ID

23819

Beschrijving

CALGB: 10603 Concomitant Medications Form Daunorubicin, Cytarabine, and Midostaurin in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia NCT00651261 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=742F65D1-34F2-9883-E040-BB89AD437120

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=742F65D1-34F2-9883-E040-BB89AD437120

Trefwoorden

Versies (3)
  1. 19-09-12 19-09-12 -
  2. 29-12-14 29-12-14 - Martin Dugas
  3. 14-07-17 14-07-17 - Martin Dugas
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14 juli 2017

DOI

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Creative Commons BY-NC 3.0
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Concomitant Medications Form (CALGB 10603) DRKS00003845

Engels

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 Formulieren  
Administrative documentation
Beschrijving

Administrative documentation

Alias
UMLS CUI-1
C1320722
CALGB Form
Beschrijving

Form ID CALGB

Datatype

text

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

Protocol ID CALGB

Datatype

text

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

Trial subject ID CALGB

Datatype

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
Treatment Reporting Period Start Date
Beschrijving

Reporting Period Start Date

Datatype

date

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

Reporting Period End Date

Datatype

date

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

Data amended

Datatype

boolean

Alias
NCI Thesaurus ValueDomain
C38148
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus Property
C25416
UMLS CUI-1
C0680532
Patient Initials (Last, First Middle)
Beschrijving

Patient Initials

Datatype

text

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

Medical Record Number

Datatype

text

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

Institution Name

Datatype

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
Beschrijving

Participating Group

Datatype

text

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

Study Number Participating Group

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25337
NCI Thesaurus ObjectClass
C25320
NCI Thesaurus Property
C25608
NCI Thesaurus Property-2
C25364
UMLS CUI-1
C3274381
UMLS CUI-2
C2347449
Participating Group Patient ID
Beschrijving

Trial subject ID Participating Group

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25337
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25608
NCI Thesaurus Property-2
C25364
UMLS CUI-1
C2348585
UMLS CUI-2
C2347449
Page (___ of ___)
Beschrijving

Additional Form Page Number

Datatype

text

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

Concomitant medication

Alias
UMLS CUI-1
C2347852
Concomitant Medication
Beschrijving

Concomitant Medication

Datatype

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
Beschrijving

Concomitant Medication Category

Datatype

integer

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

CYP3A4 inhibitor or inducer

Datatype

boolean

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

Concomitant Medication Daily Dose

Datatype

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
Beschrijving

Units

Datatype

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
Beschrijving

Concomitant Medication Start Date

Datatype

date

Alias
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25431
NCI Thesaurus ObjectClass
C1708
NCI Thesaurus Property
C25275
UMLS CUI-1
C2826734
Stop date (or)
Beschrijving

Concomitant Medication End Date

Datatype

date

Alias
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ObjectClass
C1708
NCI Thesaurus Property
C25275
UMLS CUI-1
C2826744
Ongoing
Beschrijving

Concomitant Medication Ongoing

Datatype

boolean

Alias
NCI Thesaurus ObjectClass
C459
NCI Thesaurus ObjectClass-2
C25730
NCI Thesaurus Property
C25471
NCI Thesaurus Property-2
C25409
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C2826666
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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 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative documentation
C1320722 (UMLS CUI-1)
Form ID CALGB
Item
CALGB Form
text
C25337 (NCI Thesaurus ValueDomain)
C19464 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
C25442 (NCI Thesaurus ObjectClass-2)
C3262252 (UMLS CUI-1)
C1516238 (UMLS CUI-2)
Protocol ID CALGB
Item
CALGB Study No
text
C25337 (NCI Thesaurus ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
C25442 (NCI Thesaurus Property-2)
C3274381 (UMLS CUI-1)
C1516238 (UMLS CUI-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
Treatment Reporting Period Start Date
date
C15368 (NCI Thesaurus ObjectClass)
C25616 (NCI Thesaurus Property)
C25651 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
C2361257 (UMLS CUI-1)
Reporting Period End Date
Item
Treatment Reporting Period End Date
date
C25164 (NCI Thesaurus ValueDomain)
C25616 (NCI Thesaurus Property)
C15368 (NCI Thesaurus ObjectClass)
C25651 (NCI Thesaurus Property-2)
C2361259 (UMLS CUI-1)
Data amended
Item
Are data amended
boolean
C38148 (NCI Thesaurus ValueDomain)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
C0680532 (UMLS CUI-1)
Patient Initials
Item
Patient Initials (Last, First Middle)
text
C25191 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
C2986440 (UMLS CUI-1)
Medical Record Number
Item
Patient Hospital No.
text
C25337 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C25261 (NCI Thesaurus Property)
C25198 (NCI Thesaurus Property-2)
C1301894 (UMLS CUI-1)
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)
C25608 (NCI Thesaurus ObjectClass)
C17005 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
C2347449 (UMLS CUI-1)
Study Number Participating Group
Item
Participating Group Study No
text
C25337 (NCI Thesaurus ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
C3274381 (UMLS CUI-1)
C2347449 (UMLS CUI-2)
Trial subject ID Participating Group
Item
Participating Group Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
C2348585 (UMLS CUI-1)
C2347449 (UMLS CUI-2)
Additional Form Page Number
Item
Page (___ of ___)
text
C19464 (NCI Thesaurus ObjectClass)
C25406 (NCI Thesaurus ObjectClass-2)
C25695 (NCI Thesaurus Property)
C25337 (NCI Thesaurus ValueDomain)
C42783 (NCI Thesaurus ValueDomain-2)
C1706499 (UMLS CUI-1)
C1704732 (UMLS CUI-2)
C0237753 (UMLS CUI-3)
Item Group
Concomitant medication
C2347852 (UMLS CUI-1)
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
integer
C25372 (NCI Thesaurus ValueDomain)
C459 (NCI Thesaurus ObjectClass)
C25730 (NCI Thesaurus ObjectClass-2)
C25382 (NCI Thesaurus Property)
C2826808 (UMLS CUI-1)
CL.2
Code List
Medication Category
CL Item
Antibiotic/antiviral/antifungal (1)
CL Item
Antiemetic (2)
CL Item
Antihistamine (3)
CL Item
Corticosteroid (4)
CL Item
Diuretic/antihypertensive (5)
CL Item
Growth Factor (6)
CL Item
Nsaid/opioid (7)
CL Item
Proton Pump Inhibitor/h2 Antagonist (8)
CL Item
Other (9)
CYP3A4 inhibitor or inducer
Item
CYP3A4 inhibitor/inducer
boolean
C459 (NCI Thesaurus ObjectClass)
C61367 (NCI Thesaurus ObjectClass-2)
C17573 (NCI Thesaurus ObjectClass-3)
C42791 (NCI Thesaurus ObjectClass-4)
C25409 (NCI Thesaurus Property)
C38147 (NCI Thesaurus ValueDomain)
C3830624 (UMLS CUI-1)
C3830625 (UMLS CUI-2)
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)
C25431 (NCI Thesaurus ValueDomain-2)
C1708 (NCI Thesaurus ObjectClass)
C25275 (NCI Thesaurus Property)
C2826734 (UMLS CUI-1)
Concomitant Medication End Date
Item
Stop date (or)
date
C25164 (NCI Thesaurus ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C25275 (NCI Thesaurus Property)
C2826744 (UMLS CUI-1)
Concomitant Medication Ongoing
Item
Ongoing
boolean
C459 (NCI Thesaurus ObjectClass)
C25730 (NCI Thesaurus ObjectClass-2)
C25471 (NCI Thesaurus Property)
C25409 (NCI Thesaurus Property-2)
C25704 (NCI Thesaurus ValueDomain)
C2826666 (UMLS CUI-1)
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