ID

9053

Beschrijving

NSABP-B-47 Concomitant Medications Form (Form MED) A Randomized Phase III Trial of Adjuvant Therapy Comparing Chemotherapy Alone (Six Cycles of Docetaxel Plus Cyclophosphamide or Four Cycles of Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel) to Chemotherapy Plus Trastuzumab in Women With Node- Positive or High-Risk Node-Negative HER2-Low Invasive Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=95D01C7E-6ACF-38AE-E040-BB89AD4351B3

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=95D01C7E-6ACF-38AE-E040-BB89AD4351B3

Trefwoorden

Versies (2)
  1. 27-08-12 27-08-12 -
  2. 09-01-15 09-01-15 - Martin Dugas
Geüploaded op

9 januari 2015

DOI

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Licentie

Creative Commons BY-NC 3.0 Legacy
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Breast Cancer NCT01275677 Treatment - NSABP-B-47 Concomitant Medications Form (Form MED) - 3162774v1.0

Engels

This paper worksheet may be completed to facilitate the entry of the information in NSABP Coordinator Online. Partially completed online forms may be saved in Coordinator Online. DO NOT SUBMIT THIS WORKSHEET VIA FAX OR MAIL

1 Formulieren  
Header
Beschrijving

Header

Patient Initials (Last First Middle)
Beschrijving

Patient Initials

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
NSABP Patient ID
Beschrijving

Patient ID NSABP

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1513905
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C15818
Unnamed Module 1
Beschrijving

Unnamed Module 1

Reporting Period
Beschrijving

Clinical Trial Period

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C2347804
NCI Thesaurus ObjectClass
C25214
NCI Thesaurus Property
C25616
NCI Thesaurus ObjectClass-2
C25651
Concomitant Medication
Beschrijving

Concomitant Medication

Were concomitant medications used during this reporting period? (metformin, NSAIDs, beta blockers, ace inhibitors, ARBs, diabetes medication, or hypertension medication)
Beschrijving

Concomitant Medication used

Datatype

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS CUI-1
C2347852
NCI Thesaurus ObjectClass
C1708
UMLS CUI-2
C1521801
NCI Thesaurus ObjectClass-2
C25730
NCI Thesaurus Property
C25382
Metformin
Beschrijving

MetforminHydrochlorideAgentConcurrentAdministeredInd-3

Datatype

boolean

Alias
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus ObjectClass-2
C29251
UMLS 2011AA ObjectClass-2
C0591573
NCI Thesaurus Property
C25456
UMLS 2011AA Property
C0205420
NCI Thesaurus Property-2
C25382
UMLS 2011AA Property-2
C1521801
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Aspirin
Beschrijving

PatientAcetylsalicylicAcidDailyReceivedInd-2

Datatype

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25473
UMLS 2011AA Property
C0332173
NCI Thesaurus Property-2
C25639
UMLS 2011AA Property-2
C1514756
NCI Thesaurus Property-3
C287
UMLS 2011AA Property-3
C0004057
Specify (Medication names)
Beschrijving

ConcomitantMedicationUseSpecify

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C459
UMLS 2011AA ObjectClass
C0013227
NCI Thesaurus ObjectClass-2
C25730
UMLS 2011AA ObjectClass-2
C0521115
NCI Thesaurus Property
C25340
UMLS 2011AA Property
C0457083
Specify (Medication names)
Beschrijving

ConcomitantMedicationUseSpecify

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C459
UMLS 2011AA ObjectClass
C0013227
NCI Thesaurus ObjectClass-2
C25730
UMLS 2011AA ObjectClass-2
C0521115
NCI Thesaurus Property
C25340
UMLS 2011AA Property
C0457083
Agent Duration (Round up to the nearest month months)
Beschrijving

AgentAdministeredDayDuration

Datatype

float

Alias
NCI Thesaurus ValueDomain
C25301
UMLS 2011AA ValueDomain
C0439228
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ValueDomain-2
C25330
UMLS 2011AA ValueDomain-2
C0449238
Has the patient taken any other medications during this reporting period (If yes, report the names trade name or generic name of both over the counter and prescription medications the patient has taken since submission of the previous form. For the first time point, list all medications taken within 4 weeks of randomization. For patients taking more than 9 other medications, additional rows will be available for entry online. Do not report vitamins or herbal/dietary supplements on this form)
Beschrijving

ConcomitantMedicationUseInd-3

Datatype

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C459
UMLS 2011AA ObjectClass
C0013227
NCI Thesaurus ObjectClass-2
C25730
UMLS 2011AA ObjectClass-2
C0521115
NCI Thesaurus Property
C25340
UMLS 2011AA Property
C0457083
Footer
Beschrijving

