ID

30263

Description

https://clinicaltrials.gov/show/NCT00989664 Independent Response Evaluation, Radiologist's Assessment Study ID: 104504 Clinical Study ID: BEX104504 Study Title: Multicenter, Pivotal Phase III Study of Iodine-131 Anti-B1 Antibody (Murine) Radioimmunotherapy for Chemotherapy Refractory Low Grade B Cell Lymphomas and Low Grade Lymphomas that have Transformed to Higher Grade Histologies Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00989664 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: tositumomab Trade Name: Bexxar Study Indication: Lymphoma, Non-Hodgkin

Link

https://clinicaltrials.gov/show/NCT00989664

Keywords

Versions (1)
  1. 5/25/18 5/25/18 -
Copyright Holder

GlaxoSmithKline (GSK)

Uploaded on

May 25, 2018

DOI

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License

Creative Commons BY-NC 3.0
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Multicenter, Pivotal Phase III Study of Iodine-131 Anti-B1 Antibody (Murine) Radioimmunotherapy NCT00989664

English

Independent Response Evaluation, Radiologist's Assessment

1 forms  
Radiologist's Assessment
Description

Radiologist's Assessment

Alias
UMLS CUI-1
C0031831
UMLS CUI-2
C1514693
UMLS CUI-3
C0220825
Scan Date
Description

Scan Date

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0040405
Lesion Number/Name
Description

Lesion Number/Name

Data type

text

Alias
UMLS CUI [1,1]
C0449791
UMLS CUI [1,2]
C2986546
Lesion Measurements
Description

Lesion Measurements

Data type

integer

Measurement units
  • cm x cm = cm²
Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1301886
cm x cm = cm²
Sum of Products
Description

Sum of Products

Data type

integer

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0024299
UMLS CUI [1,3]
C0439534
UMLS CUI [2]
C1704444
UMLS CUI [3,1]
C0242485
UMLS CUI [3,2]
C1515051
Date of Response:
Description

Date of Response

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0521982
Response:
Description

Response

Data type

integer

Alias
UMLS CUI [1]
C0521982
Comments:
Description

Comments

Data type

text

Alias
UMLS CUI [1]
C0947611
Consensus Criteria
Description

Consensus Criteria

Alias
UMLS CUI-1
C0376298
Indicator Lesion Numbers: (from Form 1B A)
Description

Indicator Lesion Numbers

Data type

integer

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1522602
UMLS CUI [1,3]
C0237753
Response Date
Description

Response Date

Data type

date

Alias
UMLS CUI [1,1]
C0521982
UMLS CUI [1,2]
C0011008
SPPD Indicator Lesions (cm²)
Description

SPPD Indicator Lesions

Data type

integer

Measurement units
  • cm²
Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1522602
cm²
Consensus Response
Description

Consensus Response

Data type

integer

Alias
UMLS CUI [1,1]
C0521982
UMLS CUI [1,2]
C0376298
Comments:
Description

Comments

Data type

text

Alias
UMLS CUI [1]
C0947611
Radiologist's Signature:
Description

Radiologist's Signature

Data type

text

Alias
UMLS CUI [1,1]
C1519316
UMLS CUI [1,2]
C0031831
UMLS CUI [1,3]
C1514693
Date
Description

Date

Data type

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
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Similar models

Independent Response Evaluation, Radiologist's Assessment

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Radiologist's Assessment
C0031831 (UMLS CUI-1)
C1514693 (UMLS CUI-2)
C0220825 (UMLS CUI-3)
Scan Date
Item
Scan Date
date
C0011008 (UMLS CUI [1,1])
C0040405 (UMLS CUI [1,2])
Lesion Number/Name
Item
Lesion Number/Name
text
C0449791 (UMLS CUI [1,1])
C2986546 (UMLS CUI [1,2])
Lesion Measurements
Item
Lesion Measurements
integer
C0221198 (UMLS CUI [1,1])
C1301886 (UMLS CUI [1,2])
Sum of Products
Item
Sum of Products
integer
C0221198 (UMLS CUI [1,1])
C0024299 (UMLS CUI [1,2])
C0439534 (UMLS CUI [1,3])
C1704444 (UMLS CUI [2])
C0242485 (UMLS CUI [3,1])
C1515051 (UMLS CUI [3,2])
Date of Response
Item
Date of Response:
date
C0011008 (UMLS CUI [1,1])
C0521982 (UMLS CUI [1,2])
Item
Response:
integer
C0521982 (UMLS CUI [1])
Response
Code List
Response:
CL Item
CR (1)
CL Item
CCR (2)
CL Item
PR (3)
CL Item
SD (4)
CL Item
PD (5)
CL Item
NA/(baseline) (6)
Comments
Item
Comments:
text
C0947611 (UMLS CUI [1])
Item Group
Consensus Criteria
C0376298 (UMLS CUI-1)
Indicator Lesion Numbers
Item
Indicator Lesion Numbers: (from Form 1B A)
integer
C0221198 (UMLS CUI [1,1])
C1522602 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
Response Date
Item
Response Date
date
C0521982 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
SPPD Indicator Lesions
Item
SPPD Indicator Lesions (cm²)
integer
C0221198 (UMLS CUI [1,1])
C1522602 (UMLS CUI [1,2])
Item
Consensus Response
integer
C0521982 (UMLS CUI [1,1])
C0376298 (UMLS CUI [1,2])
Consensus Response
Code List
Consensus Response
CL Item
CR (1)
CL Item
CRu (2)
CL Item
PR (3)
CL Item
SD (4)
CL Item
PD (5)
CL Item
NA (6)
Comments
Item
Comments:
text
C0947611 (UMLS CUI [1])
Radiologist's Signature
Item
Radiologist's Signature:
text
C1519316 (UMLS CUI [1,1])
C0031831 (UMLS CUI [1,2])
C1514693 (UMLS CUI [1,3])
Date
Item
Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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