ID

31034

Description

Study ID: 104505 Clinical Study ID: BEX104505 Study Title: Phase II Study of Iodine 131 Anti B1 Antibody for 1st or 2nd Relapsed Indolent B-Cell Lymphomas or B-Cell Lymphomas That Have Transformed to a More Aggressive Histology Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00950755 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: tositumomab Trade Name: Bexxar Study Indication: Lymphoma, Non-Hodgkin

Keywords

Versions (1)
  1. 7/12/18 7/12/18 -
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see clinicaltrials.gov

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July 12, 2018

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License

Creative Commons BY 4.0
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Iodine 131 B1 Antibody for B-Cell Lymphomas NCT00950755

English

Disease Staging - Baseline

1 forms  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Site Number
Description

Site number

Data type

text

Alias
UMLS CUI [1,1]
C0018704
UMLS CUI [1,2]
C0600091
Patient Number
Description

Patient Number

Data type

text

Alias
UMLS CUI [1]
C1830427
Patient Initials
Description

Patient Initials

Data type

text

Alias
UMLS CUI [1]
C2986440
Diagnostic Imaging, Head/Neck
Description

Diagnostic Imaging, Head/Neck

Alias
UMLS CUI-1
C0011923
UMLS CUI-2
C0460004
Not Done
Description

Diagnostic Imaging, Head and neck structure, Not Done

Data type

boolean

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C0460004
UMLS CUI [1,3]
C1272696
Date
Description

Diagnostic Imaging, Head and neck structure, Date

Data type

date

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C0460004
UMLS CUI [1,3]
C0011008
Imaging
Description

Diagnostic Imaging, Head/Neck

Data type

text

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C0460004
Result
Description

Diagnostic Imaging, Head/Neck, Result

Data type

text

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C0460004
UMLS CUI [1,3]
C1274040
Diagnostic Imaging; Chest
Description

Diagnostic Imaging; Chest

Alias
UMLS CUI-1
C0011923
UMLS CUI-2
C0817096
Not Done
Description

Diagnostic Imaging, Chest, Not Done

Data type

boolean

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C0817096
UMLS CUI [1,3]
C1272696
Date
Description

Diagnostic Imaging, Chest, Date

Data type

date

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C0817096
UMLS CUI [1,3]
C0011008
Imaging
Description

Diagnostic Imaging, Chest

Data type

text

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C0817096
Result
Description

Diagnostic Imaging, Chest, Results

Data type

text

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C0817096
UMLS CUI [1,3]
C1274040
Diagnostic Imaging, Abdomen
Description

Diagnostic Imaging, Abdomen

Alias
UMLS CUI-1
C0011923
UMLS CUI-2
C0000726
Not done
Description

Diagnostic Imaging, Abdomen, Not done

Data type

boolean

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C0000726
UMLS CUI [1,3]
C1272696
Date
Description

Diagnostic Imaging, Abdomen, Date

Data type

date

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C0000726
UMLS CUI [1,3]
C0011008
Imaging
Description

Diagnostic Imaging, Abdomen

Data type

text

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C0000726
Result
Description

Diagnostic Imaging, Abdomen, Result

Data type

text

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C0000726
UMLS CUI [1,3]
C1274040
Diagnostic Imaging, Pelvis
Description

Diagnostic Imaging, Pelvis

Alias
UMLS CUI-1
C0011923
UMLS CUI-2
C0030797
Not Done
Description

Diagnostic Imaging, Pelvis, Not done

Data type

boolean

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C0030797
UMLS CUI [1,3]
C1272696
Date
Description

Diagnostic Imaging, Pelvis, Date

Data type

date

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C0030797
UMLS CUI [1,3]
C0011008
Imaging
Description

Diagnostic Imaging, Pelvis

Data type

text

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C0030797
Result
Description

Diagnostic Imaging, Pelvis, Result

Data type

text

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C0030797
UMLS CUI [1,3]
C1274040
Diagnostic Imaging, Other
Description

Diagnostic Imaging, Other

Alias
UMLS CUI-1
C0011923
UMLS CUI-2
C0205394
Not Done
Description

Diagnostic Imaging, Other, Not Done

Data type

boolean

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C1272696
Date
Description

Diagnostic Imaging, Other, Date

Data type

date

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0011008
Imaging
Description

Diagnostic Imaging, Other

Data type

text

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C0205394
Result
Description

Diagnostic Imaging, Other, Result

Data type

text

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C1274040
Bone Marrow Biopsy
Description

Bone Marrow Biopsy

Alias
UMLS CUI-1
C0005954
Date of biopsy
Description

Biopsy, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0005558
UMLS CUI [1,2]
C0011008
Marrow cellularity
Description

Bone marrow cellularity finding

Data type

text

Alias
UMLS CUI [1]
C1561532
Tumor involvement
Description

Malignant Neoplasms, Involvement with

Data type

integer

Measurement units
  • %
Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C1314939
%
Tumor involvement
Description

