ID

8879

Description

Adverse Events - CTCAE v3.0 Genetic Testing or Clinical Assessment in Determining the Need for Chemotherapy in Women With Breast Cancer That Involves No More Than 3 Lymph Nodes Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=1903495E-EB08-0BEB-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=1903495E-EB08-0BEB-E044-0003BA3F9857

Keywords

Versions (3)
  1. 8/26/12 8/26/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
  3. 3/27/15 3/27/15 - Martin Dugas
Uploaded on

January 9, 2015

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Creative Commons BY-NC 3.0 Legacy
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Breast Cancer NCT00433589 Toxicity - Adverse Events - CTCAE v3.0 - 2497252v1.0

English

No Instruction available.

1 forms  
  1. StudyEvent: Adverse Events - CTCAE v3.0
    1. No Instruction available.
Header
Description

Header

Patient Birth Date
Description

Birth Date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C0421451
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus Property
C25155
Patient Hospital Number
Description

Patient Hospital No

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C0421459
NCI Thesaurus Property
C16960
NCI Thesaurus Property-2
C25364
NCI Thesaurus ObjectClass
C16696
Institution Name
Description

Institution Name

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass
C21541
NCI Thesaurus ValueDomain-2
C21541
NCI Thesaurus Property
C25364
Institution No.
Description

Institution Number

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass
C21541
UMLS CUI-2
C0805701
NCI Thesaurus Property
C25364
Physician of Record
Description

Investigator Name

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2826892
NCI Thesaurus Property
C25364
NCI Thesaurus ObjectClass
C17089
NCI Thesaurus ObjectClass-2
C25644
Unnamed2
Description

Unnamed2

Time
Description

PlannedAssessmentPeriodType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C20989
UMLS 2011AA ObjectClass
C0031809
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
Date of Assessment
Description

Assessment Date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C2985720
NCI Thesaurus ObjectClass
C25367
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus Property
C38000
Were adverse events assessed during most recent period
Description

AdverseEventMostRecentAssessmentInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property-2
C25577
UMLS 2011AA Property-2
C1513491
Clinical Tolerance: Ctca (version 3.0)
Description

Clinical Tolerance: Ctca (version 3.0)

CTC Adverse Event Term
Description

CTC Adverse Event Term

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C1516728
NCI Thesaurus ObjectClass
C49704
UMLS CUI-2
C2826934
NCI Thesaurus Property
C45559
CTC AE Grade
Description

CTC Adverse Event Grade

Data type

float

Alias
NCI Thesaurus ObjectClass
C49704
UMLS CUI-1
C2985911
NCI Thesaurus ValueDomain
C18000
NCI Thesaurus Property
C25365
CTC Adverse Event Allergy/Immunology-Other (Specify)
Description

CommonToxicityCriteriaAdverseEventOtherHypersensitivitySpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus Property-2
C3114
UMLS 2011AA Property-2
C0020517
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
CTC Adverse Event Cardiac General-Other (Specify)
Description

CommonToxicityCriteriaAdverseEventOtherCardiovascularSpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus Property-2
C25292
UMLS 2011AA Property-2
C0007226
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
CTC Adverse Event Constitutional Symptoms-Other (Specify)
Description

CommonToxicityCriteriaAdverseEventOtherConstitutionalSymptomSpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Metathesaurus Property
C0009812
CTC Adverse Event Dermatology/Skin-Other (Specify)
Description

CommonToxicityCriteriaAdverseEventOtherSkinSpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus Property-2
C12470
UMLS 2011AA Property-2
C1123023
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
CTC Adverse Event Endocrine-Other (Specify)
Description

CommonToxicityCriteriaAdverseEventOtherEndocrineSystemSpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Metathesaurus Property
C0014136
CTC Adverse Event Gastrointestinal-Other (Specify)
Description

CommonToxicityCriteriaAdverseEventOtherGastrointestinalSymptomSpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Metathesaurus Property
C0426576
CTC Adverse Event Hemorrhage/Bleeding-Other (Specify)
Description

