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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
Unnamed1
PatientInitialsName
Item
Patient Initials (Last, First Middle)
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA Property)
PatientNationalSurgicalAdjuvantBreastProjectIdentifierNumber
Item
NSABP Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C15818 (NCI Thesaurus Property)
C1513905 (UMLS 2011AA Property)
InstitutionName
Item
Institution Name
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C21541 (NCI Thesaurus ValueDomain)
C0018704 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
AffiliatedInstitutionName
Item
Affiliate Name
text
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C25413 (NCI Thesaurus ObjectClass)
C1510826 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ValueDomain)
C0018704 (UMLS 2011AA ValueDomain)
ResponsiblePersonName
Item
Person Completing Form (Phone)
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25657 (NCI Thesaurus ObjectClass)
C1273518 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
ResponsiblePersonName
Item
Person Completing Form (Phone)
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25657 (NCI Thesaurus ObjectClass)
C1273518 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
ResponsiblePersonName
Item
Person Completing Form (Phone)
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25657 (NCI Thesaurus ObjectClass)
C1273518 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
Item
Are data amended (check box if yes, and circle amended items)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)
CL.1
Code List
Are data amended (check box if yes, and circle amended items)
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item Group
Vital Status
Item
Patient's Vital Status
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C18003 (NCI Thesaurus ValueDomain)
C0442732 (UMLS 2011AA ValueDomain)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CL.2
Code List
Patient's Vital Status
CL Item
Alive (Alive)
CL Item
Dead (Dead)
PatientLastContactDate
Item
Date of Last Contact or Death (month day year)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25367 (NCI Thesaurus ValueDomain)
C25461 (NCI Thesaurus Property)
C0337611 (UMLS 2011AA Property)
Item
Source of Survival Information (if alive)
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)
C0038952 (UMLS 2011AA Property)
CL.3
Code List
Source of Survival Information (if alive)
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)
Other(specify)
Item
Other
text
Item
Primary cause of Death (if dead)
text
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C28554 (NCI Thesaurus Property)
C0011065 (UMLS 2011AA Property)
C28554 (NCI Thesaurus ValueDomain)
C0011065 (UMLS 2011AA ValueDomain)
CL.4
Code List
Primary cause of Death (if dead)
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)
PatientDeathSpecify
Item
Describe Cause of Death (provide documentation)
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
Was there evidence of recurrence at the time of death?
text
C28554 (NCI Thesaurus Property)
C0011065 (UMLS 2011AA Property)
C38155 (NCI Thesaurus ObjectClass)
C0277556 (UMLS 2011AA ObjectClass)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
CL.5
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
Item
Has the patient had a documented clinical assessment for this cancer (since submission of the last follow-up form)?
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C16033 (NCI Thesaurus Property)
C1522577 (UMLS 2011AA Property)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CL.6
Code List
Has the patient had a documented clinical assessment for this cancer (since submission of the last follow-up form)?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CancerFollow-UpStatusDate
Item
Date of Last Clinical Assessment (if applicable)
date
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C16033 (NCI Thesaurus Property)
C1522577 (UMLS 2011AA Property)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
Item Group
First Local-regional Recurrence
Item
Has the patient been diagnosed with first local-regional recurrence (since submission of the last follow-up form)?
text
C19987 (NCI Thesaurus ObjectClass)
C0242656 (UMLS 2011AA ObjectClass)
C25388 (NCI Thesaurus Property)
C1947913 (UMLS 2011AA Property)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.7
Code List
Has the patient been diagnosed with first local-regional recurrence (since submission of the last follow-up form)?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
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
CL.8
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 2011AA)
CL Item
Axilla (Axilla)
C12674 (NCI Thesaurus)
C0004454 (UMLS 2011AA)
CL Item
Axillary Nodes (Axillary nodes)
CL Item
Internal Mammary (Internal mammary nodes)
CL Item
Infraclavicular Nodes (Infraclavicular nodes)
CL Item
Supraclavicular Nodes (Supraclavicular nodes)
Item Group
First Distant Recurrence
Item
Has the patient been diagnosed with first distant recurrence/progression (since submission of the last follow-up form)?
text
C19987 (NCI Thesaurus ObjectClass)
C0242656 (UMLS 2011AA ObjectClass)
C25321 (NCI Thesaurus Property)
C0443203 (UMLS 2011AA Property)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.9
Code List
Has the patient been diagnosed with first distant recurrence/progression (since submission of the last follow-up form)?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
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)
C1279901 (UMLS 2011AA Property)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
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)
C1279901 (UMLS 2011AA Property)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
Item Group
New Primary Cancer Or Mds
Item
Has a new primary cancer or MDS been diagnosed that has not been previously reported?
