ID

7551

Descripción

CALGB 30506 Treatment And Response Form Chemotherapy or Observation in Treating Patients With Early Stage Non-Small Cell Lung Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=5E92C67F-DAF6-CFB0-E040-BB89AD432DA1

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=5E92C67F-DAF6-CFB0-E040-BB89AD432DA1

Palabras clave

Versiones (3)
  1. 19/9/12 19/9/12 -
  2. 9/1/15 9/1/15 - Martin Dugas
  3. 12/6/15 12/6/15 -
Subido en

9 de enero de 2015

DOI

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Licencia

Creative Commons BY-NC 3.0 Legacy
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Lung Cancer NCT00863512 Treatment - CALGB 30506 Treatment And Response Form - 2817736v1.0

Inglés

INSTRUCTIONS: Complete and submit this form as required by the protocol. Information in the upper right box must be completed for this form to be accepted. For optimal accuracy use black ink. Mark an X in the appropriate box for fields with a choice

1 formularios  
Header
Descripción

Header

CALGB Form
Descripción

Form ID CALGB

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3262252
NCI Thesaurus ObjectClass
C19464
UMLS CUI-2
C1516238
NCI Thesaurus Property
C25364
NCI Thesaurus ObjectClass-2
C25442
CALGB Study No.
Descripción

Protocol ID CALGB

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C1516238
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25442
CALGB Patient ID
Descripción

Trial subject ID CALGB

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1516238
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25442
Date of First dose for this reporting period (MM DD YYYY)
Descripción

Treatment Start Date

Tipo de datos

date

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25509
UMLS CUI-1
C3173309
NCI Thesaurus Property-2
C25256
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25431
Reporting Period End Date (MM DD YYYY)
Descripción

Reporting Period End Date

Tipo de datos

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C2361259
NCI Thesaurus Property
C25616
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property-2
C25651
Are data amended
Descripción

Data amended

Tipo de datos

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C0680532
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus Property
C25416
Unnamed2
Descripción

Unnamed2

Patient Initials (Last, First Middle)
Descripción

Patient Initials

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
Patient Hospital No.
Descripción

Medical Record Number

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1301894
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25261
NCI Thesaurus Property-2
C25198
Institution/Affiliate
Descripción

Institution Name

Tipo de datos

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
Participating Group
Descripción

Participating Group

Tipo de datos

text

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

Study Number Participating Group

Tipo de datos

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 Group Patient ID
Descripción

Trial subject ID Participating Group

Tipo de datos

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
Patient Data
Descripción

Patient Data

Cycle Number
Descripción

Cycle Number

Tipo de datos

integer

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2045829
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25379
Weight (kg)
Descripción

Patient Weight

Tipo de datos

float

Unidades de medida
  • Kg
Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0005910
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25208
Kg
BSA (m^2)
Descripción

Body Surface Area

Tipo de datos

float

Unidades de medida
  • m2
Alias
NCI Thesaurus ObjectClass
C25190
UMLS CUI-1
C0005902
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus Property
C25157
m2
First Treatment (cycles 1 ¿ 6)
Descripción

First Treatment (cycles 1 ¿ 6)

Agent
Descripción

Agent

Tipo de datos

text

Alias
NCI Thesaurus Property
C25364
UMLS CUI-1
C1521826
NCI Thesaurus ObjectClass
C1708
NCI Thesaurus ValueDomain
C1708
NCI Thesaurus ValueDomain-2
C42614
Total Dose of Agents/Drugs for this Cycle
Descripción

Agent Total Dose

Tipo de datos

float

Alias
NCI Thesaurus ValueDomain
C25304
UMLS CUI-1
C2986497
NCI Thesaurus Property
C25379
NCI Thesaurus ValueDomain-2
C25488
NCI Thesaurus ObjectClass
C1708
Dose Modifications
Descripción

Dose Modifications

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

Dose Modification

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS CUI-1
C1707811
NCI Thesaurus ObjectClass
C25256
NCI Thesaurus Property
C25572
NCI Thesaurus ValueDomain-2
C25572
Reason Treatment Ended
Descripción

