ID

2936

Beschrijving

AMC-051 Adverse Events Form (ADV) Sirolimus in Treating Patients With HIV-Related Kaposi's Sarcoma Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=2FDFA89A-0516-6018-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=2FDFA89A-0516-6018-E044-0003BA3F9857

Trefwoorden

Versies (5)
  1. 19-09-12 19-09-12 -
  2. 09-01-15 09-01-15 - Martin Dugas
  3. 09-01-15 09-01-15 - Martin Dugas
  4. 09-01-15 09-01-15 - Martin Dugas
  5. 08-07-15 08-07-15 -
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19 september 2012

DOI

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Creative Commons BY-NC 3.0 Legacy
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Sarcoma NCT00450320 Toxicity - AMC-051 Adverse Events Form (ADV) - 2635763v1.0

Engels

No Instruction available.

1 Formulieren  
  1. StudyEvent: AMC-051 Adverse Events Form (ADV)
    1. No Instruction available.
Unnamed1
Beschrijving

Unnamed1

CTC Adverse Event Category
Beschrijving

CTCAdverseEventCategory

Datatype

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
Beschrijving

CommonToxicityCriteriaAdverseEventTermType

Datatype

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
Beschrijving

CommonToxicityCriteriaAdverseEventGrade

Datatype

double

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
Beschrijving

CTCAdverseEventOnsetDate

Datatype

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25367
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus Property
C25279
UMLS 2011AA Property
C0332162
Unnamed2
Beschrijving

Unnamed2

MedDRA Code
Beschrijving

MedDRACode

Datatype

double

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
Beschrijving

AdverseEventDescriptionText

Datatype

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
Beschrijving

AcquiredImmunodeficiencySyndromeClinicalTrialAdverseEventPredictionObservedInd-2

Datatype

text

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

AgentName

Datatype

text

Alias
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus ValueDomain
C1708
UMLS 2011AA ValueDomain
C0450442
NCI Thesaurus ValueDomain
C42614
UMLS 2011AA ValueDomain
C0027365
CTC AE Attribution Code
Beschrijving

CTCAdverseEventAttributionScale

Datatype

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
Beschrijving

AcquiredImmunodeficiencySyndromeAdverseEventAlternativeAttributionType

Datatype

text

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

AcquiredImmunodeficiencySyndromeAdverseEventActionType

Datatype

text

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

AcquiredImmunodeficiencySyndromeAdverseEventActionSpecify

Datatype

text

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

AcquiredImmunodeficiencySyndromeTherapyResponsiblePersonModificationType

Datatype

text

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass
C2851
UMLS 2011AA ObjectClass
C0001175
NCI Thesaurus Property
C25657
UMLS 2011AA Property
C1273518
NCI Thesaurus Property
C25572
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Unnamed3
Beschrijving

Unnamed3

Outcome of Adverse Event
Beschrijving

AcquiredImmunodeficiencySyndromeAdverseEventOutcomeType

Datatype

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
C2851
UMLS 2011AA ObjectClass
C0001175
AE Resolution Date
Beschrijving

CTCAdverseEventResolutionDate

Datatype

date

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

AcquiredImmunodeficiencySyndromeAdverseEventResolvedwithSequelaeOutcomeSpecify

Datatype

text

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus ObjectClass
C2851
UMLS 2011AA ObjectClass
C0001175
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C49495
UMLS 2011AA Property
C1709862
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Seriousness Attributed to Adverse Event
Beschrijving

AdverseEventSeriousnessAttributionScale

Datatype

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
Beschrijving

Comments

Comments
Beschrijving

ResearchCommentsText

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
UMLS 2011AA Property
C0282411
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Similar models

No Instruction available.

1 Formulieren
  1. StudyEvent: AMC-051 Adverse Events Form (ADV)
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Unnamed1
CTCAdverseEventCategory
Item
CTC Adverse Event 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)
Item
CTC Adverse Event Grade
double
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C18000 (NCI Thesaurus ValueDomain)
C0919553 (UMLS 2011AA ValueDomain)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CL.1
Code List
CTC Adverse Event Grade
CL Item
No Adverse Event Or Within Normal Limits (0)
CL Item
Mild Adverse Event (1)
C41338 (NCI Thesaurus)
C1513302 (UMLS 2011AA)
CL Item
Moderate Adverse Event (2)
C41339 (NCI Thesaurus)
C1513374 (UMLS 2011AA)
CL Item
Severe Adverse Event (3)
C41340 (NCI Thesaurus)
C1519275 (UMLS 2011AA)
CL Item
Life-threatening Or Disabling Adverse Event (4)
CL Item
Death Related To Adverse Event (5)
C48275 (NCI Thesaurus)
C1705232 (UMLS 2011AA)
CTCAdverseEventOnsetDate
Item
Adverse Event Onset Date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C25279 (NCI Thesaurus Property)
C0332162 (UMLS 2011AA Property)
Item Group
Unnamed2
MedDRACode
Item
MedDRA Code
double
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)
Item
Was this event expected or anticipated
text
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C2851 (NCI Thesaurus ObjectClass)
C0001175 (UMLS 2011AA ObjectClass)
C71104 (NCI Thesaurus ObjectClass)
C0008976 (UMLS 2011AA ObjectClass)
C25599 (NCI Thesaurus Property)
C1441672 (UMLS 2011AA Property)
C54156 (NCI Thesaurus Property)
C0681842 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.2
Code List
Was this event expected or anticipated
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
AgentName
Item
Agent Name
text
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ValueDomain)
C0450442 (UMLS 2011AA ValueDomain)
C42614 (NCI Thesaurus ValueDomain)
C0027365 (UMLS 2011AA ValueDomain)
Item
CTC AE 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 AE Attribution Code
CL Item
Definite (Definite)
CL209464 (NCI Metathesaurus)
CL Item
Possible (Possible)
C0332149 (NCI Metathesaurus)
CL Item
Probable (Probable)
C0332148 (NCI Metathesaurus)
CL Item
Unlikely (Unlikely)
CL Item
Unrelated (Unrelated)
C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)
Item
Alternative etiology
text
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C2851 (NCI Thesaurus ObjectClass)
C0001175 (UMLS 2011AA ObjectClass)
C25415 (NCI Thesaurus Property)
C1523987 (UMLS 2011AA Property)
C25358 (NCI Thesaurus Property)
C0596130 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.4
Code List
Alternative etiology
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))
CL Item
None Apparent (None apparent)
CL Item
Other Pre-existing Disease Or Condition (Other pre-existing disease or condition)
CL Item
Study Disease (Study disease)
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)
C0001175 (UMLS 2011AA ObjectClass)
C25404 (NCI Thesaurus Property)
C0441472 (UMLS 2011AA Property)
CL.5
Code List
Action Taken at Time of Adverse Event
CL Item
Hospitalization For Ae (Hospitalization)
CL Item
Otc/non-rx (OTC/non-Rx)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Prescription (Prescription)
C28180 (NCI Thesaurus)
C1521941 (UMLS 2011AA)
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
Study Dose Was Reduced As A Result Of The Adverse Event (study dose reduced)
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)
C0001175 (UMLS 2011AA ObjectClass)
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)
C0001175 (UMLS 2011AA ObjectClass)
C25657 (NCI Thesaurus Property)
C1273518 (UMLS 2011AA Property)
C25572 (NCI Thesaurus Property)
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 Group
Unnamed3
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)
C0001175 (UMLS 2011AA ObjectClass)
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 At Protocol Completion (Unresolved at protocol completion)
CL Item
Unresolved, Protocol Ongoing (Unresolved, protocol ongoing)
CTCAdverseEventResolutionDate
Item
AE Resolution Date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
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)
C0001175 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C49495 (NCI Thesaurus Property)
C1709862 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
Item
Seriousness Attributed to Adverse Event
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.8
Code List
Seriousness Attributed to Adverse Event
CL Item
Congenital Anomaly (Congenital anomaly)
CL Item
Death (Death)
C28554 (NCI Thesaurus)
C0011065 (UMLS 2011AA)
CL Item
Disability (Disability/incapacity)
C21007 (NCI Thesaurus)
C0231170 (UMLS 2011AA)
CL Item
Hospitalized (Hospitalization, initial or prolonged)
CL Item
Life Threatening (Life threatening)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Intervention Required (Required intervention to prevent permanent impairment/damage)
Item Group
Comments
ResearchCommentsText
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
C0282411 (UMLS 2011AA Property)
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