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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 forms  
Header
Description

Header

CALGB Form
Description

Form ID CALGB

Data type

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
Description

Protocol ID CALGB

Data type

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
Description

Trial subject ID CALGB

Data type

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
Reporting Period Start Date
Description

Reporting Period Start Date

Data type

date

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25616
UMLS CUI-1
C2361257
NCI Thesaurus Property-2
C25651
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25431
Reporting Period End Date
Description

Reporting Period End Date

Data type

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
Description

Data amended

Data type

boolean

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

Unnamed2

Patient Initials (Last, First Middle)
Description

Patient Initials

Data type

text

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

Participating Group

Data type

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
Description

Study Number Participating Group

Data type

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
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
Header
Description

Header

Page (___ of ___)
Description

Additional Form Page Number

Data type

text

Alias
NCI Thesaurus ObjectClass
C19464
UMLS CUI-1
C1706499
NCI Thesaurus ObjectClass-2
C25406
UMLS CUI-2
C1704732
NCI Thesaurus Property
C25695
UMLS CUI-3
C0237753
NCI Thesaurus ValueDomain
C25337
NCI Thesaurus ValueDomain-2
C42783
Concomitant Medication
Description

Concomitant Medication

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C2347852
NCI Thesaurus ObjectClass
C459
NCI Thesaurus Property
C25639
NCI Thesaurus ObjectClass-2
C25730
Medication Category
Description

Concomitant Medication Category

Data type

text

Alias
NCI Thesaurus ValueDomain
C25372
UMLS CUI-1
C2826808
NCI Thesaurus ObjectClass
C459
NCI Thesaurus ObjectClass-2
C25730
NCI Thesaurus Property
C25382
CYP3A4 inhibitor/inducer
Description

CYP3A4 inhibitor or inducer

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C459
UMLS CUI-1
C3830624
NCI Thesaurus ObjectClass-2
C61367
UMLS CUI-2
C3830625
NCI Thesaurus ObjectClass-3
C17573
NCI Thesaurus ObjectClass-4
C42791
NCI Thesaurus Property
C25409
NCI Thesaurus ValueDomain
C38147
Agent Total Dose (per day)
Description

Concomitant Medication Daily Dose

Data type

float

Alias
NCI Thesaurus ObjectClass
C25473
UMLS CUI-1
C2826638
NCI Thesaurus ObjectClass-2
C1708
NCI Thesaurus Property
C25304
NCI Thesaurus Property-2
C25256
NCI Thesaurus ValueDomain
C25488
NCI Thesaurus ValueDomain-2
C1708
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
Start date
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
Stop date (or)
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
Ongoing
Description

Concomitant Medication Ongoing

Data type

text

Alias
NCI Thesaurus ObjectClass
C459
UMLS CUI-1
C2826666
NCI Thesaurus ObjectClass-2
C25730
NCI Thesaurus Property
C25471
NCI Thesaurus Property-2
C25409
NCI Thesaurus ValueDomain
C25704
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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 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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)
Reporting Period Start Date
Item
Reporting Period Start Date
date
C15368 (NCI Thesaurus ObjectClass)
C25616 (NCI Thesaurus Property)
C2361257 (UMLS CUI-1)
C25651 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
Reporting Period End Date
Item
Reporting Period End Date
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
Header
Additional Form Page Number
Item
Page (___ of ___)
text
C19464 (NCI Thesaurus ObjectClass)
C1706499 (UMLS CUI-1)
C25406 (NCI Thesaurus ObjectClass-2)
C1704732 (UMLS CUI-2)
C25695 (NCI Thesaurus Property)
C0237753 (UMLS CUI-3)
C25337 (NCI Thesaurus ValueDomain)
C42783 (NCI Thesaurus ValueDomain-2)
Concomitant Medication
Item
Concomitant Medication
text
C25704 (NCI Thesaurus ValueDomain)
C2347852 (UMLS CUI-1)
C459 (NCI Thesaurus ObjectClass)
C25639 (NCI Thesaurus Property)
C25730 (NCI Thesaurus ObjectClass-2)
Item
Medication Category
text
C25372 (NCI Thesaurus ValueDomain)
C2826808 (UMLS CUI-1)
C459 (NCI Thesaurus ObjectClass)
C25730 (NCI Thesaurus ObjectClass-2)
C25382 (NCI Thesaurus Property)
CL.2
Code List
Medication Category
CL Item
Antibiotic/antiviral/antifungal (Antibiotic/antiviral/antifungal)
CL Item
Antiemetic (Antiemetic)
CL Item
Antihistamine (Antihistamine)
C29716 (NCI Thesaurus)
CL Item
Corticosteroid (Corticosteroid)
C2322 (NCI Thesaurus)
C0001617 (UMLS 2011AA)
CL Item
Diuretic/antihypertensive (Diuretic/antihypertensive)
CL Item
Growth Factor (Growth Factor)
C20424 (NCI Thesaurus)
C0018284 (UMLS 2011AA)
CL Item
Nsaid/opioid (NSAID/opioid)
CL Item
Other (Other)
CL Item
Proton Pump Inhibitor/h2 Antagonist (Proton pump inhibitor/H2 antagonist)
CYP3A4 inhibitor or inducer
Item
CYP3A4 inhibitor/inducer
boolean
C459 (NCI Thesaurus ObjectClass)
C3830624 (UMLS CUI-1)
C61367 (NCI Thesaurus ObjectClass-2)
C3830625 (UMLS CUI-2)
C17573 (NCI Thesaurus ObjectClass-3)
C42791 (NCI Thesaurus ObjectClass-4)
C25409 (NCI Thesaurus Property)
C38147 (NCI Thesaurus ValueDomain)
Concomitant Medication Daily Dose
Item
Agent Total Dose (per day)
float
C25473 (NCI Thesaurus ObjectClass)
C2826638 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass-2)
C25304 (NCI Thesaurus Property)
C25256 (NCI Thesaurus Property-2)
C25488 (NCI Thesaurus ValueDomain)
C1708 (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)
Concomitant Medication Start Date
Item
Start date
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
Stop date (or)
date
C25164 (NCI Thesaurus ValueDomain)
C2826744 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C25275 (NCI Thesaurus Property)
Concomitant Medication Ongoing
Item
Ongoing
text
C459 (NCI Thesaurus ObjectClass)
C2826666 (UMLS CUI-1)
C25730 (NCI Thesaurus ObjectClass-2)
C25471 (NCI Thesaurus Property)
C25409 (NCI Thesaurus Property-2)
C25704 (NCI Thesaurus ValueDomain)
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