ID

31377

Description

Study ID: 104507 Clinical Study ID: BEX104507 Study Title: Phase II Study of Iodine-131 Anti-B1 Antibody for Non Hodgkin’s Lymphoma Patients who have Previously Received Rituximab Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00996593 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 (2)
  1. 7/23/18 7/23/18 -
  2. 8/18/18 8/18/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

August 18, 2018

DOI

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License

Creative Commons BY-NC 3.0
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Iodine-131 Anti-B1 Antibody for Non Hodgkin’s Lymphomas NCT00996593

English

Post- Treatment Response Follow- Up

1 forms  
Visit Week
Description

Visit Week

Alias
UMLS CUI-1
C0545082
UMLS CUI-2
C0439230
Please check the appropriate visit week
Description

visit week

Data type

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0439230
Other Visit Week
Description

Visit; Week; Other

Data type

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0439230
UMLS CUI [1,3]
C0205394
CT or other Radiological Imaging Results
Description

CT or other Radiological Imaging Results

Alias
UMLS CUI-1
C0040405
UMLS CUI-2
C1274040
UMLS CUI-3
C0011923
UMLS CUI-4
C0205483
UMLS CUI-5
C1274040
Imaging Location
Description

Location

Data type

text

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C0450429
Imaging Finding
Description

Finding

Data type

text

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C0243095
If abnormal finding, please specify
Description

If abnormal, please specify

Data type

text

Alias
UMLS CUI [1,1]
C0243095
UMLS CUI [1,2]
C0205161
UMLS CUI [1,3]
C2348235
Imaging Type
Description

Imaging Type

Data type

text

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C0332307
Date of Imaging
Description

Date of Imaging

Data type

date

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C0011008
Bone Marrow Biopsy
Description

Bone Marrow Biopsy

Alias
UMLS CUI-1
C0005954
Bone Marrow Biopsy
Description

Bone Marrow Biopsy

Data type

text

Alias
UMLS CUI [1]
C0005954
Date of Biopsy
Description

Date of Biopsy

Data type

date

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

Marrow cellularity

Data type

text

Alias
UMLS CUI [1]
C1561532
Tumor involvement
Description

Tumor involvement

Data type

text

Measurement units
  • %
Alias
UMLS CUI [1]
C1517677
%
Tumor Involvement Dimension
Description

Dimension

Data type

text

Alias
UMLS CUI [1,1]
C1517677
UMLS CUI [1,2]
C0439534
Measurable Lymphoma Disease
Description

Measurable Lymphoma Disease

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

Site

Data type

text

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

Method of Determination

Data type

text

Alias
UMLS CUI [1]
C2911685
Evaluation Date (mm/dd/yy)
Description

Date

Data type

date

Alias
UMLS CUI [1,1]
C0220825
UMLS CUI [1,2]
C0011008
Tumor Measurements (cm x cm)
Description

Tumor Measurements

Data type

text

Alias
UMLS CUI [1,1]
C0242485
UMLS CUI [1,2]
C0027651
Tumor Measurements
Description

Tumor Measurements

Data type

float

Measurement units
  • cm2
Alias
UMLS CUI [1,1]
C0242485
UMLS CUI [1,2]
C0027651
cm2
Non- Measurable Disease
Description

Non- Measurable Disease

Alias
UMLS CUI-1
C1334988
Non- Measurable Disease
Description

Non- Measurable Disease

Data type

text

Alias
UMLS CUI [1]
C1334988
Disease Site
Description

Site

Data type

text

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

Method of Determination

Data type

text

Alias
UMLS CUI [1]
C2911685
Evaluation Date (mm/dd/yy)
Description

Date

Data type

date

Alias
UMLS CUI [1,1]
C0220825
UMLS CUI [1,2]
C0011008
Finding
Description

Finding

Data type

text

Alias
UMLS CUI [1]
C0243095
Response
Description

Response

Alias
UMLS CUI-1
C0521982
Response
Description

Response

Data type

text

Alias
UMLS CUI [1]
C0521982
Date of Response Evaluation
Description

Date of Response Evaluation

Data type

date

Alias
UMLS CUI [1,1]
C0521982
UMLS CUI [1,2]
C0220825
UMLS CUI [1,3]
C0011008
Comments
Description

Comments

Data type

text

Alias
UMLS CUI [1]
C0947611
Administrative
Description

Administrative

Alias
UMLS CUI-1
C1320722
Series page
Description

Series page

Data type

text

Alias
UMLS CUI [1,1]
C0205549
UMLS CUI [1,2]
C1704732
Last Page
Description

Last Page

Data type

boolean

Alias
UMLS CUI [1,1]
C1704732
UMLS CUI [1,2]
C1517741
Signature of Investigator
Description

Signature of Investigator

Data type

text

Alias
UMLS CUI [1]
C2346576
Evaluation Date
Description

Date

Data type

date

Alias
UMLS CUI [1,1]
C0220825
UMLS CUI [1,2]
C0011008
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Similar models

