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  1. StudyEvent: Common Toxicity Reporting Form, GOG-0212, Form T
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header Module
Form Completion Date
Item
Date form originally completed (m d y)
date
C19464 (NCI Thesaurus ObjectClass)
C1549507 (UMLS CUI-1)
C25250 (NCI Thesaurus Property)
C25604 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
Amendment date
Item
Date form amended (m d y)
date
C19464 (NCI Thesaurus ObjectClass)
C0680532 (UMLS CUI-1)
C25250 (NCI Thesaurus Property)
C0011008 (UMLS CUI-2)
C25416 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
Person Amending Form
Item
Person amending form, last name
text
C25191 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25190 (NCI Thesaurus ObjectClass)
C1547383 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
Patient Initials
Item
Patient Initials (First, Middle, Last)
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Patient Study ID
Item
Patient Study ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25462 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Person Completing Form Last Name
Item
Person Completing Form, Last Name
text
C25190 (NCI Thesaurus ObjectClass)
C1550483 (UMLS CUI-1)
C25657 (NCI Thesaurus ObjectClass-2)
C1301584 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25551 (NCI Thesaurus Property-2)
C25191 (NCI Thesaurus ValueDomain)
Item Group
Adverse Events - Section 1
Cycle Number
Item
Current course number (The toxicities listed below occurred following this course of therapy)
integer
C25337 (NCI Thesaurus ValueDomain)
C2045829 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass)
C25379 (NCI Thesaurus Property)
Item
Has the patient received any transfusions during this course of therapy?
text
C25180 (NCI Thesaurus ValueDomain)
C1879316 (UMLS CUI-1)
C15366 (NCI Thesaurus ObjectClass)
C25382 (NCI Thesaurus Property)
Code List
Has the patient received any transfusions during this course of therapy?
CL Item
No Transfusion (No)
CL Item
Transfusion With Red Blood Cells (Yes, red blood cells)
CL Item
Transfusion With Platelets (Yes, platelets)
InpatientHospitalizationInd
Item
Was patient hospitalized as a result of reported adverse events?
boolean
Cytokine Therapy
Item
Were cytokines administered this course?
boolean
C38148 (NCI Thesaurus ValueDomain)
C0199974 (UMLS CUI-1)
C20464 (NCI Thesaurus Property)
C1708 (NCI Thesaurus ObjectClass)
C25382 (NCI Thesaurus Property-2)
AgentCytokineAdministeredSpecify
Item
Yes specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C20464 (NCI Thesaurus Property)
C0079189 (UMLS 2011AA Property)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
AdverseEventReportInd-3
Item
Has an Adverse Drug Reaction Report been filed?
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25375 (NCI Thesaurus Property)
C0684224 (UMLS 2011AA Property)
C17648 (NCI Thesaurus ObjectClass-2)
C0439064 (UMLS 2011AA ObjectClass-2)
Item Group
Adverse Events - Section 2
WBC done
Item
Peripheral WBC count done?
boolean
C38148 (NCI Thesaurus ValueDomain)
C0023508 (UMLS CUI-1)
C12529 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
Leukocytes (WBC)
Item
Peripheral WBC count (1000/mm3 Nadir)
float
C25294 (NCI Thesaurus ObjectClass)
C0023508 (UMLS CUI-1)
C12529 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C38024 (NCI Thesaurus ValueDomain-2)
LaboratoryProcedureAbsoluteNeutrophilCountGranulocyteOutcomeInd-3
Item
Peripheral Granulocytes count done? (ANC/)
boolean
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C12530 (NCI Thesaurus Property-2)
C0018183 (UMLS 2011AA Property-2)
C63321 (NCI Thesaurus Property-3)
C0948762 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
Granulocyte count
Item
Peripheral Granulocytes count (ANC/ 1000/mm3 Nadir)
float
C20200 (NCI Thesaurus Property)
C0857490 (UMLS CUI-1)
C12530 (NCI Thesaurus Property-2)
C25463 (NCI Thesaurus ValueDomain)
C25294 (NCI Thesaurus ObjectClass)
Platelets
Item
Peripheral Platelet count done?
boolean
C38148 (NCI Thesaurus ValueDomain)
C0005821 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C12520 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
Platelets
Item
Peripheral Platelet count (mm3 Nadir)
float
C20200 (NCI Thesaurus Property)
C0005821 (UMLS CUI-1)
C12520 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
Hemoglobin
Item
Hemoglobin done?
