CALGBFormIdentifierNumber
Item
CALGB Form (C-1241)
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C19464 (NCI Thesaurus ObjectClass)
C0376315 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25442 (NCI Thesaurus ObjectClass)
C1516238 (UMLS 2011AA ObjectClass)
ProtocolCALGBIdentifierNumber
Item
CALGB Study No.
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25442 (NCI Thesaurus Property)
C1516238 (UMLS 2011AA Property)
PatientCALGBIdentifierNumber
Item
CALGB 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)
C25442 (NCI Thesaurus Property)
C1516238 (UMLS 2011AA Property)
LesionAssessmentDate
Item
Date of Evaluation
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C25367 (NCI Thesaurus ValueDomain)
Item
Reporting Period (Entry required; mark one with an X.)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25214 (NCI Thesaurus ObjectClass)
C0220825 (UMLS 2011AA ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25651 (NCI Thesaurus ObjectClass)
C0700287 (UMLS 2011AA ObjectClass)
Code List
Reporting Period (Entry required; mark one with an X.)
CL Item
0 To 3 Days After Surgery (Day 0-3 after surgery)
CL Item
4 To 30 Days After Surgery (Day 4-30 after surgery)
Item
Are data amended
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)
Code List
Are data amended
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
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)
PatientMedicalRecordNumber
Item
Patient Hospital No.
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25261 (NCI Thesaurus Property)
C0205476 (UMLS 2011AA Property)
C25198 (NCI Thesaurus Property)
C0034869 (UMLS 2011AA Property)
CombinedInstitutionName
Item
Institution/Affiliate
text
C25454 (NCI Thesaurus ObjectClass)
C0205195 (UMLS 2011AA ObjectClass)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (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)
ParticipatingGroupName
Item
Participating Group
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25608 (NCI Thesaurus ObjectClass)
C0679823 (UMLS 2011AA ObjectClass)
C17005 (NCI Thesaurus ObjectClass)
C1257890 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
ProtocolParticipatingIdentifierNumber
Item
Participating Group Study No.
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
PatientParticipatingIdentifierNumber
Item
Participating Group Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
MedDRACode
Item
MedDRA Code
double
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
CL104089 (NCI Metathesaurus ObjectClass)
Item
CTC AE Grade
double
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C18000 (NCI Thesaurus ValueDomain)
C0919553 (UMLS 2011AA ValueDomain)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CL Item
No Adverse Event Or Within Normal Limits (0)
CL Item
Mild Adverse Event (1)
C41338 (NCI Thesaurus)
C1513302 (UMLS 2011AA)
CL Item
Moderate Adverse Event (2)
C41339 (NCI Thesaurus)
C1513374 (UMLS 2011AA)
CL Item
Severe Adverse Event (3)
C41340 (NCI Thesaurus)
C1519275 (UMLS 2011AA)
CL Item
Life-threatening Or Disabling Adverse Event (4)
CL Item
Death Related To Adverse Event (5)
C48275 (NCI Thesaurus)
C1705232 (UMLS 2011AA)
Item
CTC Adverse Event Term
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C45559 (NCI Thesaurus Property)
C1705313 (UMLS 2011AA Property)
Code List
CTC Adverse Event Term
CL Item
Cerebral Ischaemia (CNS cerebrovascular ischemia)
C0917798 (NCI Metathesaurus)
CL Item
Myocardial Ischaemia (Cardiac ischemia/infarction)
C0151744 (NCI Metathesaurus)
CL Item
Arrhythmia Nos (Cardiac Arrhythmia-Other (Specify))
CL Item
Supraventricular Arrhythmia Nos (Supraventricular and nodal arrhythmia - Supraventricular arrhythmia NOS)
CL Item
Ventricular Arrhythmia Nos (Ventricular arrhythmia - Ventricular arrhythmia NOS)
CL Item
Peripheral Ischaemia Nos (Peripheral arterial ischemia)
CL Item
Thrombosis Nos (Thrombosis/thrombus/embolism)
CL Item
Oedema Nos (Edema: limb)
CL Item
Edema: Trunk/genital (Edema: trunk/genital)
CL Item
Lymphocele (Lymphocele)
C0024248 (NCI Metathesaurus)
CL Item
Leak (including Anastomotic), Gu (Leak (including anastomotic), GU - Urethra)
CL Item
Stricture/stenosis (including Anastomotic), Gu (Stricture/stenosis (including anastomotic), GU - Bladder)
CL Item
Urinary Retention (Urinary retention (including neurogenic bladder))
C0080274 (NCI Metathesaurus)
CommonToxicityCriteriaAdverseEventIntraoperativeInjurySpecify
Item
Other Specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C3671 (NCI Thesaurus Property)
C0043250 (UMLS 2011AA Property)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
CL223124 (NCI Metathesaurus Property)
MedDRACode
Item
MedDRA Code
double
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
CL104089 (NCI Metathesaurus ObjectClass)
Item
CTC AE Grade
double
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C18000 (NCI Thesaurus ValueDomain)
C0919553 (UMLS 2011AA ValueDomain)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CL Item
No Adverse Event Or Within Normal Limits (0)
CL Item
Mild Adverse Event (1)
C41338 (NCI Thesaurus)
C1513302 (UMLS 2011AA)
CL Item
Moderate Adverse Event (2)
C41339 (NCI Thesaurus)
C1513374 (UMLS 2011AA)
CL Item
Severe Adverse Event (3)
C41340 (NCI Thesaurus)
C1519275 (UMLS 2011AA)
CL Item
Life-threatening Or Disabling Adverse Event (4)
CL Item
Death Related To Adverse Event (5)
C48275 (NCI Thesaurus)
C1705232 (UMLS 2011AA)
Item
CTC Adverse Event Term
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C45559 (NCI Thesaurus Property)
C1705313 (UMLS 2011AA Property)
Code List
CTC Adverse Event Term
CL Item
Cerebral Ischaemia (CNS cerebrovascular ischemia)
C0917798 (NCI Metathesaurus)
CL Item
Myocardial Ischaemia (Cardiac ischemia/infarction)
C0151744 (NCI Metathesaurus)
CL Item
Arrhythmia Nos (Cardiac Arrhythmia-Other (Specify))
CL Item
Supraventricular Arrhythmia Nos (Supraventricular and nodal arrhythmia - Supraventricular arrhythmia NOS)
CL Item
Ventricular Arrhythmia Nos (Ventricular arrhythmia - Ventricular arrhythmia NOS)
CL Item
Peripheral Ischaemia Nos (Peripheral arterial ischemia)
CL Item
Thrombosis Nos (Thrombosis/thrombus/embolism)
CL Item
Oedema Nos (Edema: limb)
CL Item
Edema: Trunk/genital (Edema: trunk/genital)
CL Item
Lymphocele (Lymphocele)
C0024248 (NCI Metathesaurus)
CL Item
Leak (including Anastomotic), Gu (Leak (including anastomotic), GU - Urethra)
CL Item
Stricture/stenosis (including Anastomotic), Gu (Stricture/stenosis (including anastomotic), GU - Bladder)
CL Item
Urinary Retention (Urinary retention (including neurogenic bladder))
C0080274 (NCI Metathesaurus)
SurgicalProcedurePostoperativeFeverComplicationDuration
Item
Duration (number of days [for Postoperative fever >38.5 degrees C 101.5 degrees F])
double
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C28006 (NCI Thesaurus Property)
C0032790 (UMLS 2011AA Property)
C3038 (NCI Thesaurus Property)
C0015967 (UMLS 2011AA Property)
C2959 (NCI Thesaurus Property)
C0009566 (UMLS 2011AA Property)
C25301 (NCI Thesaurus ValueDomain)
C0439228 (UMLS 2011AA ValueDomain)
C25330 (NCI Thesaurus ValueDomain)
C0449238 (UMLS 2011AA ValueDomain)
Item
Wound complication, non-infectious (Mark one with an X._)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C28006 (NCI Thesaurus Property)
C0032790 (UMLS 2011AA Property)
C50863 (NCI Thesaurus Property)
C0259768 (UMLS 2011AA Property)
Code List
Wound complication, non-infectious (Mark one with an X._)
CL Item
Dehiscence Requiring Return To Operating Wound (Dehiscence requiring return to operating wound)
CL Item
Dehiscence Requiring Local Wound Care Only (Dehiscence requiring local wound care only)
CommonToxicityCriteriaAdverseEventOtherInfectionSpecify
Item
Other Specify (for Infection - other, specify)
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C26726 (NCI Thesaurus Property)
C0009450 (UMLS 2011AA Property)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
Item
Postoperative events (Recommended term - no Question on CRF following "Respiratory failure ARDS?" mark all that apply with an X:)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C28006 (NCI Thesaurus ObjectClass)
C0032790 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
Code List
Postoperative events (Recommended term - no Question on CRF following "Respiratory failure ARDS?" mark all that apply with an X:)
CL Item
Requiring Assisted Ventilation (Ventilation required >24 hours post-operatively)
CL Item
Reintubation (Reintubation required >24 hours post-operatively)
CL Item
Tracheostomy (Tracheostomy)
C15341 (NCI Thesaurus)
C0040590 (UMLS 2011AA)
PostoperativeAdverseEventVentilatorAdultRespiratoryDistressSyndromeDayDuration
Item
Duration (number of days [for Ventilation required >24 hours post-operatively])
double
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C28006 (NCI Thesaurus ObjectClass)
C0032790 (UMLS 2011AA ObjectClass)
C3353 (NCI Thesaurus Property)
C0035222 (UMLS 2011AA Property)
C38388 (NCI Thesaurus Property)
C0087153 (UMLS 2011AA Property)
