ID

3181

Beschreibung

CALGB: 90202 TREATMENT SUMMARY Zoledronate in Preventing Skeletal (Bone)-Related Events in Patients Who Are Receiving Androgen Deprivation Therapy For Prostate Cancer and Bone Metastases Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B4606983-04B2-052B-E034-0003BA12F5E7

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B4606983-04B2-052B-E034-0003BA12F5E7

Stichworte

Versionen (4)
  1. 19.09.12 19.09.12 -
  2. 08.01.15 08.01.15 - Martin Dugas
  3. 09.01.15 09.01.15 - Martin Dugas
  4. 05.07.15 05.07.15 -
Hochgeladen am

19. September 2012

DOI

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Lizenz

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Prostate Cancer NCT00079001 Treatment - CALGB: 90202 TREATMENT SUMMARY - 2078448v3.0

Englisch

All Patients

1 Formulare  
  1. StudyEvent: CALGB: 90202 TREATMENT SUMMARY
    1. All Patients
Unnamed1
Beschreibung

Unnamed1

CALGB Form
Beschreibung

CALGBForm

Datentyp

text

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
First date (any modality of) protocol therapy was given
Beschreibung

TreatmentBeginDate

Datentyp

date

Last date (any modality of) protocol therapy was given
Beschreibung

TreatmentEndDate

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25275
UMLS 2011AA Property
C2745955
Amended data?
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
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
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
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
Participating Group Protocol 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
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 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
Treatment Phase
Beschreibung

Treatment Phase

Treatment Phase
Beschreibung

TreatmentPhaseType

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25257
UMLS 2011AA Property
C0205390
Total number of cycles completed
Beschreibung

ChemotherapyTotalCycleCompleteCount

Datentyp

double

Alias
NCI Thesaurus ObjectClass
C15632
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus Property
C25250
UMLS 2011AA Property
C0205197
NCI Thesaurus Property
C25304
UMLS 2011AA Property
C0439810
NCI Thesaurus Property
C25472
UMLS 2011AA Property
C1511572
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
Unnamed3
Beschreibung

Unnamed3

Patient's vital status
Beschreibung

PatientVitalStatus

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ValueDomain
C18003
UMLS 2011AA ValueDomain
C0442732
NCI Thesaurus ValueDomain
C25688
UMLS 2011AA ValueDomain
C0449438
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Primary cause of death
Beschreibung

PatientDeathPrimaryReason

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25638
UMLS 2011AA ValueDomain
C0392360
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C28554
UMLS 2011AA Property
C0011065
NCI Thesaurus ValueDomain
C28554
UMLS 2011AA ValueDomain
C0011065
Describe cause of death
Beschreibung

PatientDeathSpecify

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C28554
UMLS 2011AA Property
C0011065
Date of last contact or death
Beschreibung

PatientLastContactDate

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ValueDomain
C25367
NCI Thesaurus Property
C25461
UMLS 2011AA Property
C0337611
Has the patient had a documented clinical assessment for this cancer since submission of the previous follow-up form?
Beschreibung

CancerFollow-upStatusInd

Datentyp

text

Date of last clinical assessment
Beschreibung

CancerFollow-upStatusDate

Datentyp

date

Alias
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
treatment step
Beschreibung

TreatmentArmNumber

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus Property
C32141
UMLS 2011AA Property
C1140618
NCI Thesaurus ObjectClass
C15368
Reason treatment ended (mark one with an X)
Beschreibung

Off-treatmentReason

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C25601
UMLS 2011AA ObjectClass
C1518544
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Patient off treatment for other complicating disease, specify
Beschreibung

OffTreatmentReason,ComplicatingDisease

Datentyp

text

Alternative therapy, specify
Beschreibung

OffTreatmentReason,AlternativeTherapy

Datentyp

text

Other, specify (reason treatment ended)
Beschreibung

OffTreatmentReason,Other

Datentyp

text

Were there any dose modifications or additions/omissions to protocol treatment?
Beschreibung

DoseModificationInd

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C25256
UMLS 2011AA ObjectClass
C1265611
NCI Thesaurus Property
C25572
NCI Thesaurus ValueDomain
C25572
specify therapy
Beschreibung

TherapyModificationName

Datentyp

text

Indicate reason for therapy modification
Beschreibung

TherapyModificationReason

Datentyp

text

Has the patient developed a first progression (or relapse) that has not been previously reported?
Beschreibung

