ID

43181

Description

Phase II Consortium - Phase II Lung Cancer - NSCLC Advanced On-Study Form Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=FF7A9F25-B26C-5224-E034-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=FF7A9F25-B26C-5224-E034-0003BA3F9857

Keywords

Versions (6)
  1. 8/11/14 8/11/14 - Martin Dugas
  2. 8/11/14 8/11/14 - Martin Dugas
  3. 8/11/14 8/11/14 - Martin Dugas
  4. 8/11/14 8/11/14 - Martin Dugas
  5. 12/31/14 12/31/14 - Martin Dugas
  6. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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On-Study - Phase II Lung Cancer - NSCLC Advanced On-Study Form - 2398811v1.0

English

Phase II Lung Cancer - NSCLC Advanced On-Study Form

1 forms  
  1. StudyEvent: Phase II Lung Cancer - NSCLC Advanced On-Study Form
    1. Phase II Lung Cancer - NSCLC Advanced On-Study Form
CRF Header
Description

CRF Header

Alias
UMLS CUI-1
C1320722
Coordinating Group Protocol No.
Description

Protocol ID Coordinating Group

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C1711341
NCI Thesaurus Property
C25462
NCI Thesaurus Property-2
C25364
Coordinating Group Code
Description

Coordinating Group Code

Data type

text

Alias
NCI Thesaurus ValueDomain
C25162
UMLS CUI-1
C1711341
NCI Thesaurus ObjectClass
C17005
UMLS CUI-2
C0805701
NCI Thesaurus ObjectClass-2
C25462
NCI Thesaurus Property
C25364
Protocol Title
Description

Protocol Title

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986303
NCI Thesaurus ObjectClass
C25320
NCI Thesaurus Property
C42774
Patient Study ID
Description

Patient Study ID

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25462
NCI Thesaurus Property-2
C25364
Registering Group Code
Description

Registering Group Code

Data type

text

Alias
NCI Thesaurus ValueDomain
C25162
UMLS CUI-1
C2347449
NCI Thesaurus ObjectClass
C17005
UMLS CUI-2
C0805701
NCI Thesaurus Property
C25364
NCI Thesaurus ObjectClass-2
C25645
Patient Medical Record Number
Description

Medical Record Number

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1301894
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25261
NCI Thesaurus Property-2
C25198
Other Patient ID
Description

Trial subject ID Participating Group

Data type

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
Institution/Affiliate
Description

Institution Name

Data type

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
Registering Institution Code
Description

Registering Institution Code

Data type

text

Alias
NCI Thesaurus ValueDomain
C25162
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass
C21541
UMLS CUI-2
C0805701
NCI Thesaurus Property
C25364
NCI Thesaurus ObjectClass-2
C25645
Physician of Record
Description

Investigator Name

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2826892
NCI Thesaurus Property
C25364
NCI Thesaurus ObjectClass
C17089
NCI Thesaurus ObjectClass-2
C25644
Person Completing Form
Description

Person Completing Form

Data type

text

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

Date Form Completed

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1115437
NCI Thesaurus ObjectClass
C40988
NCI Thesaurus Property
C25250
NCI Thesaurus ValueDomain-2
C25367
Are data amended (If data are amended, please circle in red when using paper form)
Description

Data amended

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C0680532
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus Property
C25416
Lung: Pre-treatment Characteristics
Description

Lung: Pre-treatment Characteristics

Patient Weight
Description

Patient Weight

Data type

float

Measurement units
  • kg
Alias
NCI Thesaurus ValueDomain
C25209
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25208
UMLS CUI-1
C0005910
kg
Weight Loss in Previous Six Months (Approximate check one)
Description

Weight Loss past six months

Data type

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS CUI-1
C1262477
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C3828652
NCI Thesaurus Property
C3445
NCI Thesaurus ValueDomain-2
C25613
Weight loss in previous 6 months (Approximate kg)
Description

Weight Loss past six months

Data type

double

Measurement units
  • %
Alias
NCI Thesaurus ObjectClass
C16960
UMLS CUI-1
C1262477
NCI Thesaurus Property
C3445
UMLS CUI-2
C3828652
NCI Thesaurus ValueDomain
C25613
NCI Thesaurus ValueDomain-2
C25712
%
Smoking History
Description

Smoking history

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C1519384
NCI Thesaurus ObjectClass
C17934
NCI Thesaurus Property
C18772
Does the patient currently smoke
Description

Current Smoker

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C3241966
NCI Thesaurus Property
C25471
NCI Thesaurus ObjectClass
C17934
NCI Metathesaurus Property
C0449865
Number of Cigarettes per day (If yes,)
Description

Smoker amount smoked

Data type

text

Alias
NCI Thesaurus ObjectClass
C17934
UMLS CUI-1
C1608325
NCI Thesaurus Property
C25471
NCI Metathesaurus Property
C0449865
NCI Thesaurus ValueDomain
C25473
NCI Thesaurus ValueDomain-2
C25515
Time since last cigarette (If no,)
Description