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25586 (NCI Thesaurus ObjectClass)
C0205314 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
CL.10
Code List
Has a new primary cancer or MDS been diagnosed that has not been previously reported?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
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)
C0006826 (UMLS 2011AA ObjectClass)
Item Group
Unnamed3
Item
Has the patient had a menstrual period or vaginal bleeding in the last 12 months?
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C3232 (NCI Thesaurus ObjectClass)
C0025344 (UMLS 2011AA ObjectClass)
CL.11
Code List
Has the patient had a menstrual period or vaginal bleeding in the last 12 months?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Has the patient had a hysterectomy?
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C15256 (NCI Thesaurus ObjectClass)
C0020699 (UMLS 2011AA ObjectClass)
CL.12
Code List
Has the patient had a hysterectomy?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Has the patient had a bilateral oophorectomy?
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C13332 (NCI Thesaurus ObjectClass)
C0238767 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C15291 (NCI Thesaurus ObjectClass)
C0029936 (UMLS 2011AA ObjectClass)
CL.13
Code List
Has the patient had a bilateral oophorectomy?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Was patient randomized to receive Celecoxib or Placebo?
text
C15368 (NCI Thesaurus ObjectClass)
C42651 (NCI Thesaurus ObjectClass)
C0442711 (UMLS 2011AA ObjectClass)
C28295 (NCI Thesaurus ObjectClass)
C753 (NCI Thesaurus Property)
C0032042 (UMLS 2011AA Property)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.14
Code List
Was patient randomized to receive Celecoxib or Placebo?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Did the patient experience any of the following adverse events that have not been previously reported?
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25279 (NCI Thesaurus Property)
C0332162 (UMLS 2011AA Property)
CL.15
Code List
Did the patient experience any of the following adverse events that have not been previously reported?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item Group
Unnamed6
Item
Adverse Event
text
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C49704 (NCI Thesaurus Property)
C1516728 (UMLS 2011AA Property)
C45559 (NCI Thesaurus Property)
C1705313 (UMLS 2011AA Property)
C45255 (NCI Thesaurus ValueDomain)
C1708523 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ValueDomain)
C1516728 (UMLS 2011AA ValueDomain)
C42614 (NCI Thesaurus ValueDomain)
C0027365 (UMLS 2011AA ValueDomain)
C45559 (NCI Thesaurus ValueDomain)
C1705313 (UMLS 2011AA ValueDomain)
C25714 (NCI Thesaurus ValueDomain)
C0333052 (UMLS 2011AA ValueDomain)
CL.19
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)
C0877248 (UMLS 2011AA ObjectClass)
C48309 (NCI Thesaurus Property)
C0441800 (UMLS 2011AA Property)
C49705 (NCI Thesaurus Property)
C1710065 (UMLS 2011AA Property)
C25676 (NCI Thesaurus Property)
C0439793 (UMLS 2011AA Property)
C41331 (NCI Thesaurus ValueDomain)
C0877248 (UMLS 2011AA ValueDomain)
C48309 (NCI Thesaurus ValueDomain)
C0441800 (UMLS 2011AA ValueDomain)
C25676 (NCI Thesaurus ValueDomain)
C0439793 (UMLS 2011AA ValueDomain)
CL.20
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
Unnamed6
Item
Has the patient experienced any severe (Grade >= 3) adverse event, possibly related to the chemotherapy, that has not been previously reported?
