ID

7810

Description

E4A03 Thrombotic Event Prior September 14, 2005 Summary Form Lenalidomide and Dexamethasone With or Without Thalidomide in Treating Patients With Multiple Myeloma Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=0615D022-651B-5424-E044-0003BA3F9857

Lien

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=0615D022-651B-5424-E044-0003BA3F9857

Mots-clés

Versions (3)
  1. 19/09/2012 19/09/2012 -
  2. 09/01/2015 09/01/2015 - Martin Dugas
  3. 16/06/2015 16/06/2015 -
Téléchargé le

9 janvier 2015

DOI

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Licence

Creative Commons BY-NC 3.0 Legacy
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Multiple Myeloma and Plasma Cell Neoplasm NCT00098475 Treatment - E4A03 Thrombotic Event Prior September 14, 2005 Summary Form - 2432193v1.0

Anglais

ONLY if patient?s disease is still stable or in partial or complete remission and has not progressed/relapsed from protocol therapy.

1 Formulaires  
Header
Description

Header

ECOG Protocol Number
Description

Protocol Number ECOG

Type de données

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
DCI Name
Description

Generic drug form

Type de données

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
Description

Registration Number

Type de données

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
ECOG Patient ID
Description

Patient ID ECOG

Type de données

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
Reporting Period
Description

Clinical Trial Period

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C2347804
NCI Thesaurus ObjectClass
C25214
NCI Thesaurus Property
C25616
NCI Thesaurus ObjectClass-2
C25651
Unnamed2
Description

Unnamed2

Patient Initials
Description

Patient Initials

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
ECOG Protocol Number
Description

Protocol Number ECOG

Type de données

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
Participating Group Protocol Number
Description

Study Number Participating Group

Type de données

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
Description

Institution Name

Type de données

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
ECOG Patient ID
Description

Patient ID ECOG

Type de données

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
Participating Group Patient ID
Description

Trial subject ID Participating Group

Type de données

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
Unnamed3
Description

Unnamed3

Please mark an 'X' if data have been amended
Description

Data amended

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0680532
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus Property
C25416
Date data amended
Description

Data amended date

Type de données

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 4
Description

Unnamed 4

Did patient recieve DVT prophylaxis (prior to September 14, 2005)
Description

Deep Vein Thrombosis prophylaxis

Type de données

boolean

Alias
NCI Thesaurus ObjectClass
C49343
UMLS CUI-1
C0853245
NCI Thesaurus ObjectClass-2
C15368
NCI Thesaurus ObjectClass-3
C15405
NCI Thesaurus Property
C25639
NCI Thesaurus ValueDomain
C38147
Start date of first (prophylactic) treatment
Description

DVT prophylaxis start date

Type de données

date

Alias
NCI Thesaurus ObjectClass
C49343
UMLS CUI-1
C0853245
NCI Thesaurus ObjectClass-2
C15368
NCI Thesaurus ObjectClass-3
C15405
NCI Thesaurus Property
C25639
UMLS CUI-2
C0808070
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25431
Date of most recent (prophylactic) treatment
Description

DVT prophylaxis most recent date

Type de données

date

Alias
NCI Thesaurus ObjectClass
C49343
UMLS CUI-1
C0853245
NCI Thesaurus ObjectClass-2
C15368
NCI Thesaurus ObjectClass-3
C15405
NCI Thesaurus Property
C25639
UMLS CUI-2
C1513491
NCI Thesaurus ValueDomain
C25164
UMLS CUI-3
C0011008
NCI Thesaurus ValueDomain-2
C25577
Aspirin (81 mg) (Were any of the following given prior to the first thrombotic event this report period? answer no 1 or yes 2 for each of the following)
Description

Aspirin 81 mg

Type de données

boolean

Alias
NCI Thesaurus ObjectClass
C49343
UMLS CUI-1
C0783425
NCI Thesaurus ObjectClass-2
C15368
NCI Thesaurus ObjectClass-3
C15405
NCI Thesaurus Property
C25639
NCI Thesaurus Property-2
C49341
NCI Thesaurus Property-3
C287
NCI Thesaurus ValueDomain
C38147
Aspirin (325 mg)
Description

Aspirin 325 mg

Type de données

boolean

Alias
NCI Thesaurus ObjectClass
C49343
UMLS CUI-1
C0714615
NCI Thesaurus ObjectClass-2
C15368
NCI Thesaurus ObjectClass-3
C15405
NCI Thesaurus Property
C25639
NCI Thesaurus Property-2
C287
NCI Thesaurus Property-3
C49342
NCI Thesaurus ValueDomain
C38147
Aspirin (other dose)
Description

Aspirin, other dose

Type de données

boolean

Alias
NCI Thesaurus ObjectClass
C49343
UMLS CUI-1
C0004057
NCI Thesaurus ObjectClass-2
C15368
NCI Thesaurus ObjectClass-3
C15405
NCI Thesaurus Property
C17649
NCI Thesaurus Property-2
C25639
NCI Thesaurus Property-3
C287
NCI Thesaurus Property-4
C25256
NCI Thesaurus ValueDomain
C38147
If other dose of Aspirin given, specify dose
Description

Aspirin dose

Type de données

float

Alias
NCI Thesaurus ObjectClass
C49343
UMLS CUI-1
C0004057
NCI Thesaurus ObjectClass-2
C15368
NCI Thesaurus ObjectClass-3
C15405
NCI Thesaurus Property
C17649
UMLS CUI-2
C0178602
NCI Thesaurus Property-2
C25639
NCI Thesaurus Property-3
C287
NCI Thesaurus Property-4
C25256
NCI Thesaurus ValueDomain
C25488
Coumadin
Description

Warfarin

Type de données

boolean

Alias
NCI Thesaurus ObjectClass
C49343
UMLS CUI-1
C0043031
NCI Thesaurus ObjectClass-2
C15368
NCI Thesaurus ObjectClass-3
C15405
NCI Thesaurus Property
C25639
NCI Thesaurus Property-2
C945
NCI Thesaurus ValueDomain
C38147
If Coumadin given, specify dose
Description

Warfarin dose

Type de données

boolean

Alias
NCI Thesaurus ObjectClass
C49343
UMLS CUI-1
C0366686
NCI Thesaurus ObjectClass-2
C15368
NCI Thesaurus ObjectClass-3
C15405
NCI Thesaurus Property
C25639
NCI Thesaurus Property-2
C945
NCI Thesaurus ValueDomain
C25488
Low molecular weight heparin (enoxaparin; Lovenox)
Description

Heparin, Low-Molecular-Weight

Type de données

boolean

Alias
NCI Thesaurus ObjectClass
C49343
UMLS CUI-1
C0019139
NCI Thesaurus ObjectClass-2
C15368
NCI Thesaurus ObjectClass-3
C15405
NCI Thesaurus Property
C25639
NCI Thesaurus Property-2
C2578
NCI Thesaurus ValueDomain
C38147
Other, specify
Description

DVT prevention, specify

Type de données

text

Alias
NCI Thesaurus ObjectClass
C49343
UMLS CUI-1
C0853245
NCI Thesaurus ObjectClass-2
C15368
NCI Thesaurus ObjectClass-3
C15405
NCI Thesaurus Property
C25639
UMLS CUI-2
C1521902
NCI Thesaurus ValueDomain
C25685
Has the patient received erythropoietin-type agents (e.g., Epogen, Procrit or Aranesp) (prior to the first thrombotic event?)
Description

Erythropoietin-type agents

Type de données

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C0014822
NCI Thesaurus ObjectClass
C20429
NCI Thesaurus ObjectClass-2
C37902
NCI Thesaurus Property
C25382
Unnamed 5
Description

Unnamed 5

Did patient experience a thrombotic event (NOTE: Event must be reported through AdEERS and on the E4A03 Adverse Event Form)
Description

ThrombosisAdverseEventObservedInd-3

Type de données

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus ObjectClass-2
C26891
UMLS 2011AA ObjectClass-2
C0040053
NCI Thesaurus Property
C25599
UMLS 2011AA Property
C1441672
Date of thrombotic event (If yes, - List Date of thrombotic events this report period. Mark an ¿X¿ in the box on the right if not applicable.)
Description

ThrombosisAdverseEventObservedDate

Type de données

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus ObjectClass-2
C26891
UMLS 2011AA ObjectClass-2
C0040053
NCI Thesaurus Property
C25599
UMLS 2011AA Property
C1441672
Mark an 'X' if N/A
Description

DataUnknownText

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C25474
UMLS 2011AA ObjectClass
C1511726
NCI Thesaurus Property
C17998
UMLS 2011AA Property
C0439673
Was the patient on thrombotic prophylaxis (NOTE: If more then one thrombotic event this report period, answer question below with regards to the first thrombotic event this report period.)
Description

ThrombosisPreventionTherapyReceivedInd-2

Type de données

boolean

Alias
NCI Thesaurus ObjectClass
C26891
UMLS 2011AA ObjectClass
C0040053
NCI Thesaurus ObjectClass-2
C15368
NCI Thesaurus ObjectClass-3
C15405
NCI Thesaurus Property
C25639
UMLS 2011AA Property
C1514756
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Aspirin (81 mg) (Were any of the following given prior to the first thrombotic event this report period? answer no 1 or yes 2 for each of the following)
Description

Aspirin 81 mg

Type de données

boolean

Alias
NCI Thesaurus ObjectClass
C49343
UMLS CUI-1
C0783425
NCI Thesaurus ObjectClass-2
C15368
NCI Thesaurus ObjectClass-3
C15405
NCI Thesaurus Property
C25639
NCI Thesaurus Property-2
C49341
NCI Thesaurus Property-3
C287
NCI Thesaurus ValueDomain
C38147
Aspirin (325 mg)
Description

Aspirin 325 mg

Type de données

boolean

Alias
NCI Thesaurus ObjectClass
C49343
UMLS CUI-1
C0714615
NCI Thesaurus ObjectClass-2
C15368
NCI Thesaurus ObjectClass-3
C15405
NCI Thesaurus Property
C25639
NCI Thesaurus Property-2
C287
NCI Thesaurus Property-3
C49342
NCI Thesaurus ValueDomain
C38147
Aspirin (other dose)
Description

Aspirin, other dose

Type de données

boolean

Alias
NCI Thesaurus ObjectClass
C49343
UMLS CUI-1
C0004057
NCI Thesaurus ObjectClass-2
C15368
NCI Thesaurus ObjectClass-3
C15405
NCI Thesaurus Property
C17649
NCI Thesaurus Property-2
C25639
NCI Thesaurus Property-3
C287
NCI Thesaurus Property-4
C25256
NCI Thesaurus ValueDomain
C38147
If other dose of Aspirin given, specify dose
Description

Aspirin dose

Type de données

float

Alias
NCI Thesaurus ObjectClass
C49343
UMLS CUI-1
C0004057
NCI Thesaurus ObjectClass-2
C15368
NCI Thesaurus ObjectClass-3
C15405
NCI Thesaurus Property
C17649
UMLS CUI-2
C0178602
NCI Thesaurus Property-2
C25639
NCI Thesaurus Property-3
C287
NCI Thesaurus Property-4
C25256
NCI Thesaurus ValueDomain
C25488
Coumadin
Description

Warfarin

Type de données

boolean

Alias
NCI Thesaurus ObjectClass
C49343
UMLS CUI-1
C0043031
NCI Thesaurus ObjectClass-2
C15368
NCI Thesaurus ObjectClass-3
C15405
NCI Thesaurus Property
C25639
NCI Thesaurus Property-2
C945
NCI Thesaurus ValueDomain
C38147
If Coumadin given, specify dose
Description

Warfarin dose

Type de données

boolean

Alias
NCI Thesaurus ObjectClass
C49343
UMLS CUI-1
C0366686
NCI Thesaurus ObjectClass-2
C15368
NCI Thesaurus ObjectClass-3
C15405
NCI Thesaurus Property
C25639
NCI Thesaurus Property-2
C945
NCI Thesaurus ValueDomain
C25488
Low molecular weight heparin (enoxaparin; Lovenox)
Description

Heparin, Low-Molecular-Weight

Type de données

boolean

Alias
NCI Thesaurus ObjectClass
C49343
UMLS CUI-1
C0019139
NCI Thesaurus ObjectClass-2
C15368
NCI Thesaurus ObjectClass-3
C15405
NCI Thesaurus Property
C25639
NCI Thesaurus Property-2
C2578
NCI Thesaurus ValueDomain
C38147
Other, specify
Description

DVT prevention, specify

Type de données

text

Alias
NCI Thesaurus ObjectClass
C49343
UMLS CUI-1
C0853245
NCI Thesaurus ObjectClass-2
C15368
NCI Thesaurus ObjectClass-3
C15405
NCI Thesaurus Property
C25639
UMLS CUI-2
C1521902
NCI Thesaurus ValueDomain
C25685
Has the patient received erythropoietin-type agents (e.g., Epogen, Procrit or Aranesp) (prior to the first thrombotic event?)
Description

Erythropoietin-type agents

Type de données

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C0014822
NCI Thesaurus ObjectClass
C20429
NCI Thesaurus ObjectClass-2
C37902
NCI Thesaurus Property
C25382
Comments
Description

Comments

Investigator Signature
Description

Investigator Signature

Type de données

text

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

Investigator Signature Date

Type de données

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

ONLY if patient?s disease is still stable or in partial or complete remission and has not progressed/relapsed from protocol therapy.