CommonToxicityCriteriaAdverseEventOtherHemorrhageSpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus Property-2
C26791
UMLS 2011AA Property-2
C0019080
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
CTC Adverse Event Infection-Other (Specify)
Description

CommonToxicityCriteriaAdverseEventOtherInfectionSpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus Property-2
C26726
UMLS 2011AA Property-2
C0009450
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
CTC Adverse Event Metabolic/Laboratory-Other (Specify)
Description

CommonToxicityCriteriaAdverseEventOtherLabSpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus Property-2
C37984
UMLS 2011AA Property-2
C0022877
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
CTC Adverse Event Musculoskeletal/Soft Tissue-Other (Specify)
Description

CommonToxicityCriteriaAdverseEventOtherMusculoskeletalSpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus Property-2
C25348
UMLS 2011AA Property-2
C0497254
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
CTC Adverse Event Neurology-Other (Specify)
Description

CommonToxicityCriteriaAdverseEventOtherNeurologicSpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus Property-2
C25262
UMLS 2011AA Property-2
C0205494
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
CTC Adverse Event Pain-Other (Specify)
Description

CommonToxicityCriteriaAdverseEventOtherPainSpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus Property-2
C3303
UMLS 2011AA Property-2
C0030193
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
CTC Adverse Event Pulmonary/Upper Respiratory-Other (Specify)
Description

CommonToxicityCriteriaAdverseEventOtherPulmonarySpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Metathesaurus Property
CL317978
CTC Adverse Event Renal/Genitourinary-Other (Specify)
Description

CommonToxicityCriteriaAdverseEventOtherGenitourinarySpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus Property-2
C25350
UMLS 2011AA Property-2
C2709259
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
CTC Adverse Event Sexual/Reproductive Function-Other (Specify)
Description

CommonToxicityCriteriaAdverseEventOtherReproductiveFunctionSpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Metathesaurus Property
C0232896
CTC Adverse Event Vascular-Other (Specify)
Description

CommonToxicityCriteriaAdverseEventOtherVascularSpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus Property-2
C13311
UMLS 2011AA Property-2
C1801960
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
Unnamed6
Description

Unnamed6

CTCAE v3.0 Short Name
Description

CommonToxicityCriteriaAdverseEventShortNameType

Data type

text

Alias
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Metathesaurus ValueDomain
C0332307
NCI Thesaurus Property-2
C25249
UMLS 2011AA Property-2
C1806781
CTCAE v3.0 "Select" Term (if applicable)
Description

CTC Adverse Event Term

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C1516728
NCI Thesaurus ObjectClass
C49704
UMLS CUI-2
C2826934
NCI Thesaurus Property
C38024
NCI Thesaurus Property-2
C45559
CTC AE Grade
Description

CTC Adverse Event Grade

Data type

float

Alias
NCI Thesaurus ObjectClass
C49704
UMLS CUI-1
C2985911
NCI Thesaurus ValueDomain
C18000
NCI Thesaurus Property
C25365
Were adverse events assessed during most recent period
Description

AdverseEventMostRecentAssessmentInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property-2
C25577
UMLS 2011AA Property-2
C1513491
Comments
Description

Comments

Date
Description

Investigator Signature Date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C2346576
NCI Thesaurus Property
C25678
UMLS CUI-2
C0011008
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus ObjectClass
C17089
Investigator Signature
Description