Smoking Discontinued Duration

Data type

text

Alias
NCI Thesaurus Property
C25484
UMLS CUI-1
C0453997
NCI Thesaurus ObjectClass
C17934
NCI Thesaurus ValueDomain
C25330
Lung: Disease Description NSCLC Stage I-III
Description

Lung: Disease Description NSCLC Stage I-III

Tumor Stage
Description

Tumor Stage

Data type

text

Alias
NCI Thesaurus ObjectClass
C3262
NCI Thesaurus ObjectClass-2
C12468
NCI Thesaurus ValueDomain
C16899
NCI Thesaurus Property
C25523
UMLS CUI-1
C1300072
Histologic Type
Description

Histologic Type

Data type

text

Alias
NCI Thesaurus ObjectClass
C3262
UMLS CUI-1
C0449574
NCI Thesaurus ObjectClass-2
C12468
NCI Thesaurus Property
C25526
NCI Thesaurus Property-2
C25161
NCI Thesaurus ValueDomain
C25372
NCI Thesaurus ValueDomain-2
C25526
Specify Other Histologic Type
Description

Histologic Type, other

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS CUI-1
C1299220
NCI Thesaurus ObjectClass
C3262
NCI Thesaurus Property
C25526
NCI Thesaurus Property-2
C25161
Is measurable disease present? (only applicable in studies where there is disease at baseline)
Description

Measurable Disease

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C1513041
NCI Thesaurus Property
C25626
NCI Thesaurus ObjectClass
C2991
NCI Thesaurus ObjectClass-2
C37894
Is non-measurable disease present? (only applicable in studies where there is disease at baseline)
Description

Non-Measurable Disease

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C1334988
NCI Thesaurus Property
C25626
NCI Thesaurus ObjectClass
C2991
NCI Thesaurus ObjectClass-2
C25589
Metastatic Sites (check all that apply)
Description

Metastatic Sites

Data type

text

Alias
NCI Thesaurus ObjectClass
C12468
UMLS CUI-1
C0280457
NCI Thesaurus ObjectClass-2
C9305
NCI Thesaurus Property
C14174
NCI Thesaurus Property-2
C25548
NCI Thesaurus ValueDomain
C13717
Other specify
Description

Metastatic Sites, other

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS CUI-1
C0280457
NCI Thesaurus Property
C14174
UMLS CUI-2
C3844311
NCI Thesaurus ObjectClass
C9305
NCI Thesaurus Property-2
C25548
Lung: Prior Treatment (CDUS Module) NSCLC Stage I-III
Description

Lung: Prior Treatment (CDUS Module) NSCLC Stage I-III

Prior therapy type (per CDUS reporting guidelines check all that apply)
Description

Prior therapy type

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C1514463
NCI Thesaurus ObjectClass
C25629
NCI Thesaurus ObjectClass-2
C15368
NCI Thesaurus Property
C25365
Number of prior therapy regimens (For example, planned treatment of chemotherapy + RT = 1 regimen)
Description

Number of prior therapy regimens

Data type

integer

Alias
NCI Thesaurus ObjectClass
C25629
UMLS CUI-1
C0750480
NCI Thesaurus ObjectClass-2
C15368
NCI Thesaurus ValueDomain
C25463
UMLS CUI-2
C0040808
NCI Thesaurus Property
C15697
UMLS CUI-3
C0332152
MedDRA Code (for Primary Disease Site)
Description

Primary Site MedDRA Code

Data type

text

Alias
NCI Thesaurus ObjectClass
C41331
UMLS CUI-1
C0449695
NCI Thesaurus ObjectClass-2
C71886
UMLS CUI-2
C1552878
NCI Thesaurus Property
C25162
NCI Thesaurus Property-2
C43820
NCI Thesaurus ValueDomain
C25162
NCI Thesaurus ValueDomain-2
C41331
NCI Thesaurus ValueDomain-3
C45255
NCI Thesaurus ValueDomain-4
C43820
NCI Thesaurus ValueDomain-5
C25714
Lung: Prior Systemic Therapy NSCLC Advanced
Description

Lung: Prior Systemic Therapy NSCLC Advanced

Prior systemic therapy
Description

Prior systemic therapy

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS CUI-1
C1515119
NCI Thesaurus ObjectClass
C15698
UMLS CUI-2
C0332152
NCI Thesaurus ObjectClass-2
C25629
NCI Thesaurus Property
C25382
Number of prior therapy regimens (For example, planned treatment of chemotherapy + RT = 1 regimen)
Description

Number of prior therapy regimens

Data type

integer

Alias
NCI Thesaurus ObjectClass
C25629
UMLS CUI-1
C0750480
NCI Thesaurus ObjectClass-2
C15368
NCI Thesaurus ValueDomain
C25463
UMLS CUI-2
C0040808
NCI Thesaurus Property
C15697
UMLS CUI-3
C0332152
Agent Name
Description

