ID

30170

Beschreibung

https://clinicaltrials.gov/show/NCT00989664 Eligibility check 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 (1)
  1. 16.05.18 16.05.18 - Halim Ugurlu
Rechteinhaber

GlaxoSmithKline (GSK)

Hochgeladen am

16. Mai 2018

DOI

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Lizenz

Creative Commons BY-NC 3.0
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29981_Multicenter Pivotal Phase III Study of Iodine-131 Anti-B1 Antibody (Murine) Radioimmunotherapy

Englisch

History of Lymphoma, Prior Therapy and Prior Radiation Therapy

1 Formulare  
Administration
Beschreibung

Administration

Alias
UMLS CUI-1
C1320722
Site Number:
Beschreibung

Site Number

Datentyp

integer

Alias
UMLS CUI [1,1]
C0018704
UMLS CUI [1,2]
C0600091
Patient Number
Beschreibung

Patient Number

Datentyp

integer

Alias
UMLS CUI [1]
C1830427
Patient Initials
Beschreibung

Patient Initials

Datentyp

text

Alias
UMLS CUI [1]
C2986440
Stage
Beschreibung

Stage

Alias
UMLS CUI-1
C1300072
UMLS CUI-2
C0024299
Date of diagnosis
Beschreibung

Date of diagnosis

Datentyp

date

Alias
UMLS CUI [1]
C2316983
Stage at Diagnosis
Beschreibung

Stage at Diagnosis

Datentyp

integer

Alias
UMLS CUI [1,1]
C1300072
UMLS CUI [1,2]
C0024299
UMLS CUI [1,3]
C0011900
Stage at Enrollment
Beschreibung

Stage at Enrollment

Datentyp

integer

Alias
UMLS CUI [1,1]
C1300072
UMLS CUI [1,2]
C0024299
UMLS CUI [1,3]
C2348568
Lymphoma at Diagnosis/Enrollment
Beschreibung

Lymphoma at Diagnosis/Enrollment

Alias
UMLS CUI-1
C0024299
UMLS CUI-2
C0011900
UMLS CUI-3
C1516879
Cell Type at Diagnosis
Beschreibung

Cell Type at Diagnosis

Datentyp

integer

Alias
UMLS CUI [1,1]
C0449475
UMLS CUI [1,2]
C0024299
UMLS CUI [1,3]
C0011900
Cell Type at Enrollment
Beschreibung

Cell Type at Enrollment

Datentyp

integer

Alias
UMLS CUI [1,1]
C0449475
UMLS CUI [1,2]
C0024299
UMLS CUI [1,3]
C1516879
Grade at Diagnosis
Beschreibung

Grade at Diagnosis

Datentyp

integer

Alias
UMLS CUI [1,1]
C0919553
UMLS CUI [1,2]
C0011900
Grade at Enrollment
Beschreibung

Grade at Enrollment

Datentyp

integer

Alias
UMLS CUI [1,1]
C0919553
UMLS CUI [1,2]
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

Please check the method

Datentyp

text

Alias
UMLS CUI [1]
C0054946
Date tissue obtained (CD20 Reactivity)
Beschreibung

Date tissue obtained (CD20 Reactivity)

Datentyp

date

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C0011008
Date of assay (CD20 Reactivity)
Beschreibung

Date of assay (CD20 Reactivity)

Datentyp

date

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

Evidence of bulky disease (>500 gm)

Datentyp

integer

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

Maximum unidimensional tumor diameter (excluding organs)

Datentyp

float

Maßeinheiten
  • cm
Alias
UMLS CUI [1,1]
C3272927
UMLS CUI [1,2]
C0806909
cm
Prior Therapy
Beschreibung

Prior Therapy

Alias
UMLS CUI-1
C1514463
Chemotherapy Code
Beschreibung

Chemotherapy Code

Datentyp

integer

Alias
UMLS CUI [1]
C0392920
List drug names only If code is not given
Beschreibung

Drugs

Datentyp

text

Alias
UMLS CUI [1]
C0013227
Start Date
Beschreibung

Start Date

Datentyp

date

Alias
UMLS CUI [1]
C0808070
Stop Date
Beschreibung

Stop Date

Datentyp

date

Alias
UMLS CUI [1]
C0806020
Number of Cycles
Beschreibung

Number of Cycles

Datentyp

integer

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

Therapy Outcome

Datentyp

text

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

Duration of Response

Datentyp

float

Alias
UMLS CUI [1]
C0237585
Prior Radiation Therapy
Beschreibung

Prior Radiation Therapy

Alias
UMLS CUI-1
C0279134
Prior Radiation Therapy
Beschreibung

Prior Radiation Therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0279134
Start Date
Beschreibung

Start Date

Datentyp

date

Alias
UMLS CUI [1]
C0808070
Stop Date
Beschreibung

Stop Date

Datentyp

date

Alias
UMLS CUI [1]
C0806020
Total Dose in cGy
Beschreibung

Total Dose in cGy

Datentyp

float

Alias
UMLS CUI [1]
C2169193
Location (sites treated)
Beschreibung

Location

Datentyp

text

Alias
UMLS CUI [1,1]
C0450429
UMLS CUI [1,2]
C2169202
Therapy Outcome at Irradiated Location
Beschreibung

Therapy Outcome at Irradiated Location

Datentyp

integer

Alias
UMLS CUI [1,1]
C2169202
UMLS CUI [1,2]
C1518681
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Ähnliche Modelle

