ID

10976

Description

AMC-061 Adverse Events Form (ADV) NCT00890747 Sunitinib Malate in Treating HIV-Positive Patients With Cancer Undergoing Highly Active Antiretroviral Therapy Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=71988CF7-F8CE-68F0-E040-BB89AD4358A1

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=71988CF7-F8CE-68F0-E040-BB89AD4358A1

Keywords

Versions (3)
  1. 8/26/12 8/26/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
  3. 6/16/15 6/16/15 -
Uploaded on

June 16, 2015

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0 Legacy
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

AMC-061 Adverse Events Form (ADV) NCT00890747

English

Based on information entered, an AdEERS Report must be submitted. Please go to the CTEP website and access the AdEERS system

1 forms  
Adverse Event Information
Description

Adverse Event Information

CTC AE Category
Description

CTCAdverseEventCategory

Data type

text

Alias
NCI Thesaurus ValueDomain
C25372
UMLS 2011AA ValueDomain
C0683312
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus Property
C25161
UMLS 2011AA Property
C0008902
CTC Adverse Event Term
Description

CommonToxicityCriteriaAdverseEventTermType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus Property
C45559
UMLS 2011AA Property
C1705313
CTC Adverse Event Grade
Description

CommonToxicityCriteriaAdverseEventGrade

Data type

float

Alias
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus ValueDomain
C18000
UMLS 2011AA ValueDomain
C0919553
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Adverse Event Onset Date (mm/dd/yyyy)
Description

CTCAdverseEventOnsetDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus Property
C25279
UMLS 2011AA Property
C0332162
MedDRA Code
Description

MedDRACode

Data type

float

Alias
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Metathesaurus ObjectClass
CL104089
If other CTC event selected, please provide description of event
Description

AdverseEventDescriptionText

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Metathesaurus Property
C0678257
Was this event expected or anticipated
Description

AcquiredImmunodeficiencySyndromeClinicalTrialAdverseEventPredictionObservedInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus ObjectClass-2
C2851
UMLS 2011AA ObjectClass-2
C0001175
NCI Thesaurus ObjectClass-3
C71104
UMLS 2011AA ObjectClass-3
C0008976
NCI Thesaurus Property
C25599
UMLS 2011AA Property
C1441672
NCI Thesaurus Property-2
C54156
UMLS 2011AA Property-2
C0681842
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Agent Name
Description

Agent

Data type

text

Alias
NCI Thesaurus Property
C25364
UMLS CUI-1
C1521826
NCI Thesaurus ObjectClass
C1708
NCI Thesaurus ValueDomain
C1708
NCI Thesaurus ValueDomain-2
C42614
CTC Adverse Event Attribution Code
Description

CTCAdverseEventAttributionScale

Data type

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS 2011AA ValueDomain
C0349674
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus Property
C25358
UMLS 2011AA Property
C0596130
Alternative etiology
Description

AcquiredImmunodeficiencySyndromeAdverseEventAlternativeAttributionType

Data type

text

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus ObjectClass-2
C2851
UMLS 2011AA ObjectClass-2
C0001175
NCI Thesaurus Property
C25415
UMLS 2011AA Property
C1523987
NCI Thesaurus Property-2
C25358
UMLS 2011AA Property-2
C0596130
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Action Taken at Time of Adverse Event
Description

AcquiredImmunodeficiencySyndromeAdverseEventActionType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus ObjectClass-2
C2851
UMLS 2011AA ObjectClass-2
C0001175
NCI Thesaurus Property
C25404
UMLS 2011AA Property
C0441472
Other, specify
Description

AcquiredImmunodeficiencySyndromeAdverseEventActionSpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus ObjectClass-2
C2851
UMLS 2011AA ObjectClass-2
C0001175
NCI Thesaurus Property
C25404
UMLS 2011AA Property
C0441472
If modification was made to study therapy, who initiated modification
Description

AcquiredImmunodeficiencySyndromeTherapyResponsiblePersonModificationType

Data type

text

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass-2
C2851
UMLS 2011AA ObjectClass
C0001175
NCI Thesaurus Property
C25657
UMLS 2011AA Property
C1273518
NCI Thesaurus Property-2
C25572
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Outcome of Adverse Event
Description

AcquiredImmunodeficiencySyndromeAdverseEventOutcomeType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ObjectClass-2
C2851
UMLS 2011AA ObjectClass-2
C0001175
AE Resolution Date (If "Resolved" mm/dd/yyyy)
Description

CTCAdverseEventResolutionDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus Property
C25655
UMLS 2011AA Property
C1514893
If resolved with sequelae, specify
Description

AcquiredImmunodeficiencySyndromeAdverseEventResolvedwithSequelaeOutcomeSpecify

Data type

text

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus ObjectClass-2
C2851
UMLS 2011AA ObjectClass-2
C0001175
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C49495
UMLS 2011AA Property-2
C1709862
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Was this considered a Serious Adverse Event
Description

NationalCancerInstituteDefinitionSeriousAdverseEventPresentInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C41335
UMLS 2011AA ObjectClass
C1519255
NCI Thesaurus ObjectClass-2
C19202
UMLS 2011AA ObjectClass-2
C1513882
NCI Thesaurus ObjectClass-3
C42777
UMLS 2011AA ObjectClass-3
C1704788
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Seriousness Attributed to Adverse Event (If "Yes" check "Yes" for all that apply Please note that checking "Yes" to any of the events below will require SAE notification according to protocol requirements.)
Description

AdverseEventSeriousnessAttributionScale

Data type

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS 2011AA ValueDomain
C0349674
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25358
UMLS 2011AA Property
C0596130
Comments
Description

Comments

Comments
Description

Research Comments

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0947611
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
Back to the top of the page

Similar models

Based on information entered, an AdEERS Report must be submitted. Please go to the CTEP website and access the AdEERS system