Agent

Data type

text

Alias
NCI Thesaurus Property
C25364
UMLS CUI-1
C1521826
NCI Thesaurus ObjectClass
C1708
NCI Thesaurus ValueDomain
C1708
NCI Thesaurus ValueDomain-2
C42614
Agent Start Date (MM DD YYYY)
Description

Concomitant Medication Start Date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C2826734
NCI Thesaurus ValueDomain-2
C25431
NCI Thesaurus ObjectClass
C1708
NCI Thesaurus Property
C25275
Agent End Date (MM DD YYYY)
Description

Concomitant Medication End Date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C2826744
NCI Thesaurus ObjectClass
C1708
NCI Thesaurus Property
C25275
Agent Total Cumulative Dose
Description

Cumulative Dose Agent

Data type

float

Alias
NCI Thesaurus ObjectClass
C1708
UMLS CUI-1
C2986497
NCI Thesaurus ObjectClass-2
C25470
UMLS CUI-2
C1521826
NCI Thesaurus Property
C25304
NCI Thesaurus Property-2
C25256
NCI Thesaurus ValueDomain
C25304
NCI Thesaurus ValueDomain-2
C25488
Units
Description

Units

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C1519795
NCI Thesaurus ValueDomain-2
C44278
NCI Thesaurus ObjectClass
C1708
NCI Thesaurus Property
C25256
Overall Response Duration (weeks)
Description

Overall Response Duration

Data type

float

Alias
NCI Thesaurus ObjectClass
C25755
UMLS CUI-1
C0237585
NCI Thesaurus Property
C25605
NCI Thesaurus Property-2
C25275
NCI Thesaurus ValueDomain
C25605
NCI Thesaurus ValueDomain-2
C25330
Procedure Description
Description

Procedure Description

Prior Surgery
Description

Prior Surgery

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C0744961
NCI Thesaurus Property
C38000
NCI Thesaurus ObjectClass
C15329
NCI Thesaurus ObjectClass-2
C25629
Surgical Approach
Description

Surgical Approach

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C0449446
NCI Thesaurus ObjectClass
C12468
NCI Thesaurus ObjectClass-2
C15329
NCI Thesaurus Property
C25382
Primary Surgery Type
Description

Primary Surgery Type

Data type

text

Alias
NCI Thesaurus ObjectClass
C25251
UMLS CUI-1
C0944781
NCI Thesaurus ObjectClass-2
C12468
NCI Thesaurus ObjectClass-3
C15329
NCI Thesaurus Property
C38000
NCI Thesaurus ValueDomain
C25284
Surgery Date (MM DD YYYY)
Description

Surgery Date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1628561
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus ObjectClass
C15329
NCI Thesaurus Property
C25275
Lung: Prior Radiation Therapy NSCLC Advanced
Description

Lung: Prior Radiation Therapy NSCLC Advanced

Prior Radiation Therapy
Description

Prior Radiation Therapy

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C1522449
NCI Thesaurus ObjectClass
C15313
UMLS CUI-2
C0332152
NCI Thesaurus ObjectClass-2
C25629
NCI Thesaurus Property
C25382
Total Dose to Lung (cGy)
Description

Total Dose to Lung

Data type

float

Alias
NCI Thesaurus ObjectClass
C15313
UMLS CUI-1
C2169193
NCI Thesaurus Property
C12468
UMLS CUI-2
C0024109
NCI Thesaurus Property-2
C25382
NCI Thesaurus ValueDomain
C25304
NCI Thesaurus ValueDomain-2
C25488
Radiation Therapy End Date (MM DD YYYY)
Description

Radiation Therapy End Date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1522449
NCI Thesaurus ObjectClass
C15313
UMLS CUI-2
C0806020
NCI Thesaurus Property
C25275
NCI Thesaurus Property-2
C25496
Type of Radiation Therapy Administered
Description

Radiation Therapy Type

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C1522449
NCI Thesaurus ObjectClass
C15313
UMLS CUI-2
C0683312
NCI Thesaurus Property
C25382
Other specify
Description

Radiotherapy type

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS CUI-1
C1522449
NCI Thesaurus ObjectClass
C15313
UMLS CUI-2
C1521902
NCI Thesaurus Property
C25365
Radiation Therapy Site
Description

Radiation Therapy Body Site

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1997599
NCI Thesaurus Property
C25341
NCI Thesaurus ObjectClass
C15313
RT Dose per Fraction
Description

Radiation Therapy Dose per Fraction

Data type

float

Alias
NCI Thesaurus ObjectClass
C15313
UMLS CUI-1
C1522449
NCI Thesaurus ValueDomain
C25488
UMLS CUI-2
C0178602
NCI Thesaurus Property
C25514
UMLS CUI-3
C1264633
Units
Description

Units

Data type

text

Alias
NCI Thesaurus ObjectClass
C1708
UMLS CUI-1
C1519795
NCI Thesaurus Property
C25256
NCI Thesaurus ValueDomain
C25709
Total Number of Fractions
Description