boolean
C38148 (NCI Thesaurus ValueDomain)
C0019046 (UMLS CUI-1)
C16676 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
Hemoglobin
Item
Hemoglobin (G/DL Nadir)
float
C16676 (NCI Thesaurus Property)
C0019046 (UMLS CUI-1)
C20200 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
Laboratory Procedure Date
Item
Hemoglobin, Date
date
C25164 (NCI Thesaurus ValueDomain)
C0022885 (UMLS CUI-1)
C25214 (NCI Thesaurus Property)
C0011008 (UMLS CUI-2)
C38000 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
Laboratory Procedure Date
Item
Hemoglobin, Date
date
C25164 (NCI Thesaurus ValueDomain)
C0022885 (UMLS CUI-1)
C25214 (NCI Thesaurus Property)
C0011008 (UMLS CUI-2)
C38000 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
CTC Adverse Event Grade
Item
CTC Adverse Event Grade
float
C49704 (NCI Thesaurus ObjectClass)
C2985911 (UMLS CUI-1)
C18000 (NCI Thesaurus ValueDomain)
C25365 (NCI Thesaurus Property)
Item
CTC Adverse Event Attribution Code (Attribution Codes for Relationship of Event to Treatment: 1=Unrelated, 2=Unlikely, 3=Possibly, 4=Probably, 5=Definitely)
text
C25664 (NCI Thesaurus ValueDomain)
C1706735 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C25358 (NCI Thesaurus Property)
Code List
CTC Adverse Event Attribution Code (Attribution Codes for Relationship of Event to Treatment: 1=Unrelated, 2=Unlikely, 3=Possibly, 4=Probably, 5=Definitely)
CL Item
Unrelated (Unrelated)
C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)
CL Item
Unlikely (Unlikely)
CL Item
Possible (Possibly)
C0332149 (NCI Metathesaurus)
CL Item
Probable (Probably)
C0332148 (NCI Metathesaurus)
CL Item
Definite (Definitely)
CL209464 (NCI Metathesaurus)
PeripheralGranulocytescount,Date
Item
Peripheral Granulocytes count, Date
text
PeripheralPlateletcount,Date
Item
Peripheral Platelet count, Date
text
Item Group
Adverse Events - Section 3
Item
CTC Adverse Event Term
text
C25284 (NCI Thesaurus ValueDomain)
C1516728 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C2826934 (UMLS CUI-2)
C45559 (NCI Thesaurus Property)
Code List
CTC Adverse Event Term
CL Item
Hypersensitivity Nos (Allergic reaction)
CL Item
Alopecia (Alopecia)
C2865 (NCI Thesaurus)
CL Item
Peripheral Motor Neuropathy (Neuropathy-motor)
C3500 (NCI Thesaurus)
C0018995 (UMLS 2011AA)
CL Item
Peripheral Sensory Neuropathy (Neuropathy-sensory)
C3501 (NCI Thesaurus)
C0151313 (UMLS 2011AA)
CL Item
Myalgia (Myalgia)
C27009 (NCI Thesaurus)
C0231528 (UMLS 2011AA)
CL Item
Arthralgia (Arthralgia)
C0003862 (NCI Metathesaurus)
CL Item
Febrile Neutropenia (fever Of Unknown Origin Without Clinically Or Microbiologically Documented Infection) (anc <1.0 X 10^9/l, Fever >=38.5 Degrees C) (Febrile neutropenia)
CL Item
Infection Nos (Infection - Other (specify))
CL Item
Nausea (Nausea)
C3258 (NCI Thesaurus)
C0027497 (UMLS 2011AA)
CL Item
Vomiting Nos (Vomiting)
CL Item
Diarrhoea Nos (Diarrhea)
CL Item
Dehydration (Dehydration)
C26740 (NCI Thesaurus)
C0011175 (UMLS 2011AA)
CL Item
Fatigue (Fatigue)
C3036 (NCI Thesaurus)
C0015672 (UMLS 2011AA)
Item
The CTCAE data entered above is
text
C25284 (NCI Thesaurus ValueDomain)
C1516728 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C0333052 (UMLS CUI-2)
C25714 (NCI Thesaurus Property)
Code List
The CTCAE data entered above is
CL Item
Version 2 (version 2)
CL Item
Version 3 (version 3)
CTC Adverse Event Grade
Item
CTC Adverse Event Grade
float
C49704 (NCI Thesaurus ObjectClass)
C2985911 (UMLS CUI-1)
C18000 (NCI Thesaurus ValueDomain)
C25365 (NCI Thesaurus Property)
Item
CTC Adverse Event Attribution Code (Attribution Codes for Relationship of Event to Treatment: 1=Unrelated, 2=Unlikely, 3=Possibly, 4=Probably, 5=Definitely)
text
C25664 (NCI Thesaurus ValueDomain)
C1706735 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C25358 (NCI Thesaurus Property)
Code List
CTC Adverse Event Attribution Code (Attribution Codes for Relationship of Event to Treatment: 1=Unrelated, 2=Unlikely, 3=Possibly, 4=Probably, 5=Definitely)
CL Item
Unrelated (Unrelated)
C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)
CL Item
Unlikely (Unlikely)
CL Item
Possible (Possibly)
C0332149 (NCI Metathesaurus)
CL Item
Probable (Probably)
C0332148 (NCI Metathesaurus)
CL Item
Definite (Definitely)
CL209464 (NCI Metathesaurus)
Item Group
Comments
Research Comments
Item
COMMENTS
text
C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
Item Group
Footer Module
ParticipatingGroupIdentifierCode
Item
Participating Group Code
text
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C25608 (NCI Thesaurus ObjectClass)
C0679823 (UMLS 2011AA ObjectClass)
C17005 (NCI Thesaurus ObjectClass-2)
C1257890 (UMLS 2011AA ObjectClass-2)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
Study Number Participating Group
Item
Participating Group Protocol Number
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Trial subject ID Participating Group
Item
Participating Group Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)

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