Investigator Signature

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C2346576
NCI Thesaurus Property
C25678
NCI Thesaurus ObjectClass
C17089
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1 forms
  1. StudyEvent: Adverse Events - CTCAE v3.0
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header
Birth Date
Item
Patient Birth Date
date
C25164 (NCI Thesaurus ValueDomain)
C0421451 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C25155 (NCI Thesaurus Property)
Patient Hospital No
Item
Patient Hospital Number
text
C25337 (NCI Thesaurus ValueDomain)
C0421459 (UMLS CUI-1)
C16960 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
C16696 (NCI Thesaurus ObjectClass)
Institution Name
Item
Institution Name
text
C25191 (NCI Thesaurus ValueDomain)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass)
C21541 (NCI Thesaurus ValueDomain-2)
C25364 (NCI Thesaurus Property)
Institution Number
Item
Institution No.
text
C25337 (NCI Thesaurus ValueDomain)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass)
C0805701 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
Investigator Name
Item
Physician of Record
text
C25191 (NCI Thesaurus ValueDomain)
C2826892 (UMLS CUI-1)
C25364 (NCI Thesaurus Property)
C17089 (NCI Thesaurus ObjectClass)
C25644 (NCI Thesaurus ObjectClass-2)
Item Group
Unnamed2
Item
Time
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
CL.1
Code List
Time
CL Item
Cycle 2 (Cycle 2)
CL Item
Cycle 3 (Cycle 3)
CL Item
Cycle 4 (Cycle 4)
CL Item
Cycle 5 (Cycle 5)
CL Item
Cycle 6 (Cycle 6)
CL Item
Cycle 7 (Cycle 7)
CL Item
Cycle 8 (Cycle 8)
Assessment Date
Item
Date of Assessment
date
C25164 (NCI Thesaurus ValueDomain)
C2985720 (UMLS CUI-1)
C25367 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C38000 (NCI Thesaurus Property)
AdverseEventMostRecentAssessmentInd-3
Item
Were adverse events assessed during most recent period
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25577 (NCI Thesaurus Property-2)
C1513491 (UMLS 2011AA Property-2)
Item Group
Clinical Tolerance: Ctca (version 3.0)
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)
CL.3
Code List
CTC Adverse Event Term
CL Item
Allergy/immunology Other (Allergy/Immunology-Other (Specify))
CL Item
Haemoglobin Decreased (Hemoglobin)
C0162119 (NCI Metathesaurus)
CL Item
Leucopenia Nos (Leukocytes (total WBC))
CL Item
Neutropenia (Neutrophils/granulocytes (ANC/AGC))
C3277 (NCI Thesaurus)
CL Item
Platelet Count Decreased (Platelets)
C0392386 (NCI Metathesaurus)
CL Item
Myocardial Ischaemia (Cardiac ischemia/infarction)
C0151744 (NCI Metathesaurus)
CL Item
Hypertension Nos (Hypertension)
CL Item
Hypotension Nos (Hypotension)
CL Item
Left Ventricular Failure (Left ventricular systolic dysfunction)
C0023212 (NCI Metathesaurus)
CL Item
Cardiac General Other (Cardiac General-Other (Specify))
CL Item
Fatigue (Fatigue (asthenia, lethargy, malaise))
C3036 (NCI Thesaurus)
C0015672 (UMLS 2011AA)
CL Item
Pyrexia (Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10^9/L))
CL Item
Sweating Increased (Sweating (diaphoresis))
C0700590 (NCI Metathesaurus)
CL Item
Constitutional Symptoms Other (Constitutional Symptoms-Other (Specify))
CL Item
Alopecia (Hair loss/Alopecia (scalp or body))
C2865 (NCI Thesaurus)
CL Item
Pruritus Nos (Pruritus/itching)
CL Item
Dermatitis Exfoliative Nos (Rash/desquamation)
CL Item
Localised Exfoliation (Rash: hand-foot skin reaction)
CL Item
Dermatology/skin Other (Dermatology/Skin-Other (Specify))
CL Item
Menopausal Symptoms (Hot flashes/flushes)
CL Item
Endocrine Other (Endocrine-Other (Specify))
CL Item
Constipation (Constipation)
C37930 (NCI Thesaurus)
C0009806 (UMLS 2011AA)
CL Item
Diarrhoea Nos (Diarrhea)
CL Item
Nausea (Nausea)
C3258 (NCI Thesaurus)
C0027497 (UMLS 2011AA)
CL Item
