ID

7048

Beschrijving

E5103 Hypertension Status Form Doxorubicin, Cyclophosphamide, and Paclitaxel With or Without Bevacizumab in Treating Patients With Lymph Node-Positive or High-Risk, Lymph Node-Negative Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=3AE22206-73CD-059C-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=3AE22206-73CD-059C-E044-0003BA3F9857

Trefwoorden

Versies (4)
  1. 26-08-12 26-08-12 -
  2. 08-08-14 08-08-14 - Martin Dugas
  3. 16-12-14 16-12-14 - Martin Dugas
  4. 08-01-15 08-01-15 - Martin Dugas
Geüploaded op

8 januari 2015

DOI

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Licentie

Creative Commons BY-NC 3.0 Legacy
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Breast Cancer NCT00433511 Follow-Up - E5103 Hypertension Status Form - 2683669v1.0

Engels

INSTRUCTIONS: After patient is off treatment, complete this form for each required follow-up report period (see forms submission schedule).

1 Formulieren  
General information
Beschrijving

General information

Alias
UMLS CUI-1
C1508263
ECOG Protocol Number
Beschrijving

Protocol Number ECOG

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C1512162
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25491
ECOG Patient ID
Beschrijving

Patient ID ECOG

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1512162
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25491
DCI Name
Beschrijving

Generic drug form

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C3242750
NCI Thesaurus Property
C19464
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus ObjectClass-2
C25452
Registration Step
Beschrijving

Registration Number

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1514821
NCI Thesaurus ObjectClass
C25646
UMLS CUI-2
C0237753
NCI Thesaurus Property
C16154
NCI Thesaurus ValueDomain-2
C16154
Patient Initials (Last, First)
Beschrijving

Patient Initials

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
Participating Group Protocol Number
Beschrijving

Study Number Participating Group

Datatype

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
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 Patient ID
Beschrijving

Trial subject ID Participating Group

Datatype

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
Please mark an 'X' if data have been amended. (Please circle amended items in red)
Beschrijving

Data amended

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0680532
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus Property
C25416
Date data amended (M D Y)
Beschrijving

Data amended date

Datatype

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C0680532
NCI Thesaurus ObjectClass
C25474
UMLS CUI-2
C0011008
NCI Thesaurus Property
C25416
NCI Thesaurus ValueDomain-2
C25367
Unnamed Module 4
Beschrijving

Unnamed Module 4

On Treatment Report Period
Beschrijving

Cycle number

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C2045829
NCI Thesaurus Property
C25214
NCI Thesaurus Property-2
C25616
NCI Thesaurus ObjectClass
C15368
Off Treatment Report Period
Beschrijving

PersonOff-TreatmentTimePeriodType

Datatype

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus Property-2
C25601
UMLS 2011AA Property-2
C1518544
NCI Thesaurus Property-3
C25207
UMLS 2011AA Property-3
C0040223
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Blood Pressure, Systolic
Beschrijving

Systolic blood pressure

Datatype

integer

Alias
NCI Thesaurus ValueDomain
C25209
NCI Thesaurus Property
C25214
NCI Thesaurus ObjectClass
C25298
UMLS CUI-1
C0871470
Blood pressure, Diastolic
Beschrijving

Diastolic blood pressure

Datatype

integer

Alias
NCI Thesaurus ValueDomain
C25209
NCI Thesaurus Property
C25214
NCI Thesaurus ObjectClass
C25299
UMLS CUI-1
C0428883
Mark an 'X' if not done (during this reporting period)
Beschrijving

LaboratoryProcedureNotPerformedText

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus Property
C25594
UMLS 2011AA Property
C1518422
NCI Thesaurus Property-2
C38000
UMLS 2011AA Property-2
C0884358
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
Date of Assessment (most recent)
Beschrijving

Assessment Date

Datatype

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C2985720
NCI Thesaurus ObjectClass
C25367
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus Property
C38000
Anti-Hypertensive Drugs (Please mark each agent administered this cycle For Baseline, indicate agents administered in the last 21 days)
Beschrijving

Concomitant Antihypertensive Agent Administered

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25284
NCI Thesaurus ObjectClass
C270
NCI Thesaurus ObjectClass-2
C25730
NCI Thesaurus Property
C25382
Other, specify
Beschrijving

ConcomitantAntihypertensiveAgentAdministeredSpecify

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C270
UMLS 2011AA ObjectClass
C0003364
NCI Thesaurus ObjectClass-2
C25730
UMLS 2011AA ObjectClass-2
C0521115
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Comments
Beschrijving

Comments

Investigator Signature
Beschrijving

Investigator Signature

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C2346576
NCI Thesaurus Property
C25678
NCI Thesaurus ObjectClass
C17089
Investigator Signature Date
Beschrijving

Investigator Signature Date

Datatype

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C2346576
NCI Thesaurus Property
C25678
UMLS CUI-2
C0011008
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus ObjectClass
C17089
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Similar models

INSTRUCTIONS: After patient is off treatment, complete this form for each required follow-up report period (see forms submission schedule).