History of Lymphoma, Prior Therapy and Prior Radiation Therapy

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administration
C1320722 (UMLS CUI-1)
Site Number
Item
Site Number:
integer
C0018704 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Patient Number
Item
Patient Number
integer
C1830427 (UMLS CUI [1])
Patient Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Item Group
Stage
C1300072 (UMLS CUI-1)
C0024299 (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])
C0024299 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,3])
Stage at Diagnosis
Code List
Stage at Diagnosis
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
Item
Stage at Enrollment
integer
C1300072 (UMLS CUI [1,1])
C0024299 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
Stage at Enrollment
Code List
Stage at Enrollment
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
Item Group
Lymphoma at Diagnosis/Enrollment
C0024299 (UMLS CUI-1)
C0011900 (UMLS CUI-2)
C1516879 (UMLS CUI-3)
Item
Cell Type at Diagnosis
integer
C0449475 (UMLS CUI [1,1])
C0024299 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,3])
Cell Type at Diagnosis
Code List
Cell Type at Diagnosis
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)
Item
Cell Type at Enrollment
integer
C0449475 (UMLS CUI [1,1])
C0024299 (UMLS CUI [1,2])
C1516879 (UMLS CUI [1,3])
Cell Type at Enrollment
Code List
Cell Type at Enrollment
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-cleaved  (6)
CL Item
Diffuse, mixed small-cleaved & 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) (99)
Item
Grade at Diagnosis
integer
C0919553 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Grade at Diagnosis
Code List
Grade at Diagnosis
CL Item
Low (1)
CL Item
Intermediate (2)
CL Item
High (3)
CL Item
N/A (0)
Item
Grade at Enrollment
integer
C0919553 (UMLS CUI [1,1])
C1516879 (UMLS CUI [1,2])
Grade at Enrollment
Code List
Grade at Enrollment
CL Item
Low (1)
CL Item
Intermediate (2)
CL Item
High (3)
CL Item
N/A (0)
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 nodes (0)
CL Item
1 node (1)
CL Item
2 or more sites (2)
Item
CD20 Reactivity
text
C0054946 (UMLS CUI [1])
CD20 Reactivity
Code List
CD20 Reactivity
CL Item
Histopathology (1)
CL Item
Flow Cytometry (2)
CL Item
N/A (0)
Date tissue obtained (CD20 Reactivity)
Item
Date tissue obtained (CD20 Reactivity)
date
C0200345 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Date of assay (CD20 Reactivity)
Item
Date of assay (CD20 Reactivity)
date
C0011008 (UMLS CUI [1,1])
C0005507 (UMLS CUI [1,2])
Item
Does Patient have evidence of bulky disease (>500 gm)?
integer
C0024299 (UMLS CUI [1,1])
C1511341 (UMLS CUI [1,2])
C0332120 (UMLS CUI [1,3])
Evidence of bulky disease (>500 gm)
Code List
Does Patient have evidence of bulky disease (>500 gm)?
CL Item
yes (1)
CL Item
no (2)
CL Item
NA (0)
Maximum unidimensional tumor diameter (excluding organs)
Item
Record the maximum unidimensional tumor diameter (excluding organs)
float
C3272927 (UMLS CUI [1,1])
C0806909 (UMLS CUI [1,2])
Item Group
Prior Therapy
C1514463 (UMLS CUI-1)
Item
Chemotherapy Code
integer
C0392920 (UMLS CUI [1])
Chemotherapy Code
Code List
Chemotherapy Code
CL Item
CVP  (1)
CL Item
C-MOPP  (2)
CL Item
BACOP  (3)
CL Item
COP-Bleo  (4)
CL Item
CHOP  (5)
CL Item
CHOP-Bleo  (6)
CL Item
CP  (7)
CL Item
Cyloxan  (8)
CL Item
COPP  (9)
CL Item
Pro-MACE-MOPP  (10)
CL Item
CHOP-Bleo + Alpha Interferon  (11)
CL Item
COMLA  (12)
CL Item
Fludarabine  (13)
CL Item
ACP  (14)
CL Item
MINE  (15)
CL Item
ESHAP  (16)
CL Item
DHAP  (17)
CL Item
EPOCH  (18)
CL Item
CEPP  (19)
CL Item
Pro-MACE-CytaBOM  (20)
CL Item
ICE  (21)
CL Item
COP-BLAM  (22)
CL Item
CNOP  (23)
CL Item
FNO  (24)
CL Item
MACOP-B  (25)
CL Item
m-BACOD  (26)
CL Item
VAPEC-8  (27)
CL Item
IM-VP16  (28)
CL Item
CF  (29)
CL Item
Other (specify)  (30)
CL Item
Chlorambucil  (49)
CL Item
Rltuxlmab (64)
Drugs
Item
List drug names only If code is not given
text
C0013227 (UMLS CUI [1])
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
Stop Date
Item
Stop Date
date
C0806020 (UMLS CUI [1])
Number of Cycles
Item
Number of Cycles
integer
C0449788 (UMLS CUI [1,1])
C1302181 (UMLS CUI [1,2])
Item
Therapy Outcome
text
C1518681 (UMLS CUI [1])
Therapy Outcome
Code List
Therapy Outcome
CL Item
PD (1)
CL Item
SD (2)
CL Item
PR (3)
CL Item
CCR (4)
CL Item
CR (5)
CL Item
unknown (0)
Duration of Response
Item
Duration of Response (months)
float
C0237585 (UMLS CUI [1])
Item Group
Prior Radiation Therapy
C0279134 (UMLS CUI-1)
Prior Radiation Therapy
Item
Prior Radiation Therapy
boolean
C0279134 (UMLS CUI [1])
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
Stop Date
Item
Stop Date
date
C0806020 (UMLS CUI [1])
Total Dose in cGy
Item
Total Dose in cGy
float
C2169193 (UMLS CUI [1])
Location
Item
Location (sites treated)
text
C0450429 (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
PD (1)
CL Item
SD (2)
CL Item
PR (3)
CL Item
CCR (4)
CL Item
CR (5)
CL Item
unknown (0)
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