Vomiting Nos (Vomiting)
CL Item
Gastrointestinal Other (Gastrointestinal-Other (Specify))
CL Item
Vaginal Haemorrhage (Hemorrhage, GU - Vagina)
CL Item
Hemorrhage/bleeding Other (Hemorrhage/Bleeding-Other (Specify))
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
Hypercholesteraemia (Cholesterol, serum-high (hypercholesteremia))
CL Item
Metabolic/laboratory Other (Metabolic/Laboratory-Other (Specify))
CL Item
Fracture (Fracture)
C3046 (NCI Thesaurus)
C0016658 (UMLS 2011AA)
CL Item
Osteoporosis (Osteoporosis)
C3298 (NCI Thesaurus)
C0029456 (UMLS 2011AA)
CL Item
Musculoskeletal/soft Tissue Other (Musculoskeletal/Soft Tissue-Other (Specify))
CL Item
Cerebral Ischaemia (CNS cerebrovascular ischemia)
C0917798 (NCI Metathesaurus)
CL Item
Dizziness (exc Vertigo) (Dizziness)
CL Item
Mood Alteration - Agitation (Mood alteration - agitation)
CL Item
Anxiety Nec (Mood alteration - anxiety)
CL Item
Depression Nec (Mood alteration - depression)
CL Item
Peripheral Sensory Neuropathy (Neuropathy: sensory)
C3501 (NCI Thesaurus)
C0151313 (UMLS 2011AA)
CL Item
Neurology Other (Neurology-Other (Specify))
CL Item
Bone Pain (Pain - Bone)
C38644 (NCI Thesaurus)
C0151825 (UMLS 2011AA)
CL Item
Arthralgia (Pain - Joint)
C0003862 (NCI Metathesaurus)
CL Item
Myalgia (Pain - Muscle)
C27009 (NCI Thesaurus)
C0231528 (UMLS 2011AA)
CL Item
Pain Other (Pain-Other (Specify))
CL Item
Cough (Cough)
C37935 (NCI Thesaurus)
C0010200 (UMLS 2011AA)
CL Item
Dyspnoea Nos (Dyspnea (shortness of breath))
CL Item
Pleural Effusion (Pleural effusion (non-malignant))
C3331 (NCI Thesaurus)
C0021071 (UMLS 2011AA)
CL Item
Renal/genitourinary Other (Renal/Genitourinary-Other (Specify))
CL Item
Menstruation Irregular (Irregular menses (change from baseline))
CL Item
Sexual/reproductive Function Other (Sexual/Reproductive Function-Other (Specify))
CL Item
Thrombosis/embolism (vascular Access-related) (Thrombosis/embolism (vascular access-related))
CL Item
Oedema Nos (Edema: limb)
CTC Adverse Event Grade
Item
CTC AE Grade
float
C49704 (NCI Thesaurus ObjectClass)
C2985911 (UMLS CUI-1)
C18000 (NCI Thesaurus ValueDomain)
C25365 (NCI Thesaurus Property)
CommonToxicityCriteriaAdverseEventOtherHypersensitivitySpecify
Item
CTC Adverse Event Allergy/Immunology-Other (Specify)
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C3114 (NCI Thesaurus Property-2)
C0020517 (UMLS 2011AA Property-2)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
CommonToxicityCriteriaAdverseEventOtherCardiovascularSpecify
Item
CTC Adverse Event Cardiac General-Other (Specify)
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C25292 (NCI Thesaurus Property-2)
C0007226 (UMLS 2011AA Property-2)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
CommonToxicityCriteriaAdverseEventOtherConstitutionalSymptomSpecify
Item
CTC Adverse Event Constitutional Symptoms-Other (Specify)
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C0009812 (NCI Metathesaurus Property)
CommonToxicityCriteriaAdverseEventOtherSkinSpecify
Item
CTC Adverse Event Dermatology/Skin-Other (Specify)
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C12470 (NCI Thesaurus Property-2)
C1123023 (UMLS 2011AA Property-2)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
CommonToxicityCriteriaAdverseEventOtherEndocrineSystemSpecify
Item
CTC Adverse Event Endocrine-Other (Specify)
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C0014136 (NCI Metathesaurus Property)
CommonToxicityCriteriaAdverseEventOtherGastrointestinalSymptomSpecify
Item
CTC Adverse Event Gastrointestinal-Other (Specify)
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C0426576 (NCI Metathesaurus Property)
CommonToxicityCriteriaAdverseEventOtherHemorrhageSpecify
Item
CTC Adverse Event Hemorrhage/Bleeding-Other (Specify)
