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A Phase II Trial of Ofatumumab in Previously Untreated Follicular Non-Hodgkin's Lymphoma (NHL)

1 forms  
Protocol Administration
Description

Protocol Administration

Date Informed Consent Signed (MM DD YYYY)
Description

InformedConsentFormSignedDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25367
NCI Thesaurus ObjectClass
C16468
UMLS 2011AA ObjectClass
C0009797
NCI Thesaurus Property
C25679
HIPAA Authorization Date (MM DD YYYY)
Description

PatientSignedDischargeMedicalRecordDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25679
NCI Metathesaurus Property
C0012621
NCI Thesaurus Property
C45258
UMLS 2011AA Property
C0025102
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Projected Start Date of Treatment (MM DD YYYY)
Description

TreatmentProjectedBeginDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass
C25631
NCI Thesaurus Property
C25431
UMLS 2011AA Property
C0439659
NCI Thesaurus Property
C25275
UMLS 2011AA Property
C2745955
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25431
UMLS 2011AA ValueDomain
C0439659
Pre-treatment Characteristics
Description

Pre-treatment Characteristics

Disease
Description

NewCancerDiagnosisAnatomicSite

Data type

text

Alias
NCI Thesaurus ValueDomain
C13717
UMLS 2011AA ValueDomain
C1515974
NCI Thesaurus ObjectClass
C25586
UMLS 2011AA ObjectClass
C0205314
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
Stage
Description

TumorGroupingStage

Data type

text

Alias
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ValueDomain
C16899
UMLS 2011AA ValueDomain
C1300072
NCI Thesaurus Property
C38027
UMLS 2011AA Property
C1519504
Pathologic Type
Description

PersonMalignantNeoplasmPathologyClinicalTrialEligibilityCriteriaMalignantNeoplasmPathologyType

Data type

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C9305
UMLS 2011AA Property
C0006826
NCI Thesaurus Property
C18189
UMLS 2011AA Property
C0030664
NCI Thesaurus Property
C16112
UMLS 2011AA Property
C1516637
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Certification Of Eligibility
Description

Certification Of Eligibility

In the opinion of the investigator, is the patient eligible (150910)
Description

PatientEligibilityIndicator

Data type

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25171
UMLS 2011AA Property
C0013893
Certification Of Eligibility And Protocol Design
Description

Certification Of Eligibility And Protocol Design

Assigned Treatment Arm
Description

ProtocolTreatmentArmAssignmentType

Data type

text

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass
C42651
UMLS 2011AA ObjectClass
C0442711
NCI Thesaurus Property
C32141
UMLS 2011AA Property
C1140618
NCI Thesaurus Property
C25426
UMLS 2011AA Property
C1516050
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Initial Patient Consent For Specimen Use
Description

Initial Patient Consent For Specimen Use

Patient's initial consent given for specimen use for genetic research relating to the study treatment (model consent question #1 If the patient answered "Yes" to this question, register the patient to 150910 during registration to 50901)
Description

SpecimenRelatedGeneticResearchConsentInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C19157
UMLS 2011AA ObjectClass
C0370003
NCI Thesaurus Property
C15319
NCI Thesaurus Property
C25648
UMLS 2011AA Property
C0439849
NCI Thesaurus Property
C17938
UMLS 2011AA Property
C0314603
NCI Thesaurus Property
C25460
UMLS 2011AA Property
C1511481
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Patient's Initial Consent given for specimen use for research on the patient's cancer (model consent question #2 If the patient answered "Yes" to this question, register the patient to 150910 during registration to 50901)
Description

BloodSpecimenMalignantNeoplasmRelatedResearchConsentInd-3

Data type

text

Alias
NCI Thesaurus ObjectClass
C12434
UMLS 2011AA ObjectClass
C0229664
NCI Thesaurus ObjectClass
C19157
UMLS 2011AA ObjectClass
C0370003
NCI Thesaurus Property
C15319
NCI Thesaurus Property
C25648
UMLS 2011AA Property
C0439849
NCI Thesaurus Property
C9305
UMLS 2011AA Property
C0006826
NCI Thesaurus Property
C25460
UMLS 2011AA Property
C1511481
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
In the opinion of the investigator, is the patient eligible (150910)
Description

PatientEligibilityIndicator

Data type

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25171
UMLS 2011AA Property
C0013893
Initial Patient Consent For Specimen Use
Description

Initial Patient Consent For Specimen Use

Patient's Initial Consent given for specimen kept for future use in research to learn about, prevent, or treat cancer (model consent question #3)
Description

PersonSpecimenMalignantNeoplasmResearchConsentInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C15319
NCI Thesaurus Property
C9305
UMLS 2011AA Property
C0006826
NCI Thesaurus Property
C19157
UMLS 2011AA Property
C0370003
NCI Thesaurus Property
C25460
UMLS 2011AA Property
C1511481
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Patient's initial consent given for specimen(s) may be kept for use in research to learn about, prevent, or treat other health problems (for example: diabetes, Alzheimer's disease, or heart disease) (model consent question #4)
Description

PatientOtherDiseaseorDisorderClinicalStudyConsentInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus Property
C2991
UMLS 2011AA Property
C0012634
NCI Thesaurus Property
C15206
UMLS 2011AA Property
C0008972
NCI Thesaurus Property
C25460
UMLS 2011AA Property
C1511481
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Patient's initial consent given for further contact to participate in research on future studies (model consent question #5)
Description

PatientContactConsentInd-3

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C67527
UMLS 2011AA Property
C0016884
NCI Thesaurus Property
C25460
UMLS 2011AA Property
C1511481
NCI Thesaurus Property
C16452
UMLS 2011AA Property
C0009452
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
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Similar models

