ID

31357

Beschreibung

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

Stichworte

Versionen (3)
  1. 08.07.18 08.07.18 -
  2. 21.07.18 21.07.18 -
  3. 18.08.18 18.08.18 -
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GlaxoSmithKline

Hochgeladen am

18. August 2018

DOI

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Iodine-131 Anti-B1 Antibody for Non Hodgkin’s Lymphomas NCT00996593

Englisch

History of Lymphoma

1 Formulare  
  1. StudyEvent: ODM
    1. History of Lymphoma
Tumor Stage
Beschreibung

Tumor Stage

Alias
UMLS CUI-1
C1300072
Stage at Diagnosis
Beschreibung

Stage at Diagnosis

Datentyp

text

Alias
UMLS CUI [1,1]
C1300072
UMLS CUI [1,2]
C0011900
Stage at Enrollment
Beschreibung

Stage at Enrollment

Datentyp

text

Alias
UMLS CUI [1,1]
C1300072
UMLS CUI [1,2]
C1516879
Date of Diagnosis
Beschreibung

Date of Diagnosis

Datentyp

date

Alias
UMLS CUI [1]
C2316983
Cell Type
Beschreibung

Cell Type

Alias
UMLS CUI-1
C0449475
Small lymphocytic with plasmacytoid differentiation
Beschreibung

Small lymphocytic with plasmacytoid differentiation

Datentyp

text

Alias
UMLS CUI [1,1]
C0855095
UMLS CUI [1,2]
C1403406
Small lymphocytic without plasmacytoid differentiation
Beschreibung

Small lymphocytic without plasmacytoid differentiation

Datentyp

text

Alias
UMLS CUI [1,1]
C0855095
UMLS CUI [1,2]
C1403406
UMLS CUI [1,3]
C0332288
Follicular, small- cleaved cell
Beschreibung

Follicular, small- cleaved cell

Datentyp

text

Alias
UMLS CUI [1]
C0079765
Follicular, mixed small- cleaved cell (<50% large cell)
Beschreibung

Follicular, mixed small- cleaved cell

Datentyp

text

Alias
UMLS CUI [1,1]
C0079765
UMLS CUI [1,2]
C0205430
UMLS CUI [2,1]
C0024299
UMLS CUI [2,2]
C1513997
UMLS CUI [2,3]
C0439165
Follicular, large cell
Beschreibung

Follicular, large cell

Datentyp

text

Alias
UMLS CUI [1]
C0079745
Diffuse, small cleaved
Beschreibung

Diffuse, small cleaved

Datentyp

text

Alias
UMLS CUI [1]
C1398349
Diffuse, mixed small-cleaved & large cell
Beschreibung

Diffuse, mixed small-cleaved & large cell

Datentyp

text

Alias
UMLS CUI [1,1]
C1398349
UMLS CUI [1,2]
C0079744
UMLS CUI [1,3]
C0079757
Diffuse, large cell
Beschreibung

Diffuse, large cell

Datentyp

text

Alias
UMLS CUI [1]
C0079744
Large cell, immunoblastic
Beschreibung

Large cell, immunoblastic

Datentyp

text

Alias
UMLS CUI [1]
C0079746
Lymphoblastic, convoluted
Beschreibung

Lymphoblastic, convoluted

Datentyp

text

Alias
UMLS CUI [1,1]
C0079748
UMLS CUI [1,2]
C0333859
Lymphoblastic, non-convolutet
Beschreibung

Lymphoblastic, non-convolutet

Datentyp

text

Alias
UMLS CUI [1]
C0079748
Monocytoid B- Cell
Beschreibung

Monocytoid B- Cell

Datentyp

text

Alias
UMLS CUI [1]
C0855139
Other cell type
Beschreibung

Other

Datentyp

text

Alias
UMLS CUI [1,1]
C0449475
UMLS CUI [1,2]
C0205394
If other cell type, please specify
Beschreibung

Other specify

Datentyp

text

Alias
UMLS CUI [1,1]
C0449475
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
Grade
Beschreibung

Grade

Alias
UMLS CUI-1
C0919553
Low Grade
Beschreibung

Low grade (well to moderately differentiated)

