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  1. StudyEvent: NSABP C-11 Worksheet for Surgical Complications 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)
Item Group
Header
PackedRedBloodCellTransfusionReceivedUnitCount
Item
How many units of RBC were given intraoperatively and postoperatively
float
C44278 (NCI Thesaurus ValueDomain)
C0439148 (UMLS 2011AA ValueDomain)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
C25463 (NCI Thesaurus ValueDomain-2)
C0750480 (UMLS 2011AA ValueDomain-2)
C15409 (NCI Thesaurus ObjectClass)
C0199962 (UMLS 2011AA ObjectClass)
PatientPost-OperativeHospitalizationDayCount
Item
On postoperative day
float
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25623 (NCI Thesaurus Property)
C25179 (NCI Thesaurus Property-2)
C0019993 (UMLS 2011AA Property)
C25301 (NCI Thesaurus ValueDomain)
C0439228 (UMLS 2011AA ValueDomain)
C25463 (NCI Thesaurus ValueDomain-2)
C0750480 (UMLS 2011AA ValueDomain-2)
PatientPost-OperativeHospitalizationDayCount
Item
On postoperative day
float
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25623 (NCI Thesaurus Property)
C25179 (NCI Thesaurus Property-2)
C0019993 (UMLS 2011AA Property)
C25301 (NCI Thesaurus ValueDomain)
C0439228 (UMLS 2011AA ValueDomain)
C25463 (NCI Thesaurus ValueDomain-2)
C0750480 (UMLS 2011AA ValueDomain-2)
PostoperativeLaboratoryProcedureBilirubinResultUnspecifiedValue
Item
What was the maximum postoperative bilirubin level (from post-op day 31 to the day before the start of postoperative therapy [or postoperative day 84, if postoperative therapy will not be initiated] - mg/dL)
float
C28006 (NCI Thesaurus ObjectClass)
C0032790 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus ObjectClass-2)
C0022885 (UMLS 2011AA ObjectClass-2)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C305 (NCI Thesaurus Property-2)
C0005437 (UMLS 2011AA Property-2)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
Re-excisionPerformedInd-2
Item
Need for reoperation within the 30-day postoperative period (Did the patient experience:)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C48600 (NCI Thesaurus ObjectClass)
C0184913 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
AdverseEventDeathRelatedtoAdverseEventGradeInd-2
Item
Any grade 5 event (Did the patient experience:)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C48275 (NCI Thesaurus Property)
C1705232 (UMLS 2011AA Property)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C48309 (NCI Thesaurus Property-2)
C0441800 (UMLS 2011AA Property-2)
AdverseEventBilirubinDescriptionInd-2
Item
Blood bilirubin > 10 mg/dL for > 3 consecutive days? (Hepatectomy-specific morbidity)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C305 (NCI Thesaurus Property)
C0005437 (UMLS 2011AA Property)
C25365 (NCI Thesaurus Property-2)
C0678257 (UMLS 2011AA Property-2)
AdverseEventBiliaryFistulaDescriptionInd-2
Item
Biliary fistula with drain output > 100 mL/day for > 10 days (Hepatectomy-specific morbidity)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
E11179 (CTCAE Property)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
Item
Adverse Event
text
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C49704 (NCI Thesaurus Property)
C1516728 (UMLS 2011AA Property)
C45559 (NCI Thesaurus Property-2)
C1705313 (UMLS 2011AA Property-2)
C45255 (NCI Thesaurus ValueDomain)
C1708523 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ValueDomain-2)
