Informações:
Falhas:
ID
20813
Descrição
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
Palavras-chave
Versões (1)
- 20.03.17 20.03.17 -
Transferido a
20. März 2017
DOI
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Licença
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 (Study Medication)
Radium 223 Dichloride (Alpharadin) - Study Medication
- StudyEvent: ODM
Similar models
Radium 223 Dichloride (Alpharadin) - Study Medication
- StudyEvent: ODM
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Study drug
Item
Did the subject take any Study Drug?
boolean
C0304229 (UMLS CUI [1])
Study drug
Item
Study drug
text
C0304229 (UMLS CUI [1])
Assessment period
Item
Assessment period
text
C0220825 (UMLS CUI [1,1])
C1948053 (UMLS CUI [1,2])
C1948053 (UMLS CUI [1,2])
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
Start time
Item
Start time
time
C1301880 (UMLS CUI [1])
Stop Date
Item
Stop Date
date
C0806020 (UMLS CUI [1])
Planned dose
Item
Planned dose
text
C2826283 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Decay Correction factor
Item
Decay Correction factor
text
C3166265 (UMLS CUI [1])
Declared activity of Study Drug
Item
Declared activity of Study Drug
text
C3854006 (UMLS CUI [1,1])
C0599112 (UMLS CUI [1,2])
C0599112 (UMLS CUI [1,2])
Volume
Item
Calculated Volume to be injected
text
C0449468 (UMLS CUI [1,1])
C0444686 (UMLS CUI [1,2])
C0444686 (UMLS CUI [1,2])
Calculated Radioactivity
Item
Calculated Radioactivity to be injected
text
C0444686 (UMLS CUI [1,1])
C0034553 (UMLS CUI [1,2])
C0034553 (UMLS CUI [1,2])
volume in syringe before injection
Item
Actual volume in syringe before injection
text
C4071537 (UMLS CUI [1,1])
C0585032 (UMLS CUI [1,2])
C0585032 (UMLS CUI [1,2])
Radioactivity in syringe
Item
Radioactivity in syringe before injection
text
C0034553 (UMLS CUI [1,1])
C1706071 (UMLS CUI [1,2])
C0585032 (UMLS CUI [1,3])
C1706071 (UMLS CUI [1,2])
C0585032 (UMLS CUI [1,3])
Radioactivity in syringe
Item
Radioactivity in syringe after injection
text
C0034553 (UMLS CUI [1,1])
C1706071 (UMLS CUI [1,2])
C0580203 (UMLS CUI [1,3])
C1706071 (UMLS CUI [1,2])
C0580203 (UMLS CUI [1,3])
volume in syringe after injection
Item
Actual volume in syringe after injection
text
C4071537 (UMLS CUI [1,1])
C0580203 (UMLS CUI [1,2])
C0580203 (UMLS CUI [1,2])
Dose modification
Item
Dose modification 1
text
C1707811 (UMLS CUI [1])
Dose modification reason
Item
Reason for dose modification 1
text
C1707811 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
Adverse event
Item
If Adverse event, select up to 3 most important AEs:
text
C0877248 (UMLS CUI [1])
If Other, specify
Item
If Other, specify
text
C3840932 (UMLS CUI [1])