Reason Treatment Ended

Off Treatment Reason (only applicable if protocol therapy has been discontinued permanently Mark one with an X.)
Descripción

Off Treatment Reason

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25638
UMLS CUI-1
C1518544
NCI Thesaurus ObjectClass
C25601
UMLS CUI-2
C0566251
NCI Thesaurus Property
C25365
Alternative therapy, specify
Descripción

Off Treatment Reason

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C25601
UMLS CUI-1
C1518544
NCI Thesaurus ObjectClass-2
C15368
NCI Thesaurus ObjectClass-3
C25415
UMLS CUI-2
C0566251
NCI Thesaurus Property
C25382
NCI Thesaurus ValueDomain
C25638
Other specify
Descripción

Off Treatment Reason, specify

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS CUI-1
C1518544
NCI Thesaurus ObjectClass
C25601
UMLS CUI-2
C0566251
NCI Thesaurus Property
C25365
UMLS CUI-3
C1521902
Was growth factor support employed? (during this reporting period)
Descripción

Growth factor administered

Tipo de datos

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C0018284
NCI Thesaurus ObjectClass
C20424
UMLS CUI-2
C1521801
NCI Thesaurus Property
C25382
Total No. of Doses (if yes, specify)
Descripción

Number of Doses, Total

Tipo de datos

float

Alias
NCI Thesaurus Property
C25304
UMLS CUI-1
C0178602
NCI Thesaurus ValueDomain
C25463
UMLS CUI-2
C0750480
NCI Thesaurus ObjectClass
C1708
NCI Thesaurus Property-2
C25256
Overall Response
Descripción

Overall Response

Completed by (print or type name)
Descripción

Person Completing Form

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1550483
NCI Thesaurus ObjectClass
C25657
NCI Thesaurus Property
C25364
Date Form Completed (MM DD YYYY)
Descripción

Date Form Completed

Tipo de datos

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1115437
NCI Thesaurus ObjectClass
C40988
NCI Thesaurus Property
C25250
NCI Thesaurus ValueDomain-2
C25367
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Similar models

INSTRUCTIONS: Complete and submit this form as required by the protocol. Information in the upper right box must be completed for this form to be accepted. For optimal accuracy use black ink. Mark an X in the appropriate box for fields with a choice