C1516728 (UMLS 2011AA ValueDomain-2)
C42614 (NCI Thesaurus ValueDomain-3)
C0027365 (UMLS 2011AA ValueDomain-3)
C45559 (NCI Thesaurus ValueDomain-4)
C1705313 (UMLS 2011AA ValueDomain-4)
C25714 (NCI Thesaurus ValueDomain-5)
C0333052 (UMLS 2011AA ValueDomain-5)
Code List
Adverse Event
CL Item
Acute Coronary Syndrome (Acute coronary syndrome)
CL Item
Myocardial Infarction (Myocardial infarction)
C27996 (NCI Thesaurus)
C0027051 (UMLS 2011AA)
CL Item
Ascites (Ascites)
C2885 (NCI Thesaurus)
C0003962 (UMLS 2011AA)
CL Item
Abdominal Infection (Abdominal infection)
C35669 (NCI Thesaurus)
C1112209 (UMLS 2011AA)
CL Item
Infectious Lung Disorder (Lung infection)
CL Item
Septicemia (Sepsis)
CL Item
Wound Dehiscence (Wound dehiscence)
C50863 (NCI Thesaurus)
C0259768 (UMLS 2011AA)
CL Item
Cerebrovascular Accident (Stroke)
CL Item
Transient Ischemic Attack (Transient ischemic attacks)
C50781 (NCI Thesaurus)
C0007787 (UMLS 2011AA)
CL Item
Acute Renal Failure (Acute kidney injury)
CL Item
Thromboembolism (Thromboembolic event)
Item
Grade
text
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C48309 (NCI Thesaurus Property)
C0441800 (UMLS 2011AA Property)
C49705 (NCI Thesaurus Property-2)
C1710065 (UMLS 2011AA Property-2)
C25676 (NCI Thesaurus Property-3)
C0439793 (UMLS 2011AA Property-3)
C41331 (NCI Thesaurus ValueDomain)
C0877248 (UMLS 2011AA ValueDomain)
C48309 (NCI Thesaurus ValueDomain-2)
C0441800 (UMLS 2011AA ValueDomain-2)
C25676 (NCI Thesaurus ValueDomain-3)
C0439793 (UMLS 2011AA ValueDomain-3)
Code List
Grade
CL Item
Absent Adverse Event (0)
C75533 (NCI Thesaurus)
C2699517 (UMLS 2011AA)
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)
CL Item
Life Threatening Adverse Event (4)
C84266 (NCI Thesaurus)
C1517874 (UMLS 2011AA)
CL Item
Death Related To Adverse Event (5)
C48275 (NCI Thesaurus)
C1705232 (UMLS 2011AA)
AdverseEventOtherGradeText
Item
None of the listed grades (Mark response in column below when an adverse event occurred with a grade lower than those listed, or when an adverse event did not occur.)
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C48309 (NCI Thesaurus Property-2)
C0441800 (UMLS 2011AA Property-2)
Item Group
Selected Surgical Complications
TherapyBeginPostoperativeAdministeredInd-2
Item
Did the patient start postoperative therapy on or before postoperative day 31 (If postoperative therapy will not start after surgery, report surgical complications through postoperative day 84 in this section.)
boolean
C15368 (NCI Thesaurus ObjectClass)
C28006 (NCI Thesaurus Property)
C0032790 (UMLS 2011AA Property)
C25431 (NCI Thesaurus Property-2)
C0439659 (UMLS 2011AA Property-2)
C25382 (NCI Thesaurus Property-3)
C1521801 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientPost-OperativeHospitalizationDayCount
Item
On postoperative day
float
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25623 (NCI Thesaurus Property)
C25179 (NCI Thesaurus Property-2)
C0019993 (UMLS 2011AA Property)
C25301 (NCI Thesaurus ValueDomain)
C0439228 (UMLS 2011AA ValueDomain)
C25463 (NCI Thesaurus ValueDomain-2)
C0750480 (UMLS 2011AA ValueDomain-2)
PostoperativeLaboratoryProcedureBilirubinResultUnspecifiedValue
Item
What was the maximum postoperative bilirubin level (from post-op day 31 to the day before the start of postoperative therapy [or postoperative day 84, if postoperative therapy will not be initiated] - mg/dL)
float
C28006 (NCI Thesaurus ObjectClass)
