ID

30224

Description

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

Keywords

Versions (1)
  1. 5/22/18 5/22/18 -
Copyright Holder

GlaxoSmithKline (GSK)

Uploaded on

May 22, 2018

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Multicenter, Pivotal Phase III Study of Iodine-131 Anti-B1 Antibody (Murine) Radioimmunotherapy NCT00989664

English

History of Lymphoma and Prior Therapy

1 forms  
History of Lymphoma
Description

History of Lymphoma

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

Date of Diagnosis

Data type

date

Alias
UMLS CUI [1]
C2316983
Stage at diagnosis
Description

Stage at diagnosis

Data type

integer

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

Stage at Enrollment

Data type

integer

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

Cell Type

Data type

integer

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

Time of Cell Type Specification

Data type

integer

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

Grade

Data type

integer

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

Time of Grading

Data type

integer

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

Extranodal involvement at Enrollement

Data type

integer

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

CD20 Reactivity

Data type

integer

Alias
UMLS CUI [1]
C0054946
Date tissue obtained
Description

Date tissue obtained

Data type

date

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

Date of assay

Data type

date

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

Evidence of bulky disease

Data type

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)
Description

Maximum unidimensional tumor diameter

Data type

integer

Measurement units
  • 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
Description

Prior Therapy

Alias
UMLS CUI-1
C1514463
Chemo therapy code
Description

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

Data type

integer

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

(List drug names only If code is not given)

Data type

text

Alias
UMLS CUI [1]
C0013227
Start Date
Description

Start Date

Data type

date

Alias
UMLS CUI [1]
C3173309
Stop Date
Description

Stop Date

Data type

date

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

Number of Cycles

Data type

integer

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

Therapy Outcome

Data type

integer

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

Duration of Response

Data type

integer

Measurement units
  • month
Alias
UMLS CUI [1]
C0237585
month
Prior Radiation Therapy
Description

Prior Radiation Therapy

Alias
UMLS CUI-1
C0279134
Start Date
Description

Start Date

Data type

date

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

Stop Date

Data type

date

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

Total dose in cGy

Data type

float

Measurement units
  • cGy
Alias
UMLS CUI [1]
C2169193
cGy
Location (sites treated)
Description

Location (sites treated)

Data type

text

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

Therapy Outcome at Irradiated Location

Data type

integer

Alias
UMLS CUI [1,1]
C2169202
UMLS CUI [1,2]
C1518681
Back to the top of the page

Similar models

History of Lymphoma and Prior Therapy

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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)
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial