ID

30224

Descripción

https://clinicaltrials.gov/show/NCT00989664 History of Lymphoma and Prior Therapy 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

Palabras clave

Versiones (1)
  1. 22/5/18 22/5/18 -
Titular de derechos de autor

GlaxoSmithKline (GSK)

Subido en

22 de mayo de 2018

DOI

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Licencia

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

Inglés

History of Lymphoma and Prior Therapy

1 formularios  
History of Lymphoma
Descripción

History of Lymphoma

Alias
UMLS CUI-1
C0024299
UMLS CUI-2
C0262926
Date of Diagnosis
Descripción

Date of Diagnosis

Tipo de datos

date

Alias
UMLS CUI [1]
C2316983
Stage at diagnosis
Descripción

Stage at diagnosis

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1300072
UMLS CUI [1,2]
C3172269
Stage at Enrollment
Descripción

Stage at Enrollment

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1300072
UMLS CUI [1,2]
C0024299
UMLS CUI [1,3]
C1516879
Cell Type
Descripción

Cell Type

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0449475
UMLS CUI [1,2]
C0024299
Time of Cell Type Specification
Descripción

Time of Cell Type Specification

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0449475
UMLS CUI [1,2]
C2348235
Grade
Descripción

Grade

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0919553
UMLS CUI [1,2]
C0024299
Time of Grading
Descripción

Time of Grading

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0919553
UMLS CUI [1,2]
C0040223
Extranodal involvement at Enrollement
Descripción

Extranodal involvement at Enrollement

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C3899187
UMLS CUI [1,2]
C1516879
CD20 Reactivity (please check one method)
Descripción

CD20 Reactivity

Tipo de datos

integer

Alias
UMLS CUI [1]
C0054946
Date tissue obtained
Descripción

Date tissue obtained

Tipo de datos

date

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

Date of assay

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0005507
Does patient have evidence of bulky disease (> 500 gm)?
Descripción

Evidence of bulky disease

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0024299
UMLS CUI [1,2]
C1511341
UMLS CUI [1,3]
C0332120
Record the maximum unidimensional tumor diameter (excluding organs)
Descripción

Maximum unidimensional tumor diameter

Tipo de datos

integer

Unidades de medida
  • cm
Alias
UMLS CUI [1,1]
C0242485
UMLS CUI [1,2]
C1301886
UMLS CUI [1,3]
C0027651
UMLS CUI [1,4]
C0806909
cm
Prior Therapy
Descripción

Prior Therapy

Alias
UMLS CUI-1
C1514463
Chemo therapy code
Descripción

Codes: 1 = CVP 2 = C-MOPP 3 = BACOP 4 = COP-Bleo 5=CHOP 6 = CHOP-Bleo 7 =CP 8 = Cyloxan 9 = COPP 10 = Pro-MACE-MOPP 11 = CHOP-Bleo + Alpha Interferon 12 = COMLA 13 = Ftudarablne 14 =ACP 15 = MINE 16 = ESHAP 17 = DHAP 18 = EPOCH 19 = CEPP 20 = Pro-MACE-CytaBOM 21 = ICE 22 = COP-Bl.AM 23 = CNOP 24 = FNO 25 = MACOP-B 26 = m-BACOD 27 = VAPEC-8 28 = IM-VP16 29 = CF 30 = Other (specify) 49 = Chlorambucil 64 = Rltuxlmab

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0805701
Drugs
Descripción

(List drug names only If code is not given)

Tipo de datos

text

Alias
UMLS CUI [1]
C0013227
Start Date
Descripción

Start Date

Tipo de datos

date

Alias
UMLS CUI [1]
C3173309
Stop Date
Descripción

Stop Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
Number of Cycles
Descripción

Number of Cycles

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0449788
UMLS CUI [1,2]
C1302181
Therapy Outcome
Descripción

Therapy Outcome

Tipo de datos

integer

Alias
UMLS CUI [1]
C1518681
Duration of Response (months)
Descripción

Duration of Response

Tipo de datos

integer

Unidades de medida
  • month
Alias
UMLS CUI [1]
C0237585
month
Prior Radiation Therapy
Descripción

Prior Radiation Therapy

Alias
UMLS CUI-1
C0279134
Start Date
Descripción

Start Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0808070
Stop Date
Descripción

Stop Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0806020
Total dose in cGy
Descripción

Total dose in cGy

Tipo de datos

float

Unidades de medida
  • cGy
Alias
UMLS CUI [1]
C2169193
cGy
Location (sites treated)
Descripción

Location (sites treated)

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C2169202
Therapy Outcome at Irradiated Location
Descripción

Therapy Outcome at Irradiated Location

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C2169202
UMLS CUI [1,2]
C1518681
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Similar models