Malignant Neoplasms, Involvement with

Data type

text

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C1314939
Measurable Lymphoma Disease
Description

Measurable Lymphoma Disease

Alias
UMLS CUI-1
C0024299
UMLS CUI-2
C1513041
Site
Description

Measurable Lymphoma Disease, Site

Data type

text

Alias
UMLS CUI [1,1]
C0024299
UMLS CUI [1,2]
C1513041
UMLS CUI [1,3]
C1515974
Method of Determination
Description

Measurable Lymphoma Disease, Method of Determination

Data type

text

Alias
UMLS CUI [1,1]
C0024299
UMLS CUI [1,2]
C1513041
UMLS CUI [1,3]
C2911685
Date
Description

Measurable Lymphoma Disease, Date

Data type

date

Alias
UMLS CUI [1,1]
C0024299
UMLS CUI [1,2]
C1513041
UMLS CUI [1,3]
C0242485
UMLS CUI [1,4]
C0011008
Tumor Measurements
Description

Measurable Lymphoma Disease, Tumor Measurements

Data type

integer

Measurement units
  • cm x cm = cm²
Alias
UMLS CUI [1,1]
C0024299
UMLS CUI [1,2]
C1513041
UMLS CUI [1,3]
C0475440
cm x cm = cm²
Non-Measurable Disease
Description

Non-Measurable Disease

Alias
UMLS CUI-1
C0012634
UMLS CUI-2
C1518373
Site
Description

Non-Measurable Disease, Site

Data type

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1518373
UMLS CUI [1,3]
C1515974
Method of Determination
Description

Non-Measurable Disease, Method of Determination

Data type

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1518373
UMLS CUI [1,3]
C2911685
Date
Description

Non-Measurable Disease, Date

Data type

date

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1518373
UMLS CUI [1,3]
C0011008
Check one
Description

Non-Measurable Disease, Status

Data type

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1518373
UMLS CUI [1,3]
C0449438
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Similar models