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Header
Form ID CALGB
Item
CALGB Form
text
C25337 (NCI Thesaurus ValueDomain)
C3262252 (UMLS CUI-1)
C19464 (NCI Thesaurus ObjectClass)
C1516238 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25442 (NCI Thesaurus ObjectClass-2)
Protocol ID CALGB
Item
CALGB Study No.
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1516238 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25442 (NCI Thesaurus Property-2)
Trial subject ID CALGB
Item
CALGB Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1516238 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25442 (NCI Thesaurus Property-2)
Treatment Start Date
Item
Date of First dose for this reporting period (MM DD YYYY)
date
C15368 (NCI Thesaurus ObjectClass)
C25509 (NCI Thesaurus Property)
C3173309 (UMLS CUI-1)
C25256 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
Reporting Period End Date
Item
Reporting Period End Date (MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C2361259 (UMLS CUI-1)
C25616 (NCI Thesaurus Property)
C15368 (NCI Thesaurus ObjectClass)
C25651 (NCI Thesaurus Property-2)
Data amended
Item
Are data amended
boolean
C38148 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
Item Group
Unnamed2
Patient Initials
Item
Patient Initials (Last, First Middle)
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Medical Record Number
Item
Patient Hospital No.
text
C25337 (NCI Thesaurus ValueDomain)
C1301894 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25261 (NCI Thesaurus Property)
C25198 (NCI Thesaurus Property-2)
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)
Participating Group
Item
Participating Group
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 Group 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 Group Patient ID
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
Patient Data
Cycle Number
Item
Cycle Number
integer
C25337 (NCI Thesaurus ValueDomain)
C2045829 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass)
C25379 (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)
Body Surface Area
Item
BSA (m^2)
float
C25190 (NCI Thesaurus ObjectClass)
C0005902 (UMLS CUI-1)
C25712 (NCI Thesaurus ValueDomain)
C25157 (NCI Thesaurus Property)
Item Group
First Treatment (cycles 1 ¿ 6)
Agent
Item
Agent
text
C25364 (NCI Thesaurus Property)
C1521826 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C1708 (NCI Thesaurus ValueDomain)
C42614 (NCI Thesaurus ValueDomain-2)
Agent Total Dose
Item
Total Dose of Agents/Drugs for this Cycle
float
C25304 (NCI Thesaurus ValueDomain)
C2986497 (UMLS CUI-1)
C25379 (NCI Thesaurus Property)
C25488 (NCI Thesaurus ValueDomain-2)
C1708 (NCI Thesaurus ObjectClass)
Item Group
Dose Modifications
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.2
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
Reason Treatment Ended
Item
Off Treatment Reason (only applicable if protocol therapy has been discontinued permanently Mark one with an X.)
text
C25638 (NCI Thesaurus ValueDomain)
C1518544 (UMLS CUI-1)
C25601 (NCI Thesaurus ObjectClass)
C0566251 (UMLS CUI-2)
C25365 (NCI Thesaurus Property)
CL.3
Code List
Off Treatment Reason (only applicable if protocol therapy has been discontinued permanently Mark one with an X.)
CL Item
Disease Progression, Relapse During Active Treatment (Disease progression, relapse during active treatment)
CL Item
Adverse Event/side Effects/complications (Adverse Event/Side Effects/Complications)
CL Item
Patient Withdrawal Or Refusal After Beginning Protocol Therapy (Patient withdrawal/refusal after beginning protocol therapy)
CL Item
Patient Withdrawal Or Refusal Before Beginning Protocol Therapy (Patient withdrawal/refusal prior to beginning protocol therapy)
CL Item
Alternative Therapy (Alternative therapy)
CL Item
Patient Off-treatment For Other Complicating Disease (Patient off-treatment for other complicating disease)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
Item
Alternative therapy, specify
text
C25601 (NCI Thesaurus ObjectClass)
C1518544 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass-2)
C25415 (NCI Thesaurus ObjectClass-3)
C0566251 (UMLS CUI-2)
C25382 (NCI Thesaurus Property)
C25638 (NCI Thesaurus ValueDomain)
CL.4
Code List
Alternative therapy, specify
CL Item
Removed To Undergo Surgical Resection (Removed to undergo surgical resection)
CL Item
Removed To Receive Non-protocol Chemotherapy And/or Biologic Therapy (Removed to receive non-protocol chemotherapy and/or biologic therapy)
Off Treatment Reason, specify
Item
Other specify
text
C25685 (NCI Thesaurus ValueDomain)
C1518544 (UMLS CUI-1)
C25601 (NCI Thesaurus ObjectClass)
C0566251 (UMLS CUI-2)
C25365 (NCI Thesaurus Property)
C1521902 (UMLS CUI-3)
Growth factor administered
Item
Was growth factor support employed? (during this reporting period)
boolean
C38148 (NCI Thesaurus ValueDomain)
C0018284 (UMLS CUI-1)
C20424 (NCI Thesaurus ObjectClass)
C1521801 (UMLS CUI-2)
C25382 (NCI Thesaurus Property)
Number of Doses, Total
Item
Total No. of Doses (if yes, specify)
float
C25304 (NCI Thesaurus Property)
C0178602 (UMLS CUI-1)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS CUI-2)
C1708 (NCI Thesaurus ObjectClass)
C25256 (NCI Thesaurus Property-2)
Item Group
Overall Response
Person Completing Form
Item
Completed by (print or type name)
text
C25191 (NCI Thesaurus ValueDomain)
C1550483 (UMLS CUI-1)
C25657 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
Date Form Completed
Item
Date Form Completed (MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C1115437 (UMLS CUI-1)
C40988 (NCI Thesaurus ObjectClass)
C25250 (NCI Thesaurus Property)
C25367 (NCI Thesaurus ValueDomain-2)
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