Post- Treatment Response Follow- Up

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Visit Week
C0545082 (UMLS CUI-1)
C0439230 (UMLS CUI-2)
Item
Please check the appropriate visit week
text
C0545082 (UMLS CUI [1,1])
C0439230 (UMLS CUI [1,2])
visit week
Code List
Please check the appropriate visit week
CL Item
Week 52 (1 year) (1)
CL Item
Week 78 (1,5 years) (2)
CL Item
Week 104 (2 years) (3)
Visit; Week; Other
Item
Other Visit Week
text
C0545082 (UMLS CUI [1,1])
C0439230 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Item Group
CT or other Radiological Imaging Results
C0040405 (UMLS CUI-1)
C1274040 (UMLS CUI-2)
C0011923 (UMLS CUI-3)
C0205483 (UMLS CUI-4)
C1274040 (UMLS CUI-5)
Item
Imaging Location
text
C0011923 (UMLS CUI [1,1])
C0450429 (UMLS CUI [1,2])
Location
Code List
Imaging Location
CL Item
Head/ Neck (2)
CL Item
Chest (3)
CL Item
Abdomen (4)
CL Item
Pelvis (5)
CL Item
Other (99)
Item
Imaging Finding
text
C0011923 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
Finding
Code List
Imaging Finding
CL Item
Normal (1)
CL Item
Abnormal (Specify) (2)
CL Item
Not done (0)
If abnormal, please specify
Item
If abnormal finding, please specify
text
C0243095 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item
Imaging Type
text
C0011923 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Imaging Type
Code List
Imaging Type
CL Item
CT (10)
CL Item
MRI (12)
CL Item
X-ray (1)
CL Item
Other (99)
Date of Imaging
Item
Date of Imaging
date
C0011923 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Bone Marrow Biopsy
C0005954 (UMLS CUI-1)
Item
Bone Marrow Biopsy
text
C0005954 (UMLS CUI [1])
Bone Marrow Biopsy
Code List
Bone Marrow Biopsy
CL Item
Not Done (2)
CL Item
Not indicated (BM not possible at baseline) (4)
CL Item
Not indicated (patient not in CR) (3)
Date of Biopsy
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)
Tumor involvement
Item
Tumor involvement
text
C1517677 (UMLS CUI [1])
Item
Tumor Involvement Dimension
text
C1517677 (UMLS CUI [1,1])
C0439534 (UMLS CUI [1,2])
Dimension
Code List
Tumor Involvement Dimension
CL Item
Unilateral (1)
CL Item
Bilateral (2)
Item Group
Measurable Lymphoma Disease
C0024299 (UMLS CUI-1)
C1513041 (UMLS CUI-2)
Site
Item
Disease Site
text
C0012634 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
Method of Determination
Item
Method of Determination
text
C2911685 (UMLS CUI [1])
Date
Item
Evaluation Date (mm/dd/yy)
date
C0220825 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Tumor Measurements
Item
Tumor Measurements (cm x cm)
text
C0242485 (UMLS CUI [1,1])
C0027651 (UMLS CUI [1,2])
Tumor Measurements
Item
Tumor Measurements
float
C0242485 (UMLS CUI [1,1])
C0027651 (UMLS CUI [1,2])
Item Group
Non- Measurable Disease
C1334988 (UMLS CUI-1)
Item
Non- Measurable Disease
text
C1334988 (UMLS CUI [1])
Non- Measurable Disease
Code List
Non- Measurable Disease
CL Item
None (1)
CL Item
Not done (2)
Site
Item
Disease Site
text
C0012634 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
Method of Determination
Item
Method of Determination
text
C2911685 (UMLS CUI [1])
Date
Item
Evaluation Date (mm/dd/yy)
date
C0220825 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Finding
text
C0243095 (UMLS CUI [1])
Finding
Code List
Finding
CL Item
New (1)
CL Item
Increased (2)
CL Item
Stable (3)
CL Item
Decreased (4)
Item Group
Response
C0521982 (UMLS CUI-1)
Item
Response
text
C0521982 (UMLS CUI [1])
Response
Code List
Response
CL Item
CR (5)
CL Item
CCR (4)
CL Item
PR (3)
CL Item
SD (2)
CL Item
PD (1)
Date of Response Evaluation
Item
Date of Response Evaluation
date
C0521982 (UMLS CUI [1,1])
C0220825 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Item Group
Administrative
C1320722 (UMLS CUI-1)
Series page
Item
Series page
text
C0205549 (UMLS CUI [1,1])
C1704732 (UMLS CUI [1,2])
Last Page
Item
Last Page
boolean
C1704732 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
Signature of Investigator
Item
Signature of Investigator
text
C2346576 (UMLS CUI [1])
Date
Item
Evaluation Date
date
C0220825 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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