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  1. StudyEvent: NSABP PROTOCOL R-04: FOLLOW-UP FORM
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Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header
C1320722 (UMLS CUI-1)
FirstThreeLettersofPatient'sLastName
Item
First Three Letters of Patients Last Name
text
Patient ID NSABP
Item
Patient Study ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1513905 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C15818 (NCI Thesaurus Property-2)
Affiliate Name
Item
Institution Name / Affiliate Name
text
C21541 (NCI Thesaurus ObjectClass)
C1510825 (UMLS CUI-1)
C25413 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
C25191 (NCI Thesaurus ValueDomain)
C21541 (NCI Thesaurus ValueDomain-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)
Person Completing Form First Name
Item
Person Completing Form, First Name
text
C25190 (NCI Thesaurus ObjectClass)
C1550483 (UMLS CUI-1)
C25657 (NCI Thesaurus ObjectClass-2)
C1443235 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25509 (NCI Thesaurus Property-2)
C25191 (NCI Thesaurus ValueDomain)
Person Completing Form Phone
Item
Person Completing Form, Phone
text
C25337 (NCI Thesaurus ValueDomain)
C1550483 (UMLS CUI-1)
C25190 (NCI Thesaurus ObjectClass)
C1515258 (UMLS CUI-2)
C25657 (NCI Thesaurus ObjectClass-2)
C25395 (NCI Thesaurus Property)
Data amended
Item
Are Data Amended?
boolean
C38148 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
Research Comments
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
Item Group
Follow-Up
C1522577 (UMLS CUI-1)
Item
Patient's Vital Status
text
C16960 (NCI Thesaurus ObjectClass)
C3846084 (UMLS CUI-1)
C18003 (NCI Thesaurus ValueDomain)
C25688 (NCI Thesaurus ValueDomain-2)
C25365 (NCI Thesaurus Property)
Code List
Patient's Vital Status
CL Item
Alive (Alive)
CL Item
Dead (Dead)
Date last contact
Item
Date of Last Contact or Death
date
C25164 (NCI Thesaurus ValueDomain)
C0805839 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C25461 (NCI Thesaurus Property)
Item
Source of Survival Information
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25683 (NCI Thesaurus ValueDomain)
C0449416 (UMLS 2011AA ValueDomain)
C48191 (NCI Thesaurus Property)
C1533716 (UMLS 2011AA Property)
C17177 (NCI Thesaurus Property-2)
C0038952 (UMLS 2011AA Property-2)
Code List
Source of Survival Information
CL Item
Documentation Of Hospital Or Clinic Visit (Documentation of hospital or clinic visit)
CL Item
Phone Contact To Patient (Phone contact to patient)
CL Item
Other (other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
PatientDeathSourceSpecify
Item
Other, specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C28554 (NCI Thesaurus Property)
C0011065 (UMLS 2011AA Property)
Item
Primary cause of death
text
C25638 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C28554 (NCI Thesaurus Property)
C28554 (NCI Thesaurus ValueDomain-2)
C0007465 (UMLS CUI-1)
Code List
Primary cause of death
CL Item
Due To This Disease (due to this disease)
CL Item
Due To Protocol Treatment (due to protocol treatment)
CL Item
Due To Other Cause, Specify (due to other cause)
CL Item
Unknown (unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Cause of Death, specify
Item
describe cause of death
text
C25685 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C28554 (NCI Thesaurus Property)
C0007465 (UMLS CUI-1)
Item
Was there evidence of recurrence at the time of death?
text
C28554 (NCI Thesaurus Property)
C38155 (NCI Thesaurus ObjectClass)
C15220 (NCI Thesaurus Property-2)
C0011065 (UMLS CUI-1)
C0277556 (UMLS CUI-2)
Code List
Was there evidence of recurrence at the time of death?
CL Item
Yes, Clinical (yes, clinical)
CL Item
Yes, Autopsy (yes, autopsy)
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Unknown (unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Clinical assessment
Item
Has the patient had a documented clinical assessment for this cancer?
boolean
CancerFollow-upStatusDate
Item
Date of last clinical assessment
date
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
First local-regional recurrence
Item
Has the patient been diagnosed with first local-regional recurrence?
boolean
C0027643 (UMLS CUI-1)
Item
Site(s) of disease
text
C1290853 (UMLS CUI-1)
Code List
Site(s) of disease
CL Item
Anastomosis (anastomosis)
C15609 (NCI Thesaurus)
C0677554 (UMLS CUI-1)
CL Item
Perineum (perineum)
C33301 (NCI Thesaurus)
C0031066 (UMLS CUI-1)
CL Item
Pelvis (pelvis)
C12767 (NCI Thesaurus)
C0030797 (UMLS CUI-1)
CL Item
Rectum (rectum)
C12390 (NCI Thesaurus)
C0034896 (UMLS CUI-1)
CL Item
Intra-pelvic Lymph Nodes (intra-pelvic lymph nodes)
C1277114 (UMLS CUI-1)
CL Item
Retroperitoneal Nodes (retroperitoneal nodes)
C1264215 (UMLS CUI-1)
CL Item
Other, Specify (Other, specify)
C3844311 (UMLS CUI-1)
DiseaseInvolvementSite,Other
Item
Other, specify
text
RecurrenceDate
Item
Recurrence Date
date
C0807712 (UMLS CUI-1)
ProgressionInd,FirstDistant
Item
Has the patient been diagnosed with first distanct recurrence/progression?