C25301 (NCI Thesaurus ValueDomain)
C0439228 (UMLS 2011AA ValueDomain)
C25330 (NCI Thesaurus ValueDomain)
C0449238 (UMLS 2011AA ValueDomain)
PostoperativeAdverseEventIntubationAdultRespiratoryDistressSyndromeDayDuration
Item
Duration (number of days [for Reintubation required >24 hours post-operatively])
double
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C28006 (NCI Thesaurus ObjectClass)
C0032790 (UMLS 2011AA ObjectClass)
C3353 (NCI Thesaurus Property)
C0035222 (UMLS 2011AA Property)
C37981 (NCI Thesaurus Property)
C0021925 (UMLS 2011AA Property)
C25301 (NCI Thesaurus ValueDomain)
C0439228 (UMLS 2011AA ValueDomain)
C25330 (NCI Thesaurus ValueDomain)
C0449238 (UMLS 2011AA ValueDomain)
MedDRACode
Item
MedDRA Code
double
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
CL104089 (NCI Metathesaurus ObjectClass)
Item
CTC AE Grade
double
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C18000 (NCI Thesaurus ValueDomain)
C0919553 (UMLS 2011AA ValueDomain)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CL Item
No Adverse Event Or Within Normal Limits (0)
CL Item
Mild Adverse Event (1)
C41338 (NCI Thesaurus)
C1513302 (UMLS 2011AA)
CL Item
Moderate Adverse Event (2)
C41339 (NCI Thesaurus)
C1513374 (UMLS 2011AA)
CL Item
Severe Adverse Event (3)
C41340 (NCI Thesaurus)
C1519275 (UMLS 2011AA)
CL Item
Life-threatening Or Disabling Adverse Event (4)
CL Item
Death Related To Adverse Event (5)
C48275 (NCI Thesaurus)
C1705232 (UMLS 2011AA)
Item
CTC Adverse Event Term
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C45559 (NCI Thesaurus Property)
C1705313 (UMLS 2011AA Property)
Code List
CTC Adverse Event Term
CL Item
Cerebral Ischaemia (CNS cerebrovascular ischemia)
C0917798 (NCI Metathesaurus)
CL Item
Myocardial Ischaemia (Cardiac ischemia/infarction)
C0151744 (NCI Metathesaurus)
CL Item
Arrhythmia Nos (Cardiac Arrhythmia-Other (Specify))
CL Item
Supraventricular Arrhythmia Nos (Supraventricular and nodal arrhythmia - Supraventricular arrhythmia NOS)
CL Item
Ventricular Arrhythmia Nos (Ventricular arrhythmia - Ventricular arrhythmia NOS)
CL Item
Peripheral Ischaemia Nos (Peripheral arterial ischemia)
CL Item
Thrombosis Nos (Thrombosis/thrombus/embolism)
CL Item
Oedema Nos (Edema: limb)
CL Item
Edema: Trunk/genital (Edema: trunk/genital)
CL Item
Lymphocele (Lymphocele)
C0024248 (NCI Metathesaurus)
CL Item
Leak (including Anastomotic), Gu (Leak (including anastomotic), GU - Urethra)
CL Item
Stricture/stenosis (including Anastomotic), Gu (Stricture/stenosis (including anastomotic), GU - Bladder)
CL Item
Urinary Retention (Urinary retention (including neurogenic bladder))
C0080274 (NCI Metathesaurus)
CommonToxicityCriteriaAdverseEventOtherArrhythmiaSpecify
Item
Other Specify (for Cardiac Arrhythmia, specify)
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C2881 (NCI Thesaurus Property)
C0003811 (UMLS 2011AA Property)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
CommonToxicityCriteriaAdverseEventOtherArrhythmiaText
Item
If known specify type (for Ventricular arrhythmia - NOS)
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C2881 (NCI Thesaurus Property)
C0003811 (UMLS 2011AA Property)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
CommonToxicityCriteriaAdverseEventOtherArrhythmiaText
Item
If known specify type (for Ventricular arrhythmia - NOS)
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C2881 (NCI Thesaurus Property)
C0003811 (UMLS 2011AA Property)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
SurgicalProcedureAdverseEventCorrectionTherapyText
Item
Specify type of corrective procedure (for Stricture, anastomotic, GU-bladder)
text
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus Property)
C54657 (NCI Thesaurus Property)
C1947976 (UMLS 2011AA Property)
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
SurgicalProcedureAdverseEventCorrectionTherapyCount
Item
Total number of corrective procedures (since surgery)
double
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus Property)
C54657 (NCI Thesaurus Property)
C1947976 (UMLS 2011AA Property)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
ResearchCommentsText
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
C0282411 (UMLS 2011AA Property)
ResponsiblePersonName
Item
Completed by (Last name, First name)
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)
FormCompleteDate
Item
Date Form Completed (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)
C25367 (NCI Thesaurus ValueDomain)