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
General information
C1508263 (UMLS CUI-1)
Protocol Number ECOG
Item
ECOG Protocol Number
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)
Patient ID ECOG
Item
ECOG Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)
Generic drug form
Item
DCI Name
text
C25191 (NCI Thesaurus ValueDomain)
C3242750 (UMLS CUI-1)
C19464 (NCI Thesaurus Property)
C25474 (NCI Thesaurus ObjectClass)
C25452 (NCI Thesaurus ObjectClass-2)
Registration Number
Item
Registration Step
text
C25337 (NCI Thesaurus ValueDomain)
C1514821 (UMLS CUI-1)
C25646 (NCI Thesaurus ObjectClass)
C0237753 (UMLS CUI-2)
C16154 (NCI Thesaurus Property)
C16154 (NCI Thesaurus ValueDomain-2)
Patient Initials
Item
Patient Initials (Last, First)
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Study Number Participating Group
Item
Participating Group Protocol Number
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)
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)
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)
Data amended
Item
Please mark an 'X' if data have been amended. (Please circle amended items in red)
text
C25704 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
Data amended date
Item
Date data amended (M D Y)
date
C25164 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C0011008 (UMLS CUI-2)
C25416 (NCI Thesaurus Property)
C25367 (NCI Thesaurus ValueDomain-2)
Item Group
Unnamed Module 4
Item
On Treatment Report Period
text
C25284 (NCI Thesaurus ValueDomain)
C2045829 (UMLS CUI-1)
C25214 (NCI Thesaurus Property)
C25616 (NCI Thesaurus Property-2)
C15368 (NCI Thesaurus ObjectClass)
CL.1
Code List
On Treatment Report Period
CL Item
Baseline (Baseline)
C25213 (NCI Thesaurus)
C1442488 (UMLS 2011AA)
C25213 (NCI Thesaurus-3)
C1442488 (UMLS 2011AA-4)
CL Item
Cycle 1 (Cycle 1)
CL Item
Cycle 10 (Cycle 10)
CL Item
Cycle 11 (Cycle 11)
CL Item
Cycle 12 (Cycle 12)
CL Item
Cycle 13 (Cycle 13)
CL Item
Cycle 14 (Cycle 14)
CL Item
Cycle 15 (Cycle 15)
CL Item
Cycle 16 (Cycle 16)
CL Item
Cycle 17 (Cycle 17)
CL Item
Cycle 18 (Cycle 18)
CL Item
Cycle 2 (Cycle 2)
CL Item
Cycle 3 (Cycle 3)
CL Item
Cycle 4 (cycle 4)
CL Item
Cycle 5 (Cycle 5)
CL Item
Cycle 6 (Cycle 6)
CL Item
Cycle 7 (Cycle 7)
CL Item
Cycle 8 (cycle 8)
CL Item
Cycle 9 (Cycle 9)
Item
Off Treatment Report Period
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25601 (NCI Thesaurus Property-2)
C1518544 (UMLS 2011AA Property-2)
C25207 (NCI Thesaurus Property-3)
C0040223 (UMLS 2011AA Property-3)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.2
Code List
Off Treatment Report Period
CL Item
3 Months Post-treatment (3 Months Post-Treatment)
CL Item
6 Months Post-treatment (6 Months Post-Treatment)
CL Item
9 Months Post-treatment (9 Months Post-Treatment)
CL Item
12 Months Post-treatment (12 Months Post-Treatment)
Systolic blood pressure
Item
Blood Pressure, Systolic
integer
C25209 (NCI Thesaurus ValueDomain)
C25214 (NCI Thesaurus Property)
C25298 (NCI Thesaurus ObjectClass)
C0871470 (UMLS CUI-1)
Diastolic blood pressure
Item
Blood pressure, Diastolic
integer
C25209 (NCI Thesaurus ValueDomain)
C25214 (NCI Thesaurus Property)
C25299 (NCI Thesaurus ObjectClass)
C0428883 (UMLS CUI-1)
LaboratoryProcedureNotPerformedText
Item
Mark an 'X' if not done (during this reporting period)
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25594 (NCI Thesaurus Property)
C1518422 (UMLS 2011AA Property)
C38000 (NCI Thesaurus Property-2)
C0884358 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
Assessment Date
Item
Date of Assessment (most recent)
date
C25164 (NCI Thesaurus ValueDomain)
C2985720 (UMLS CUI-1)
C25367 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C38000 (NCI Thesaurus Property)
Item
Anti-Hypertensive Drugs (Please mark each agent administered this cycle For Baseline, indicate agents administered in the last 21 days)
text
C25284 (NCI Thesaurus ValueDomain)
C270 (NCI Thesaurus ObjectClass)
C25730 (NCI Thesaurus ObjectClass-2)
C25382 (NCI Thesaurus Property)
CL.3
Code List
Anti-Hypertensive Drugs (Please mark each agent administered this cycle For Baseline, indicate agents administered in the last 21 days)
CL Item
No Medication Given (No medication given)
CL Item
Beta Blocker (Beta blockers)
CL Item
Diuretic (Diuretics)
CL Item
Calcium Channel Blocker (Calcium channel blockers)
CL Item
Angiotensin Ii Receptor Blocker (Angiotensin II inhibitors)
CL Item
Ace Inhibitor (ACE inhibitors)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
ConcomitantAntihypertensiveAgentAdministeredSpecify
Item
Other, specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C270 (NCI Thesaurus ObjectClass)
C0003364 (UMLS 2011AA ObjectClass)
C25730 (NCI Thesaurus ObjectClass-2)
C0521115 (UMLS 2011AA ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
Item Group
Comments
Investigator Signature
Item
Investigator Signature
text
C25704 (NCI Thesaurus ValueDomain)
C2346576 (UMLS CUI-1)
C25678 (NCI Thesaurus Property)
C17089 (NCI Thesaurus ObjectClass)
Investigator Signature Date
Item
Investigator Signature Date
date
C25164 (NCI Thesaurus ValueDomain)
C2346576 (UMLS CUI-1)
C25678 (NCI Thesaurus Property)
C0011008 (UMLS CUI-2)
C25367 (NCI Thesaurus ValueDomain-2)
C17089 (NCI Thesaurus ObjectClass)
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