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C26791 (NCI Thesaurus Property-2)
C0019080 (UMLS 2011AA Property-2)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
CommonToxicityCriteriaAdverseEventOtherInfectionSpecify
Item
CTC Adverse Event Infection-Other (Specify)
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C26726 (NCI Thesaurus Property-2)
C0009450 (UMLS 2011AA Property-2)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
CommonToxicityCriteriaAdverseEventOtherLabSpecify
Item
CTC Adverse Event Metabolic/Laboratory-Other (Specify)
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C37984 (NCI Thesaurus Property-2)
C0022877 (UMLS 2011AA Property-2)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
CommonToxicityCriteriaAdverseEventOtherMusculoskeletalSpecify
Item
CTC Adverse Event Musculoskeletal/Soft Tissue-Other (Specify)
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C25348 (NCI Thesaurus Property-2)
C0497254 (UMLS 2011AA Property-2)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
CommonToxicityCriteriaAdverseEventOtherNeurologicSpecify
Item
CTC Adverse Event Neurology-Other (Specify)
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C25262 (NCI Thesaurus Property-2)
C0205494 (UMLS 2011AA Property-2)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
CommonToxicityCriteriaAdverseEventOtherPainSpecify
Item
CTC Adverse Event Pain-Other (Specify)
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C3303 (NCI Thesaurus Property-2)
C0030193 (UMLS 2011AA Property-2)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
CommonToxicityCriteriaAdverseEventOtherPulmonarySpecify
Item
CTC Adverse Event Pulmonary/Upper Respiratory-Other (Specify)
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
CL317978 (NCI Metathesaurus Property)
CommonToxicityCriteriaAdverseEventOtherGenitourinarySpecify
Item
CTC Adverse Event Renal/Genitourinary-Other (Specify)
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C25350 (NCI Thesaurus Property-2)
C2709259 (UMLS 2011AA Property-2)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
CommonToxicityCriteriaAdverseEventOtherReproductiveFunctionSpecify
Item
CTC Adverse Event Sexual/Reproductive Function-Other (Specify)
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C0232896 (NCI Metathesaurus Property)
CommonToxicityCriteriaAdverseEventOtherVascularSpecify
Item
CTC Adverse Event Vascular-Other (Specify)
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C13311 (NCI Thesaurus Property-2)
C1801960 (UMLS 2011AA Property-2)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
Item Group
Unnamed6
CommonToxicityCriteriaAdverseEventShortNameType
Item
CTCAE v3.0 Short Name
text
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C0332307 (NCI Metathesaurus ValueDomain)
C25249 (NCI Thesaurus Property-2)
C1806781 (UMLS 2011AA Property-2)
CTC Adverse Event Term
Item
CTCAE v3.0 "Select" Term (if applicable)
text
C25284 (NCI Thesaurus ValueDomain)
C1516728 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C2826934 (UMLS CUI-2)
C38024 (NCI Thesaurus Property)
C45559 (NCI Thesaurus Property-2)
CTC Adverse Event Grade
Item
CTC AE Grade
float
C49704 (NCI Thesaurus ObjectClass)
C2985911 (UMLS CUI-1)
C18000 (NCI Thesaurus ValueDomain)
C25365 (NCI Thesaurus Property)
AdverseEventMostRecentAssessmentInd-3
Item
Were adverse events assessed during most recent period
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25577 (NCI Thesaurus Property-2)
C1513491 (UMLS 2011AA Property-2)
Item Group
Comments
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 Signature
text
C25704 (NCI Thesaurus ValueDomain)
C2346576 (UMLS CUI-1)
C25678 (NCI Thesaurus Property)
C17089 (NCI Thesaurus ObjectClass)
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