DiseaseProgressionInd-3

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C25331
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
Date of first biochemical progression
Beschreibung

ProgressionDate,FirstBiochemical

Datentyp

date

PSA value at progression
Beschreibung

ProgressionPSAValue

Datentyp

double

Date of first skeletal related event
Beschreibung

Dateoffirstskeletalrelatedevent

Datentyp

text

Site of skeletal related event
Beschreibung

PatientSkeletalSystemEventType

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25499
UMLS 2011AA Property
C0441471
NCI Thesaurus Property
C12788
UMLS 2011AA Property
C0037253
Date of first distant progression
Beschreibung

ProgressionDate,FirstDistant

Datentyp

date

Site(s) of first distant progression
Beschreibung

ProgressionSite,FirstDistant

Datentyp

text

PSA value (total)
Beschreibung

PSAValue

Datentyp

double

Date of PSA assessment
Beschreibung

PSADate

Datentyp

date

Is the patient receiving any non-protocol therapy not previously reported?
Beschreibung

Non-protocolTherapyAdministeredInd-3

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass
C25590
UMLS 2011AA ObjectClass
C1518384
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Non-protocol hormonal therapy
Beschreibung

Non-ProtocolHormonalTherapyInd

Datentyp

text

Non-protocol surgery
Beschreibung

Non-protocolSurgeryPerformedInd-3

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus ObjectClass
C15329
UMLS 2011AA ObjectClass
C0543467
NCI Thesaurus ObjectClass
C25590
UMLS 2011AA ObjectClass
C1518384
Non-protocol radiation therapy
Beschreibung

Non-ProtocolRTInd

Datentyp

text

Other non-protocol therapy
Beschreibung

OtherNon-ProtocolTherapyInd

Datentyp

text

If yes, specify therapy
Beschreibung

OtherNon-ProtocolTherapyName

Datentyp

text

Date of first non-protocol therapy
Beschreibung

Non-ProtocolTherapyDate,First

Datentyp

date

Completed By (Print or Type 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 Completed (M)
Beschreibung

FormOriginalCompleteDate

Datentyp

date

Alias
NCI Thesaurus ObjectClass
C19464
UMLS 2011AA ObjectClass
C0376315
NCI Thesaurus Property
C25250
UMLS 2011AA Property
C0205197
NCI Thesaurus Property
C25604
UMLS 2011AA Property
C0205313
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25367
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Ähnliche Modelle

