ID

7428

Description

SOUTHWEST ONCOLOGY GROUP S0421 TREATMENT FORM: Step 1 Randomization Form Docetaxel and Prednisone With or Without Atrasentan in Treating Patients With Stage IV Prostate Cancer and Bone Metastases That Did Not Respond to Previous Hormone Therapy Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=F15A78DC-93A4-2746-E034-0003BA3F9857

Lien

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=F15A78DC-93A4-2746-E034-0003BA3F9857

Mots-clés

Versions (3)
  1. 19/09/2012 19/09/2012 -
  2. 09/01/2015 09/01/2015 - Martin Dugas
  3. 28/07/2015 28/07/2015 - Julian Varghese
Téléchargé le

9 janvier 2015

DOI

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Licence

Creative Commons BY-NC 3.0 Legacy
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Metastatic Cancer NCT00134056 Treatment - SOUTHWEST ONCOLOGY GROUP S0421 TREATMENT FORM: Step 1 Randomization Form - 2304583v3.0

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No Instruction available.

1 Formulaires  
  1. StudyEvent: SOUTHWEST ONCOLOGY GROUP S0421 TREATMENT FORM: Step 1 Randomization Form
    1. No Instruction available.
Header
Description

Header

SWOG Patient ID
Description

Trial subject ID SWOG

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1519429
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25699
SWOG Study No.
Description

Protocol ID SWOG

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C1519429
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25699
Registration Step
Description

Registration Number

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1514821
NCI Thesaurus ObjectClass
C25646
UMLS CUI-2
C0237753
NCI Thesaurus Property
C16154
NCI Thesaurus ValueDomain-2
C16154
Patient Initials (L, F M)
Description

Patient Initials

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
Institution/Affiliate
Description

Institution Name

Type de données

text

Alias
NCI Thesaurus ObjectClass
C25454
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass-2
C21541
NCI Thesaurus Property
C25364
NCI Thesaurus ValueDomain
C25191
NCI Thesaurus ValueDomain-2
C21541
Physician
Description

Investigator Name

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2826892
NCI Thesaurus Property
C25364
NCI Thesaurus ObjectClass
C17089
NCI Thesaurus ObjectClass-2
C25644
Participating Group Name
Description

Participating Group

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2347449
NCI Thesaurus ObjectClass
C25608
NCI Thesaurus ObjectClass-2
C17005
NCI Thesaurus Property
C25364
Participating Study No.
Description

Study Number Participating Group

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C2347449
NCI Thesaurus Property
C25608
NCI Thesaurus Property-2
C25364
Participating Patient ID (Instructions: Please complete this form after each cycle 1 cycle = 4 weeks. All dates are MONTH, DAY, YEAR. Explain any blank dates or fields in a Comments section. Place an X in appropriate boxes. Circle AMENDED items in red and write AMENDED across top of form.)
Description

Trial subject ID Participating Group

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C2347449
NCI Thesaurus Property
C25608
NCI Thesaurus Property-2
C25364
Status
Description

Status

Vital Status
Description

Patient Status

Type de données

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS CUI-1
C3846084
NCI Thesaurus ValueDomain
C18003
NCI Thesaurus ValueDomain-2
C25688
NCI Thesaurus Property
C25717
Date of Last Contact or Death
Description

Date last contact

Type de données

date

Alias
NCI Thesaurus ObjectClass
C16960
UMLS CUI-1
C0805839
NCI Thesaurus Property
C25461
NCI Thesaurus Property-2
C25551
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25367
Has the patient progressed per the definition in Section 10.0 of the protocol?
Description

Tumor Progression

Type de données

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS CUI-1
C0178874
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25320
NCI Thesaurus Property-2
C19987
Treatment
Description

Treatment

Were there any dose modifications or additions/omissions to protocol treatment?
Description

Dose Modification

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS CUI-1
C1707811
NCI Thesaurus ObjectClass
C25256
NCI Thesaurus Property
C25572
NCI Thesaurus ValueDomain-2
C25572
Unnamed Module 3
Description

Unnamed Module 3

Current cycle number
Description

Cycle Number Chemotherapeutics

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2045829
NCI Thesaurus Property
C25471
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property-2
C25379
Treatment start date
Description