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25648 (NCI Thesaurus Property)
C0439849 (UMLS 2011AA Property)
C15632 (NCI Thesaurus Property)
C0392920 (UMLS 2011AA Property)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
CL.18
Code List
Has the patient experienced any severe (Grade >= 3) adverse event, possibly related to the chemotherapy, that has not been previously reported?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Adverse Event
text
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C49704 (NCI Thesaurus Property)
C1516728 (UMLS 2011AA Property)
C45559 (NCI Thesaurus Property)
C1705313 (UMLS 2011AA Property)
C45255 (NCI Thesaurus ValueDomain)
C1708523 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ValueDomain)
C1516728 (UMLS 2011AA ValueDomain)
C42614 (NCI Thesaurus ValueDomain)
C0027365 (UMLS 2011AA ValueDomain)
C45559 (NCI Thesaurus ValueDomain)
C1705313 (UMLS 2011AA ValueDomain)
C25714 (NCI Thesaurus ValueDomain)
C0333052 (UMLS 2011AA ValueDomain)
CL.19
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)
C0877248 (UMLS 2011AA ObjectClass)
C48309 (NCI Thesaurus Property)
C0441800 (UMLS 2011AA Property)
C49705 (NCI Thesaurus Property)
C1710065 (UMLS 2011AA Property)
C25676 (NCI Thesaurus Property)
C0439793 (UMLS 2011AA Property)
C41331 (NCI Thesaurus ValueDomain)
C0877248 (UMLS 2011AA ValueDomain)
C48309 (NCI Thesaurus ValueDomain)
C0441800 (UMLS 2011AA ValueDomain)
C25676 (NCI Thesaurus ValueDomain)
C0439793 (UMLS 2011AA ValueDomain)
CL.20
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
Ccrr Module For Nsabp Protocol B-36: Follow-up Form
Item
Is this the first time page 3 of Form F36 has been completed for this patient (If yes, answer the questions in this column. If no, answer the questions in this column.)
text
C40988 (NCI Thesaurus ObjectClass)
C1516308 (UMLS 2011AA ObjectClass)
C15818 (NCI Thesaurus ObjectClass)
C1513905 (UMLS 2011AA ObjectClass)
C16960 (NCI Thesaurus Property)
C0030705 (UMLS 2011AA Property)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.21
Code List
Is this the first time page 3 of Form F36 has been completed for this patient (If yes, answer the questions in this column. If no, answer the questions in this column.)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Did the patient receive any Herceptin treatment (since randomization since last follow-up)
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C1647 (NCI Thesaurus Property)
C0338204 (UMLS 2011AA Property)
C15262 (NCI Thesaurus ObjectClass)
C0021083 (UMLS 2011AA ObjectClass)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
CL.22
Code List
Did the patient receive any Herceptin treatment (since randomization since last follow-up)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
ImmunotherapyTrastuzumabReceivedBeginDate
Item
Herceptin Treatment Start Date
date
C15262 (NCI Thesaurus ObjectClass)
C0021083 (UMLS 2011AA ObjectClass)
C1647 (NCI Thesaurus Property)
C0338204 (UMLS 2011AA Property)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain)
C0439659 (UMLS 2011AA ValueDomain)
Item
Did the patient receive any systemic hormonal treatment (since randomization since last follow-up)
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C13310 (NCI Thesaurus Property)
C0205373 (UMLS 2011AA Property)
C15445 (NCI Thesaurus Property)
C0279025 (UMLS 2011AA Property)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.23
Code List
Did the patient receive any systemic hormonal treatment (since randomization since last follow-up)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Tamoxifen
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C855 (NCI Thesaurus Property)
C0039286 (UMLS 2011AA Property)
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
CL.24
Code List
Tamoxifen
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Anastrozole
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C1607 (NCI Thesaurus Property)
C0290882 (UMLS 2011AA Property)
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
CL.25
Code List
Anastrozole
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Exemestane
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C1097 (NCI Thesaurus Property)
C0060116 (UMLS 2011AA Property)
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
CL.26
Code List
Exemestane
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Letrozole
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C1527 (NCI Thesaurus Property)
C0246421 (UMLS 2011AA Property)
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
CL.27
Code List
Letrozole
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
LHRH agonist
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
C2022 (NCI Thesaurus ObjectClass)
C1268900 (UMLS 2011AA ObjectClass)
CL.28
Code List
LHRH agonist
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Other, specify
text
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
CL.29
Code List
Other, specify
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
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