ID

2735

Beschreibung

CALGB 90203: Late Postoperative Complications Form [Form C-1275 v1 11/06/2006] Surgery With or Without Docetaxel and Leuprolide or Goserelin in Treating Patients With High-Risk Localized Prostate Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=1E774671-33FE-1976-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=1E774671-33FE-1976-E044-0003BA3F9857

Stichworte

Versionen (3)
  1. 19.09.12 19.09.12 -
  2. 09.01.15 09.01.15 - Martin Dugas
  3. 21.06.15 21.06.15 -
Hochgeladen am

19. September 2012

DOI

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Prostate Cancer NCT00430183 Toxicity - CALGB 90203: Late Postoperative Complications Form - 2523234v1.0

Englisch

Instructions: Complete and submit this form as required by the protocol. Information in the upper right box must be completed for this form to be accepted. For optimal accuracy use black ink. If data are amended, circle amended items and...

1 Formulare  
Unnamed1
Beschreibung

Unnamed1

CALGB Form (C-1241)
Beschreibung

CALGBFormIdentifierNumber

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C19464
UMLS 2011AA ObjectClass
C0376315
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ObjectClass
C25442
UMLS 2011AA ObjectClass
C1516238
CALGB Study No.
Beschreibung

ProtocolCALGBIdentifierNumber

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C25320
UMLS 2011AA ObjectClass
C1507394
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property
C25442
UMLS 2011AA Property
C1516238
CALGB Patient ID
Beschreibung

PatientCALGBIdentifierNumber

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property
C25442
UMLS 2011AA Property
C1516238
Assessment Date (mm dd yyyy)
Beschreibung

AdverseEventAssessmentDate

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus ValueDomain
C25367
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
Are data amended
Beschreibung

DataAmendedInd-3

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C25474
UMLS 2011AA ObjectClass
C1511726
NCI Thesaurus Property
C25416
UMLS 2011AA Property
C1691222
Unnamed2
Beschreibung

Unnamed2

Patient Initials (Last, First Middle)
Beschreibung

PatientInitialsName

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25536
UMLS 2011AA Property
C1555582
Patient Hospital No.
Beschreibung

PatientMedicalRecordNumber

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25261
UMLS 2011AA Property
C0205476
NCI Thesaurus Property
C25198
UMLS 2011AA Property
C0034869
Institution/Affiliate
Beschreibung

CombinedInstitutionName

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C25454
UMLS 2011AA ObjectClass
C0205195
NCI Thesaurus ObjectClass
C21541
UMLS 2011AA ObjectClass
C0018704
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ValueDomain
C21541
UMLS 2011AA ValueDomain
C0018704
Participating Group
Beschreibung

ParticipatingGroupName

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C25608
UMLS 2011AA ObjectClass
C0679823
NCI Thesaurus ObjectClass
C17005
UMLS 2011AA ObjectClass
C1257890
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Participating Group Study No.
Beschreibung

ProtocolParticipatingIdentifierNumber

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C25320
UMLS 2011AA ObjectClass
C1507394
NCI Thesaurus Property
C25608
UMLS 2011AA Property
C0679823
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Participating Group Patient ID
Beschreibung

PatientParticipatingIdentifierNumber

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25608
UMLS 2011AA Property
C0679823
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Unnamed3
Beschreibung

Unnamed3

Reporting Period (time since surgery Mark one with an X.)
Beschreibung

ReportingEvaluationPeriodType

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C25214
UMLS 2011AA ObjectClass
C0220825
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus ObjectClass
C25651
UMLS 2011AA ObjectClass
C0700287
Expected Adverse Events
Beschreibung

Expected Adverse Events

MedDRA Code
Beschreibung

MedDRACode

Datentyp

double

Alias
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Metathesaurus ObjectClass
CL104089
CTC AE Grade (2 AE is defined as Adverse Event; 1 Use NCI CTCAE v3.x or most current version with MedDRA codes posted at http://www.calgb.org to grade each adverse event. Grade= -1 if category not evaluated. Grade= 0 if category evaluated by event not reported.)
Beschreibung