A Phase II Trial of Ofatumumab in Previously Untreated Follicular Non-Hodgkin's Lymphoma (NHL)

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Protocol Administration
InformedConsentFormSignedDate
Item
Date Informed Consent Signed (MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
C16468 (NCI Thesaurus ObjectClass)
C0009797 (UMLS 2011AA ObjectClass)
C25679 (NCI Thesaurus Property)
PatientSignedDischargeMedicalRecordDate
Item
HIPAA Authorization Date (MM DD YYYY)
date
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25679 (NCI Thesaurus Property)
C0012621 (NCI Metathesaurus Property)
C45258 (NCI Thesaurus Property)
C0025102 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
TreatmentProjectedBeginDate
Item
Projected Start Date of Treatment (MM DD YYYY)
date
C15368 (NCI Thesaurus ObjectClass)
C25631 (NCI Thesaurus ObjectClass)
C25431 (NCI Thesaurus Property)
C0439659 (UMLS 2011AA Property)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain)
C0439659 (UMLS 2011AA ValueDomain)
Item Group
Pre-treatment Characteristics
Item
Disease
text
C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)
C25586 (NCI Thesaurus ObjectClass)
C0205314 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
CL.1
Code List
Disease
CL Item
Nhl (NHL)
Item
Stage
text
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)
C38027 (NCI Thesaurus Property)
C1519504 (UMLS 2011AA Property)
CL.2
Code List
Stage
CL Item
Iii, Iv, Or Bulky Stage Ii (III, IV, or bulky stage II)
Item
Pathologic Type
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus Property)
C0006826 (UMLS 2011AA Property)
C18189 (NCI Thesaurus Property)
C0030664 (UMLS 2011AA Property)
C16112 (NCI Thesaurus Property)
C1516637 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.3
Code List
Pathologic Type
CL Item
Follicular Lymphoma (Follicular Lymphoma)
C3209 (NCI Thesaurus)
C0024301 (UMLS 2011AA)
Item Group
Certification Of Eligibility
Item
In the opinion of the investigator, is the patient eligible (150910)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
CL.8
Code List
In the opinion of the investigator, is the patient eligible (150910)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item Group
Certification Of Eligibility And Protocol Design
Item
Assigned Treatment Arm
text
C15368 (NCI Thesaurus ObjectClass)
C42651 (NCI Thesaurus ObjectClass)
C0442711 (UMLS 2011AA ObjectClass)
C32141 (NCI Thesaurus Property)
C1140618 (UMLS 2011AA Property)
C25426 (NCI Thesaurus Property)
C1516050 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.5
Code List
Assigned Treatment Arm
CL Item
Ofatumumab 500 Mg (Ofatumumab 500 mg)
CL Item
Ofatumumab 1000 Mg (Ofatumumab 1000 mg)
Item Group
Initial Patient Consent For Specimen Use
Item
Patient's initial consent given for specimen use for genetic research relating to the study treatment (model consent question #1 If the patient answered "Yes" to this question, register the patient to 150910 during registration to 50901)
text
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C15319 (NCI Thesaurus Property)
C25648 (NCI Thesaurus Property)
C0439849 (UMLS 2011AA Property)
C17938 (NCI Thesaurus Property)
C0314603 (UMLS 2011AA Property)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.6
Code List
Patient's initial consent given for specimen use for genetic research relating to the study treatment (model consent question #1 If the patient answered "Yes" to this question, register the patient to 150910 during registration to 50901)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Patient's Initial Consent given for specimen use for research on the patient's cancer (model consent question #2 If the patient answered "Yes" to this question, register the patient to 150910 during registration to 50901)
text
C12434 (NCI Thesaurus ObjectClass)
C0229664 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C15319 (NCI Thesaurus Property)
C25648 (NCI Thesaurus Property)
C0439849 (UMLS 2011AA Property)
C9305 (NCI Thesaurus Property)
C0006826 (UMLS 2011AA Property)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.7
Code List
Patient's Initial Consent given for specimen use for research on the patient's cancer (model consent question #2 If the patient answered "Yes" to this question, register the patient to 150910 during registration to 50901)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
In the opinion of the investigator, is the patient eligible (150910)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
CL.8
Code List
In the opinion of the investigator, is the patient eligible (150910)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item Group
Initial Patient Consent For Specimen Use
Item
Patient's Initial Consent given for specimen kept for future use in research to learn about, prevent, or treat cancer (model consent question #3)
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C15319 (NCI Thesaurus Property)
C9305 (NCI Thesaurus Property)
C0006826 (UMLS 2011AA Property)
C19157 (NCI Thesaurus Property)
C0370003 (UMLS 2011AA Property)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.9
Code List
Patient's Initial Consent given for specimen kept for future use in research to learn about, prevent, or treat cancer (model consent question #3)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Patient's initial consent given for specimen(s) may be kept for use in research to learn about, prevent, or treat other health problems (for example: diabetes, Alzheimer's disease, or heart disease) (model consent question #4)
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C2991 (NCI Thesaurus Property)
C0012634 (UMLS 2011AA Property)
C15206 (NCI Thesaurus Property)
C0008972 (UMLS 2011AA Property)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.10
Code List
Patient's initial consent given for specimen(s) may be kept for use in research to learn about, prevent, or treat other health problems (for example: diabetes, Alzheimer's disease, or heart disease) (model consent question #4)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Patient's initial consent given for further contact to participate in research on future studies (model consent question #5)
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C67527 (NCI Thesaurus Property)
C0016884 (UMLS 2011AA Property)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
C16452 (NCI Thesaurus Property)
C0009452 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.11
Code List
Patient's initial consent given for further contact to participate in research on future studies (model consent question #5)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
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