Instructions: To be completed by attending surgeon. Please complete 90 days after surgery. Surgeons should be provided with this form prior to the surgical event. All dates are MONTH, DAY, YEAR. Explain any blank fields or blank dates in the Comments section. Place an X in appropriate boxes. Circle AMENDED items in red and write AMENDED across top of form

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header
Trial subject ID SWOG
Item
SWOG Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1519429 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25699 (NCI Thesaurus Property-2)
Protocol ID SWOG
Item
SWOG Study No.
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1519429 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25699 (NCI Thesaurus Property-2)
Registration Number
Item
Registration Step
text
C25337 (NCI Thesaurus ValueDomain)
C1514821 (UMLS CUI-1)
C25646 (NCI Thesaurus ObjectClass)
C0237753 (UMLS CUI-2)
C16154 (NCI Thesaurus Property)
C16154 (NCI Thesaurus ValueDomain-2)
Patient Initials
Item
Patient Initials (L, F M)
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
FormCompletionDate
Item
Date of completion (MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C40988 (NCI Thesaurus ObjectClass)
C1516308 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
Institution Name
Item
Institution/Affiliate
text
C25454 (NCI Thesaurus ObjectClass)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
C25191 (NCI Thesaurus ValueDomain)
C21541 (NCI Thesaurus ValueDomain-2)
Investigator Name
Item
Physician
text
C25191 (NCI Thesaurus ValueDomain)
C2826892 (UMLS CUI-1)
C25364 (NCI Thesaurus Property)
C17089 (NCI Thesaurus ObjectClass)
C25644 (NCI Thesaurus ObjectClass-2)
Participating Group
Item
Participating Group Name
text
C25191 (NCI Thesaurus ValueDomain)
C2347449 (UMLS CUI-1)
C25608 (NCI Thesaurus ObjectClass)
C17005 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
Study Number Participating Group
Item
Participating Group Study No.
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Trial subject ID Participating Group
Item
Participating Group Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Item Group
Complications
SurgicalProcedureAdverseEventAssessmentInd-2
Item
Was the assessment done
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C15329 (NCI Thesaurus ObjectClass-2)
C0543467 (UMLS 2011AA ObjectClass-2)
SurgicalProcedureComplicationSpecify
Item
Other, specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C2959 (NCI Thesaurus Property)
C0009566 (UMLS 2011AA Property)
SurgicalProcedureComplicationSpecify
Item
Other, specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C2959 (NCI Thesaurus Property)
C0009566 (UMLS 2011AA Property)
AdverseEventSymptomBeginDate
Item
Start date (MM DD YYYY should be the date of hospital discharge)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25431 (NCI Thesaurus ValueDomain-2)
C0439659 (UMLS 2011AA ValueDomain-2)
C4876 (NCI Thesaurus Property)
C1457887 (UMLS 2011AA Property)
AdverseEventSymptomEndDate
Item
Stop date (MM DD YYYY should be 90 days post surgery)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C4876 (NCI Thesaurus Property)
C1457887 (UMLS 2011AA Property)
Item
Surgical Complications (Record any events that occurred following hospital discharge to 90 days post-op)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C2959 (NCI Thesaurus Property)
C0009566 (UMLS 2011AA Property)
CL.2
Code List
Surgical Complications (Record any events that occurred following hospital discharge to 90 days post-op)
CL Item
Superficial Wound Infection (Superficial wound infection)
C45234 (NCI Thesaurus)
C0043241 (UMLS 2011AA)
C25239 (NCI Thesaurus-3)
C0205124 (UMLS 2011AA-4)
CL Item
Deep Wound Infection (Deep wound infection)
C45234 (NCI Thesaurus)
C0043241 (UMLS 2011AA)
C25240 (NCI Thesaurus-3)
C0205125 (UMLS 2011AA-4)
CL Item
Wound Disruption (Wound disruption)
C25486 (NCI Thesaurus)
C0332453 (UMLS 2011AA)
C3671 (NCI Thesaurus-3)
C0043250 (UMLS 2011AA-4)
CL Item
Pneumonia (PNEUMONIA)
C3333 (NCI Thesaurus)
C0032285 (UMLS 2011AA)
CL Item
Intubation (Re-intubation)
C37981 (NCI Thesaurus)
C0021925 (UMLS 2011AA)
CL Item
Pulmonary Embolism (Pulmonary Embolism)
C50713 (NCI Thesaurus)
C0034065 (UMLS 2011AA)
CL Item
Deep Vein Thrombosis (Deep venous thrombosis)
C49343 (NCI Thesaurus)
C0149871 (UMLS 2011AA)
CL Item
Failure To Wean From Ventilator Within 48 Hours (Failure to wean from ventilator within 48 hours)
CL Item
Sepsis (Sepsis)
E11560 (CTCAE)
CL Item
Anastomotic Bowel Leak (Anastomotic bowel leak)
CL Item
Renal Insufficiency Dialysis (Renal insufficiency requiring dialysis)
C1565489 (NCI Metathesaurus)
C15221 (NCI Thesaurus)
C0011946 (UMLS 2011AA)
CL Item
Symptomatic Lymph Leakage/lymphocele (Symptomatic lymph leakage/lymphocele)
CL Item