CommonToxicityCriteriaAdverseEventGrade

Datentyp

double

Alias
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus ValueDomain
C18000
UMLS 2011AA ValueDomain
C0919553
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
CTC Adverse Event Term (Specify below any other postoperative complications, grade 3 or higher, that occurred during this reporting period.)
Beschreibung

CommonToxicityCriteriaAdverseEventTermType

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus Property
C45559
UMLS 2011AA Property
C1705313
Specify type of corrective procedure
Beschreibung

SurgicalProcedureAdverseEventCorrectionTherapyText

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus ObjectClass
C15329
UMLS 2011AA ObjectClass
C0543467
NCI Thesaurus Property
C15368
NCI Thesaurus Property
C54657
UMLS 2011AA Property
C1947976
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
Total number of corrective procedures (since surgery)
Beschreibung

SurgicalProcedureAdverseEventCorrectionTherapyCount

Datentyp

double

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus ObjectClass
C15329
UMLS 2011AA ObjectClass
C0543467
NCI Thesaurus Property
C15368
NCI Thesaurus Property
C54657
UMLS 2011AA Property
C1947976
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
Ccrr Module For Calgb: 90202 Adverse Event Form
Beschreibung

Ccrr Module For Calgb: 90202 Adverse Event Form

Completed by (Last name, First name)
Beschreibung

ResponsiblePersonName

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C25657
UMLS 2011AA ObjectClass
C1273518
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Date Form Completed (mm dd yyyy)
Beschreibung

FormCompleteDate

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C40988
UMLS 2011AA ObjectClass
C1516308
NCI Thesaurus Property
C25250
UMLS 2011AA Property
C0205197
NCI Thesaurus ValueDomain
C25367
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Ähnliche Modelle

Instructions: Complete and submit this form as required by the protocol. Information in the upper right box must be completed for this form to be accepted. For optimal accuracy use black ink. If data are amended, circle amended items and...

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Unnamed1
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)
AdverseEventAssessmentDate
Item
Assessment Date (mm dd yyyy)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C25367 (NCI Thesaurus ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
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)
CL.1
Code List
Are data amended
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item Group
Unnamed2
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)
Item Group
Unnamed3
Item
Reporting Period (time since surgery 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)
CL.2
Code List
Reporting Period (time since surgery Mark one with an X.)
CL Item
3 Months (3 months)
CL Item
6 Months (6 months)
CL Item
9 Months (9 months)
CL Item
12 Months (12 months)
Item Group
Expected Adverse Events
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 (2 AE is defined as Adverse Event; 1 Use NCI CTCAE v3.x or most current version with MedDRA codes posted at http://www.calgb.org to grade each adverse event. Grade= -1 if category not evaluated. Grade= 0 if category evaluated by event not reported.)
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.3
Code List
CTC AE Grade (2 AE is defined as Adverse Event; 1 Use NCI CTCAE v3.x or most current version with MedDRA codes posted at http://www.calgb.org to grade each adverse event. Grade= -1 if category not evaluated. Grade= 0 if category evaluated by event not reported.)
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 (Specify below any other postoperative complications, grade 3 or higher, that occurred during this reporting period.)
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)
CL.4
Code List
CTC Adverse Event Term (Specify below any other postoperative complications, grade 3 or higher, that occurred during this reporting period.)
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
Urinary Incontinence (Incontinence, urinary)
C3429 (NCI Thesaurus)
C0021167 (UMLS 2011AA)
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 Frequency (Urinary frequency/urgency)
C26906 (NCI Thesaurus)
C0677481 (UMLS 2011AA)
CL Item
Urinary Retention (Urinary retention (including neurogenic bladder))
C0080274 (NCI Metathesaurus)
CL Item
Impotence (Erectile dysfunction)
C3133 (NCI Thesaurus)
C0242350 (UMLS 2011AA)
SurgicalProcedureAdverseEventCorrectionTherapyText
Item
Specify type of corrective procedure
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)
Item Group
Ccrr Module For Calgb: 90202 Adverse Event Form
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)
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