Datentyp

text

Alias
UMLS CUI [1]
C1273125
Intermediate Grade
Beschreibung

Intermediate grade histologic differentiation

Datentyp

text

Alias
UMLS CUI [1]
C1320484
High Grade
Beschreibung

High grade (poorly differentiated to undifferentiated)

Datentyp

text

Alias
UMLS CUI [1]
C1273126
Extranodal involvement at Enrollment
Beschreibung

Extranodal involvement at Enrollment

Alias
UMLS CUI-1
C3899187
UMLS CUI-2
C1516879
Extranodal involvement at Enrollment
Beschreibung

Extranodal involvement at Enrollment

Datentyp

text

Alias
UMLS CUI [1,1]
C3899187
UMLS CUI [1,2]
C1516879
CD20 Reactivity
Beschreibung

CD20 Reactivity

Alias
UMLS CUI-1
C0054946
UMLS CUI-2
C0443286
CD20 Reactivity
Beschreibung

CD20 Reactivity

Datentyp

text

Alias
UMLS CUI [1,1]
C0054946
UMLS CUI [1,2]
C0443286
Date tissue obtained
Beschreibung

Date tissue obtained

Datentyp

date

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C0011008
Date of assay
Beschreibung

Date of assay

Datentyp

date

Alias
UMLS CUI [1,1]
C1510438
UMLS CUI [1,2]
C0011008
Tumor Size
Beschreibung

Tumor Size

Alias
UMLS CUI-1
C0475440
Does the patient have evidence of bulky disease (>500gm)?
Beschreibung

undefined item

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1511341
UMLS CUI [1,2]
C0043100
Record the maximum unidimensional tumor diameter (excluding organs)
Beschreibung

Neoplasms; Maximum; Diameter (qualifier value); Measurement Unit

Datentyp

float

Maßeinheiten
  • cm
Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C0806909
UMLS CUI [1,3]
C1301886
UMLS CUI [1,4]
C0242485
cm
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Ähnliche Modelle