Treatment Begin Date

Type de données

date

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25431
UMLS CUI-1
C3173309
NCI Thesaurus Property-2
C25275
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25431
Date of last treatment
Description

LastTreatmentDate

Type de données

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass-2
C25551
UMLS 2011AA ObjectClass
C1517741
NCI Thesaurus Property
C25275
UMLS 2011AA Property
C2745955
BSA (First day this cycle - m2)
Description

Body Surface Area

Type de données

float

Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0005902
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25157
Weight (kg)
Description

Patient Weight

Type de données

float

Unités de mesure
  • Kg
Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0005910
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25208
Kg
Alkaline Phosphatase (Total - IU/L)
Description

HepaticAlkalinePhosphataseLabValue

Type de données

float

Alias
NCI Thesaurus ObjectClass
C13308
UMLS 2011AA ObjectClass
C0205054
NCI Thesaurus Property
C37984
UMLS 2011AA Property
C0022877
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus Property-2
C16276
UMLS 2011AA Property-2
C0002059
Hemoglobin (g/dL - cycles 1 & 2 only)
Description

LaboratoryProcedureHemoglobinResultSpecifiedValue

Type de données

float

Unités de mesure
  • g/dL
Alias
NCI Thesaurus Property
C16676
UMLS 2011AA Property
C0019046
NCI Thesaurus Property-2
C20200
UMLS 2011AA Property-2
C1274040
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
g/dL
Arm 1 + Arm 2
Description

Arm 1 + Arm 2

Day 1 (Docetaxel dose)
Description

DocetaxelAgentFirstDayAdministeredDose

Type de données

float

Alias
NCI Thesaurus ObjectClass
C1526
UMLS 2011AA ObjectClass
C0246415
NCI Thesaurus ObjectClass-2
C1708
UMLS 2011AA ObjectClass-2
C0450442
NCI Thesaurus Property
C25301
UMLS 2011AA Property
C0439228
NCI Thesaurus Property-2
C25509
UMLS 2011AA Property-2
C1279901
NCI Thesaurus ValueDomain
C25488
UMLS 2011AA ValueDomain
C0178602
NCI Thesaurus ValueDomain-2
C25382
UMLS 2011AA ValueDomain-2
C1521801
Was pill taken daily (Prednisone dose)
Description

PrednisonePillDailyAdministrationInd-3

Type de données

boolean

Alias
NCI Thesaurus ObjectClass
C770
UMLS 2011AA ObjectClass
C0032952
NCI Thesaurus ObjectClass-2
C25394
UMLS 2011AA ObjectClass-2
C0994475
NCI Thesaurus Property
C25473
UMLS 2011AA Property
C0332173
NCI Thesaurus Property-2
C25409
UMLS 2011AA Property-2
C1533734
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
If no
Description

PrednisonePillDailyAdministrationSpecify

Type de données

text

Alias
NCI Thesaurus ObjectClass
C770
UMLS 2011AA ObjectClass
C0032952
NCI Thesaurus ObjectClass-2
C25394
UMLS 2011AA ObjectClass-2
C0994475
NCI Thesaurus Property
C25473
UMLS 2011AA Property
C0332173
NCI Thesaurus Property-2
C25409
UMLS 2011AA Property-2
C1533734
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Was pill taken daily (Atrasentan or matching placebo)
Description

PlaceboPillDailyAdministrationInd-3

Type de données

boolean

Alias
NCI Thesaurus ObjectClass
C753
UMLS 2011AA ObjectClass
C0032042
NCI Thesaurus ObjectClass-2
C25394
UMLS 2011AA ObjectClass-2
C0994475
NCI Thesaurus Property
C25473
UMLS 2011AA Property
C0332173
NCI Thesaurus Property-2
C25409
UMLS 2011AA Property-2
C1533734
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
If no
Description

PlaceboPillDailyAdministrationSpecified

Type de données

text

Alias
NCI Thesaurus ObjectClass
C753
UMLS 2011AA ObjectClass
C0032042
NCI Thesaurus ObjectClass-2
C25394
UMLS 2011AA ObjectClass-2
C0994475
NCI Thesaurus Property
C25473
UMLS 2011AA Property
C0332173
NCI Thesaurus Property-2
C25409
UMLS 2011AA Property-2
C1533734
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Comments
Description

Comments

Comments
Description

Research Comments

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0947611
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
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1 Formulaires
  1. StudyEvent: SOUTHWEST ONCOLOGY GROUP S0421 TREATMENT FORM: Step 1 Randomization Form
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Header
Trial subject ID SWOG
Item
SWOG Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1519429 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25699 (NCI Thesaurus Property-2)
Protocol ID SWOG
Item
SWOG Study No.
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1519429 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25699 (NCI Thesaurus Property-2)
Registration Number
Item
Registration Step
text
C25337 (NCI Thesaurus ValueDomain)
C1514821 (UMLS CUI-1)
C25646 (NCI Thesaurus ObjectClass)
C0237753 (UMLS CUI-2)
C16154 (NCI Thesaurus Property)
C16154 (NCI Thesaurus ValueDomain-2)
Patient Initials
Item
Patient Initials (L, F M)
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Institution Name
Item
Institution/Affiliate
text
C25454 (NCI Thesaurus ObjectClass)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
C25191 (NCI Thesaurus ValueDomain)
C21541 (NCI Thesaurus ValueDomain-2)
Investigator Name
Item
Physician
text
C25191 (NCI Thesaurus ValueDomain)
C2826892 (UMLS CUI-1)
C25364 (NCI Thesaurus Property)
C17089 (NCI Thesaurus ObjectClass)
C25644 (NCI Thesaurus ObjectClass-2)
Participating Group
Item
Participating Group Name
text
C25191 (NCI Thesaurus ValueDomain)
C2347449 (UMLS CUI-1)
C25608 (NCI Thesaurus ObjectClass)
C17005 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
Study Number Participating Group
Item
Participating Study No.
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Trial subject ID Participating Group
Item
Participating Patient ID (Instructions: Please complete this form after each cycle 1 cycle = 4 weeks. All dates are MONTH, DAY, YEAR. Explain any blank dates or fields in a Comments section. Place an X in appropriate boxes. Circle AMENDED items in red and write AMENDED across top of form.)
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Item Group
Status
Item
Vital Status
text
C16960 (NCI Thesaurus ObjectClass)
C3846084 (UMLS CUI-1)
C18003 (NCI Thesaurus ValueDomain)
C25688 (NCI Thesaurus ValueDomain-2)
C25717 (NCI Thesaurus Property)
CL.1
Code List
Vital Status
CL Item
Alive (Alive)
CL Item
Dead (Dead)
Date last contact
Item
Date of Last Contact or Death
date
C16960 (NCI Thesaurus ObjectClass)
C0805839 (UMLS CUI-1)
C25461 (NCI Thesaurus Property)
C25551 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
Tumor Progression
Item
Has the patient progressed per the definition in Section 10.0 of the protocol?
boolean
C38147 (NCI Thesaurus ValueDomain)
C0178874 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25320 (NCI Thesaurus Property)
C19987 (NCI Thesaurus Property-2)
Item Group
Treatment
Item
Were there any dose modifications or additions/omissions to protocol treatment?
text
C25180 (NCI Thesaurus ValueDomain)
C1707811 (UMLS CUI-1)
C25256 (NCI Thesaurus ObjectClass)
C25572 (NCI Thesaurus Property)
C25572 (NCI Thesaurus ValueDomain-2)
CL.3
Code List
Were there any dose modifications or additions/omissions to protocol treatment?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes, Planned (i.e., The Treatment Was Changed According To Protocol Guidelines) (Yes, planned)
CL Item
Yes, Unplanned (i.e., The Treatment Change Was Not Part Of Protocol Guidelines) (Yes, unplanned)
Item Group
Unnamed Module 3
Cycle Number Chemotherapeutics
Item
Current cycle number
text
C25337 (NCI Thesaurus ValueDomain)
