ID

20949

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. 30/03/2017 30/03/2017 -
Téléchargé le

30 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 (Visit Independent Forms)

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Radium 223 Dichloride (Alpharadin) - Visit Independent Forms

1 Formulaires  
Medical History excluding the history of prostate cancer
Description

Medical History excluding the history of prostate cancer

Are there any Medical History findings excluding study indication that started before the subject signed the informed consent and that are considered relevant to the study?
Description

lf yes, specify below

Type de données

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C2607943
Medical History finding
Description

diagnosis, disease or surgery (List only one disease or finding per line)

Type de données

text

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C2607943
Start date
Description

dd MMM Y.Y.Y.Y

Type de données

date

Alias
UMLS CUI [1]
C0808070
Ongoing at subject's last visit
Description

Ongoing

Type de données

boolean

Alias
UMLS CUI [1]
C0549178
If not ongoing, date resolved
Description

dd MMM Y.Y.Y.Y

Type de données

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C2699488
Concomitant Medication
Description

Concomitant Medication

Has the subject received any Concomitant Medication during the study period associated with Adverse Events or Primary Malignancy?
Description

Concomitant Medication

Type de données

boolean

Alias
UMLS CUI [1]
C2347852
Trade name
Description

List only one medication per line

Type de données

text

Alias
UMLS CUI [1]
C2360065
Specify dose, unit and frequency
Description

Specify dose, unit and frequency

Type de données

text

Alias
UMLS CUI [1,1]
C1521902
UMLS CUI [1,2]
C0178602
UMLS CUI [2,1]
C1521902
UMLS CUI [2,2]
C0439148
UMLS CUI [3,1]
C1521902
UMLS CUI [3,2]
C0439603
Route
Description

lf no appropriate term can be found in the pick list, then please select 'Other'from the pick list and specify the corresponding term in the next line.

Type de données

text

Alias
UMLS CUI [1]
C2826730
Other, specify
Description

lf no appropriate term can be found in the pick list, then please select 'Other'from the pick list and specify the corresponding term in the next line.

Type de données

text

Alias
UMLS CUI [1,1]
C2826730
UMLS CUI [1,2]
C0205394
Start date
Description

ddMMMyyyy

Type de données

date

Alias
UMLS CUI [1]
C0808070
Ongoing at subjects last visit
Description

Ongoing

Type de données

boolean

Alias
UMLS CUI [1]
C2826666
Stop date
Description

ddMMMyyyy

Type de données

date

Alias
UMLS CUI [1]
C0806020
Indication
Description

If indication is either "Treatment of Adverse Event" or "Treatment of Concomitant Disease" select the corresponding term from the dynamic search list.

Type de données

text

Alias
UMLS CUI [1]
C3146298
Dynamic search list contains "Line No - Term - Start Date"
Description

Dynamic search list

Type de données

text

Alias
UMLS CUI [1,1]
C0557959
UMLS CUI [1,2]
C0745732
If indication is "Other'', specify
Description

Other indication

Type de données

text

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0205394
Concomitant Medication - Analgesics
Description

Concomitant Medication - Analgesics

Has the subject received any Concomitant Analgesic Medication during the study period?
Description

Concomitant Analgesic Medication

Type de données

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0002771
Trade name
Description

List only one medication per line

Type de données

text

Alias
UMLS CUI [1]
C2360065
Dose
Description

Medication Dose

Type de données

text

Alias
UMLS CUI [1]
C3174092
Unit
Description

Unit

Type de données

text

Alias
UMLS CUI [1]
C2348328
Frequency
Description

Medication frequency

Type de données

text

Alias
UMLS CUI [1]
C2826654
Route
Description

lf no appropriate term can be found in the picklist, then please select 'Other'from the picklist and specify the corresponding term in the next line.

Type de données

text

Alias
UMLS CUI [1]
C2826730
Other, specify
Description

lf no appropriate term can be found in the picklist, then please select 'Other'from the picklist and specify the corresponding term in the next line.

Type de données

text

Alias
UMLS CUI [1,1]
C2826730
UMLS CUI [1,2]
C0205394
Start date
Description

ddMMMyyyy

Type de données

date

Alias
UMLS CUI [1]
C0808070
Ongoing at subjects last visit
Description

Concomitant Medication Ongoing

Type de données

boolean

Alias
UMLS CUI [1]
C2826666
Stop Date
Description

ddMMMyyyy

Type de données

date

Alias
UMLS CUI [1]
C0806020
Indication
Description

If indication is either "Treatment of Adverse Event" or "Treatment of Concomitant Disease" select the corresponding term from the dynamic search list.

Type de données

text

Alias
UMLS CUI [1]
C2826696
Dynamic search list contains: "Line No - Term - Start Date"
Description

Dynamic search list

Type de données

text

Alias
UMLS CUI [1,1]
C0557959
UMLS CUI [1,2]
C0745732
If indication is "Other", specify
Description

Other Indication

Type de données

text

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0205394
Additional Primary Malignancy
Description

Additional Primary Malignancy

AE number
Description

AE number

Type de données

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0237753
Cancer type
Description

Cancer type

Type de données

text

Alias
UMLS CUI [1]
C0872066
Other, specify
Description

Other Cancer type

Type de données

text

Alias
UMLS CUI [1]
C1707251
If not AML/MDS, histopathological results:
Description

If not AML/MDS, histopathological results

Type de données

text

Alias
UMLS CUI [1,1]
C0023467
UMLS CUI [1,2]
C0243140
UMLS CUI [2,1]
C3463824
UMLS CUI [2,2]
C0243140
If AML/MDS, specify classification
Description

If AML/MDS, specify classification

Type de données

text

Alias
UMLS CUI [1,1]
C0023467
UMLS CUI [1,2]
C0683326
UMLS CUI [2,1]
C3463824
UMLS CUI [2,2]
C0683326
If AML, specify % of blasts
Description

If AML, specify percentage of blasts

Type de données

text

Alias
UMLS CUI [1,1]
C0023467
UMLS CUI [1,2]
C1318434
If MDS, Subtype
Description

MDS Subtype

Type de données

text

Alias
UMLS CUI [1,1]
C3463824
UMLS CUI [1,2]
C0449560
Diagnostic findings
Description

Please specify for blood and bone marrow

Type de données

text

Alias
UMLS CUI [1]
C0011900
Concomitant Radiotherapy
Description

Concomitant Radiotherapy

Has the subject received any concomitant radiotherapy during study?
Description

Concomitant radiotherapy

Type de données

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C1707479
Regimen number
Description

Regimen number

Type de données

text

Alias
UMLS CUI [1,1]
C0040808
UMLS CUI [1,2]
C0237753
Irradiated location 1
Description

Irradiation site

Type de données

text

Alias
UMLS CUI [1]
C2169202
Irradiated location 2
Description

Irradiation site

Type de données

text

Alias
UMLS CUI [1]
C2169202
Irradiated location 3
Description

Irradiation site

Type de données

text

Alias
UMLS CUI [1]
C2169202
Intent
Description

Intention

Type de données

text

Alias
UMLS CUI [1,1]
C1283828
UMLS CUI [1,2]
C1522449
Was this radiotherapy given to relieve skeletal symptoms?
Description

Was this radiotherapy given to relieve skeletal symptoms

Type de données

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0683368
UMLS CUI [1,3]
C1301676
Type of radiotherapy
Description

Type of radiotherapy

Type de données

text

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0332307
Date of first fraction
Description

dd MMM Y.Y.Y.Y

Type de données

date

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0011008
Date of last fraction
Description

dd MMM Y.Y.Y.Y

Type de données

date

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0011008
Total cumulative dose
Description

(include units)

Type de données

text

Alias
UMLS CUI [1,1]
C2986497
UMLS CUI [1,2]
C1522449
Concurrent Diagnostic and Therapeutic Procedures for prostate cancer
Description

Concurrent Diagnostic and Therapeutic Procedures for prostate cancer

Has the subject undergone any concurrent diagnostic or therapeutic procedures associated with the cancer under study (including surgery and biopsy)?
Description

concurrent diagnostic or therapeutic procedures

Type de données

boolean

Alias
UMLS CUI [1,1]
C0205420
UMLS CUI [1,2]
C1576868
Procedure
Description

Procedure

Type de données

text

Alias
UMLS CUI [1]
C0184661
Other procedure: please specify
Description

Other procedure

Type de données

text

Alias
UMLS CUI [1]
C0393107
Location
Description

Location

Type de données

text

Alias
UMLS CUI [1]
C0450429
Other location: please specify
Description

Other location

Type de données

text

Alias
UMLS CUI [1,1]
C0450429
UMLS CUI [1,2]
C0205394
Date of procedure
Description

ddMMMyyyy

Type de données

date

Alias
UMLS CUI [1]
C2584899
Purpose of procedure
Description

Purpose of procedure

Type de données

text

Alias
UMLS CUI [1]
C0517852
Histopathological or surgery findings
Description

Histopathological or surgery findings

Type de données

text

Alias
UMLS CUI [1,1]
C0311392
UMLS CUI [1,2]
C0243140
UMLS CUI [2,1]
C0311392
UMLS CUI [2,2]
C0038895
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Similar models

Radium 223 Dichloride (Alpharadin) - Visit Independent Forms

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Medical History excluding the history of prostate cancer
Medical History findings
Item
Are there any Medical History findings excluding study indication that started before the subject signed the informed consent and that are considered relevant to the study?
boolean
C0262926 (UMLS CUI [1,1])
C2607943 (UMLS CUI [1,2])
Medical History finding
Item
Medical History finding
text
C0262926 (UMLS CUI [1,1])
C2607943 (UMLS CUI [1,2])
Start date
Item
Start date
date
C0808070 (UMLS CUI [1])
Ongoing
Item
Ongoing at subject's last visit
boolean
C0549178 (UMLS CUI [1])
date resolved
Item
If not ongoing, date resolved
date
C0011008 (UMLS CUI [1,1])
C2699488 (UMLS CUI [1,2])
Item Group
Concomitant Medication
Concomitant Medication
Item
Has the subject received any Concomitant Medication during the study period associated with Adverse Events or Primary Malignancy?
boolean
C2347852 (UMLS CUI [1])
Trade name
Item
Trade name
text
C2360065 (UMLS CUI [1])
Specify dose, unit and frequency
Item
Specify dose, unit and frequency
text
C1521902 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1521902 (UMLS CUI [2,1])
C0439148 (UMLS CUI [2,2])
C1521902 (UMLS CUI [3,1])
C0439603 (UMLS CUI [3,2])
Concomitant Medication Route of Administration
Item
Route
text
C2826730 (UMLS CUI [1])
Other Concomitant Medication Route of Administration
Item
Other, specify
text
C2826730 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Start date
Item
Start date
date
C0808070 (UMLS CUI [1])
Ongoing
Item
Ongoing at subjects last visit
boolean
C2826666 (UMLS CUI [1])
Stop date
Item
Stop date
date
C0806020 (UMLS CUI [1])
Indication
Item
Indication
text
C3146298 (UMLS CUI [1])
Dynamic search list
Item
Dynamic search list contains "Line No - Term - Start Date"
text
C0557959 (UMLS CUI [1,1])
C0745732 (UMLS CUI [1,2])
Other indication
Item
If indication is "Other'', specify
text
C3146298 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Item Group
Concomitant Medication - Analgesics
Concomitant Analgesic Medication
Item
Has the subject received any Concomitant Analgesic Medication during the study period?
boolean
C2347852 (UMLS CUI [1,1])
C0002771 (UMLS CUI [1,2])
Trade name
Item
Trade name
text
C2360065 (UMLS CUI [1])
Medication Dose
Item
Dose
text
C3174092 (UMLS CUI [1])
Unit
Item
Unit
text
C2348328 (UMLS CUI [1])
Medication frequency
Item
Frequency
text
C2826654 (UMLS CUI [1])
Concomitant Medication Route of Administration
Item
Route
text
C2826730 (UMLS CUI [1])
Other Concomitant Medication Route of Administration
Item
Other, specify
text
C2826730 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Start date
Item
Start date
date
C0808070 (UMLS CUI [1])
Concomitant Medication Ongoing
Item
Ongoing at subjects last visit
boolean
C2826666 (UMLS CUI [1])
Stop Date
Item
Stop Date
date
C0806020 (UMLS CUI [1])
Indication
Item
Indication
text
C2826696 (UMLS CUI [1])
Dynamic search list
Item
Dynamic search list contains: "Line No - Term - Start Date"
text
C0557959 (UMLS CUI [1,1])
C0745732 (UMLS CUI [1,2])
Other Indication
Item
If indication is "Other", specify
text
C3146298 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Item Group
Additional Primary Malignancy
AE number
Item
AE number
integer
C0877248 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Cancer type
Item
Cancer type
text
C0872066 (UMLS CUI [1])
Other Cancer type
Item
Other, specify
text
C1707251 (UMLS CUI [1])
If not AML/MDS, histopathological results
Item
If not AML/MDS, histopathological results:
text
C0023467 (UMLS CUI [1,1])
C0243140 (UMLS CUI [1,2])
C3463824 (UMLS CUI [2,1])
C0243140 (UMLS CUI [2,2])
If AML/MDS, specify classification
Item
If AML/MDS, specify classification
text
C0023467 (UMLS CUI [1,1])
C0683326 (UMLS CUI [1,2])
C3463824 (UMLS CUI [2,1])
C0683326 (UMLS CUI [2,2])
If AML, specify percentage of blasts
Item
If AML, specify % of blasts
text
C0023467 (UMLS CUI [1,1])
C1318434 (UMLS CUI [1,2])
MDS Subtype
Item
If MDS, Subtype
text
C3463824 (UMLS CUI [1,1])
C0449560 (UMLS CUI [1,2])
Diagnostic findings
Item
Diagnostic findings
text
C0011900 (UMLS CUI [1])
Item Group
Concomitant Radiotherapy
Concomitant radiotherapy
Item
Has the subject received any concomitant radiotherapy during study?
boolean
C1522449 (UMLS CUI [1,1])
C1707479 (UMLS CUI [1,2])
Regimen number
Item
Regimen number
text
C0040808 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Irradiation site
Item
Irradiated location 1
text
C2169202 (UMLS CUI [1])
Irradiation site
Item
Irradiated location 2
text
C2169202 (UMLS CUI [1])
Irradiation site
Item
Irradiated location 3
text
C2169202 (UMLS CUI [1])
Intention
Item
Intent
text
C1283828 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
Was this radiotherapy given to relieve skeletal symptoms
Item
Was this radiotherapy given to relieve skeletal symptoms?
boolean
C1522449 (UMLS CUI [1,1])
C0683368 (UMLS CUI [1,2])
C1301676 (UMLS CUI [1,3])
Type of radiotherapy
Item
Type of radiotherapy
text
C1522449 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Date of first fraction
Item
Date of first fraction
date
C1522449 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Date of last fraction
Item
Date of last fraction
date
C1522449 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Total cumulative dose
Item
Total cumulative dose
text
C2986497 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
Item Group
Concurrent Diagnostic and Therapeutic Procedures for prostate cancer
concurrent diagnostic or therapeutic procedures
Item
Has the subject undergone any concurrent diagnostic or therapeutic procedures associated with the cancer under study (including surgery and biopsy)?
boolean
C0205420 (UMLS CUI [1,1])
C1576868 (UMLS CUI [1,2])
Procedure
Item
Procedure
text
C0184661 (UMLS CUI [1])
Other procedure
Item
Other procedure: please specify
text
C0393107 (UMLS CUI [1])
Location
Item
Location
text
C0450429 (UMLS CUI [1])
Other location
Item
Other location: please specify
text
C0450429 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Date of procedure
Item
Date of procedure
date
C2584899 (UMLS CUI [1])
Purpose of procedure
Item
Purpose of procedure
text
C0517852 (UMLS CUI [1])
Histopathological or surgery findings
Item
Histopathological or surgery findings
text
C0311392 (UMLS CUI [1,1])
C0243140 (UMLS CUI [1,2])
C0311392 (UMLS CUI [2,1])
C0038895 (UMLS CUI [2,2])
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