Lymph Leakage/lymphocele Requiring Intervention (Lymph leakage/lymphocele requiring intervention)
CL Item
Acute Renal Failure (Acute renal failure)
C26808 (NCI Thesaurus)
C0022660 (UMLS 2011AA)
CL Item
Urinary Tract Infection (Urinary tract infection)
C50791 (NCI Thesaurus)
C0042029 (UMLS 2011AA)
CL Item
Cerebrovascular Accident Stroke (CVA/stroke)
C3390 (NCI Thesaurus)
C0038454 (UMLS 2011AA)
E12826 (CTCAE)
CL Item
Cardiac Event With Cpr (Cardiac event with CPR)
CL Item
Myocardial Infarction (Myocardial infarction)
E10152 (CTCAE)
CL Item
Ileus (Ileus)
E10812 (CTCAE)
CL Item
Bowel Obstruction (Bowel obstruction)
CL Item
Hemorrhage Postoperative (Bleeding > 4 units postoperative)
C26791 (NCI Thesaurus)
C0019080 (UMLS 2011AA)
C28006 (NCI Thesaurus-3)
C0032790 (UMLS 2011AA-4)
CL Item
Death Within 30 Days Of Cystectomy (Death within 30 days of cystectomy)
CL Item
Death (Death)
C28554 (NCI Thesaurus)
C0011065 (UMLS 2011AA)
CL Item
Other, Specify (Other, Specify)
Item
Surgical Complication Grade
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C15329 (NCI Thesaurus Property-2)
C0543467 (UMLS 2011AA Property-2)
C2959 (NCI Thesaurus Property-3)
C0009566 (UMLS 2011AA Property-3)
C48309 (NCI Thesaurus Property-4)
C0441800 (UMLS 2011AA Property-4)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.3
Code List
Surgical Complication Grade
CL Item
Use Of Oral Medications Or Bedside Intervention (Use of oral medications or bedside intervention)
CL Item
Use Of Intravenous Medication, Total Parenteral Nutrition (tpn), Enteral Nutrition, Or Blood Transfusion (Use of intravenous medication, total parenteral nutrition (TPN), enteral nutrition, or blood transfusion)
CL Item
Interventional Radiology, Therapeutic Endoscopy, Intubation, Angiography, Or Operation (Interventional radiology, therapeutic endoscopy, intubation, angiography, or operation)
CL Item
Residual Lasting Disability Requiring Major Rehabilitation Or Organ Resection (Residual lasting disability requiring major rehabilitation or organ resection)
CL Item
Death (Death of patient)
C28554 (NCI Thesaurus)
C0011065 (UMLS 2011AA)
Item Group
Neoadjuvant Treatment Related To This Bladder Cancer
PriorAdjuvantChemotherapyAdministeredInd-2
Item
Prior Adjuvant Chemotherapy
boolean
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C2140 (NCI Thesaurus ObjectClass-3)
C0001552 (UMLS 2011AA ObjectClass-3)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
AdjuvantChemotherapyAdministeredInd-2
Item
Will the patient receive adjuvant chemotherapy (Please complete if the answer was "No" to adjuvant chemotherapy)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C2140 (NCI Thesaurus ObjectClass-2)
C0001552 (UMLS 2011AA ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
Item
Chemotherapy Regimen (Please complete if the answer was "Yes" to adjuvant chemotherapy select all that apply)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C15697 (NCI Thesaurus Property)
C0040808 (UMLS 2011AA Property)
CL.6
Code List
Chemotherapy Regimen (Please complete if the answer was "Yes" to adjuvant chemotherapy select all that apply)
CL Item
Doxorubicin Vinblastine Methotrexate Cisplatin (MVAC)
C456 (NCI Thesaurus)
C0013089 (UMLS 2011AA)
C376 (NCI Thesaurus-3)
C0008838 (UMLS 2011AA-4)
C642 (NCI Thesaurus-5)
C0025677 (UMLS 2011AA-6)
C930 (NCI Thesaurus-7)
C0042670 (UMLS 2011AA-8)
CL Item
Gemcitabine (Gemcitabine)
C66876 (NCI Thesaurus)
C0045093 (UMLS 2011AA)
CL Item
Cisplatin (Cisplatin)
C376 (NCI Thesaurus)
C0008838 (UMLS 2011AA)
CL Item
Carboplatin (Carboplatin)
C1282 (NCI Thesaurus)
C0079083 (UMLS 2011AA)
CL Item
Paclitaxel (Paclitaxel)
C1411 (NCI Thesaurus)
C0144576 (UMLS 2011AA)
PriorChemotherapyRegimenText
Item
Specify agent (other)
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C15697 (NCI Thesaurus Property)
C0040808 (UMLS 2011AA Property)
AgentCourseCount
Item
Number of Cycles
float
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C25379 (NCI Thesaurus Property)
C0750729 (UMLS 2011AA Property)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
Treatment Start Date
Item
Treatment Start Date (MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C3173309 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass)
C25431 (NCI Thesaurus Property)
C25275 (NCI Thesaurus Property-2)
AdjuvantTherapyPlanCompleteInd-2
Item
Did the patient complete the planned adjuvant therapy (Please indicate "Yes" if the patient completed the planned adjuvant chemotherapy as of this form submission)
boolean
C15368 (NCI Thesaurus ObjectClass)
C2140 (NCI Thesaurus ObjectClass-2)
C0001552 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C25619 (NCI Thesaurus Property-2)
C1301732 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item Group
Comments
Research Comments
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
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