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  1. StudyEvent: NSABP PROTOCOL B-36: FOLLOW-UP FORM
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Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header
Patient Initials
Item
Patient Initials (Last, First Middle)
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Patient ID NSABP
Item
NSABP Patient 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)
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)
Affiliate Name
Item
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
Item
Person Completing Form (Phone)
text
C25191 (NCI Thesaurus ValueDomain)
C1550483 (UMLS CUI-1)
C25657 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
Data amended
Item
Are data amended (check box if yes, and circle amended items)
boolean
C38148 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
Item Group
Vital Status
Item
Patient's Vital Status
text
C16960 (NCI Thesaurus ObjectClass)
C18003 (NCI Thesaurus ValueDomain)
C25688 (NCI Thesaurus ValueDomain-2)
C25365 (NCI Thesaurus Property)
C3846084 (UMLS CUI-1)
Code List
Patient's Vital Status
CL Item
Alive (Alive)
C2584946 (UMLS CUI-1)
CL Item
Dead (Dead)
C0011065 (UMLS CUI-1)
Date last contact
Item
Date of Last Contact or Death (month day year)
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 (if alive)
text
C25190 (NCI Thesaurus ObjectClass)
C25683 (NCI Thesaurus ValueDomain)
C48191 (NCI Thesaurus Property)
C17177 (NCI Thesaurus Property-2)
C0807975 (UMLS CUI-1)
Code List
Source of Survival Information (if alive)
CL Item
Documentation Of Hospital Or Clinic Visit (1)
CL Item
Phone Contact To Patient (2)
CL Item
Other (3)
Other(specify)
Item
Other
text
Item
Primary cause of Death (if dead)
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 (if dead)
CL Item
Due To This Disease (1)
CL Item
Due To Protocol Treatment (2)
CL Item
Due To Other Cause, Specify (3)
CL Item
Unknown (4)
Cause of Death, specify
Item
Describe Cause of Death (provide documentation)
text
C25685 (NCI Thesaurus ValueDomain)
C0007465 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1521902 (UMLS CUI-2)
C28554 (NCI Thesaurus Property)
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)
Item Group
Cancer Follow-up Status
Documented clinical assessment for this cancer
Item
Has the patient had a documented clinical assessment for this cancer (since submission of the last follow-up form)?
boolean
C38148 (NCI Thesaurus ValueDomain)
C1522577 (UMLS CUI-1)
C16033 (NCI Thesaurus Property)
C0006826 (UMLS CUI-2)
C9305 (NCI Thesaurus ObjectClass)
C25365 (NCI Thesaurus Property-2)
Follow-Up Date
Item
Date of Last Clinical Assessment (if applicable)
date
C9305 (NCI Thesaurus ObjectClass)
C3694716 (UMLS CUI-1)
C16033 (NCI Thesaurus Property)
C25365 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
Item Group
First Local-regional Recurrence
Neoplasm Recurrence, locoregional
Item
Has the patient been diagnosed with first local-regional recurrence (since submission of the last follow-up form)?
boolean
C19987 (NCI Thesaurus ObjectClass)
C0027643 (UMLS CUI-1)
C25388 (NCI Thesaurus Property)
C25509 (NCI Thesaurus Property-2)
C15220 (NCI Thesaurus Property-3)
C38148 (NCI Thesaurus ValueDomain)
FirstRecurrenceLocalRegionalDate
Item
Date of First Local-Regional Recurrence (if applicable)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C3352 (NCI Thesaurus ObjectClass)
C0034897 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
Item
Site(s) of First Local-Regional Recurrence (mark all ipsilateral sites that apply)
text
C0027643 (UMLS CUI-1)
C1515974 (UMLS CUI-2)
Code List
Site(s) of First Local-Regional Recurrence (mark all ipsilateral sites that apply)
CL Item
Ipsilateral Breast (Ipsilateral breast)
CL Item
Chest Wall (Chest wall)
CL035093 (NCI Metathesaurus)
C62484 (NCI Thesaurus)
C0205076 (UMLS CUI-1)
CL Item
Axilla (Axilla)
C12674 (NCI Thesaurus)
C0004454 (UMLS CUI-1)
CL Item
Axillary Nodes (Axillary nodes)
C0729594 (UMLS CUI-1)
CL Item
Internal Mammary (Internal mammary nodes)
CL Item
Infraclavicular Nodes (Infraclavicular nodes)
C0229743 (UMLS CUI-1)
CL Item
Supraclavicular Nodes (Supraclavicular nodes)
C0229730 (UMLS CUI-1)
Item Group
First Distant Recurrence
Distant metastasis
Item
Has the patient been diagnosed with first distant recurrence/progression (since submission of the last follow-up form)?