Total Number of Fractions

Data type

integer

Alias
NCI Thesaurus Property
C25304
UMLS CUI-1
C1522449
NCI Thesaurus ObjectClass
C15313
UMLS CUI-2
C1264633
NCI Thesaurus ValueDomain
C25463
UMLS CUI-3
C0750480
NCI Thesaurus Property-2
C25514
RT Total Dose
Description

Radiation Therapy Total Dose

Data type

float

Alias
NCI Thesaurus ValueDomain
C25304
UMLS CUI-1
C2169193
NCI Thesaurus ObjectClass
C15313
NCI Thesaurus ValueDomain-2
C25488
NCI Thesaurus Property
C25382
Were there any unscheduled interruptions in radiation therapy?
Description

Unscheduled Interruptions in Radiation Therapy

Data type

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS CUI-1
C1522449
NCI Thesaurus ObjectClass
C15313
UMLS CUI-2
C1512900
NCI Thesaurus Property
C25542
RT Interruptions Reason (Specify)
Description

Radiation Therapy Interruptions Reason

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C1522449
NCI Thesaurus ObjectClass
C15313
UMLS CUI-2
C1512900
NCI Thesaurus Property
C25542
UMLS CUI-3
C0566251
Comments
Description

Comments

Comments
Description

Research Comments

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0947611
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
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Similar models