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Header
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)
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 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)
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
Deep Vein Thrombosis (DVT)
Item Group
Unnamed2
Patient Initials
Item
Patient Initials
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
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)
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)
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)
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
Unnamed3
Data amended
Item
Please mark an 'X' if data have been amended
text
C25704 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
Data amended date
Item
Date data amended
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 4
Deep Vein Thrombosis prophylaxis
Item
Did patient recieve DVT prophylaxis (prior to September 14, 2005)
boolean
C49343 (NCI Thesaurus ObjectClass)
C0853245 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass-2)
C15405 (NCI Thesaurus ObjectClass-3)
C25639 (NCI Thesaurus Property)
C38147 (NCI Thesaurus ValueDomain)
DVT prophylaxis start date
Item
Start date of first (prophylactic) treatment
date
C49343 (NCI Thesaurus ObjectClass)
C0853245 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass-2)
C15405 (NCI Thesaurus ObjectClass-3)
C25639 (NCI Thesaurus Property)
C0808070 (UMLS CUI-2)
C25164 (NCI Thesaurus ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
DVT prophylaxis most recent date
Item
Date of most recent (prophylactic) treatment
date
C49343 (NCI Thesaurus ObjectClass)
C0853245 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass-2)
C15405 (NCI Thesaurus ObjectClass-3)
C25639 (NCI Thesaurus Property)
C1513491 (UMLS CUI-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS CUI-3)
C25577 (NCI Thesaurus ValueDomain-2)
Aspirin 81 mg
Item
Aspirin (81 mg) (Were any of the following given prior to the first thrombotic event this report period? answer no 1 or yes 2 for each of the following)
boolean
C49343 (NCI Thesaurus ObjectClass)
C0783425 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass-2)
C15405 (NCI Thesaurus ObjectClass-3)
C25639 (NCI Thesaurus Property)
C49341 (NCI Thesaurus Property-2)
C287 (NCI Thesaurus Property-3)
C38147 (NCI Thesaurus ValueDomain)
Aspirin 325 mg
Item
Aspirin (325 mg)
boolean
C49343 (NCI Thesaurus ObjectClass)
C0714615 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass-2)
C15405 (NCI Thesaurus ObjectClass-3)
C25639 (NCI Thesaurus Property)
C287 (NCI Thesaurus Property-2)
C49342 (NCI Thesaurus Property-3)
C38147 (NCI Thesaurus ValueDomain)
Aspirin, other dose
Item
Aspirin (other dose)
boolean
C49343 (NCI Thesaurus ObjectClass)
C0004057 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass-2)
C15405 (NCI Thesaurus ObjectClass-3)
C17649 (NCI Thesaurus Property)
C25639 (NCI Thesaurus Property-2)
C287 (NCI Thesaurus Property-3)
C25256 (NCI Thesaurus Property-4)
C38147 (NCI Thesaurus ValueDomain)
Aspirin dose
Item
If other dose of Aspirin given, specify dose
float
C49343 (NCI Thesaurus ObjectClass)
C0004057 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass-2)
C15405 (NCI Thesaurus ObjectClass-3)
C17649 (NCI Thesaurus Property)
C0178602 (UMLS CUI-2)
C25639 (NCI Thesaurus Property-2)
C287 (NCI Thesaurus Property-3)
C25256 (NCI Thesaurus Property-4)
C25488 (NCI Thesaurus ValueDomain)
Warfarin
Item
Coumadin
boolean
C49343 (NCI Thesaurus ObjectClass)
C0043031 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass-2)
C15405 (NCI Thesaurus ObjectClass-3)
C25639 (NCI Thesaurus Property)
C945 (NCI Thesaurus Property-2)
C38147 (NCI Thesaurus ValueDomain)
Warfarin dose
Item
If Coumadin given, specify dose
boolean
C49343 (NCI Thesaurus ObjectClass)
C0366686 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass-2)
C15405 (NCI Thesaurus ObjectClass-3)
C25639 (NCI Thesaurus Property)
C945 (NCI Thesaurus Property-2)
C25488 (NCI Thesaurus ValueDomain)
Heparin, Low-Molecular-Weight
Item
Low molecular weight heparin (enoxaparin; Lovenox)
boolean
C49343 (NCI Thesaurus ObjectClass)
C0019139 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass-2)
C15405 (NCI Thesaurus ObjectClass-3)
C25639 (NCI Thesaurus Property)
C2578 (NCI Thesaurus Property-2)
C38147 (NCI Thesaurus ValueDomain)
DVT prevention, specify
Item
Other, specify
text
C49343 (NCI Thesaurus ObjectClass)
C0853245 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass-2)
C15405 (NCI Thesaurus ObjectClass-3)
C25639 (NCI Thesaurus Property)
C1521902 (UMLS CUI-2)
C25685 (NCI Thesaurus ValueDomain)
Erythropoietin-type agents
Item
Has the patient received erythropoietin-type agents (e.g., Epogen, Procrit or Aranesp) (prior to the first thrombotic event?)
boolean
C38148 (NCI Thesaurus ValueDomain)
C0014822 (UMLS CUI-1)
C20429 (NCI Thesaurus ObjectClass)
C37902 (NCI Thesaurus ObjectClass-2)
C25382 (NCI Thesaurus Property)
Item Group
Unnamed 5
ThrombosisAdverseEventObservedInd-3
Item
Did patient experience a thrombotic event (NOTE: Event must be reported through AdEERS and on the E4A03 Adverse Event Form)
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C26891 (NCI Thesaurus ObjectClass-2)
C0040053 (UMLS 2011AA ObjectClass-2)
C25599 (NCI Thesaurus Property)
C1441672 (UMLS 2011AA Property)
ThrombosisAdverseEventObservedDate
Item
Date of thrombotic event (If yes, - List Date of thrombotic events this report period. Mark an ¿X¿ in the box on the right if not applicable.)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C26891 (NCI Thesaurus ObjectClass-2)
C0040053 (UMLS 2011AA ObjectClass-2)
C25599 (NCI Thesaurus Property)
C1441672 (UMLS 2011AA Property)
DataUnknownText
Item
Mark an 'X' if N/A
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C17998 (NCI Thesaurus Property)
C0439673 (UMLS 2011AA Property)
ThrombosisPreventionTherapyReceivedInd-2
Item
Was the patient on thrombotic prophylaxis (NOTE: If more then one thrombotic event this report period, answer question below with regards to the first thrombotic event this report period.)
boolean
C26891 (NCI Thesaurus ObjectClass)
C0040053 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass-2)
C15405 (NCI Thesaurus ObjectClass-3)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Aspirin 81 mg
Item
Aspirin (81 mg) (Were any of the following given prior to the first thrombotic event this report period? answer no 1 or yes 2 for each of the following)
boolean
C49343 (NCI Thesaurus ObjectClass)
C0783425 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass-2)
C15405 (NCI Thesaurus ObjectClass-3)
C25639 (NCI Thesaurus Property)
C49341 (NCI Thesaurus Property-2)
C287 (NCI Thesaurus Property-3)
C38147 (NCI Thesaurus ValueDomain)
Aspirin 325 mg
Item
Aspirin (325 mg)
boolean
C49343 (NCI Thesaurus ObjectClass)
C0714615 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass-2)
C15405 (NCI Thesaurus ObjectClass-3)
C25639 (NCI Thesaurus Property)
C287 (NCI Thesaurus Property-2)
C49342 (NCI Thesaurus Property-3)
C38147 (NCI Thesaurus ValueDomain)
Aspirin, other dose
Item
Aspirin (other dose)
boolean
C49343 (NCI Thesaurus ObjectClass)
C0004057 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass-2)
C15405 (NCI Thesaurus ObjectClass-3)
C17649 (NCI Thesaurus Property)
C25639 (NCI Thesaurus Property-2)
C287 (NCI Thesaurus Property-3)
C25256 (NCI Thesaurus Property-4)
C38147 (NCI Thesaurus ValueDomain)
Aspirin dose
Item
If other dose of Aspirin given, specify dose
float
C49343 (NCI Thesaurus ObjectClass)
C0004057 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass-2)
C15405 (NCI Thesaurus ObjectClass-3)
C17649 (NCI Thesaurus Property)
C0178602 (UMLS CUI-2)
C25639 (NCI Thesaurus Property-2)
C287 (NCI Thesaurus Property-3)
C25256 (NCI Thesaurus Property-4)
C25488 (NCI Thesaurus ValueDomain)
Warfarin
Item
Coumadin
boolean
C49343 (NCI Thesaurus ObjectClass)
C0043031 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass-2)
C15405 (NCI Thesaurus ObjectClass-3)
C25639 (NCI Thesaurus Property)
C945 (NCI Thesaurus Property-2)
C38147 (NCI Thesaurus ValueDomain)
Warfarin dose
Item
If Coumadin given, specify dose
boolean
C49343 (NCI Thesaurus ObjectClass)
C0366686 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass-2)
C15405 (NCI Thesaurus ObjectClass-3)
C25639 (NCI Thesaurus Property)
C945 (NCI Thesaurus Property-2)
C25488 (NCI Thesaurus ValueDomain)
Heparin, Low-Molecular-Weight
Item
Low molecular weight heparin (enoxaparin; Lovenox)
boolean
C49343 (NCI Thesaurus ObjectClass)
C0019139 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass-2)
C15405 (NCI Thesaurus ObjectClass-3)
C25639 (NCI Thesaurus Property)
C2578 (NCI Thesaurus Property-2)
C38147 (NCI Thesaurus ValueDomain)
DVT prevention, specify
Item
Other, specify
text
C49343 (NCI Thesaurus ObjectClass)
C0853245 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass-2)
C15405 (NCI Thesaurus ObjectClass-3)
C25639 (NCI Thesaurus Property)
C1521902 (UMLS CUI-2)
C25685 (NCI Thesaurus ValueDomain)
Erythropoietin-type agents
Item
Has the patient received erythropoietin-type agents (e.g., Epogen, Procrit or Aranesp) (prior to the first thrombotic event?)
boolean
C38148 (NCI Thesaurus ValueDomain)
C0014822 (UMLS CUI-1)
C20429 (NCI Thesaurus ObjectClass)
C37902 (NCI Thesaurus ObjectClass-2)
C25382 (NCI Thesaurus 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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