ID

44324

Beschreibung

https://clinicaltrials.gov/show/NCT00989664 Central Pathology 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

Stichworte

Versionen (2)
  1. 25.05.18 25.05.18 -
  2. 20.09.21 20.09.21 -
Rechteinhaber

GlaxoSmithKline (GSK)

Hochgeladen am

20. September 2021

DOI

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Lizenz

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

Englisch

Central Pathology Assessment

1 Formulare  
Central Pathology Assessment
Beschreibung

Central Pathology Assessment

Alias
UMLS CUI-1
C0030664
Biopsy Number
Beschreibung

Biopsy Number

Datentyp

integer

Alias
UMLS CUI [1,1]
C0005558
UMLS CUI [1,2]
C0237753
Biopsy date:
Beschreibung

Biopsy date

Datentyp

date

Alias
UMLS CUI [1,1]
C0005558
UMLS CUI [1,2]
C0011008
Site:
Beschreibung

Biopsy site

Datentyp

text

Alias
UMLS CUI [1]
C1301128
Accession #:
Beschreibung

Accession #

Datentyp

integer

Alias
UMLS CUI [1,1]
C1510755
UMLS CUI [1,2]
C0005558
Number of slides:
Beschreibung

Number of slides

Datentyp

integer

Alias
UMLS CUI [1,1]
C1705201
UMLS CUI [1,2]
C0449788
Name/location of original path site:
Beschreibung

Name/location of original path site

Datentyp

text

Alias
UMLS CUI [1,1]
C1527021
UMLS CUI [1,2]
C0205145
UMLS CUI [1,3]
C0027365
Working Formulation Classification: Histology
Beschreibung

Histology Number

Datentyp

integer

Alias
UMLS CUI [1,1]
C0019638
UMLS CUI [1,2]
C0237753
Histology - Cell types
Beschreibung

Histology - Cell types

Datentyp

integer

Alias
UMLS CUI [1]
C0449574
Specify: Other cell type
Beschreibung

Other Cell type

Datentyp

text

Alias
UMLS CUI [1,1]
C0449475
UMLS CUI [1,2]
C2348235
Central Pathologist Assessment
Beschreibung

Central Pathologist Assessment

Datentyp

integer

Alias
UMLS CUI [1,1]
C0334866
UMLS CUI [1,2]
C1516048
Transformed Low-Grade NHL
Beschreibung

Transformed Low-Grade NHL

Datentyp

integer

Alias
UMLS CUI [1,1]
C0024305
UMLS CUI [1,2]
C1282907
UMLS CUI [1,3]
C0457344
Basis of Assessment
Beschreibung

Basis of Assessment

Datentyp

integer

Alias
UMLS CUI [1,1]
C0220825
UMLS CUI [1,2]
C1874451
Pathology Assessment Description
Beschreibung

Pathology Assessment Description

Alias
UMLS CUI-1
C0030664
UMLS CUI-2
C0678257
Description:
Beschreibung

Description

Datentyp

text

Alias
UMLS CUI [1,1]
C0678257
UMLS CUI [1,2]
C0030664
Central Pathology Diagnosis:
Beschreibung

Central Pathology Diagnosis

Datentyp

text

Alias
UMLS CUI [1,1]
C0030664
UMLS CUI [1,2]
C0011900
Concordance with Original Pathology Report:
Beschreibung

Concordance with Original Pathology Report

Datentyp

integer

Alias
UMLS CUI [1,1]
C0449438
UMLS CUI [1,2]
C2347585
UMLS CUI [1,3]
C0680240
Concordance with Study Site Pathology Report:
Beschreibung

Concordance with Study Site Pathology Report

Datentyp

integer

Alias
UMLS CUI [1,1]
C0449438
UMLS CUI [1,2]
C2347585
UMLS CUI [1,3]
C0680240
Administration
Beschreibung

Administration

Alias
UMLS CUI-1
C1320722
Signature
Beschreibung

Signature

Datentyp

text

Alias
UMLS CUI [1]
C2346576
Date
Beschreibung

Date

Datentyp

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
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Ähnliche Modelle

Central Pathology Assessment

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Central Pathology Assessment
C0030664 (UMLS CUI-1)
Item
Biopsy Number
integer
C0005558 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Biopsy Number
Code List
Biopsy Number
CL Item
1 (1)
CL Item
2 (2)
Biopsy date
Item
Biopsy date:
date
C0005558 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Biopsy site
Item
Site:
text
C1301128 (UMLS CUI [1])
Accession #
Item
Accession #:
integer
C1510755 (UMLS CUI [1,1])
C0005558 (UMLS CUI [1,2])
Number of slides
Item
Number of slides:
integer
C1705201 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Name/location of original path site
Item
Name/location of original path site:
text
C1527021 (UMLS CUI [1,1])
C0205145 (UMLS CUI [1,2])
C0027365 (UMLS CUI [1,3])
Item
Working Formulation Classification: Histology
integer
C0019638 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Histology Number
Code List
Working Formulation Classification: Histology
CL Item
1 (1)
CL Item
2 (2)
Item
Histology - Cell types
integer
C0449574 (UMLS CUI [1])
Histology - Cell types
Code List
Histology - Cell types
CL Item
Small lymphocytic with plasmacytoid differentiation (1)
CL Item
Small lymphocytic without plasmacytoid differentiation (2)
CL Item
Follicular small-cleaved cell (3)
CL Item
Follicular mixed ( <50% large cell) (4)
CL Item
Follicular large cell (5)
CL Item
Diffuse small-cleaved cell (6)
CL Item
Diffuse mixed small-cell and large cell (7)
CL Item
Diffuse large cell (8)
CL Item
Large cell, immunoblastic (9)
CL Item
Lymphoblastic, convoluted (10)
CL Item
Lymphoblastic, non-convoluted (11)
CL Item
Other, specify (12)
Other Cell type
Item
Specify: Other cell type
text
C0449475 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Item
Central Pathologist Assessment
integer
C0334866 (UMLS CUI [1,1])
C1516048 (UMLS CUI [1,2])
Central Pathologist Assessment
Code List
Central Pathologist Assessment
CL Item
Low-Grade NHL (1)
CL Item
Transformed Low-Grade NHL (2)
CL Item
Non-diagnostic (3)
Item
Transformed Low-Grade NHL
integer
C0024305 (UMLS CUI [1,1])
C1282907 (UMLS CUI [1,2])
C0457344 (UMLS CUI [1,3])
Transformed Low-Grade NHL
Code List
Transformed Low-Grade NHL
CL Item
subsequent to low-grade diagnosis (1)
CL Item
composite (single biopsy site) (2)
CL Item
concurrent with low-grade diagnosis (multiple biopsy sites) (3)
Item
Basis of Assessment
integer
C0220825 (UMLS CUI [1,1])
C1874451 (UMLS CUI [1,2])
Basis of Assessment
Code List
Basis of Assessment
CL Item
Pathology Specimen(s) (1)
CL Item
Pathology Report(s) (2)
Item Group
Pathology Assessment Description
C0030664 (UMLS CUI-1)
C0678257 (UMLS CUI-2)
Description
Item
Description:
text
C0678257 (UMLS CUI [1,1])
C0030664 (UMLS CUI [1,2])
Central Pathology Diagnosis
Item
Central Pathology Diagnosis:
text
C0030664 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
Concordance with Original Pathology Report:
integer
C0449438 (UMLS CUI [1,1])
C2347585 (UMLS CUI [1,2])
C0680240 (UMLS CUI [1,3])
Concordance with Original Pathology Report
Code List
Concordance with Original Pathology Report:
CL Item
Yes (1)
CL Item
No (2)
CL Item
Report unavailable (3)
Item
Concordance with Study Site Pathology Report:
integer
C0449438 (UMLS CUI [1,1])
C2347585 (UMLS CUI [1,2])
C0680240 (UMLS CUI [1,3])
Concordance with Study Site Pathology Report
Code List
Concordance with Study Site Pathology Report:
CL Item
Yes (1)
CL Item
No (2)
CL Item
Report unavailable (3)
Item Group
Administration
C1320722 (UMLS CUI-1)
Signature
Item
Signature
text
C2346576 (UMLS CUI [1])
Date
Item
Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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