Phase II Lung Cancer - NSCLC Advanced On-Study Form

1 forms
  1. StudyEvent: Phase II Lung Cancer - NSCLC Advanced On-Study Form
    1. Phase II Lung Cancer - NSCLC Advanced On-Study Form
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
CRF Header
C1320722 (UMLS CUI-1)
Protocol ID Coordinating Group
Item
Coordinating Group Protocol No.
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1711341 (UMLS CUI-2)
C25462 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Coordinating Group Code
Item
Coordinating Group Code
text
C25162 (NCI Thesaurus ValueDomain)
C1711341 (UMLS CUI-1)
C17005 (NCI Thesaurus ObjectClass)
C0805701 (UMLS CUI-2)
C25462 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
Protocol Title
Item
Protocol Title
text
C25191 (NCI Thesaurus ValueDomain)
C2986303 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C42774 (NCI Thesaurus Property)
Patient Study ID
Item
Patient Study ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25462 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Registering Group Code
Item
Registering Group Code
text
C25162 (NCI Thesaurus ValueDomain)
C2347449 (UMLS CUI-1)
C17005 (NCI Thesaurus ObjectClass)
C0805701 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25645 (NCI Thesaurus ObjectClass-2)
Medical Record Number
Item
Patient Medical Record Number
text
C25337 (NCI Thesaurus ValueDomain)
C1301894 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25261 (NCI Thesaurus Property)
C25198 (NCI Thesaurus Property-2)
Trial subject ID Participating Group
Item
Other 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)
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)
Registering Institution Code
Item
Registering Institution Code
text
C25162 (NCI Thesaurus ValueDomain)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass)
C0805701 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25645 (NCI Thesaurus ObjectClass-2)
Investigator Name
Item
Physician of Record
text
C25191 (NCI Thesaurus ValueDomain)
C2826892 (UMLS CUI-1)
C25364 (NCI Thesaurus Property)
C17089 (NCI Thesaurus ObjectClass)
C25644 (NCI Thesaurus ObjectClass-2)
Person Completing Form
Item
Person Completing Form
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)
Data amended
Item
Are data amended (If data are amended, please circle in red when using paper form)
boolean
C38148 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
Item Group
Lung: Pre-treatment Characteristics
Patient Weight
Item
Patient Weight
float
C25209 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C25208 (NCI Thesaurus Property)
C0005910 (UMLS CUI-1)
Item
Weight Loss in Previous Six Months (Approximate check one)
text
C25664 (NCI Thesaurus ValueDomain)
C1262477 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C3828652 (UMLS CUI-2)
C3445 (NCI Thesaurus Property)
C25613 (NCI Thesaurus ValueDomain-2)
CL.2
Code List
Weight Loss in Previous Six Months (Approximate check one)
CL Item
<5% Of Body Weight (< 5% of body weight)
CL Item
5 To <10% Of Body Weight (5 to < 10% of body weight)
CL Item
10 To <20% Of Body Weight (10 to <20% of body weight)
CL Item
> Or = 20% Of Body Weight (> or = 20% of body weight)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Weight Loss past six months
Item
Weight loss in previous 6 months (Approximate kg)
double
C16960 (NCI Thesaurus ObjectClass)
C1262477 (UMLS CUI-1)
C3445 (NCI Thesaurus Property)
C3828652 (UMLS CUI-2)
C25613 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
Item
Smoking History
text
C25284 (NCI Thesaurus ValueDomain)
C1519384 (UMLS CUI-1)
C17934 (NCI Thesaurus ObjectClass)
C18772 (NCI Thesaurus Property)
CL.3
Code List
Smoking History
CL Item
Never Smoked (Never smoked)
CL Item
Pipe Or Cigar Smoker Only (Pipe or cigar smoker only)
CL Item
Cigarette Smoker <20 Pack-years (Cigarette smoker, <20 pack-years)
CL Item
Cigarette Smoker 20-40 Pack-years (Cigarette smoker, 20-40 pack-years)
CL Item
Cigarette Smoker >40 Pack-years (Cigarette smoker, >40 pack-years)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Current Smoker
Item
Does the patient currently smoke
boolean
C38148 (NCI Thesaurus ValueDomain)
C3241966 (UMLS CUI-1)
C25471 (NCI Thesaurus Property)
C17934 (NCI Thesaurus ObjectClass)
C0449865 (NCI Metathesaurus Property)
Item
Number of Cigarettes per day (If yes,)
text
C17934 (NCI Thesaurus ObjectClass)
C1608325 (UMLS CUI-1)
C25471 (NCI Thesaurus Property)
C0449865 (NCI Metathesaurus Property)
C25473 (NCI Thesaurus ValueDomain)
C25515 (NCI Thesaurus ValueDomain-2)
CL.5
Code List
Number of Cigarettes per day (If yes,)
CL Item
Fewer Than 10 Cigarettes (Fewer than 10 cigarettes)
CL Item
10 To 20 Cigarettes (10 to 20 cigarettes)
CL Item
More Than 20 Cigarettes (More than 20 cigarettes)
CL Item
Not Applicable (Not applicable)
C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)
Item
Time since last cigarette (If no,)
text
C25484 (NCI Thesaurus Property)
C0453997 (UMLS CUI-1)
C17934 (NCI Thesaurus ObjectClass)
C25330 (NCI Thesaurus ValueDomain)
CL.6
Code List
Time since last cigarette (If no,)
CL Item
Less Than 1 Month (Less than 1 month)
CL Item
1 Month To <6 Months (1 month to <6 months)
CL Item
6 Months To <1 Year (6 months to <1 year)
CL Item
1 Year To <5 Years (1 year to <5 years)
CL Item
5 Years To <10 Years (5 years to <10 years)
CL Item
More Than 10 Years (More than 10 years)
CL Item
Not Applicable (Not applicable)
C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)
Item Group
Lung: Disease Description NSCLC Stage I-III
Item
Tumor Stage
text
C3262 (NCI Thesaurus ObjectClass)
C12468 (NCI Thesaurus ObjectClass-2)
C16899 (NCI Thesaurus ValueDomain)
C25523 (NCI Thesaurus Property)
C1300072 (UMLS CUI-1)
CL.7
Code List
Tumor Stage
CL Item
Recurrent (Recurrent)
C14173 (NCI Thesaurus)
C2945760 (UMLS 2011AA)
CL Item
IIIB (not recurrent) (Stage IIIb)
CL Item
IV (not recurrent) (Stage IV)
Item
Histologic Type
text
C3262 (NCI Thesaurus ObjectClass)
C0449574 (UMLS CUI-1)
C12468 (NCI Thesaurus ObjectClass-2)
C25526 (NCI Thesaurus Property)
C25161 (NCI Thesaurus Property-2)
C25372 (NCI Thesaurus ValueDomain)
C25526 (NCI Thesaurus ValueDomain-2)
CL.8
Code List
Histologic Type
CL Item
Squamous Cell Carcinoma (Squamous cell carcinoma)
C2929 (NCI Thesaurus)
C0007137 (UMLS 2011AA)
CL Item
Adenocarcinoma (Adenocarcinoma)
C2852 (NCI Thesaurus)
C0001418 (UMLS 2011AA)
CL Item
Adenocarcinoma With Bac Features (Adenocarcinoma with BAC features)
CL Item
Large Cell Undifferentiated (Large cell undifferentiated)
CL Item
Bronchoalveolar (bac) (Bronchoalveolar carcinoma (BAC))
CL Item
Non-small Cell Lung Cancer (nsclc), Nos (Non-small cell lung cancer NOS)
CL Item
Large Cell With Neuroendocrine Features (Large cell with neuroendocrine features)
CL Item
Other (Other specify)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
C17649 (NCI Thesaurus-3)
C0205394 (UMLS 2011AA-4)
Histologic Type, other
Item
Specify Other Histologic Type
text
C25685 (NCI Thesaurus ValueDomain)
C1299220 (UMLS CUI-1)
C3262 (NCI Thesaurus ObjectClass)
C25526 (NCI Thesaurus Property)
C25161 (NCI Thesaurus Property-2)
Measurable Disease
Item
Is measurable disease present? (only applicable in studies where there is disease at baseline)
boolean
C38148 (NCI Thesaurus ValueDomain)
C1513041 (UMLS CUI-1)
C25626 (NCI Thesaurus Property)
C2991 (NCI Thesaurus ObjectClass)
C37894 (NCI Thesaurus ObjectClass-2)
Non-Measurable Disease
Item
Is non-measurable disease present? (only applicable in studies where there is disease at baseline)
boolean
C38148 (NCI Thesaurus ValueDomain)
C1334988 (UMLS CUI-1)
C25626 (NCI Thesaurus Property)
C2991 (NCI Thesaurus ObjectClass)
C25589 (NCI Thesaurus ObjectClass-2)
Item
Metastatic Sites (check all that apply)
text
C12468 (NCI Thesaurus ObjectClass)
C0280457 (UMLS CUI-1)
C9305 (NCI Thesaurus ObjectClass-2)
C14174 (NCI Thesaurus Property)
C25548 (NCI Thesaurus Property-2)
C13717 (NCI Thesaurus ValueDomain)
CL.11
Code List
Metastatic Sites (check all that apply)
CL Item
Hilar Nodes (Hilar nodes)
CL Item
Mediastinal Nodes (Mediastinal nodes)
CL Item
Supraclavicular Or Scalene Nodes (Supraclavicular/scalene nodes)
CL Item
Ipsilateral Lung (Ipsilateral lung)
CL Item
Contralateral Lung (Contralateral lung)
CL Item
Pleura (Pleura)
C12469 (NCI Thesaurus)
C0032225 (UMLS 2011AA)
CL Item
Liver (Liver)
C12392 (NCI Thesaurus)
C0023884 (UMLS 2011AA)
CL Item
Adrenal Gland (Adrenal(s))
C12666 (NCI Thesaurus)
C0001625 (UMLS 2011AA)
CL Item
Bone (Bone)
C12366 (NCI Thesaurus)
C0262950 (UMLS 2011AA)
CL Item
Brain (Brain)
C12439 (NCI Thesaurus)
C0006104 (UMLS 2011AA)
CL Item
Skin (Skin)
C12470 (NCI Thesaurus)
C1123023 (UMLS 2011AA)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
Metastatic Sites, other
Item
Other specify
text
C25685 (NCI Thesaurus ValueDomain)
C0280457 (UMLS CUI-1)
C14174 (NCI Thesaurus Property)
C3844311 (UMLS CUI-2)
C9305 (NCI Thesaurus ObjectClass)
C25548 (NCI Thesaurus Property-2)
Item Group
Lung: Prior Treatment (CDUS Module) NSCLC Stage I-III
Item
Prior therapy type (per CDUS reporting guidelines check all that apply)
text
C25284 (NCI Thesaurus ValueDomain)
C1514463 (UMLS CUI-1)
C25629 (NCI Thesaurus ObjectClass)
C15368 (NCI Thesaurus ObjectClass-2)
C25365 (NCI Thesaurus Property)
CL.12
Code List
Prior therapy type (per CDUS reporting guidelines check all that apply)
CL Item
