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  1. StudyEvent: ANZGOG-0902 Toxicity - Follow-up
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Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header
Patient Initials
Item
Patient Initials
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Patient Study ID
Item
Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25462 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Institution Number
Item
Institution Code
text
C25337 (NCI Thesaurus ValueDomain)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass)
C0805701 (UMLS CUI-2)
C25364 (NCI Thesaurus 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-2)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
Adverse Event
Item
Has the patient experienced any toxicities related to study treatment since the last report?
boolean
C25648 (NCI Thesaurus ObjectClass)
C0877248 (UMLS CUI-1)
C41331 (NCI Thesaurus ObjectClass-2)
C15368 (NCI Thesaurus ObjectClass-3)
C0684224 (NCI Metathesaurus Property)
C38148 (NCI Thesaurus ValueDomain)
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-2)
C1705313 (UMLS 2011AA Property-2)
C45255 (NCI Thesaurus ValueDomain)
C1708523 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ValueDomain-2)
C1516728 (UMLS 2011AA ValueDomain-2)
C42614 (NCI Thesaurus ValueDomain-3)
C0027365 (UMLS 2011AA ValueDomain-3)
C45559 (NCI Thesaurus ValueDomain-4)
C1705313 (UMLS 2011AA ValueDomain-4)
C25714 (NCI Thesaurus ValueDomain-5)
C0333052 (UMLS 2011AA ValueDomain-5)
CL.2
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-2)
C1705313 (UMLS 2011AA Property-2)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25704 (NCI Thesaurus ValueDomain-2)
C1527021 (UMLS 2011AA ValueDomain-2)
C17649 (NCI Thesaurus ValueDomain-3)
C0205394 (UMLS 2011AA ValueDomain-3)
C45255 (NCI Thesaurus ValueDomain-4)
C1708523 (UMLS 2011AA ValueDomain-4)
C49704 (NCI Thesaurus ValueDomain-5)
C1516728 (UMLS 2011AA ValueDomain-5)
C45559 (NCI Thesaurus ValueDomain-6)
C1705313 (UMLS 2011AA ValueDomain-6)
C25714 (NCI Thesaurus ValueDomain-7)
C0333052 (UMLS 2011AA ValueDomain-7)
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-2)
C1710065 (UMLS 2011AA Property-2)
C25676 (NCI Thesaurus Property-3)
C0439793 (UMLS 2011AA Property-3)
C41331 (NCI Thesaurus ValueDomain)
C0877248 (UMLS 2011AA ValueDomain)
C48309 (NCI Thesaurus ValueDomain-2)
C0441800 (UMLS 2011AA ValueDomain-2)
C25676 (NCI Thesaurus ValueDomain-3)
C0439793 (UMLS 2011AA ValueDomain-3)
CL.3
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)
C1706735 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C25358 (NCI Thesaurus Property)
CL.4
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)
Investigator Signature Date
Item
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)
Investigator Signature
Item
Investigator's signature
text
C25704 (NCI Thesaurus ValueDomain)
C2346576 (UMLS CUI-1)
C25678 (NCI Thesaurus Property)
C17089 (NCI Thesaurus ObjectClass)
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