boolean
C19987 (NCI Thesaurus ObjectClass)
C25321 (NCI Thesaurus Property)
C25509 (NCI Thesaurus Property-2)
C15220 (NCI Thesaurus Property-3)
C38148 (NCI Thesaurus ValueDomain)
C0456957 (UMLS CUI-1)
RecurrentDiseaseFirstDistantDiagnosisDate
Item
Date of First Distant Recurrence (if applicable)
date
C38155 (NCI Thesaurus ObjectClass)
C0277556 (UMLS 2011AA ObjectClass)
C25321 (NCI Thesaurus Property)
C0443203 (UMLS 2011AA Property)
C25509 (NCI Thesaurus Property-2)
C1279901 (UMLS 2011AA Property-2)
C15220 (NCI Thesaurus Property-3)
C0011900 (UMLS 2011AA Property-3)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
RecurrentDiseaseFirstDistantDiagnosisText
Item
Site(s) of First Distant Recurrence
text
C38155 (NCI Thesaurus ObjectClass)
C0277556 (UMLS 2011AA ObjectClass)
C25321 (NCI Thesaurus Property)
C0443203 (UMLS 2011AA Property)
C25509 (NCI Thesaurus Property-2)
C1279901 (UMLS 2011AA Property-2)
C15220 (NCI Thesaurus Property-3)
C0011900 (UMLS 2011AA Property-3)
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
Item Group
New Primary Cancer Or Mds
NewCancerDiagnosisInd-3
Item
Has a new primary cancer or MDS been diagnosed that has not been previously reported?
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25586 (NCI Thesaurus ObjectClass)
C0205314 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus ObjectClass-2)
C0006826 (UMLS 2011AA ObjectClass-2)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
NewCancerDiagnosisDate
Item
Date of Diagnosis (if applicable)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
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
Patient data
C2707520 (UMLS CUI-1)
Menstruation
Item
Has the patient had a menstrual period or vaginal bleeding in the last 12 months?
boolean
C38148 (NCI Thesaurus ValueDomain)
C25275 (NCI Thesaurus Property)
C3232 (NCI Thesaurus ObjectClass)
C0025344 (UMLS CUI-1)
Hysterectomy
Item
Has the patient had a hysterectomy?
boolean
C38148 (NCI Thesaurus ValueDomain)
C38000 (NCI Thesaurus Property)
C15256 (NCI Thesaurus ObjectClass)
C0020699 (UMLS CUI-1)
Oophorectomy
Item
Has the patient had a bilateral oophorectomy?
boolean
C38147 (NCI Thesaurus ValueDomain)
C13332 (NCI Thesaurus ObjectClass)
C38000 (NCI Thesaurus Property)
C15291 (NCI Thesaurus ObjectClass-2)
C0029936 (UMLS CUI-1)
randomized to receive Celecoxib or Placebo
Item
Was patient randomized to receive Celecoxib or Placebo?
boolean
C15368 (NCI Thesaurus ObjectClass)
C42651 (NCI Thesaurus ObjectClass-2)
C28295 (NCI Thesaurus ObjectClass-3)
C753 (NCI Thesaurus Property)
C25639 (NCI Thesaurus Property-2)
C38147 (NCI Thesaurus ValueDomain)
Adverse event
Item
Did the patient experience any of the following adverse events that have not been previously reported?
boolean
C38147 (NCI Thesaurus ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C25279 (NCI Thesaurus Property)
C0877248 (UMLS CUI-1)
Item Group
Adverse Events
C0877248 (UMLS CUI-1)
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)
C2826934 (UMLS CUI-1)
Code List
Adverse Event
CL Item
Acute Coronary Syndrome (Acute coronary syndrome)
E10066 (CTCAE)
C0948089 (UMLS CUI-1)
CL Item
Anorexia (Anorexia)
E12252 (CTCAE)
C0003123 (UMLS CUI-1)
CL Item
Arthralgia (Arthralgia)
E12374 (CTCAE)
C0003862 (UMLS CUI-1)
CL Item
Back Pain (Back pain)
E12388 (CTCAE)
C0004604 (UMLS CUI-1)
CL Item
Cholesterol High (Cholesterol high)
E12127 (CTCAE)
C0020443 (UMLS CUI-1)
CL Item
Constipation (Constipation)
E10562 (CTCAE)
C0009806 (UMLS CUI-1)
CL Item
Depression (Depression)
E12909 (CTCAE)
C0011581 (UMLS CUI-1)
CL Item
Diarrhea (Diarrhea)
E10572 (CTCAE)
C0011991 (UMLS CUI-1)
CL Item
Dizziness (Dizziness)
E12631 (CTCAE)
C0012833 (UMLS CUI-1)
CL Item
Dyspnea (Dyspnea)
E13368 (CTCAE)
C0013404 (UMLS CUI-1)
CL Item
Edema Limbs (Edema limbs)
E11086 (CTCAE)
C1962951 (UMLS CUI-1)
CL Item
Fatigue (Fatigue)
E11098 (CTCAE)
C0015672 (UMLS CUI-1)
CL Item
Headache (Headache)
E12678 (CTCAE)
C0018681 (UMLS CUI-1)
CL Item
Hot Flashes (Hot flashes)
E13781 (CTCAE)
C0600142 (UMLS CUI-1)
CL Item
Hypertriglyceridemia (Hypertriglyceridemia)
E12299 (CTCAE)
C0020557 (UMLS CUI-1)
CL Item
Insomnia (Insomnia)
E12925 (CTCAE)
C0917801 (UMLS CUI-1)
CL Item
Ischemia Cerebrovascular (Ischemia cerebrovascular)
E12702 (CTCAE)
C0917798 (UMLS CUI-1)
CL Item
Myalgia (Myalgia)
E12485 (CTCAE)
C0231528 (UMLS CUI-1)
CL Item
Myocardial Infarction (Myocardial infarction)
E10152 (CTCAE)
C0027051 (UMLS CUI-1)
CL Item
Nausea (Nausea)
E10878 (CTCAE)
C0027497 (UMLS CUI-1)
CL Item
Peripheral Ischemia (Peripheral ischemia)
E13810 (CTCAE)
C0235490 (UMLS CUI-1)
CL Item
Somnolence (Somnolence)
E12814 (CTCAE)
C2830004 (UMLS CUI-1)
CL Item
Stroke (Stroke)
E12826 (CTCAE)
C0038454 (UMLS CUI-1)
CL Item
Thromboembolic Event (Thromboembolic event)
E13825 (CTCAE)
C0040038 (UMLS CUI-1)
CL Item
Transient Ischemic Attacks (Transient ischemic attacks)
E12834 (CTCAE)
C0007787 (UMLS CUI-1)
CL Item
Vaginal Hemorrhage (Vaginal hemorrhage)
E13264 (CTCAE)
C2979982 (UMLS CUI-1)
CL Item
Visceral Arterial Ischemia (Visceral arterial ischemia)
E13843 (CTCAE)
C0853812 (UMLS CUI-1)
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)
Item Group
Late Adverse Events
C0877248 (UMLS CUI-1)
C0205087 (UMLS CUI-2)
Severe adverse event
Item
Has the patient experienced any severe (Grade >= 3) adverse event, possibly related to the chemotherapy, that has not been previously reported?
boolean
C38147 (NCI Thesaurus ValueDomain)
C25648 (NCI Thesaurus Property)
C15632 (NCI Thesaurus Property-2)
C41331 (NCI Thesaurus ObjectClass)
C2919019 (UMLS CUI-1)
Item Group
Therapy
C0087111 (UMLS CUI-1)
Herceptin
Item
Did the patient receive any Herceptin treatment (since randomization since last follow-up)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1647 (NCI Thesaurus Property)
C15262 (NCI Thesaurus ObjectClass)
C25639 (NCI Thesaurus Property-2)
C0338204 (UMLS CUI-1)
Trastuzumab start date
Item
Herceptin Treatment Start Date
date
C15262 (NCI Thesaurus ObjectClass)
C1647 (NCI Thesaurus Property)
C25639 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
C0338204 (UMLS CUI-1)
C3173309 (UMLS CUI-2)
Hormone Therapy, systemic
Item
Did the patient receive any systemic hormonal treatment (since randomization since last follow-up)
boolean
C16960 (NCI Thesaurus ObjectClass)
C13310 (NCI Thesaurus Property)
C15445 (NCI Thesaurus Property-2)
C25639 (NCI Thesaurus Property-3)
C38147 (NCI Thesaurus ValueDomain)
C0279025 (UMLS CUI-1)
C0205373 (UMLS CUI-2)
Tamoxifen
Item
Tamoxifen
boolean
C38148 (NCI Thesaurus ValueDomain)
C855 (NCI Thesaurus Property)
C15445 (NCI Thesaurus ObjectClass)
C25639 (NCI Thesaurus Property-2)
C0039286 (UMLS CUI-1)
Anastrozole
Item
Anastrozole
boolean
C38148 (NCI Thesaurus ValueDomain)
C1607 (NCI Thesaurus Property)
C15445 (NCI Thesaurus ObjectClass)
C25639 (NCI Thesaurus Property-2)
C0290882 (UMLS CUI-1)
Exemestane
Item
Exemestane
boolean
C38148 (NCI Thesaurus ValueDomain)
C1097 (NCI Thesaurus Property)
C15445 (NCI Thesaurus ObjectClass)
C25639 (NCI Thesaurus Property-2)
C0851344 (UMLS CUI-1)
Letrozole
Item
Letrozole
boolean
C38148 (NCI Thesaurus ValueDomain)
C1527 (NCI Thesaurus Property)
C15445 (NCI Thesaurus ObjectClass)
C25639 (NCI Thesaurus Property-2)
C0246421 (UMLS CUI-1)
LHRH agonist
Item
LHRH agonist
boolean
C38148 (NCI Thesaurus ValueDomain)
C15445 (NCI Thesaurus ObjectClass)
C25639 (NCI Thesaurus Property)
C2022 (NCI Thesaurus ObjectClass-2)
C1518041 (UMLS CUI-1)
Hormone Therapy, other
Item
Other, specify
boolean
C17649 (NCI Thesaurus Property)
C38148 (NCI Thesaurus ValueDomain)
C15445 (NCI Thesaurus ObjectClass)
C25639 (NCI Thesaurus Property-2)
C0279025 (UMLS CUI-1)
C0205394 (UMLS CUI-2)

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