boolean
Date of first distant recurrence
Item
Date of first distant recurrence
date
C38155 (NCI Thesaurus ObjectClass)
C25321 (NCI Thesaurus Property)
C25509 (NCI Thesaurus Property-2)
C15220 (NCI Thesaurus Property-3)
C25164 (NCI Thesaurus ValueDomain)
C0804769 (UMLS CUI-1)
C0011008 (UMLS CUI-2)
Site First Distant Recurrence
Item
Site(s) of First Distant Recurrence
text
C38155 (NCI Thesaurus ObjectClass)
C25321 (NCI Thesaurus Property)
C25509 (NCI Thesaurus Property-2)
C15220 (NCI Thesaurus Property-3)
C25704 (NCI Thesaurus ValueDomain)
C0807713 (UMLS CUI-1)
New primary cancer
Item
Has a new primary or MDS been diagnosed that has not been previously reported?
boolean
C38148 (NCI Thesaurus ValueDomain)
C25586 (NCI Thesaurus ObjectClass)
C9305 (NCI Thesaurus ObjectClass-2)
C15220 (NCI Thesaurus Property)
C0751623 (UMLS CUI-1)
New Primary Cancer Date
Item
Date of diagnosis
date
C25164 (NCI Thesaurus ValueDomain)
C9305 (NCI Thesaurus ObjectClass)
C15220 (NCI Thesaurus Property)
C0205314 (UMLS CUI-1)
C0006826 (UMLS CUI-2)
C0011900 (UMLS CUI-3)
C0011008 (UMLS CUI-4)
NewCancerSiteText
Item
Site(s) of new primary
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25586 (NCI Thesaurus ObjectClass)
C0205314 (UMLS 2011AA ObjectClass)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C9305 (NCI Thesaurus ObjectClass-2)
C0006826 (UMLS 2011AA ObjectClass-2)
Item Group
Late Adverse Events
C0877248 (UMLS CUI-1)
C0205087 (UMLS CUI-2)
Item
Adverse Event
text
C41331 (NCI Thesaurus ObjectClass)
C49704 (NCI Thesaurus Property)
C45559 (NCI Thesaurus Property-2)
C45255 (NCI Thesaurus ValueDomain)
C49704 (NCI Thesaurus ValueDomain-2)
C42614 (NCI Thesaurus ValueDomain-3)
C45559 (NCI Thesaurus ValueDomain-4)
C25714 (NCI Thesaurus ValueDomain-5)
C1516728 (UMLS CUI-1)
C2826934 (UMLS CUI-2)
Code List
Adverse Event
CL Item
Acute Coronary Syndrome (Acute coronary syndrome)
E10066 (CTCAE)
CL Item
Anorexia (Anorexia)
E12252 (CTCAE)
CL Item
Arthralgia (Arthralgia)
E12374 (CTCAE)
CL Item
Back Pain (Back pain)
E12388 (CTCAE)
CL Item
Cholesterol High (Cholesterol high)
E12127 (CTCAE)
CL Item
Constipation (Constipation)
E10562 (CTCAE)
CL Item
Depression (Depression)
E12909 (CTCAE)
CL Item
Diarrhea (Diarrhea)
E10572 (CTCAE)
CL Item
Dizziness (Dizziness)
E12631 (CTCAE)
CL Item
Dyspnea (Dyspnea)
E13368 (CTCAE)
CL Item
Edema Limbs (Edema limbs)
E11086 (CTCAE)
CL Item
Fatigue (Fatigue)
E11098 (CTCAE)
CL Item
Headache (Headache)
E12678 (CTCAE)
CL Item
Hot Flashes (Hot flashes)
E13781 (CTCAE)
CL Item
Hypertriglyceridemia (Hypertriglyceridemia)
E12299 (CTCAE)
CL Item
Insomnia (Insomnia)
E12925 (CTCAE)
CL Item
Ischemia Cerebrovascular (Ischemia cerebrovascular)
E12702 (CTCAE)
CL Item
Myalgia (Myalgia)
E12485 (CTCAE)
CL Item
Myocardial Infarction (Myocardial infarction)
E10152 (CTCAE)
CL Item
Nausea (Nausea)
E10878 (CTCAE)
CL Item
Peripheral Ischemia (Peripheral ischemia)
E13810 (CTCAE)
CL Item
Somnolence (Somnolence)
E12814 (CTCAE)
CL Item
Stroke (Stroke)
E12826 (CTCAE)
CL Item
Thromboembolic Event (Thromboembolic event)
E13825 (CTCAE)
CL Item
Transient Ischemic Attacks (Transient ischemic attacks)
E12834 (CTCAE)
CL Item
Vaginal Hemorrhage (Vaginal hemorrhage)
E13264 (CTCAE)
CL Item
Visceral Arterial Ischemia (Visceral arterial ischemia)
E13843 (CTCAE)
Item
Grade
text
C41331 (NCI Thesaurus ObjectClass)
C48309 (NCI Thesaurus Property)
C49705 (NCI Thesaurus Property-2)
C25676 (NCI Thesaurus Property-3)
C41331 (NCI Thesaurus ValueDomain)
C48309 (NCI Thesaurus ValueDomain-2)
C25676 (NCI Thesaurus ValueDomain-3)
C2985921 (UMLS CUI-1)
Code List
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)

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