung
General Chemistry - Serum
Beschreibung
Date of specimen collection
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0032976
- UMLS CUI [1,2]
- C0011008
Beschreibung
Sodium
Datentyp
float
Alias
- UMLS CUI [1]
- C0337443
Beschreibung
Creatinine
Datentyp
float
Alias
- UMLS CUI [1]
- C0201976
Beschreibung
SGOT/AST
Datentyp
integer
Alias
- UMLS CUI [1]
- C0201899
Beschreibung
SGPT/ALT
Datentyp
integer
Alias
- UMLS CUI [1]
- C0201836
Beschreibung
Alkaline Phosphatase
Datentyp
float
Alias
- UMLS CUI [1]
- C0201850
Beschreibung
Bilirubin, total
Datentyp
float
Alias
- UMLS CUI [1]
- C0201913
Beschreibung
Prostate Specific Antigen
Datentyp
integer
Alias
- UMLS CUI [1]
- C0201544
Beschreibung
Skeletal Related Events
Beschreibung
external beam radiotherapy
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1517033
Beschreibung
external beam radiotherapy
Datentyp
text
Alias
- UMLS CUI [1]
- C1517033
Beschreibung
skeletal symptoms (bone pain)
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0037088
- UMLS CUI [1,2]
- C0151825
Beschreibung
pathological bone fractures
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0016663
Beschreibung
pathological bone fractures
Datentyp
text
Alias
- UMLS CUI [1]
- C0016663
Beschreibung
tumor-related orthopedic surgical intervention
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0549433
- UMLS CUI [1,2]
- C0162439
- UMLS CUI [1,3]
- C1868739
Beschreibung
tumor-related orthopedic surgical intervention
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0549433
- UMLS CUI [1,2]
- C0162439
- UMLS CUI [1,3]
- C1868739
Beschreibung
tumor-related orthopedic surgical intervention
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0549433
- UMLS CUI [1,2]
- C0162439
- UMLS CUI [1,3]
- C1868739
Beschreibung
spinal cord compression
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0037926
Beschreibung
spinal cord compression: Date of diagnosis
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0037926
- UMLS CUI [1,2]
- C2316983
Beschreibung
spinal cord compression
Datentyp
text
Alias
- UMLS CUI [1]
- C0037926
Ähnliche Modelle
Radium 223 Dichloride (Alpharadin) - Subsequent Cycle
- StudyEvent: ODM
C3898741 (UMLS CUI [1,2])
(Comment:en)
(Comment:en)
C3828673 (UMLS CUI [1,2])
(Comment:en)
(Comment:en)
C3641836 (UMLS CUI [1,2])
(Comment:en)
(Comment:en)
C3840282 (UMLS CUI [1,2])
(Comment:en)
(Comment:en)
C0030193 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
(Comment:en)
(Comment:en)
C0521102 (UMLS CUI [1,2])
C0441655 (UMLS CUI [1,3])
(Comment:en)
(Comment:en)
C0521102 (UMLS CUI [1,2])
C0026516 (UMLS CUI [1,3])
(Comment:en)
(Comment:en)
C0521102 (UMLS CUI [1,2])
C0559964 (UMLS CUI [1,3])
(Comment:en)
(Comment:en)
C0521102 (UMLS CUI [1,2])
C3898033 (UMLS CUI [1,3])
(Comment:en)
(Comment:en)
C0521102 (UMLS CUI [1,2])
C0021797 (UMLS CUI [1,3])
(Comment:en)
(Comment:en)
C0521102 (UMLS CUI [1,2])
C0037313 (UMLS CUI [1,3])
(Comment:en)
(Comment:en)
C0521102 (UMLS CUI [1,2])
C0424131 (UMLS CUI [1,3])
(Comment:en)
(Comment:en)
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])