ID

20944

Descripción

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

Palabras clave

Versiones (1)
  1. 30/3/17 30/3/17 -
Subido en

30 de marzo de 2017

DOI

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Licencia

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 (End of Active Follow-up)

Inglés

Radium 223 Dichloride (Alpharadin) - End of Active Follow-up

1 formularios  
Subject Visit
Descripción

Subject Visit

Visit Date
Descripción

Visit Date

Tipo de datos

date

Alias
UMLS CUI [1]
C1320303
ECOG Performance Status
Descripción

ECOG Performance Status

Date of performance status
Descripción

Date of performance status

Tipo de datos

date

Alias
UMLS CUI [1]
C2985720
Performance status
Descripción

Performance status

Tipo de datos

integer

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

Hematology (with DBC)

Date of specimen collection
Descripción

Date of specimen collection

Tipo de datos

date

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

Hematocrit

Tipo de datos

float

Alias
UMLS CUI [1]
C0518014
Hemoglobin
Descripción

Hemoglobin

Tipo de datos

float

Alias
UMLS CUI [1]
C0019046
RBC
Descripción

RBC

Tipo de datos

float

Alias
UMLS CUI [1]
C0014772
WBC
Descripción

WBC

Tipo de datos

float

Alias
UMLS CUI [1]
C0023508
Platelets
Descripción

Platelets

Tipo de datos

float

Alias
UMLS CUI [1]
C0005821
Neutrophils absolute count
Descripción

Neutrophils absolute count

Tipo de datos

integer

Alias
UMLS CUI [1]
C0948762
Lymphocytes absolute count
Descripción

Lymphocytes absolute count

Tipo de datos

float

Alias
UMLS CUI [1]
C3544087
Monocytes absolute count
Descripción

Monocytes absolute count

Tipo de datos

float

Alias
UMLS CUI [1]
C0200637
Eosinophils absolute count
Descripción

Eosinophils absolute count

Tipo de datos

float

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

Basophils absolute count

Tipo de datos

float

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

Neutrophils total

Tipo de datos

float

Unidades de medida
  • %
Alias
UMLS CUI [1]
C0200633
%
Lymphocytes
Descripción

Lymphocytes

Tipo de datos

float

Unidades de medida
  • %
Alias
UMLS CUI [1]
C0024264
%
Monocytes
Descripción

Monocytes

Tipo de datos

float

Unidades de medida
  • %
Alias
UMLS CUI [1]
C0026473
%
Eosinophils
Descripción

Eosinophils

Tipo de datos

float

Unidades de medida
  • %
Alias
UMLS CUI [1]
C0945354
%
Basophils
Descripción

Basophils

Tipo de datos

float

Unidades de medida
  • %
Alias
UMLS CUI [1]
C0200641
%
General Chemistry - Serum
Descripción

General Chemistry - Serum

Date of specimen collection
Descripción

Date of specimen collection

Tipo de datos

date

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

Sodium

Tipo de datos

float

Alias
UMLS CUI [1]
C0337443
Creatinine
Descripción

Creatinine

Tipo de datos

float

Alias
UMLS CUI [1]
C0201976
SGOT/AST
Descripción

SGOT/AST

Tipo de datos

integer

Alias
UMLS CUI [1]
C0201899
SGPT/ALT
Descripción

SGPT/ALT

Tipo de datos

integer

Alias
UMLS CUI [1]
C0201836
Alkaline Phosphatase
Descripción

Alkaline Phosphatase

Tipo de datos

float

Alias
UMLS CUI [1]
C0201850
Bilirubin, total
Descripción

Bilirubin, total

Tipo de datos

float

Alias
UMLS CUI [1]
C0201913
Prostate Specific Antigen
Descripción

Prostate Specific Antigen

Tipo de datos

integer

Alias
UMLS CUI [1]
C0201544
End of Active Follow-up
Descripción

End of Active Follow-up

Primary reason for discontinuation of active follow-up
Descripción

Primary reason for discontinuation of active follow-up

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C1549995
If primary reason is "Adverse Event(s) not associated with clinical disease progression", give number(s).
Descripción

Up to 3 AE numbers can be entered:

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1444662
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C0877248
Dynamic search list contains: "Number - Term - Start Date"
Descripción

Dynamic search list

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0557959
UMLS CUI [1,2]
C0745732
If primary reason is "Adverse Event(s) associated with clinical disease progression", give number(s).
Descripción

Up to 3 AE numbers can be entered:

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1444662
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C0877248
Dynamic search list contains: "Number - Term - Start Date"
Descripción

Dynamic search list

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0557959
UMLS CUI [1,2]
C0745732
If primary reason is `Withdrawal by subject (Consent withdrawn)`,specify
Descripción

primary reason Consent withdrawn

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1549995
UMLS CUI [1,2]
C1707492
If primary reason is "Other", specify
Descripción

primary reason Other

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1549995
UMLS CUI [1,2]
C0205394
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Similar models

Radium 223 Dichloride (Alpharadin) - End of Active Follow-up

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Subject Visit
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
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])
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 ( 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
End of Active Follow-up
Primary reason for discontinuation of active follow-up
Item
Primary reason for discontinuation of active follow-up
text
C0008976 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C1549995 (UMLS CUI [1,3])
primary reason
Item
If primary reason is "Adverse Event(s) not associated with clinical disease progression", give number(s).
text
C1444662 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
Dynamic search list
Item
Dynamic search list contains: "Number - Term - Start Date"
text
C0557959 (UMLS CUI [1,1])
C0745732 (UMLS CUI [1,2])
primary reason
Item
If primary reason is "Adverse Event(s) associated with clinical disease progression", give number(s).
text
C1444662 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
Dynamic search list
Item
Dynamic search list contains: "Number - Term - Start Date"
text
C0557959 (UMLS CUI [1,1])
C0745732 (UMLS CUI [1,2])
primary reason Consent withdrawn
Item
If primary reason is `Withdrawal by subject (Consent withdrawn)`,specify
text
C1549995 (UMLS CUI [1,1])
C1707492 (UMLS CUI [1,2])
primary reason Other
Item
If primary reason is "Other", specify
text
C1549995 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
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