History of Lymphoma

1 Formulare
  1. StudyEvent: ODM
    1. History of Lymphoma
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Tumor Stage
C1300072 (UMLS CUI-1)
Item
Stage at Diagnosis
text
C1300072 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Stage at Diagnosis
Code List
Stage at Diagnosis
CL Item
I (1)
CL Item
II (2)
CL Item
III (3)
CL Item
IV (4)
Item
Stage at Enrollment
text
C1300072 (UMLS CUI [1,1])
C1516879 (UMLS CUI [1,2])
Stage at Enrollment
Code List
Stage at Enrollment
CL Item
I (1)
CL Item
II (2)
CL Item
III (3)
CL Item
IV (4)
Date of Diagnosis
Item
Date of Diagnosis
date
C2316983 (UMLS CUI [1])
Item Group
Cell Type
C0449475 (UMLS CUI-1)
Item
Small lymphocytic with plasmacytoid differentiation
text
C0855095 (UMLS CUI [1,1])
C1403406 (UMLS CUI [1,2])
undefined item
Code List
Small lymphocytic with plasmacytoid differentiation
CL Item
At Diagnosis (1)
CL Item
At Enrollment (2)
Item
Small lymphocytic without plasmacytoid differentiation
text
C0855095 (UMLS CUI [1,1])
C1403406 (UMLS CUI [1,2])
C0332288 (UMLS CUI [1,3])
undefined item
Code List
Small lymphocytic without plasmacytoid differentiation
CL Item
At Diagnosis (1)
CL Item
At Enrollment (2)
Item
Follicular, small- cleaved cell
text
C0079765 (UMLS CUI [1])
Follicular, small- cleaved cell
Code List
Follicular, small- cleaved cell
CL Item
At Diagnosis (1)
CL Item
At Enrollment (2)
Item
Follicular, mixed small- cleaved cell (<50% large cell)
text
C0079765 (UMLS CUI [1,1])
C0205430 (UMLS CUI [1,2])
C0024299 (UMLS CUI [2,1])
C1513997 (UMLS CUI [2,2])
C0439165 (UMLS CUI [2,3])
Follicular, mixed small- cleaved cell
Code List
Follicular, mixed small- cleaved cell (<50% large cell)
CL Item
At Diagnosis (1)
CL Item
At Enrollment (2)
Item
Follicular, large cell
text
C0079745 (UMLS CUI [1])
Follicular, large cell
Code List
Follicular, large cell
CL Item
At Diagnosis (1)
CL Item
At Enrollment (2)
Item
Diffuse, small cleaved
text
C1398349 (UMLS CUI [1])
Diffuse, small cleaved
Code List
Diffuse, small cleaved
CL Item
At Enrollment (1)
Item
Diffuse, mixed small-cleaved & large cell
text
C1398349 (UMLS CUI [1,1])
C0079744 (UMLS CUI [1,2])
C0079757 (UMLS CUI [1,3])
Diffuse, mixed small-cleaved & large cell
Code List
Diffuse, mixed small-cleaved & large cell
CL Item
At Enrollment (1)
Item
Diffuse, large cell
text
C0079744 (UMLS CUI [1])
Diffuse, large cell
Code List
Diffuse, large cell
CL Item
At Enrollment (1)
Item
Large cell, immunoblastic
text
C0079746 (UMLS CUI [1])
Large cell, immunoblastic
Code List
Large cell, immunoblastic
CL Item
At Enrollment (1)
Item
Lymphoblastic, convoluted
text
C0079748 (UMLS CUI [1,1])
C0333859 (UMLS CUI [1,2])
Lymphoblastic, convoluted
Code List
Lymphoblastic, convoluted
CL Item
At Enrollment (1)
Item
Lymphoblastic, non-convolutet
text
C0079748 (UMLS CUI [1])
Lymphoblastic, non-convolutet
Code List
Lymphoblastic, non-convolutet
CL Item
At Enrollment (1)
Item
Monocytoid B- Cell
text
C0855139 (UMLS CUI [1])
Monocytoid B- Cell
Code List
Monocytoid B- Cell
CL Item
At Enrollment (1)
Item
Other cell type
text
C0449475 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Other
Code List
Other cell type
CL Item
At Diagnosis (1)
CL Item
At Enrollment (2)
Other specify
Item
If other cell type, please specify
text
C0449475 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item Group
Grade
C0919553 (UMLS CUI-1)
Item
Low Grade
text
C1273125 (UMLS CUI [1])
Low grade (well to moderately differentiated)
Code List
Low Grade
CL Item
At Diagnosis (1)
CL Item
At Enrollment (2)
Item
Intermediate Grade
text
C1320484 (UMLS CUI [1])
Intermediate grade histologic differentiation
Code List
Intermediate Grade
CL Item
At Diagnosis (1)
CL Item
At Enrollment (2)
Item
High Grade
text
C1273126 (UMLS CUI [1])
High grade (poorly differentiated to undifferentiated)
Code List
High Grade
CL Item
At Diagnosis (1)
CL Item
At Enrollment (2)
Item Group
Extranodal involvement at Enrollment
C3899187 (UMLS CUI-1)
C1516879 (UMLS CUI-2)
Item
Extranodal involvement at Enrollment
text
C3899187 (UMLS CUI [1,1])
C1516879 (UMLS CUI [1,2])
Extranodal involvement at Enrollment
Code List
Extranodal involvement at Enrollment
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 or more sites (3)
Item Group
CD20 Reactivity
C0054946 (UMLS CUI-1)
C0443286 (UMLS CUI-2)
Item
CD20 Reactivity
text
C0054946 (UMLS CUI [1,1])
C0443286 (UMLS CUI [1,2])
CD20 Reactivity
Code List
CD20 Reactivity
CL Item
Histopathology (1)
CL Item
Flow Cytometry (2)
Date tissue obtained
Item
Date tissue obtained
date
C0200345 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Date of assay
Item
Date of assay
date
C1510438 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Tumor Size
C0475440 (UMLS CUI-1)
undefined item
Item
Does the patient have evidence of bulky disease (>500gm)?
boolean
C1511341 (UMLS CUI [1,1])
C0043100 (UMLS CUI [1,2])
Neoplasms; Maximum; Diameter (qualifier value); Measurement Unit
Item
Record the maximum unidimensional tumor diameter (excluding organs)
float
C0027651 (UMLS CUI [1,1])
C0806909 (UMLS CUI [1,2])
C1301886 (UMLS CUI [1,3])
C0242485 (UMLS CUI [1,4])
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