ID

20944

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

Versioner (1)
  1. 2017-03-30 2017-03-30 -
Uppladdad den

30 mars 2017

DOI

För en begäran logga in.

Licens

Creative Commons BY-NC 3.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Radium-223 Dichloride (Alpharadin) DRKS00006460 NCT01618370 in Castration-Resistant (Hormone-Refractory) Prostate Cancer Patients With Bone Metastases (End of Active Follow-up)

Engelsk

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

1 Formulär  
Subject Visit
Beskrivning

Subject Visit

Visit Date
Beskrivning

Visit Date

Datatyp

date

Alias
UMLS CUI [1]
C1320303
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
End of Active Follow-up
Beskrivning

End of Active Follow-up

Primary reason for discontinuation of active follow-up
Beskrivning

Primary reason for discontinuation of active follow-up

Datatyp

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).
Beskrivning

Up to 3 AE numbers can be entered:

Datatyp

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"
Beskrivning

Dynamic search list

Datatyp

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).
Beskrivning

Up to 3 AE numbers can be entered:

Datatyp

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"
Beskrivning

Dynamic search list

Datatyp

text

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If primary reason is `Withdrawal by subject (Consent withdrawn)`,specify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

primary reason Consent withdrawn

Datatyp

text

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

primary reason Other

Datatyp

text

Alias
UMLS CUI [1,1]
C1549995
UMLS CUI [1,2]
C0205394
Tillbaka till toppen

Similar models

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

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial