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  1. StudyEvent: ANZGOG-0902 Toxicity - Follow-up
    1. No Instruction available.
Header
Description

Header

Patient Initials
Description

PatientInitialsName

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25536
UMLS 2011AA Property
C1555582
Patient ID
Description

PatientCoordinatingIdentifierNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25462
UMLS 2011AA Property
C0700114
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Institution Code
Description

InstitutionIdentifierNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C21541
UMLS 2011AA ObjectClass
C0018704
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Date of Symptom/Event Assessment
Description

AdverseEventAssessmentDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus ValueDomain
C25367
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
Has the patient experienced any toxicities related to study treatment since the last report?
Description

TreatmentRelatedAdverseEventReportInd-3

Data type

text

Alias
NCI Thesaurus ObjectClass
C25648
UMLS 2011AA ObjectClass
C0439849
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus ObjectClass
C15368
NCI Metathesaurus Property
C0684224
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Toxicities
Description

Toxicities

CTCAE V4.0 Term
Description

CommonTerminologyCriteriaforAdverseEventsVersion4.0LowLevelTermName

Data type

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
CTCAE v4.0 - Other, Specify
Description

CommonTerminologyCriteriaforAdverseEventsVersion4.0LowLevelTermOtherSpecifyText

Data type

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
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ValueDomain
C17649
UMLS 2011AA ValueDomain
C0205394
NCI Thesaurus ValueDomain
C45255
UMLS 2011AA ValueDomain
C1708523
NCI Thesaurus ValueDomain
C49704
UMLS 2011AA ValueDomain
C1516728
NCI Thesaurus ValueDomain
C45559
UMLS 2011AA ValueDomain
C1705313
NCI Thesaurus ValueDomain
C25714
UMLS 2011AA ValueDomain
C0333052
CTC Adverse Event Grade
Description

AdverseEventSeverityGrade

Data type

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
CTC AE 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
Footer Module
Description

Footer Module

Investigator Name
Description

InvestigatorName

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ObjectClass
C17089
UMLS 2011AA ObjectClass
C0035173
Date
Description

InvestigatorSignatureDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C25678
UMLS 2011AA Property
C1519316
NCI Thesaurus ValueDomain
C25367
NCI Thesaurus ObjectClass
C17089
UMLS 2011AA ObjectClass
C0035173
Investigator's signature
Description

InvestigatorSignatureText

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus Property
C25678
UMLS 2011AA Property
C1519316
NCI Thesaurus ObjectClass
C17089
UMLS 2011AA ObjectClass
C0035173

Similar models

No Instruction available.

  1. StudyEvent: ANZGOG-0902 Toxicity - Follow-up
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header
PatientInitialsName
Item
Patient Initials
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA Property)
PatientCoordinatingIdentifierNumber
Item
Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25462 (NCI Thesaurus Property)
C0700114 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
InstitutionIdentifierNumber
Item
Institution Code
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
AdverseEventAssessmentDate
Item
Date of Symptom/Event Assessment
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C25367 (NCI Thesaurus ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
Item
Has the patient experienced any toxicities related to study treatment since the last report?
text
C25648 (NCI Thesaurus ObjectClass)
C0439849 (UMLS 2011AA ObjectClass)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass)
C0684224 (NCI Metathesaurus Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
Code List
Has the patient experienced any toxicities related to study treatment since the last report?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item Group
Toxicities
Item
CTCAE V4.0 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)
Code List
CTCAE V4.0 Term
CL Item
Anemia (Anemia)
E10010 (CTCAE)
CL Item
Lymphocyte Count Decreased (Lymphocyte count decreased)
E12190 (CTCAE)
CL Item
Neutrophil Count Decreased (Neutrophil count decreased)
E12198 (CTCAE)
CL Item
Platelet Count Decreased (Platelet count decreased)
E12207 (CTCAE)
CL Item
Febrile Neutropenia (Febrile neutropenia)
E10033 (CTCAE)
CL Item
Alanine Aminotransferase Increased (Alanine aminotransferase increased)
E12077 (CTCAE)
CL Item
Aspartate Aminotransferase Increased (Aspartate aminotransferase increased)
E12087 (CTCAE)
CL Item
Creatinine Increased (Creatinine increased)
E12137 (CTCAE)
CL Item
Diarrhea (Diarrhea)
E10572 (CTCAE)
CL Item
Colitis (Colitis)
E10521 (CTCAE)
CL Item
Enterocolitis (Enterocolitis)
E10627 (CTCAE)
CL Item
Proctitis (Proctitis)
E10943 (CTCAE)
CL Item
Dermatitis Radiation (Dermatitis radiation)
E11675 (CTCAE)
CL Item
Rectal Hemorrhage (Rectal hemorrhage)
E10955 (CTCAE)
CL Item
Cystitis Noninfective (Cystitis noninfective)
E12994 (CTCAE)
CL Item
Allergic Reaction (Allergic reaction)
E11248 (CTCAE)
CL Item
Fatigue (Fatigue)
E11098 (CTCAE)
CL Item
Thromboembolic Event (Thromboembolic event)
E13825 (CTCAE)
CL Item
Peripheral Motor Neuropathy (Peripheral motor neuropathy)
E12762 (CTCAE)
CL Item
Peripheral Sensory Neuropathy (Peripheral sensory neuropathy)
E12768 (CTCAE)
CL Item
Hearing Impaired (Hearing impaired)
E10276 (CTCAE)
CL Item
Nausea (Nausea)
E10878 (CTCAE)
CL Item
Vomiting (Vomiting)
E11068 (CTCAE)
CL Item
Dehydration (Dehydration)
E12258 (CTCAE)
CL Item
Mucositis Oral (Mucositis oral)
E10872 (CTCAE)
CL Item
Myalgia (Myalgia)
E12485 (CTCAE)
CL Item
Alopecia (Alopecia)
E13611 (CTCAE)
CommonTerminologyCriteriaforAdverseEventsVersion4.0LowLevelTermOtherSpecifyText
Item
CTCAE v4.0 - Other, Specify
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)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C17649 (NCI Thesaurus ValueDomain)
C0205394 (UMLS 2011AA ValueDomain)
C45255 (NCI Thesaurus ValueDomain)
C1708523 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ValueDomain)
C1516728 (UMLS 2011AA ValueDomain)
C45559 (NCI Thesaurus ValueDomain)
C1705313 (UMLS 2011AA ValueDomain)
C25714 (NCI Thesaurus ValueDomain)
C0333052 (UMLS 2011AA ValueDomain)
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)
Code List
CTC Adverse Event Grade
CL Item
Mild Adverse Event (1)
C84263 (NCI Thesaurus)
C1513302 (UMLS 2011AA)
CL Item
Moderate Adverse Event (2)
C84264 (NCI Thesaurus)
C1513374 (UMLS 2011AA)
CL Item
Severe Adverse Event (3)
C84265 (NCI Thesaurus)
C2919019 (UMLS 2011AA)
CL Item
Life Threatening Adverse Event (4)
C84266 (NCI Thesaurus)
C1517874 (UMLS 2011AA)
CL Item
Death Related To Adverse Event (5)
C48275 (NCI Thesaurus)
C1705232 (UMLS 2011AA)
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)
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 Group
Footer Module
InvestigatorName
Item
Investigator Name
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)
InvestigatorSignatureDate
Item
Date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25678 (NCI Thesaurus Property)
C1519316 (UMLS 2011AA Property)
C25367 (NCI Thesaurus ValueDomain)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)
InvestigatorSignatureText
Item
Investigator's signature
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25678 (NCI Thesaurus Property)
C1519316 (UMLS 2011AA Property)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)