ID

20821

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 (1)
  1. 20/03/2017 20/03/2017 -
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 (End of Study Treatment)

Anglais

Radium 223 Dichloride (Alpharadin) - End of Study Treatment

1 Formulaires  
End of Study Treatment
Description

End of Study Treatment

Did the subject complete the treatment period?
Description

treatment period completed

Type de données

boolean

Alias
UMLS CUI [1]
C2732579
Primary reason for discontinuation of study treatment
Description

Primary reason for discontinuation of study treatment

Type de données

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). Up to 3 AE numbers can be entered:
Description

Dynamic search /ist contains: "Number - Term - Start Date"

Type de données

text

Alias
UMLS CUI [1,1]
C1444662
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C0877248
If primary reason is "Withdrawal by subject (Consent withdrawn)",specify
Description

primary reason Consent withdrawn

Type de données

text

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

If primary reason is "Other",specify

Type de données

text

Alias
UMLS CUI [1,1]
C1549995
UMLS CUI [1,2]
C0205394
Subject entered active follow-up?
Description

Subject entered active follow-up?

Type de données

text

Alias
UMLS CUI [1]
C0589120
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Similar models

Radium 223 Dichloride (Alpharadin) - End of Study Treatment

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
End of Study Treatment
treatment period completed
Item
Did the subject complete the treatment period?
boolean
C2732579 (UMLS CUI [1])
Primary reason for discontinuation of study treatment
Item
Primary reason for discontinuation of study treatment
text
C0008976 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C1549995 (UMLS CUI [1,3])
primary reason Adverse Event
Item
If primary reason is "Adverse Event(s) not associated with clinical disease progression", give number(s). Up to 3 AE numbers can be entered:
text
C1444662 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
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])
If primary reason is "Other",specify
Item
If primary reason is "Other",specify
text
C1549995 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Subject entered active follow-up?
Item
Subject entered active follow-up?
text
C0589120 (UMLS CUI [1])
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