ID

20816

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. 3/20/17 3/20/17 -
Uploaded on

March 20, 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 (Adverse Events)

English

Radium 223 Dichloride (Alpharadin) - Adverse Events

1 forms  
Adverse Events (Y/N)
Description

Adverse Events (Y/N)

Were there any Adverse Events?
Description

If yes, please record details on Adverse Event form

Data type

boolean

Alias
UMLS CUI [1]
C0877248
Adverse Events
Description

Adverse Events

AE Number
Description

AE Number

Data type

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0449788
Adverse Event, specify, give diagnosis if possible
Description

Adverse Event diagnosis

Data type

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0011900
CTCAE term
Description

(NCI short name)

Data type

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C3888020
Serious
Description

lf Yes,fill in the complementary page for Serious Adverse Events and report to Pharmacovigilance immediately.

Data type

boolean

Alias
UMLS CUI [1]
C1710056
Reason, check all that apply
Description

SAE Reason, check all that apply

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0392360
Start Date
Description

Start Date

Data type

date

Alias
UMLS CUI [1]
C0808070
If the start date of the Adverse Event is the SAME DATE as the first dose of study treatment, did the AE occur prior to the first dose of Study Treatment? If not, leave the question blank.
Description

Adverse event start date

Data type

text

Alias
UMLS CUI [1]
C2697888
Stop Date
Description

Stop Date

Data type

date

Alias
UMLS CUI [1]
C0806020
Reasonable causal relationship to Study drug
Description

Reasonable causal relationship to Study drug

Data type

text

Alias
UMLS CUI [1]
C3641099
Reasonable causal relationship to protocol required procedure(s)
Description

Reasonable causal relationship to protocol required procedure(s)

Data type

text

Alias
UMLS CUI [1]
C3641099
Outcome of Adverse Event
Description

Outcome of Adverse Event

Data type

text

Alias
UMLS CUI [1]
C1705586
CTCAE grade
Description

CTCAE grade

Data type

text

Alias
UMLS CUI [1,1]
C3888020
UMLS CUI [1,2]
C0441800
Date of grade change
Description

(worsening or improving)

Data type

date

Alias
UMLS CUI [1,1]
C3888020
UMLS CUI [1,2]
C0443172
UMLS CUI [1,3]
C0011008
Action 1 taken with Study drug
Description

Action taken with Study drug

Data type

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0441472
UMLS CUI [1,3]
C0013227
Action 2 taken with Study drug
Description

Action taken with Study drug

Data type

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0441472
UMLS CUI [1,3]
C0013227
Action 3 taken with Study drug
Description

Action taken with Study drug

Data type

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0441472
UMLS CUI [1,3]
C0013227
Other specific treatment(s) of Adverse Event
Description

check all that apply

Data type

integer

Alias
UMLS CUI [1]
C2981656
Other specific treatment(s) of Adverse Event: Comment
Description

(if applicable)

Data type

text

Alias
UMLS CUI [1,1]
C2981656
UMLS CUI [1,2]
C0947611
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Similar models

Radium 223 Dichloride (Alpharadin) - Adverse Events

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Adverse Events (Y/N)
Adverse Events
Item
Were there any Adverse Events?
boolean
C0877248 (UMLS CUI [1])
Item Group
Adverse Events
AE Number
Item
AE Number
text
C0877248 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Adverse Event diagnosis
Item
Adverse Event, specify, give diagnosis if possible
text
C0877248 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
CTCAE term
Item
CTCAE term
text
C0877248 (UMLS CUI [1,1])
C3888020 (UMLS CUI [1,2])
Seriousness of Adverse Event
Item
Serious
boolean
C1710056 (UMLS CUI [1])
Item
Reason, check all that apply
integer
C1519255 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
SAE Reason, check all that apply
Code List
Reason, check all that apply
CL Item
Results in death (1)
CL Item
Is life threatening (2)
CL Item
Requires or prolongs hospitalization (3)
CL Item
Congenital anomaly or birth defect (4)
CL Item
Persistent or significant disability/ incapacity (5)
CL Item
Other medically important serious event (6)
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
Adverse event start date
Item
If the start date of the Adverse Event is the SAME DATE as the first dose of study treatment, did the AE occur prior to the first dose of Study Treatment? If not, leave the question blank.
text
C2697888 (UMLS CUI [1])
Stop Date
Item
Stop Date
date
C0806020 (UMLS CUI [1])
Reasonable causal relationship to Study drug
Item
Reasonable causal relationship to Study drug
text
C3641099 (UMLS CUI [1])
Reasonable causal relationship to protocol required procedure(s)
Item
Reasonable causal relationship to protocol required procedure(s)
text
C3641099 (UMLS CUI [1])
Outcome of Adverse Event
Item
Outcome of Adverse Event
text
C1705586 (UMLS CUI [1])
CTCAE grade
Item
CTCAE grade
text
C3888020 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
CTCAE grade date of change
Item
Date of grade change
date
C3888020 (UMLS CUI [1,1])
C0443172 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Action taken with Study drug
Item
Action 1 taken with Study drug
text
C0877248 (UMLS CUI [1,1])
C0441472 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
Action taken with Study drug
Item
Action 2 taken with Study drug
text
C0877248 (UMLS CUI [1,1])
C0441472 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
Action taken with Study drug
Item
Action 3 taken with Study drug
text
C0877248 (UMLS CUI [1,1])
C0441472 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
Item
Other specific treatment(s) of Adverse Event
integer
C2981656 (UMLS CUI [1])
AE treatment
Code List
Other specific treatment(s) of Adverse Event
CL Item
Remedial drug therapy (specify on Concomitant Medication CRF page) (1)
CL Item
None (2)
CL Item
Other, specify in comment field (3)
AE treatment: Comment
Item
Other specific treatment(s) of Adverse Event: Comment
text
C2981656 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
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