C0032790 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus ObjectClass-2)
C0022885 (UMLS 2011AA ObjectClass-2)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C305 (NCI Thesaurus Property-2)
C0005437 (UMLS 2011AA Property-2)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
AdverseEventDeathRelatedtoAdverseEventGradeInd-2
Item
Any grade 5 event (Did the patient experience:)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C48275 (NCI Thesaurus Property)
C1705232 (UMLS 2011AA Property)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C48309 (NCI Thesaurus Property-2)
C0441800 (UMLS 2011AA Property-2)
TherapyPatientInitiationAdministeredInd-2
Item
Did the patient initiate postoperative therapy
boolean
C15368 (NCI Thesaurus ObjectClass)
C16960 (NCI Thesaurus Property)
C0030705 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
C47938 (NCI Thesaurus Property-3)
C1704686 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item
Adverse Event
text
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C49704 (NCI Thesaurus Property)
C1516728 (UMLS 2011AA Property)
C45559 (NCI Thesaurus Property-2)
C1705313 (UMLS 2011AA Property-2)
C45255 (NCI Thesaurus ValueDomain)
C1708523 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ValueDomain-2)
C1516728 (UMLS 2011AA ValueDomain-2)
C42614 (NCI Thesaurus ValueDomain-3)
C0027365 (UMLS 2011AA ValueDomain-3)
C45559 (NCI Thesaurus ValueDomain-4)
C1705313 (UMLS 2011AA ValueDomain-4)
C25714 (NCI Thesaurus ValueDomain-5)
C0333052 (UMLS 2011AA ValueDomain-5)
Code List
Adverse Event
CL Item
Acute Coronary Syndrome (Acute coronary syndrome)
CL Item
Myocardial Infarction (Myocardial infarction)
C27996 (NCI Thesaurus)
C0027051 (UMLS 2011AA)
CL Item
Ascites (Ascites)
C2885 (NCI Thesaurus)
C0003962 (UMLS 2011AA)
CL Item
Abdominal Infection (Abdominal infection)
C35669 (NCI Thesaurus)
C1112209 (UMLS 2011AA)
CL Item
Infectious Lung Disorder (Lung infection)
CL Item
Septicemia (Sepsis)
CL Item
Wound Dehiscence (Wound dehiscence)
C50863 (NCI Thesaurus)
C0259768 (UMLS 2011AA)
CL Item
Cerebrovascular Accident (Stroke)
CL Item
Transient Ischemic Attack (Transient ischemic attacks)
C50781 (NCI Thesaurus)
C0007787 (UMLS 2011AA)
CL Item
Acute Renal Failure (Acute kidney injury)
CL Item
Thromboembolism (Thromboembolic event)
Item
Grade
text
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C48309 (NCI Thesaurus Property)
C0441800 (UMLS 2011AA Property)
C49705 (NCI Thesaurus Property-2)
C1710065 (UMLS 2011AA Property-2)
C25676 (NCI Thesaurus Property-3)
C0439793 (UMLS 2011AA Property-3)
C41331 (NCI Thesaurus ValueDomain)
C0877248 (UMLS 2011AA ValueDomain)
C48309 (NCI Thesaurus ValueDomain-2)
C0441800 (UMLS 2011AA ValueDomain-2)
C25676 (NCI Thesaurus ValueDomain-3)
C0439793 (UMLS 2011AA ValueDomain-3)
Code List
Grade
CL Item
Absent Adverse Event (0)
C75533 (NCI Thesaurus)
C2699517 (UMLS 2011AA)
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)
CL Item
Life Threatening Adverse Event (4)
C84266 (NCI Thesaurus)
C1517874 (UMLS 2011AA)
CL Item
Death Related To Adverse Event (5)
C48275 (NCI Thesaurus)
C1705232 (UMLS 2011AA)
AdverseEventOtherGradeText
Item
None of the listed grades (Mark response in column below when an adverse event occurred with a grade lower than those listed, or when an adverse event did not occur.)
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C48309 (NCI Thesaurus Property-2)
C0441800 (UMLS 2011AA Property-2)

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