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Adverse Event Information
CTCAdverseEventCategory
Item
CTC AE Category
text
C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C25161 (NCI Thesaurus Property)
C0008902 (UMLS 2011AA Property)
CommonToxicityCriteriaAdverseEventTermType
Item
CTC Adverse Event Term
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C45559 (NCI Thesaurus Property)
C1705313 (UMLS 2011AA Property)
CommonToxicityCriteriaAdverseEventGrade
Item
CTC Adverse Event Grade
float
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C18000 (NCI Thesaurus ValueDomain)
C0919553 (UMLS 2011AA ValueDomain)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CTCAdverseEventOnsetDate
Item
Adverse Event Onset Date (mm/dd/yyyy)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C25279 (NCI Thesaurus Property)
C0332162 (UMLS 2011AA Property)
MedDRACode
Item
MedDRA Code
float
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
CL104089 (NCI Metathesaurus ObjectClass)
AdverseEventDescriptionText
Item
If other CTC event selected, please provide description of event
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C0678257 (NCI Metathesaurus Property)
AcquiredImmunodeficiencySyndromeClinicalTrialAdverseEventPredictionObservedInd-2
Item
Was this event expected or anticipated
boolean
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C2851 (NCI Thesaurus ObjectClass-2)
C0001175 (UMLS 2011AA ObjectClass-2)
C71104 (NCI Thesaurus ObjectClass-3)
C0008976 (UMLS 2011AA ObjectClass-3)
C25599 (NCI Thesaurus Property)
C1441672 (UMLS 2011AA Property)
C54156 (NCI Thesaurus Property-2)
C0681842 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Agent
Item
Agent Name
text
C25364 (NCI Thesaurus Property)
C1521826 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C1708 (NCI Thesaurus ValueDomain)
C42614 (NCI Thesaurus ValueDomain-2)
Item
CTC Adverse Event Attribution Code
text
C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C25358 (NCI Thesaurus Property)
C0596130 (UMLS 2011AA Property)
CL.3
Code List
CTC Adverse Event Attribution Code
CL Item
Unrelated (Unrelated)
C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)
CL Item
Unlikely (Unlikely)
CL Item
Possible (Possible)
C0332149 (NCI Metathesaurus)
CL Item
Probable (Probable)
C0332148 (NCI Metathesaurus)
CL Item
Definite (Definite)
CL209464 (NCI Metathesaurus)
Item
Alternative etiology
text
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C2851 (NCI Thesaurus ObjectClass-2)
C0001175 (UMLS 2011AA ObjectClass-2)
C25415 (NCI Thesaurus Property)
C1523987 (UMLS 2011AA Property)
C25358 (NCI Thesaurus Property-2)
C0596130 (UMLS 2011AA Property-2)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.4
Code List
Alternative etiology
CL Item
None Apparent (None apparent)
CL Item
Study Disease (Study disease)
CL Item
Other Pre-existing Disease Or Condition (Other pre-existing disease or condition)
CL Item
Accident, Trauma, Or External Factors (Accident, trauma, or external factors)
CL Item
Concurrent Illness/condition (not Pre-existing) (Concurrent illness/condition (not pre-existing))
Item
Action Taken at Time of Adverse Event
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C2851 (NCI Thesaurus ObjectClass-2)
C0001175 (UMLS 2011AA ObjectClass-2)
C25404 (NCI Thesaurus Property)
C0441472 (UMLS 2011AA Property)
CL.5
Code List
Action Taken at Time of Adverse Event
CL Item
Study Dose Was Reduced As A Result Of The Adverse Event (study dose reduced)
CL Item
Protocol Treatment Was Delayed As A Result Of The Adverse Event (protocol treatment delayed)
CL Item
Protocol Treatment Was Discontinued As A Result Of The Adverse Event (protocol treatment discontinued)
CL Item
Prescription (Prescription)
C28180 (NCI Thesaurus)
C1521941 (UMLS 2011AA)
CL Item
Otc/non-rx (OTC/non-Rx)
CL Item
Hospitalization For Ae (Hospitalization)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
AcquiredImmunodeficiencySyndromeAdverseEventActionSpecify
Item
Other, specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C2851 (NCI Thesaurus ObjectClass-2)
C0001175 (UMLS 2011AA ObjectClass-2)
C25404 (NCI Thesaurus Property)
C0441472 (UMLS 2011AA Property)
Item
If modification was made to study therapy, who initiated modification
text
C15368 (NCI Thesaurus ObjectClass)
C2851 (NCI Thesaurus ObjectClass-2)
C0001175 (UMLS 2011AA ObjectClass)
C25657 (NCI Thesaurus Property)
C1273518 (UMLS 2011AA Property)
C25572 (NCI Thesaurus Property-2)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.6
Code List
If modification was made to study therapy, who initiated modification
CL Item
Patient Initiated (Patient initiated)
CL Item
Physician Initiated (Physician initiated)
Item
Outcome of Adverse Event
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C2851 (NCI Thesaurus ObjectClass-2)
C0001175 (UMLS 2011AA ObjectClass-2)
CL.7
Code List
Outcome of Adverse Event
CL Item
Adverse Event Is Resolved (Resolved)
CL Item
Adverse Event Is Resolved With Sequelae (Resolved with sequelae)
CL Item
Unresolved, Protocol Ongoing (Unresolved, protocol ongoing)
CL Item
Unresolved At Protocol Completion (Unresolved at protocol completion)
CTCAdverseEventResolutionDate
Item
AE Resolution Date (If "Resolved" mm/dd/yyyy)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C25655 (NCI Thesaurus Property)
C1514893 (UMLS 2011AA Property)
AcquiredImmunodeficiencySyndromeAdverseEventResolvedwithSequelaeOutcomeSpecify
Item
If resolved with sequelae, specify
text
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C2851 (NCI Thesaurus ObjectClass-2)
C0001175 (UMLS 2011AA ObjectClass-2)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C49495 (NCI Thesaurus Property-2)
C1709862 (UMLS 2011AA Property-2)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
NationalCancerInstituteDefinitionSeriousAdverseEventPresentInd-2
Item
Was this considered a Serious Adverse Event
boolean
C41335 (NCI Thesaurus ObjectClass)
C1519255 (UMLS 2011AA ObjectClass)
C19202 (NCI Thesaurus ObjectClass-2)
C1513882 (UMLS 2011AA ObjectClass-2)
C42777 (NCI Thesaurus ObjectClass-3)
C1704788 (UMLS 2011AA ObjectClass-3)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item
Seriousness Attributed to Adverse Event (If "Yes" check "Yes" for all that apply Please note that checking "Yes" to any of the events below will require SAE notification according to protocol requirements.)
text
C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25358 (NCI Thesaurus Property)
C0596130 (UMLS 2011AA Property)
CL.9
Code List
Seriousness Attributed to Adverse Event (If "Yes" check "Yes" for all that apply Please note that checking "Yes" to any of the events below will require SAE notification according to protocol requirements.)
CL Item
Death (Death)
C28554 (NCI Thesaurus)
C0011065 (UMLS 2011AA)
CL Item
Life Threatening (Life threatening)
CL Item
Disability (Disability/incapacity)
C21007 (NCI Thesaurus)
C0231170 (UMLS 2011AA)
CL Item
Congenital Anomaly (Congenital anomaly)
CL Item
Intervention Required (Required intervention to prevent permanent impairment/damage)
CL Item
Hospitalized (Hospitalization, initial or prolonged)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
Item Group
Comments
Research Comments
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial