ID

44365

Descripción

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

Palabras clave

Versiones (4)
  1. 6/8/18 6/8/18 -
  2. 6/8/18 6/8/18 -
  3. 18/8/18 18/8/18 -
  4. 20/9/21 20/9/21 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

20 de septiembre de 2021

DOI

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Licencia

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

Inglés

Central Pathology Assessment and Description

1 formularios  
Biopsy 1
Descripción

Biopsy 1

Alias
UMLS CUI-1
C0005558
Biopsy Date
Descripción

Biopsy Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0005558
UMLS CUI [1,2]
C0011008
Biopsy Site
Descripción

Biopsy Site

Tipo de datos

text

Alias
UMLS CUI [1]
C1301128
Accession #
Descripción

Accession Number (identifier)

Tipo de datos

integer

Alias
UMLS CUI [1]
C1510755
Number of slides
Descripción

Slide (glass microscope); Count

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1705201
UMLS CUI [1,2]
C0750480
Name/ location of original path site
Descripción

Anatomic Site; Original; Name | Anatomic Site; Original; Location

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C0205313
UMLS CUI [1,3]
C0027365
UMLS CUI [2,1]
C1515974
UMLS CUI [2,2]
C0205313
UMLS CUI [2,3]
C0450429
Biopsy 2
Descripción

Biopsy 2

Alias
UMLS CUI-1
C0005558
Biopsy Date
Descripción

Biopsy Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0005558
UMLS CUI [1,2]
C0011008
Biopsy Site
Descripción

Biopsy Site

Tipo de datos

text

Alias
UMLS CUI [1]
C1301128
Accession #
Descripción

Accession Number (identifier)

Tipo de datos

integer

Alias
UMLS CUI [1]
C1510755
Number of slides
Descripción

Slide (glass microscope); Count

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1705201
UMLS CUI [1,2]
C0750480
Name/ location of original path site
Descripción

Anatomic Site; Original; Name | Anatomic Site; Original; Location

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C0205313
UMLS CUI [1,3]
C0027365
UMLS CUI [2,1]
C1515974
UMLS CUI [2,2]
C0205313
UMLS CUI [2,3]
C0450429
Working Formulation Classification
Descripción

Working Formulation Classification

Alias
UMLS CUI-1
C0024305
UMLS CUI-2
C0008902
Working Formulation Classification
Descripción

Lymphoma, Non-Hodgkin | Classification

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0024305
UMLS CUI [1,2]
C0008902
If other classification, please specify
Descripción

Classification; Other; Specification

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0008902
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
Histology 1 or 2
Descripción

Histology

Tipo de datos

text

Alias
UMLS CUI [1]
C0019638
Central Pathologist Assessment
Descripción

Central Pathologist Assessment

Alias
UMLS CUI-1
C1294089
UMLS CUI-2
C0205099
Central Pathologist Assessment
Descripción

Pathologist evaluation; Central

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1294089
UMLS CUI [1,2]
C0205099
Basis of Assessment
Descripción

Basis of Assessment

Alias
UMLS CUI-1
C0220825
UMLS CUI-2
C1874451
Basis of Assessment
Descripción

Basis of Assessment

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0220825
UMLS CUI [1,2]
C1874451
Central Pathologist Assessment Description
Descripción

Central Pathologist Assessment Description

Alias
UMLS CUI-1
C1294089
UMLS CUI-2
C0205099
UMLS CUI-3
C0678257
Description
Descripción

Description

Tipo de datos

text

Alias
UMLS CUI [1]
C0678257
Central Pathology Diagnosis
Descripción

Diagnosis; Pathology; Central

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0030664
UMLS CUI [1,3]
C0205099
Concordance with Original Pathology Report
Descripción

Pathology report; Original; Agreement

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0807321
UMLS CUI [1,2]
C0205313
UMLS CUI [1,3]
C0680240
Concordance with Study Site Pathology Report
Descripción

Pathology report; Study Site; Agreement

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0807321
UMLS CUI [1,2]
C2825164
UMLS CUI [1,3]
C0680240
Administrative
Descripción

Administrative

Alias
UMLS CUI-1
C1320722
Signature
Descripción

Signature

Tipo de datos

text

Alias
UMLS CUI [1]
C1519316
Date of evaluation
Descripción

Assessment Date

Tipo de datos

date

Alias
UMLS CUI [1]
C2985720
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Similar models

Central Pathology Assessment and Description

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Biopsy 1
C0005558 (UMLS CUI-1)
Biopsy Date
Item
Biopsy Date
date
C0005558 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Biopsy Site
Item
Biopsy Site
text
C1301128 (UMLS CUI [1])
Accession Number (identifier)
Item
Accession #
integer
C1510755 (UMLS CUI [1])
Slide (glass microscope); Count
Item
Number of slides
integer
C1705201 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
Anatomic Site; Original; Name | Anatomic Site; Original; Location
Item
Name/ location of original path site
text
C1515974 (UMLS CUI [1,1])
C0205313 (UMLS CUI [1,2])
C0027365 (UMLS CUI [1,3])
C1515974 (UMLS CUI [2,1])
C0205313 (UMLS CUI [2,2])
C0450429 (UMLS CUI [2,3])
Item Group
Biopsy 2
C0005558 (UMLS CUI-1)
Biopsy Date
Item
Biopsy Date
date
C0005558 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Biopsy Site
Item
Biopsy Site
text
C1301128 (UMLS CUI [1])
Accession Number (identifier)
Item
Accession #
integer
C1510755 (UMLS CUI [1])
Slide (glass microscope); Count
Item
Number of slides
integer
C1705201 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
Anatomic Site; Original; Name | Anatomic Site; Original; Location
Item
Name/ location of original path site
text
C1515974 (UMLS CUI [1,1])
C0205313 (UMLS CUI [1,2])
C0027365 (UMLS CUI [1,3])
C1515974 (UMLS CUI [2,1])
C0205313 (UMLS CUI [2,2])
C0450429 (UMLS CUI [2,3])
Item Group
Working Formulation Classification
C0024305 (UMLS CUI-1)
C0008902 (UMLS CUI-2)
Item
Working Formulation Classification
text
C0024305 (UMLS CUI [1,1])
C0008902 (UMLS CUI [1,2])
Lymphoma, Non-Hodgkin | Classification
Code List
Working Formulation Classification
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
Difuse 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 (12)
Classification; Other; Specification
Item
If other classification, please specify
text
C0008902 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item
Histology 1 or 2
text
C0019638 (UMLS CUI [1])
Histology
Code List
Histology 1 or 2
CL Item
Histology1 (1)
CL Item
Histology 2 (2)
Item Group
Central Pathologist Assessment
C1294089 (UMLS CUI-1)
C0205099 (UMLS CUI-2)
Item
Central Pathologist Assessment
text
C1294089 (UMLS CUI [1,1])
C0205099 (UMLS CUI [1,2])
Pathologist evaluation; Central
Code List
Central Pathologist Assessment
CL Item
Low- Grade NHL (1)
CL Item
Transformed Low- Grade NHL (2)
CL Item
Transformed subsequent to low- grade diagnosis (3)
CL Item
Transformed composite (single biopsy site) (4)
CL Item
Transformed concurrent with low grade diagnosis (multiple biopsy sites) (5)
CL Item
Non- diagnostic (6)
Item Group
Basis of Assessment
C0220825 (UMLS CUI-1)
C1874451 (UMLS CUI-2)
Item
Basis of Assessment
text
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
Central Pathologist Assessment Description
C1294089 (UMLS CUI-1)
C0205099 (UMLS CUI-2)
C0678257 (UMLS CUI-3)
Description
Item
Description
text
C0678257 (UMLS CUI [1])
Diagnosis; Pathology; Central
Item
Central Pathology Diagnosis
text
C0011900 (UMLS CUI [1,1])
C0030664 (UMLS CUI [1,2])
C0205099 (UMLS CUI [1,3])
Item
Concordance with Original Pathology Report
text
C0807321 (UMLS CUI [1,1])
C0205313 (UMLS CUI [1,2])
C0680240 (UMLS CUI [1,3])
Pathology report; Original; Agreement
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
text
C0807321 (UMLS CUI [1,1])
C2825164 (UMLS CUI [1,2])
C0680240 (UMLS CUI [1,3])
undefined item
Code List
Concordance with Study Site Pathology Report
CL Item
yes (1)
CL Item
No (2)
CL Item
Report unavailable (3)
Item Group
Administrative
C1320722 (UMLS CUI-1)
Signature
Item
Signature
text
C1519316 (UMLS CUI [1])
Assessment Date
Item
Date of evaluation
date
C2985720 (UMLS CUI [1])
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