Agents Administered To Control The Replication And/or Spread Of Viruses (Anti-retroviral therapy)
CL Item
Treatment With An Agent That Prevents Or Impairs The Translation Of The Genetic Message For Production Of A Specific Protein (Antisense)
CL Item
High Dose Chemotherapy Combined With Transplantation Of Bone Marrow Cells (Bone marrow transplant)
CL Item
Non-systemic Chemotherapy Treatment Or Chemotherapy Not Described By Chemotherapy Single Agent Systemic Or Multi-agent Systemic (Chemotherapy (NOS))
CL Item
Systemic Chemotherapy With A Regimen Containing Multiple Agents (Chemotherapy multiple agents systemic)
CL Item
Prior Therapy With Agents That Are Not Known To Cause Damage To Cycling Cells (Chemotherapy non-cytotoxic)
CL Item
Systemic Chemotherapy With A Single Agent Regimen (Chemotherapy single agent systemic)
CL Item
Treatment Of Human Disease By Gene Transfer (Gene transfer)
CL Item
Cancer Therapy Which Incorporates Hormonal Manipulation (Hormonal therapy)
CL Item
Drug And/or Immunotherapy (Drug and/or Immunotherapy)
CL Item
No Previous Exposure To Drug (nos) (No prior therapy)
CL Item
Anticancer Treatment With A Live, Replication-competent Virus (Oncolytic virotherapy)
CL Item
Prior Therapy (nos) (Prior therapy NOS)
CL Item
Targeted Ionizing Radiation Therapy Utilizing Radioactive Implants Or Seeds (Radiation therapy)
CL Item
Surgical Procedure, Or Operation, With Therapeutic Intent (Surgery)
CL Item
Therapy Nos (Therapy (NOS))
CL Item
Substance Or Group Of Substances Administered To Induce The Immune System To Recognize And Destroy Tumors Or Microorganisms (Vaccine)
Number of prior therapy regimens
Item
Number of prior therapy regimens (For example, planned treatment of chemotherapy + RT = 1 regimen)
integer
C25629 (NCI Thesaurus ObjectClass)
C0750480 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass-2)
C25463 (NCI Thesaurus ValueDomain)
C0040808 (UMLS CUI-2)
C15697 (NCI Thesaurus Property)
C0332152 (UMLS CUI-3)
Primary Site MedDRA Code
Item
MedDRA Code (for Primary Disease Site)
text
C41331 (NCI Thesaurus ObjectClass)
C0449695 (UMLS CUI-1)
C71886 (NCI Thesaurus ObjectClass-2)
C1552878 (UMLS CUI-2)
C25162 (NCI Thesaurus Property)
C43820 (NCI Thesaurus Property-2)
C25162 (NCI Thesaurus ValueDomain)
C41331 (NCI Thesaurus ValueDomain-2)
C45255 (NCI Thesaurus ValueDomain-3)
C43820 (NCI Thesaurus ValueDomain-4)
C25714 (NCI Thesaurus ValueDomain-5)
Item Group
Lung: Prior Systemic Therapy NSCLC Advanced
Prior systemic therapy
Item
Prior systemic therapy
boolean
C38147 (NCI Thesaurus ValueDomain)
C1515119 (UMLS CUI-1)
C15698 (NCI Thesaurus ObjectClass)
C0332152 (UMLS CUI-2)
C25629 (NCI Thesaurus ObjectClass-2)
C25382 (NCI Thesaurus Property)
Number of prior therapy regimens
Item
Number of prior therapy regimens (For example, planned treatment of chemotherapy + RT = 1 regimen)
integer
C25629 (NCI Thesaurus ObjectClass)
C0750480 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass-2)
C25463 (NCI Thesaurus ValueDomain)
C0040808 (UMLS CUI-2)
C15697 (NCI Thesaurus Property)
C0332152 (UMLS CUI-3)
Agent
Item
Agent Name
text
C25364 (NCI Thesaurus Property)
C1521826 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C1708 (NCI Thesaurus ValueDomain)
C42614 (NCI Thesaurus ValueDomain-2)
Concomitant Medication Start Date
Item
Agent Start Date (MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C2826734 (UMLS CUI-1)
C25431 (NCI Thesaurus ValueDomain-2)
C1708 (NCI Thesaurus ObjectClass)
C25275 (NCI Thesaurus Property)
Concomitant Medication End Date
Item
Agent End Date (MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C2826744 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C25275 (NCI Thesaurus Property)
Cumulative Dose Agent
Item
Agent Total Cumulative Dose
float
C1708 (NCI Thesaurus ObjectClass)
C2986497 (UMLS CUI-1)
C25470 (NCI Thesaurus ObjectClass-2)
C1521826 (UMLS CUI-2)
C25304 (NCI Thesaurus Property)
C25256 (NCI Thesaurus Property-2)
C25304 (NCI Thesaurus ValueDomain)
C25488 (NCI Thesaurus ValueDomain-2)
Units
Item
Units
text
C25704 (NCI Thesaurus ValueDomain)
C1519795 (UMLS CUI-1)
C44278 (NCI Thesaurus ValueDomain-2)
C1708 (NCI Thesaurus ObjectClass)
C25256 (NCI Thesaurus Property)
Overall Response Duration
Item
Overall Response Duration (weeks)
float
C25755 (NCI Thesaurus ObjectClass)
C0237585 (UMLS CUI-1)
C25605 (NCI Thesaurus Property)
C25275 (NCI Thesaurus Property-2)
C25605 (NCI Thesaurus ValueDomain)
C25330 (NCI Thesaurus ValueDomain-2)
Item Group
Procedure Description
Prior Surgery
Item
Prior Surgery
boolean
C38148 (NCI Thesaurus ValueDomain)
C0744961 (UMLS CUI-1)
C38000 (NCI Thesaurus Property)
C15329 (NCI Thesaurus ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
Item
