ID

578

Beskrivning

AMC-078 Adverse Events Form (ADV) Vorinostat in Combination With Paclitaxel and Carboplatin in Treating Patients With Metastatic or Recurrent Solid Tumors and HIV Infection Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=9A357A24-85C8-31A4-E040-BB89AD4314CA

Länk

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=9A357A24-85C8-31A4-E040-BB89AD4314CA

Nyckelord

Versioner (4)
  1. 2012-08-26 2012-08-26 -
  2. 2015-01-09 2015-01-09 - Martin Dugas
  3. 2015-01-09 2015-01-09 - Martin Dugas
  4. 2015-01-09 2015-01-09 - Martin Dugas
Uppladdad den

26 augusti 2012

DOI

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Licens

Creative Commons BY-NC 3.0 Legacy
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Anal Cancer NCT01249443 Toxicity - AMC-078 Adverse Events Form (ADV) - 3184680v1.0

Engelsk

No Instruction available.

1 Formulär  
  1. StudyEvent: AMC-078 Adverse Events Form (ADV)
    1. No Instruction available.
Unnamed1
Beskrivning

Unnamed1

System Organ Class (SOC)
Beskrivning

MedDRASystemOrganClassTermName

Datatyp

text

Alias
NCI Thesaurus ObjectClass
C71888
UMLS 2011AA ObjectClass
C2347091
NCI Thesaurus Property
C43820
UMLS 2011AA Property
C1140263
NCI Thesaurus Property
C45559
UMLS 2011AA Property
C1705313
NCI Thesaurus ValueDomain
C71888
UMLS 2011AA ValueDomain
C2347091
NCI Thesaurus ValueDomain
C42614
UMLS 2011AA ValueDomain
C0027365
CTC Adverse Event Term
Beskrivning

CommonTerminologyCriteriaforAdverseEventsVersion4.0LowLevelTermName

Datatyp

text

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C49704
UMLS 2011AA Property
C1516728
NCI Thesaurus Property
C45559
UMLS 2011AA Property
C1705313
NCI Thesaurus ValueDomain
C45255
UMLS 2011AA ValueDomain
C1708523
NCI Thesaurus ValueDomain
C49704
UMLS 2011AA ValueDomain
C1516728
NCI Thesaurus ValueDomain
C42614
UMLS 2011AA ValueDomain
C0027365
NCI Thesaurus ValueDomain
C45559
UMLS 2011AA ValueDomain
C1705313
NCI Thesaurus ValueDomain
C25714
UMLS 2011AA ValueDomain
C0333052
CTC Adverse Event Grade
Beskrivning

AdverseEventSeverityGrade

Datatyp

text

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C48309
UMLS 2011AA Property
C0441800
NCI Thesaurus Property
C49705
UMLS 2011AA Property
C1710065
NCI Thesaurus Property
C25676
UMLS 2011AA Property
C0439793
NCI Thesaurus ValueDomain
C41331
UMLS 2011AA ValueDomain
C0877248
NCI Thesaurus ValueDomain
C48309
UMLS 2011AA ValueDomain
C0441800
NCI Thesaurus ValueDomain
C25676
UMLS 2011AA ValueDomain
C0439793
Adverse Event Onset Date (mm/dd/yyyy)
Beskrivning

CTCAdverseEventOnsetDate

Datatyp

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
Beskrivning

Unnamed2

MedDRA Code
Beskrivning

AdverseEventMedDRALowLevelTermVersionInteger::12.0Code

Datatyp

double

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus ObjectClass
C71886
UMLS 2011AA ObjectClass
C2347090
NCI Thesaurus Property
C25162
UMLS 2011AA Property
C0805701
NCI Thesaurus Property
C43820
UMLS 2011AA Property
C1140263
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
NCI Thesaurus ValueDomain
C41331
UMLS 2011AA ValueDomain
C0877248
NCI Thesaurus ValueDomain
C45255
UMLS 2011AA ValueDomain
C1708523
NCI Thesaurus ValueDomain
C43820
UMLS 2011AA ValueDomain
C1140263
NCI Thesaurus ValueDomain
C25714
UMLS 2011AA ValueDomain
C0333052
If other CTC event selected, please provide description of event
Beskrivning

AdverseEventDescriptionText

Datatyp

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
Beskrivning

AcquiredImmunodeficiencySyndromeClinicalTrialAdverseEventPredictionObservedInd-2

Datatyp

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
Beskrivning

AgentName

Datatyp

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 Adverse Event Attribution Code
Beskrivning

CTCAdverseEventAttributionScale

Datatyp

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
Beskrivning

AcquiredImmunodeficiencySyndromeAdverseEventAlternativeAttributionType

Datatyp

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 (check "Yes" for all that apply)
Beskrivning

AcquiredImmunodeficiencySyndromeAdverseEventActionType

Datatyp

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
Beskrivning

AcquiredImmunodeficiencySyndromeAdverseEventActionSpecify

Datatyp

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
Beskrivning

AcquiredImmunodeficiencySyndromeTherapyResponsiblePersonModificationType

Datatyp

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
Beskrivning

Unnamed3

Outcome of Adverse Event
Beskrivning

AcquiredImmunodeficiencySyndromeAdverseEventOutcomeType

Datatyp

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 (If "Resolved" mm/dd/yyyy)
Beskrivning

CTCAdverseEventResolutionDate

Datatyp

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
Beskrivning

AcquiredImmunodeficiencySyndromeAdverseEventResolvedwithSequelaeOutcomeSpecify

Datatyp

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
Was this considered a Serious Adverse Event
Beskrivning

NationalCancerInstituteDefinitionSeriousAdverseEventPresentInd-2

Datatyp

text

Alias
NCI Thesaurus ObjectClass
C41335
UMLS 2011AA ObjectClass
C1519255
NCI Thesaurus ObjectClass
C19202
UMLS 2011AA ObjectClass
C1513882
NCI Thesaurus ObjectClass
C42777
UMLS 2011AA ObjectClass
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.)
Beskrivning

AdverseEventSeriousnessAttributionScale

Datatyp

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
Beskrivning

Comments

Comments
Beskrivning

ResearchCommentsText

Datatyp

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 Formulär
  1. StudyEvent: AMC-078 Adverse Events Form (ADV)
    1. No Instruction available.
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Unnamed1
MedDRASystemOrganClassTermName
Item
System Organ Class (SOC)
text
C71888 (NCI Thesaurus ObjectClass)
C2347091 (UMLS 2011AA ObjectClass)
C43820 (NCI Thesaurus Property)
C1140263 (UMLS 2011AA Property)
C45559 (NCI Thesaurus Property)
C1705313 (UMLS 2011AA Property)
C71888 (NCI Thesaurus ValueDomain)
C2347091 (UMLS 2011AA ValueDomain)
C42614 (NCI Thesaurus ValueDomain)
C0027365 (UMLS 2011AA ValueDomain)
CommonTerminologyCriteriaforAdverseEventsVersion4.0LowLevelTermName
Item
CTC Adverse Event Term
text
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C49704 (NCI Thesaurus Property)
C1516728 (UMLS 2011AA Property)
C45559 (NCI Thesaurus Property)
C1705313 (UMLS 2011AA Property)
C45255 (NCI Thesaurus ValueDomain)
C1708523 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ValueDomain)
C1516728 (UMLS 2011AA ValueDomain)
C42614 (NCI Thesaurus ValueDomain)
C0027365 (UMLS 2011AA ValueDomain)
C45559 (NCI Thesaurus ValueDomain)
C1705313 (UMLS 2011AA ValueDomain)
C25714 (NCI Thesaurus ValueDomain)
C0333052 (UMLS 2011AA ValueDomain)
AdverseEventSeverityGrade
Item
CTC Adverse Event Grade
text
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C48309 (NCI Thesaurus Property)
C0441800 (UMLS 2011AA Property)
C49705 (NCI Thesaurus Property)
C1710065 (UMLS 2011AA Property)
C25676 (NCI Thesaurus Property)
C0439793 (UMLS 2011AA Property)
C41331 (NCI Thesaurus ValueDomain)
C0877248 (UMLS 2011AA ValueDomain)
C48309 (NCI Thesaurus ValueDomain)
C0441800 (UMLS 2011AA ValueDomain)
C25676 (NCI Thesaurus ValueDomain)
C0439793 (UMLS 2011AA ValueDomain)
CTCAdverseEventOnsetDate
Item
Adverse Event Onset Date (mm/dd/yyyy)
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
AdverseEventMedDRALowLevelTermVersionInteger::12.0Code
Item
MedDRA Code
double
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C71886 (NCI Thesaurus ObjectClass)
C2347090 (UMLS 2011AA ObjectClass)
C25162 (NCI Thesaurus Property)
C0805701 (UMLS 2011AA Property)
C43820 (NCI Thesaurus Property)
C1140263 (UMLS 2011AA Property)
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ValueDomain)
C0877248 (UMLS 2011AA ValueDomain)
C45255 (NCI Thesaurus ValueDomain)
C1708523 (UMLS 2011AA ValueDomain)
C43820 (NCI Thesaurus ValueDomain)
C1140263 (UMLS 2011AA ValueDomain)
C25714 (NCI Thesaurus ValueDomain)
C0333052 (UMLS 2011AA ValueDomain)
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.1
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 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.2
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)
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.3
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 (check "Yes" for all that apply)
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.4
Code List
Action Taken at Time of Adverse Event (check "Yes" for all that apply)
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)
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.5
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.6
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)
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
Was this considered a Serious Adverse Event
text
C41335 (NCI Thesaurus ObjectClass)
C1519255 (UMLS 2011AA ObjectClass)
C19202 (NCI Thesaurus ObjectClass)
C1513882 (UMLS 2011AA ObjectClass)
C42777 (NCI Thesaurus ObjectClass)
C1704788 (UMLS 2011AA ObjectClass)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.7
Code List
Was this considered a Serious Adverse Event
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
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.8
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
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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