Footer

Comments (optional)
Beschrijving

Research Comments

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0947611
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
Person Completing Form
Beschrijving

Person Completing Form

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1550483
NCI Thesaurus ObjectClass
C25657
NCI Thesaurus Property
C25364
Date Form Completed
Beschrijving

Date Form Completed

Datatype

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

This paper worksheet may be completed to facilitate the entry of the information in NSABP Coordinator Online. Partially completed online forms may be saved in Coordinator Online. DO NOT SUBMIT THIS WORKSHEET VIA FAX OR MAIL

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Header
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)
Patient ID NSABP
Item
NSABP Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1513905 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C15818 (NCI Thesaurus Property-2)
Item Group
Unnamed Module 1
Item
Reporting Period
text
C25284 (NCI Thesaurus ValueDomain)
C2347804 (UMLS CUI-1)
C25214 (NCI Thesaurus ObjectClass)
C25616 (NCI Thesaurus Property)
C25651 (NCI Thesaurus ObjectClass-2)
CL.1
Code List
Reporting Period
CL Item
Baseline (Baseline)
C25213 (NCI Thesaurus)
C1442488 (UMLS 2011AA)
CL Item
12 Months Post Randomization (12 Months Post Randomization)
CL Item
24 Months Post Randomization (24 Months Post Randomization)
CL Item
36 Months Post Randomization (36 Months Post Randomization)
CL Item
48 Months Post Randomization (48 Months Post Randomization)
CL Item
60 Months Post Randomization (60 Months Post Randomization)
Item Group
Concomitant Medication
Concomitant Medication used
Item
Were concomitant medications used during this reporting period? (metformin, NSAIDs, beta blockers, ace inhibitors, ARBs, diabetes medication, or hypertension medication)
boolean
C38147 (NCI Thesaurus ValueDomain)
C2347852 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C1521801 (UMLS CUI-2)
C25730 (NCI Thesaurus ObjectClass-2)
C25382 (NCI Thesaurus Property)
MetforminHydrochlorideAgentConcurrentAdministeredInd-3
Item
Metformin
boolean
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C29251 (NCI Thesaurus ObjectClass-2)
C0591573 (UMLS 2011AA ObjectClass-2)
C25456 (NCI Thesaurus Property)
C0205420 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
PatientAcetylsalicylicAcidDailyReceivedInd-2
Item
Aspirin
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25473 (NCI Thesaurus Property)
C0332173 (UMLS 2011AA Property)
C25639 (NCI Thesaurus Property-2)
C1514756 (UMLS 2011AA Property-2)
C287 (NCI Thesaurus Property-3)
C0004057 (UMLS 2011AA Property-3)
ConcomitantMedicationUseSpecify
Item
Specify (Medication names)
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C459 (NCI Thesaurus ObjectClass)
C0013227 (UMLS 2011AA ObjectClass)
C25730 (NCI Thesaurus ObjectClass-2)
C0521115 (UMLS 2011AA ObjectClass-2)
C25340 (NCI Thesaurus Property)
C0457083 (UMLS 2011AA Property)
ConcomitantMedicationUseSpecify
Item
Specify (Medication names)
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C459 (NCI Thesaurus ObjectClass)
C0013227 (UMLS 2011AA ObjectClass)
C25730 (NCI Thesaurus ObjectClass-2)
C0521115 (UMLS 2011AA ObjectClass-2)
C25340 (NCI Thesaurus Property)
C0457083 (UMLS 2011AA Property)
AgentAdministeredDayDuration
Item
Agent Duration (Round up to the nearest month months)
float
C25301 (NCI Thesaurus ValueDomain)
C0439228 (UMLS 2011AA ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25330 (NCI Thesaurus ValueDomain-2)
C0449238 (UMLS 2011AA ValueDomain-2)
ConcomitantMedicationUseInd-3
Item
Has the patient taken any other medications during this reporting period (If yes, report the names trade name or generic name of both over the counter and prescription medications the patient has taken since submission of the previous form. For the first time point, list all medications taken within 4 weeks of randomization. For patients taking more than 9 other medications, additional rows will be available for entry online. Do not report vitamins or herbal/dietary supplements on this form)
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C459 (NCI Thesaurus ObjectClass)
C0013227 (UMLS 2011AA ObjectClass)
C25730 (NCI Thesaurus ObjectClass-2)
C0521115 (UMLS 2011AA ObjectClass-2)
C25340 (NCI Thesaurus Property)
C0457083 (UMLS 2011AA Property)
Item Group
Footer
Research Comments
Item
Comments (optional)
text
C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
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
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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