History of Lymphoma and Prior Therapy

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
History of Lymphoma
C0024299 (UMLS CUI-1)
C0262926 (UMLS CUI-2)
Date of Diagnosis
Item
Date of Diagnosis
date
C2316983 (UMLS CUI [1])
Item
Stage at diagnosis
integer
C1300072 (UMLS CUI [1,1])
C3172269 (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
integer
C1300072 (UMLS CUI [1,1])
C0024299 (UMLS CUI [1,2])
C1516879 (UMLS CUI [1,3])
Stage at Enrollment
Code List
Stage at Enrollment
CL Item
I (1)
CL Item
II (2)
CL Item
III (3)
CL Item
IV (4)
Item
Cell Type
integer
C0449475 (UMLS CUI [1,1])
C0024299 (UMLS CUI [1,2])
Cell Type
Code List
Cell Type
CL Item
Small lymphocytic With plasmaeytoid differentiation (1)
CL Item
Small lymphocytic without plasmacytoid differentiation (2)
CL Item
Follicular, small-cleaved cell (3)
CL Item
Follicular, mixed small-cleaved cell(< 50% large cell) (4)
CL Item
Follicular, large cell (5)
CL Item
Diffuse, small-deaved (6)
CL Item
Diffuse, mixed smal-c::leaved & large cell (7)
CL Item
Diffuse, large cell (8)
CL Item
Large cell, immunoblastic (9)
CL Item
Lymphoblastic, convoluted (10)
CL Item
Lymphoblastlc, non-convoluted (11)
CL Item
Monocytoid B-cell (12)
CL Item
Other (specify) (13)
Item
Time of Cell Type Specification
integer
C0449475 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Time of Cell Type Specification
Code List
Time of Cell Type Specification
CL Item
At Diagnosis (1)
CL Item
At Enrollment (2)
Item
Grade
integer
C0919553 (UMLS CUI [1,1])
C0024299 (UMLS CUI [1,2])
Grade
Code List
Grade
CL Item
Low (1)
CL Item
Intermediate (2)
CL Item
High (3)
Item
Time of Grading
integer
C0919553 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Time of Grading
Code List
Time of Grading
CL Item
At Diagnosis (1)
CL Item
At Enrollment (2)
Item
Extranodal involvement at Enrollement
integer
C3899187 (UMLS CUI [1,1])
C1516879 (UMLS CUI [1,2])
Extranodal involvement at Enrollement
Code List
Extranodal involvement at Enrollement
CL Item
O (1)
CL Item
1 (2)
CL Item
2 or more Sites (3)
Item
CD20 Reactivity (please check one method)
integer
C0054946 (UMLS CUI [1])
CD20 Reactivity
Code List
CD20 Reactivity (please check one method)
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
C0011008 (UMLS CUI [1,1])
C0005507 (UMLS CUI [1,2])
Evidence of bulky disease
Item
Does patient have evidence of bulky disease (> 500 gm)?
boolean
C0024299 (UMLS CUI [1,1])
C1511341 (UMLS CUI [1,2])
C0332120 (UMLS CUI [1,3])
Maximum unidimensional tumor diameter
Item
Record the maximum unidimensional tumor diameter (excluding organs)
integer
C0242485 (UMLS CUI [1,1])
C1301886 (UMLS CUI [1,2])
C0027651 (UMLS CUI [1,3])
C0806909 (UMLS CUI [1,4])
Item Group
Prior Therapy
C1514463 (UMLS CUI-1)
Chemo therapy code
Item
Chemo therapy code
integer
C0392920 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
Drugs
Item
Drugs
text
C0013227 (UMLS CUI [1])
Start Date
Item
Start Date
date
C3173309 (UMLS CUI [1])
Stop Date
Item
Stop Date
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Number of Cycles
Item
Number of Cycles
integer
C0449788 (UMLS CUI [1,1])
C1302181 (UMLS CUI [1,2])
Item
Therapy Outcome
integer
C1518681 (UMLS CUI [1])
Therapy Outcome
Code List
Therapy Outcome
CL Item
CR (1)
CL Item
CCR (2)
CL Item
PR (3)
CL Item
SD (4)
CL Item
PD (5)
CL Item
Unknown (6)
Duration of Response
Item
Duration of Response (months)
integer
C0237585 (UMLS CUI [1])
Item Group
Prior Radiation Therapy
C0279134 (UMLS CUI-1)
Start Date
Item
Start Date
date
C1522449 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Stop Date
Item
Stop Date
date
C1522449 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Total dose in cGy
Item
Total dose in cGy
float
C2169193 (UMLS CUI [1])
Location (sites treated)
Item
Location (sites treated)
text
C1522449 (UMLS CUI [1,1])
C2169202 (UMLS CUI [1,2])
Item
Therapy Outcome at Irradiated Location
integer
C2169202 (UMLS CUI [1,1])
C1518681 (UMLS CUI [1,2])
Therapy Outcome at Irradiated Location
Code List
Therapy Outcome at Irradiated Location
CL Item
CR (1)
CL Item
CCR (2)
CL Item
PR (3)
CL Item
SD (4)
CL Item
PD (5)
CL Item
Unknown (6)
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