C2045829 (UMLS CUI-1)
C25471 (NCI Thesaurus Property)
C15368 (NCI Thesaurus ObjectClass)
C25379 (NCI Thesaurus Property-2)
Treatment Begin Date
Item
Treatment start date
date
C15368 (NCI Thesaurus ObjectClass)
C25431 (NCI Thesaurus Property)
C3173309 (UMLS CUI-1)
C25275 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
LastTreatmentDate
Item
Date of last treatment
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25551 (NCI Thesaurus ObjectClass-2)
C1517741 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
Body Surface Area
Item
BSA (First day this cycle - m2)
float
C25209 (NCI Thesaurus ValueDomain)
C0005902 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25157 (NCI Thesaurus Property)
Patient Weight
Item
Weight (kg)
float
C25209 (NCI Thesaurus ValueDomain)
C0005910 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25208 (NCI Thesaurus Property)
HepaticAlkalinePhosphataseLabValue
Item
Alkaline Phosphatase (Total - IU/L)
float
C13308 (NCI Thesaurus ObjectClass)
C0205054 (UMLS 2011AA ObjectClass)
C37984 (NCI Thesaurus Property)
C0022877 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C16276 (NCI Thesaurus Property-2)
C0002059 (UMLS 2011AA Property-2)
LaboratoryProcedureHemoglobinResultSpecifiedValue
Item
Hemoglobin (g/dL - cycles 1 & 2 only)
float
C16676 (NCI Thesaurus Property)
C0019046 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
Item Group
Arm 1 + Arm 2
DocetaxelAgentFirstDayAdministeredDose
Item
Day 1 (Docetaxel dose)
float
C1526 (NCI Thesaurus ObjectClass)
C0246415 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ObjectClass-2)
C0450442 (UMLS 2011AA ObjectClass-2)
C25301 (NCI Thesaurus Property)
C0439228 (UMLS 2011AA Property)
C25509 (NCI Thesaurus Property-2)
C1279901 (UMLS 2011AA Property-2)
C25488 (NCI Thesaurus ValueDomain)
C0178602 (UMLS 2011AA ValueDomain)
C25382 (NCI Thesaurus ValueDomain-2)
C1521801 (UMLS 2011AA ValueDomain-2)
PrednisonePillDailyAdministrationInd-3
Item
Was pill taken daily (Prednisone dose)
boolean
C770 (NCI Thesaurus ObjectClass)
C0032952 (UMLS 2011AA ObjectClass)
C25394 (NCI Thesaurus ObjectClass-2)
C0994475 (UMLS 2011AA ObjectClass-2)
C25473 (NCI Thesaurus Property)
C0332173 (UMLS 2011AA Property)
C25409 (NCI Thesaurus Property-2)
C1533734 (UMLS 2011AA Property-2)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
PrednisonePillDailyAdministrationSpecify
Item
If no
text
C770 (NCI Thesaurus ObjectClass)
C0032952 (UMLS 2011AA ObjectClass)
C25394 (NCI Thesaurus ObjectClass-2)
C0994475 (UMLS 2011AA ObjectClass-2)
C25473 (NCI Thesaurus Property)
C0332173 (UMLS 2011AA Property)
C25409 (NCI Thesaurus Property-2)
C1533734 (UMLS 2011AA Property-2)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
PlaceboPillDailyAdministrationInd-3
Item
Was pill taken daily (Atrasentan or matching placebo)
boolean
C753 (NCI Thesaurus ObjectClass)
C0032042 (UMLS 2011AA ObjectClass)
C25394 (NCI Thesaurus ObjectClass-2)
C0994475 (UMLS 2011AA ObjectClass-2)
C25473 (NCI Thesaurus Property)
C0332173 (UMLS 2011AA Property)
C25409 (NCI Thesaurus Property-2)
C1533734 (UMLS 2011AA Property-2)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
PlaceboPillDailyAdministrationSpecified
Item
If no
text
C753 (NCI Thesaurus ObjectClass)
C0032042 (UMLS 2011AA ObjectClass)
C25394 (NCI Thesaurus ObjectClass-2)
C0994475 (UMLS 2011AA ObjectClass-2)
C25473 (NCI Thesaurus Property)
C0332173 (UMLS 2011AA Property)
C25409 (NCI Thesaurus Property-2)
C1533734 (UMLS 2011AA Property-2)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
Item Group
Comments
Research Comments
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
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