All Patients

1 Formulare
  1. StudyEvent: CALGB: 90202 TREATMENT SUMMARY
    1. All Patients
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Unnamed1
CALGBForm
Item
CALGB Form
text
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)
TreatmentBeginDate
Item
First date (any modality of) protocol therapy was given
date
TreatmentEndDate
Item
Last date (any modality of) protocol therapy was given
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
Item
Amended data?
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
Amended data?
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item Group
Unnamed2
PatientInitialsName
Item
Patient Initials
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)
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)
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)
ProtocolParticipatingIdentifierNumber
Item
Participating Group Protocol 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)
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)
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
Treatment Phase
Item
Treatment Phase
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25257 (NCI Thesaurus Property)
C0205390 (UMLS 2011AA Property)
CL.2
Code List
Treatment Phase
CL Item
Double-blinded (Double-blinded)
CL Item
Open Label (Open label)
ChemotherapyTotalCycleCompleteCount
Item
Total number of cycles completed
double
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C25304 (NCI Thesaurus Property)
C0439810 (UMLS 2011AA Property)
C25472 (NCI Thesaurus Property)
C1511572 (UMLS 2011AA Property)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
Item Group
Unnamed3
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.3
Code List
Patient's vital status
CL Item
Alive (alive)
CL Item
Dead (dead)
Item
Primary cause of death
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
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
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)
PatientLastContactDate
Item
Date of last contact or death
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
Has the patient had a documented clinical assessment for this cancer since submission of the previous follow-up form?
text
CL.5
Code List
Has the patient had a documented clinical assessment for this cancer since submission of the previous follow-up form?
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
Unknown (unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CancerFollow-upStatusDate
Item
Date of last clinical assessment
date
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
TreatmentArmNumber
Item
treatment step
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C32141 (NCI Thesaurus Property)
C1140618 (UMLS 2011AA Property)
C15368 (NCI Thesaurus ObjectClass)
Item
Reason treatment ended (mark one with an X)
text
C25601 (NCI Thesaurus ObjectClass)
C1518544 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CL.6
Code List
Reason treatment ended (mark one with an X)
CL Item
Treatment Completed Per Protocol Criteria (Treatment completed per protocol criteria)
CL Item
Disease Progression, Relapse During Active Treatment (Disease progression/relapse during active treatment)
CL Item
Adverse Event/side Effects/complications (Toxicity/side effects/complications)
CL Item
Death On Study (Death on study)
CL Item
Patient Withdrawal Or Refusal After Beginning Protocol Therapy (Patient withdrawal or refusal after beginning protocol therapy)
CL Item
Patient Withdrawal Or Refusal Before Beginning Protocol Therapy (Patient withdrawal or refusal prior to beginning protocol therapy)
CL Item
Patient Off-treatment For Other Complicating Disease (Patient off treatment for other complicating disease)
CL Item
Alternative Therapy (Alternative therapy)
CL Item
Other (Other, specify)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
OffTreatmentReason,ComplicatingDisease
Item
Patient off treatment for other complicating disease, specify
text
OffTreatmentReason,AlternativeTherapy
Item
Alternative therapy, specify
text
OffTreatmentReason,Other
Item
Other, specify (reason treatment ended)
text
Item
Were there any dose modifications or additions/omissions to protocol treatment?
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C25256 (NCI Thesaurus ObjectClass)
C1265611 (UMLS 2011AA ObjectClass)
C25572 (NCI Thesaurus Property)
C25572 (NCI Thesaurus ValueDomain)
CL.7
Code List
Were there any dose modifications or additions/omissions to protocol treatment?
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes, Planned (i.e., The Treatment Was Changed According To Protocol Guidelines) (yes, planned)
CL Item
Yes, Unplanned (i.e., The Treatment Change Was Not Part Of Protocol Guidelines) (Yes, unplanned)
CL Item
Unknown (unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
TherapyModificationName
Item
specify therapy
text
TherapyModificationReason
Item
Indicate reason for therapy modification
text
Item
Has the patient developed a first progression (or relapse) that has not been previously reported?
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25331 (NCI Thesaurus Property)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
CL.8
Code List
Has the patient developed a first progression (or relapse) that has not been previously reported?
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
ProgressionDate,FirstBiochemical
Item
Date of first biochemical progression
date
ProgressionPSAValue
Item
PSA value at progression
double
Dateoffirstskeletalrelatedevent
Item
Date of first skeletal related event
text
Item
Site of skeletal related event
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25499 (NCI Thesaurus Property)
C0441471 (UMLS 2011AA Property)
C12788 (NCI Thesaurus Property)
C0037253 (UMLS 2011AA Property)
CL.9
Code List
Site of skeletal related event
CL Item
Radiation To Bone (radiation to bone)
CL Item
Fracture (fracture)
C3046 (NCI Thesaurus)
C0016658 (UMLS 2011AA)
CL Item
Surgery To Bone (surgery to bone)
CL Item
Spinal Cord Compression (spinal cord compression)
C3380 (NCI Thesaurus)
C0037926 (UMLS 2011AA)
ProgressionDate,FirstDistant
Item
Date of first distant progression
date
ProgressionSite,FirstDistant
Item
Site(s) of first distant progression
text
PSAValue
Item
PSA value (total)
double
PSADate
Item
Date of PSA assessment
date
Item
Is the patient receiving any non-protocol therapy not previously reported?
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25590 (NCI Thesaurus ObjectClass)
C1518384 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
CL.10
Code List
Is the patient receiving any non-protocol therapy not previously reported?
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Non-protocol hormonal therapy
text
CL.11
Code List
Non-protocol hormonal therapy
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Non-protocol surgery
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C25590 (NCI Thesaurus ObjectClass)
C1518384 (UMLS 2011AA ObjectClass)
CL.12
Code List
Non-protocol surgery
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Non-protocol radiation therapy
text
CL.13
Code List
Non-protocol radiation therapy
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Other non-protocol therapy
text
CL.14
Code List
Other non-protocol therapy
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
OtherNon-ProtocolTherapyName
Item
If yes, specify therapy
text
Non-ProtocolTherapyDate,First
Item
Date of first non-protocol therapy
date
ResponsiblePersonName
Item
Completed By (Print or Type 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)
FormOriginalCompleteDate
Item
Date Completed (M)
date
C19464 (NCI Thesaurus ObjectClass)
C0376315 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C25604 (NCI Thesaurus Property)
C0205313 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
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