Surgical Approach
text
C25284 (NCI Thesaurus ValueDomain)
C0449446 (UMLS CUI-1)
C12468 (NCI Thesaurus ObjectClass)
C15329 (NCI Thesaurus ObjectClass-2)
C25382 (NCI Thesaurus Property)
CL.15
Code List
Surgical Approach
CL Item
Thoracotomy (thoracotomy)
CL Item
Thoracoscopy / Video-assisted (vats) (Thoracoscopy / Video-assisted (VATS))
CL Item
Thoracoscopy / Video-assisted (vats), With Conversion To Thoracotomy (Thoracoscopy / Video-assisted (VATS), with conversion to Thoracotomy)
Item
Primary Surgery Type
text
C25251 (NCI Thesaurus ObjectClass)
C0944781 (UMLS CUI-1)
C12468 (NCI Thesaurus ObjectClass-2)
C15329 (NCI Thesaurus ObjectClass-3)
C38000 (NCI Thesaurus Property)
C25284 (NCI Thesaurus ValueDomain)
CL.16
Code List
Primary Surgery Type
CL Item
Exploration, No Resection (Exploration, No Resection)
CL Item
Segmentectomy (Segmentectomy)
CL Item
Wedge Resection (Wedge Resection)
CL Item
Lobectomy (Lobectomy)
C15272 (NCI Thesaurus)
C0023928 (UMLS 2011AA)
CL Item
Bilobectomy (Bilobectomy)
CL Item
Pneumonectomy (Pneumonectomy)
C15305 (NCI Thesaurus)
C0032284 (UMLS 2011AA)
Surgery Date
Item
Surgery Date (MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C1628561 (UMLS CUI-1)
C25367 (NCI Thesaurus ValueDomain-2)
C15329 (NCI Thesaurus ObjectClass)
C25275 (NCI Thesaurus Property)
Item Group
Lung: Prior Radiation Therapy NSCLC Advanced
Prior Radiation Therapy
Item
Prior Radiation Therapy
boolean
C38148 (NCI Thesaurus ValueDomain)
C1522449 (UMLS CUI-1)
C15313 (NCI Thesaurus ObjectClass)
C0332152 (UMLS CUI-2)
C25629 (NCI Thesaurus ObjectClass-2)
C25382 (NCI Thesaurus Property)
Total Dose to Lung
Item
Total Dose to Lung (cGy)
float
C15313 (NCI Thesaurus ObjectClass)
C2169193 (UMLS CUI-1)
C12468 (NCI Thesaurus Property)
C0024109 (UMLS CUI-2)
C25382 (NCI Thesaurus Property-2)
C25304 (NCI Thesaurus ValueDomain)
C25488 (NCI Thesaurus ValueDomain-2)
Radiation Therapy End Date
Item
Radiation Therapy End Date (MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C1522449 (UMLS CUI-1)
C15313 (NCI Thesaurus ObjectClass)
C0806020 (UMLS CUI-2)
C25275 (NCI Thesaurus Property)
C25496 (NCI Thesaurus Property-2)
Item
Type of Radiation Therapy Administered
text
C25284 (NCI Thesaurus ValueDomain)
C1522449 (UMLS CUI-1)
C15313 (NCI Thesaurus ObjectClass)
C0683312 (UMLS CUI-2)
C25382 (NCI Thesaurus Property)
CL.18
Code List
Type of Radiation Therapy Administered
CL Item
External Beam Radiation (External beam radiation)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
C17649 (NCI Thesaurus-3)
C0205394 (UMLS 2011AA-4)
Radiotherapy type
Item
Other specify
text
C25685 (NCI Thesaurus ValueDomain)
C1522449 (UMLS CUI-1)
C15313 (NCI Thesaurus ObjectClass)
C1521902 (UMLS CUI-2)
C25365 (NCI Thesaurus Property)
Radiation Therapy Body Site
Item
Radiation Therapy Site
text
C25191 (NCI Thesaurus ValueDomain)
C1997599 (UMLS CUI-1)
C25341 (NCI Thesaurus Property)
C15313 (NCI Thesaurus ObjectClass)
Radiation Therapy Dose per Fraction
Item
RT Dose per Fraction
float
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS CUI-1)
C25488 (NCI Thesaurus ValueDomain)
C0178602 (UMLS CUI-2)
C25514 (NCI Thesaurus Property)
C1264633 (UMLS CUI-3)
Item
Units
text
C1708 (NCI Thesaurus ObjectClass)
C1519795 (UMLS CUI-1)
C25256 (NCI Thesaurus Property)
C25709 (NCI Thesaurus ValueDomain)
CL.20
Code List
Units
CL Item
Grays (Gy)
CL Item
Millicurie (mCi)
Total Number of Fractions
Item
Total Number of Fractions
integer
C25304 (NCI Thesaurus Property)
C1522449 (UMLS CUI-1)
C15313 (NCI Thesaurus ObjectClass)
C1264633 (UMLS CUI-2)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS CUI-3)
C25514 (NCI Thesaurus Property-2)
Radiation Therapy Total Dose
Item
RT Total Dose
float
C25304 (NCI Thesaurus ValueDomain)
C2169193 (UMLS CUI-1)
C15313 (NCI Thesaurus ObjectClass)
C25488 (NCI Thesaurus ValueDomain-2)
C25382 (NCI Thesaurus Property)
Item
Were there any unscheduled interruptions in radiation therapy?
text
C25180 (NCI Thesaurus ValueDomain)
C1522449 (UMLS CUI-1)
C15313 (NCI Thesaurus ObjectClass)
C1512900 (UMLS CUI-2)
C25542 (NCI Thesaurus Property)
CL.21
Code List
Were there any unscheduled interruptions in radiation therapy?
CL Item
Yes, Due To Toxicity (Yes, due to toxicity)
CL Item
Yes, Due To Other Reason (Yes, due to other reasons)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Radiation Therapy Interruptions Reason
Item
RT Interruptions Reason (Specify)
text
C25704 (NCI Thesaurus ValueDomain)
C1522449 (UMLS CUI-1)
C15313 (NCI Thesaurus ObjectClass)
C1512900 (UMLS CUI-2)
C25542 (NCI Thesaurus Property)
C0566251 (UMLS CUI-3)
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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