ID

20813

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

Keywords

Versions (1)
  1. 20-03-17 20-03-17 -
Uploaded on

20 maart 2017

DOI

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License

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)

English

Radium 223 Dichloride (Alpharadin) - Study Medication

1 forms  
Study Drug Exposure, radioactive material
Description

Study Drug Exposure, radioactive material

Did the subject take any Study Drug?
Description

Study drug

Data type

boolean

Alias
UMLS CUI [1]
C0304229
Study drug
Description

Study drug

Data type

text

Alias
UMLS CUI [1]
C0304229
Assessment period
Description

Assessment period

Data type

text

Alias
UMLS CUI [1,1]
C0220825
UMLS CUI [1,2]
C1948053
Start Date
Description

Start Date

Data type

date

Alias
UMLS CUI [1]
C0808070
Start time
Description

(24-hour clock)

Data type

time

Alias
UMLS CUI [1]
C1301880
Stop Date
Description

Stop Date

Data type

date

Alias
UMLS CUI [1]
C0806020
Planned dose
Description

Planned dose

Data type

text

Measurement units
  • kBq/kg body weight
Alias
UMLS CUI [1]
C2826283
kBq/kg body weight
Weight
Description

Weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Decay Correction factor
Description

Decay Correction factor

Data type

text

Alias
UMLS CUI [1]
C3166265
Declared activity of Study Drug
Description

Declared activity of Study Drug

Data type

text

Measurement units
  • kBq/mL
Alias
UMLS CUI [1,1]
C3854006
UMLS CUI [1,2]
C0599112
kBq/mL
Calculated Volume to be injected
Description

Volume

Data type

text

Measurement units
  • ml
Alias
UMLS CUI [1,1]
C0449468
UMLS CUI [1,2]
C0444686
ml
Calculated Radioactivity to be injected
Description

Calculated Radioactivity

Data type

text

Measurement units
  • kBq
Alias
UMLS CUI [1,1]
C0444686
UMLS CUI [1,2]
C0034553
kBq
Actual volume in syringe before injection
Description

volume in syringe before injection

Data type

text

Measurement units
  • ml
Alias
UMLS CUI [1,1]
C4071537
UMLS CUI [1,2]
C0585032
ml
Radioactivity in syringe before injection
Description

Radioactivity in syringe

Data type

text

Measurement units
  • kBq
Alias
UMLS CUI [1,1]
C0034553
UMLS CUI [1,2]
C1706071
UMLS CUI [1,3]
C0585032
kBq
Radioactivity in syringe after injection
Description

Radioactivity in syringe

Data type

text

Measurement units
  • kBq
Alias
UMLS CUI [1,1]
C0034553
UMLS CUI [1,2]
C1706071
UMLS CUI [1,3]
C0580203
kBq
Actual volume in syringe after injection
Description

volume in syringe after injection

Data type

text

Measurement units
  • ml
Alias
UMLS CUI [1,1]
C4071537
UMLS CUI [1,2]
C0580203
ml
Dose modification 1
Description

Dose modification

Data type

text

Alias
UMLS CUI [1]
C1707811
Reason for dose modification 1
Description

Dose modification reason

Data type

text

Alias
UMLS CUI [1,1]
C1707811
UMLS CUI [1,2]
C0392360
If Adverse event, select up to 3 most important AEs:
Description

Dynamic search list contains: "Number - Term - Start Date"

Data type

text

Alias
UMLS CUI [1]
C0877248
If Other, specify
Description

If Other, specify

Data type

text

Alias
UMLS CUI [1]
C3840932
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Similar models

Radium 223 Dichloride (Alpharadin) - Study Medication

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Study Drug Exposure, radioactive material
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])
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])
Volume
Item
Calculated Volume to be injected
text
C0449468 (UMLS CUI [1,1])
C0444686 (UMLS CUI [1,2])
Calculated Radioactivity
Item
Calculated Radioactivity to be injected
text
C0444686 (UMLS CUI [1,1])
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])
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])
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])
volume in syringe after injection
Item
Actual volume in syringe after injection
text
C4071537 (UMLS CUI [1,1])
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])
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])
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