Disease Staging - Baseline

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Site number
Item
Site Number
text
C0018704 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Patient Number
Item
Patient Number
text
C1830427 (UMLS CUI [1])
Patient Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Item Group
Diagnostic Imaging, Head/Neck
C0011923 (UMLS CUI-1)
C0460004 (UMLS CUI-2)
Diagnostic Imaging, Head and neck structure, Not Done
Item
Not Done
boolean
C0011923 (UMLS CUI [1,1])
C0460004 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Diagnostic Imaging, Head and neck structure, Date
Item
Date
date
C0011923 (UMLS CUI [1,1])
C0460004 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Imaging
text
C0011923 (UMLS CUI [1,1])
C0460004 (UMLS CUI [1,2])
Diagnostic Imaging, Head/Neck
Code List
Imaging
CL Item
CT (CT)
CL Item
MRI (MRI)
CL Item
X-ray (X-ray)
CL Item
Other (Other)
Item
Result
text
C0011923 (UMLS CUI [1,1])
C0460004 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Diagnostic Imaging, Head/Neck
Code List
Result
CL Item
Normal (Normal)
CL Item
Abnormal (specify) (Abnormal (specify))
Item Group
Diagnostic Imaging; Chest
C0011923 (UMLS CUI-1)
C0817096 (UMLS CUI-2)
Diagnostic Imaging, Chest, Not Done
Item
Not Done
boolean
C0011923 (UMLS CUI [1,1])
C0817096 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Diagnostic Imaging, Chest, Date
Item
Date
date
C0011923 (UMLS CUI [1,1])
C0817096 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Imaging
text
C0011923 (UMLS CUI [1,1])
C0817096 (UMLS CUI [1,2])
Diagnostic Imaging, Chest
Code List
Imaging
CL Item
CT (CT)
CL Item
MRI (MRI)
CL Item
X-ray (X-ray)
CL Item
Other (Other)
Item
Result
text
C0011923 (UMLS CUI [1,1])
C0817096 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Diagnostic Imaging, Chest
Code List
Result
CL Item
Normal (Normal)
CL Item
Abnormal (specify) (Abnormal (specify))
Item Group
Diagnostic Imaging, Abdomen
C0011923 (UMLS CUI-1)
C0000726 (UMLS CUI-2)
Diagnostic Imaging, Abdomen, Not done
Item
Not done
boolean
C0011923 (UMLS CUI [1,1])
C0000726 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Diagnostic Imaging, Abdomen, Date
Item
Date
date
C0011923 (UMLS CUI [1,1])
C0000726 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Imaging
text
C0011923 (UMLS CUI [1,1])
C0000726 (UMLS CUI [1,2])
Diagnostic Imaging, Abdomen
Code List
Imaging
CL Item
CT (CT)
CL Item
MRI (MRI)
CL Item
X-ray (X-ray)
CL Item
Other (Other)
Item
Result
text
C0011923 (UMLS CUI [1,1])
C0000726 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Diagnostic Imaging, Abdomen
Code List
Result
CL Item
Normal (Normal)
CL Item
Abnormal (specify) (Abnormal (specify))
Item Group
Diagnostic Imaging, Pelvis
C0011923 (UMLS CUI-1)
C0030797 (UMLS CUI-2)
Diagnostic Imaging, Pelvis, Not done
Item
Not Done
boolean
C0011923 (UMLS CUI [1,1])
C0030797 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Diagnostic Imaging, Pelvis, Date
Item
Date
date
C0011923 (UMLS CUI [1,1])
C0030797 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Imaging
text
C0011923 (UMLS CUI [1,1])
C0030797 (UMLS CUI [1,2])
Diagnostic Imaging, Pelvis
Code List
Imaging
CL Item
CT (CT)
CL Item
MRI (MRI)
CL Item
X-ray (X-ray)
CL Item
Other (Other)
Item
Result
text
C0011923 (UMLS CUI [1,1])
C0030797 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Diagnostic Imaging, Pelvis
Code List
Result
CL Item
Normal (Normal)
CL Item
Abnormal (specify) (Abnormal (specify))
Item Group
Diagnostic Imaging, Other
C0011923 (UMLS CUI-1)
C0205394 (UMLS CUI-2)
Diagnostic Imaging, Other, Not Done
Item
Not Done
boolean
C0011923 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Diagnostic Imaging, Other, Date
Item
Date
date
C0011923 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Imaging
text
C0011923 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Diagnostic Imaging, Other
Code List
Imaging
CL Item
CT (CT)
CL Item
MRI (MRI)
CL Item
X-ray (X-ray)
CL Item
Other (Other)
Item
Result
text
C0011923 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Diagnostic Imaging, Other
Code List
Result
CL Item
Normal (Normal)
CL Item
Abnormal (specify) (Abnormal (specify))
Item Group
Bone Marrow Biopsy
C0005954 (UMLS CUI-1)
Biopsy, Date in time
Item
Date of biopsy
date
C0005558 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Marrow cellularity
text
C1561532 (UMLS CUI [1])
Marrow cellularity
Code List
Marrow cellularity
CL Item
Normal (1)
CL Item
Hypocellular (2)
CL Item
Hypercellular (3)
Malignant Neoplasms, Involvement with
Item
Tumor involvement
integer
C0006826 (UMLS CUI [1,1])
C1314939 (UMLS CUI [1,2])
Item
Tumor involvement
text
C0006826 (UMLS CUI [1,1])
C1314939 (UMLS CUI [1,2])
Malignant Neoplasms, Involvement with
Code List
Tumor involvement
CL Item
Unilateral (1)
CL Item
Bilateral (2)
Item Group
Measurable Lymphoma Disease
C0024299 (UMLS CUI-1)
C1513041 (UMLS CUI-2)
Measurable Lymphoma Disease, Site
Item
Site
text
C0024299 (UMLS CUI [1,1])
C1513041 (UMLS CUI [1,2])
C1515974 (UMLS CUI [1,3])
Measurable Lymphoma Disease, Method of Determination
Item
Method of Determination
text
C0024299 (UMLS CUI [1,1])
C1513041 (UMLS CUI [1,2])
C2911685 (UMLS CUI [1,3])
Measurable Lymphoma Disease, Date
Item
Date
date
C0024299 (UMLS CUI [1,1])
C1513041 (UMLS CUI [1,2])
C0242485 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Measurable Lymphoma Disease, Tumor Measurements
Item
Tumor Measurements
integer
C0024299 (UMLS CUI [1,1])
C1513041 (UMLS CUI [1,2])
C0475440 (UMLS CUI [1,3])
Item Group
Non-Measurable Disease
C0012634 (UMLS CUI-1)
C1518373 (UMLS CUI-2)
Non-Measurable Disease, Site
Item
Site
text
C0012634 (UMLS CUI [1,1])
C1518373 (UMLS CUI [1,2])
C1515974 (UMLS CUI [1,3])
Non-Measurable Disease, Method of Determination
Item
Method of Determination
text
C0012634 (UMLS CUI [1,1])
C1518373 (UMLS CUI [1,2])
C2911685 (UMLS CUI [1,3])
Non-Measurable Disease, Date
Item
Date
date
C0012634 (UMLS CUI [1,1])
C1518373 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Check one
text
C0012634 (UMLS CUI [1,1])
C1518373 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,3])
Non-Measurable Disease, Status
Code List
Check one
CL Item
New (New)
CL Item
Increased (Increased)
CL Item
Stable (Stable)
CL Item
Decreased (Decreased)
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