ID

31377

Beskrivning

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

Nyckelord

Versioner (2)
  1. 2018-07-23 2018-07-23 -
  2. 2018-08-18 2018-08-18 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

18 augusti 2018

DOI

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

Engelsk

Post- Treatment Response Follow- Up

1 Formulär  
Visit Week
Beskrivning

Visit Week

Alias
UMLS CUI-1
C0545082
UMLS CUI-2
C0439230
Please check the appropriate visit week
Beskrivning

visit week

Datatyp

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0439230
Other Visit Week
Beskrivning

Visit; Week; Other

Datatyp

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0439230
UMLS CUI [1,3]
C0205394
CT or other Radiological Imaging Results
Beskrivning

CT or other Radiological Imaging Results

Alias
UMLS CUI-1
C0040405
UMLS CUI-2
C1274040
UMLS CUI-3
C0011923
UMLS CUI-4
C0205483
UMLS CUI-5
C1274040
Imaging Location
Beskrivning

Location

Datatyp

text

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C0450429
Imaging Finding
Beskrivning

Finding

Datatyp

text

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C0243095
If abnormal finding, please specify
Beskrivning

If abnormal, please specify

Datatyp

text

Alias
UMLS CUI [1,1]
C0243095
UMLS CUI [1,2]
C0205161
UMLS CUI [1,3]
C2348235
Imaging Type
Beskrivning

Imaging Type

Datatyp

text

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C0332307
Date of Imaging
Beskrivning

Date of Imaging

Datatyp

date

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C0011008
Bone Marrow Biopsy
Beskrivning

Bone Marrow Biopsy

Alias
UMLS CUI-1
C0005954
Bone Marrow Biopsy
Beskrivning

Bone Marrow Biopsy

Datatyp

text

Alias
UMLS CUI [1]
C0005954
Date of Biopsy
Beskrivning

Date of Biopsy

Datatyp

date

Alias
UMLS CUI [1,1]
C0005558
UMLS CUI [1,2]
C0011008
Marrow cellularity
Beskrivning

Marrow cellularity

Datatyp

text

Alias
UMLS CUI [1]
C1561532
Tumor involvement
Beskrivning

Tumor involvement

Datatyp

text

Måttenheter
  • %
Alias
UMLS CUI [1]
C1517677
%
Tumor Involvement Dimension
Beskrivning

Dimension

Datatyp

text

Alias
UMLS CUI [1,1]
C1517677
UMLS CUI [1,2]
C0439534
Measurable Lymphoma Disease
Beskrivning

Measurable Lymphoma Disease

Alias
UMLS CUI-1
C0024299
UMLS CUI-2
C1513041
Disease Site
Beskrivning

Site

Datatyp

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1515974
Method of Determination
Beskrivning

Method of Determination

Datatyp

text

Alias
UMLS CUI [1]
C2911685
Evaluation Date (mm/dd/yy)
Beskrivning

Date

Datatyp

date

Alias
UMLS CUI [1,1]
C0220825
UMLS CUI [1,2]
C0011008
Tumor Measurements (cm x cm)
Beskrivning

Tumor Measurements

Datatyp

text

Alias
UMLS CUI [1,1]
C0242485
UMLS CUI [1,2]
C0027651
Tumor Measurements
Beskrivning

Tumor Measurements

Datatyp

float

Måttenheter
  • cm2
Alias
UMLS CUI [1,1]
C0242485
UMLS CUI [1,2]
C0027651
cm2
Non- Measurable Disease
Beskrivning

Non- Measurable Disease

Alias
UMLS CUI-1
C1334988
Non- Measurable Disease
Beskrivning

Non- Measurable Disease

Datatyp

text

Alias
UMLS CUI [1]
C1334988
Disease Site
Beskrivning

Site

Datatyp

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1515974
Method of Determination
Beskrivning

Method of Determination

Datatyp

text

Alias
UMLS CUI [1]
C2911685
Evaluation Date (mm/dd/yy)
Beskrivning

Date

Datatyp

date

Alias
UMLS CUI [1,1]
C0220825
UMLS CUI [1,2]
C0011008
Finding
Beskrivning

Finding

Datatyp

text

Alias
UMLS CUI [1]
C0243095
Response
Beskrivning

Response

Alias
UMLS CUI-1
C0521982
Response
Beskrivning

Response

Datatyp

text

Alias
UMLS CUI [1]
C0521982
Date of Response Evaluation
Beskrivning

Date of Response Evaluation

Datatyp

date

Alias
UMLS CUI [1,1]
C0521982
UMLS CUI [1,2]
C0220825
UMLS CUI [1,3]
C0011008
Comments
Beskrivning

Comments

Datatyp

text

Alias
UMLS CUI [1]
C0947611
Administrative
Beskrivning

Administrative

Alias
UMLS CUI-1
C1320722
Series page
Beskrivning

Series page

Datatyp

text

Alias
UMLS CUI [1,1]
C0205549
UMLS CUI [1,2]
C1704732
Last Page
Beskrivning

Last Page

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1704732
UMLS CUI [1,2]
C1517741
Signature of Investigator
Beskrivning

Signature of Investigator

Datatyp

text

Alias
UMLS CUI [1]
C2346576
Evaluation Date
Beskrivning

Date

Datatyp

date

Alias
UMLS CUI [1,1]
C0220825
UMLS CUI [1,2]
C0011008
Tillbaka till toppen

Similar models

Post- Treatment Response Follow- Up

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Visit Week
C0545082 (UMLS CUI-1)
C0439230 (UMLS CUI-2)
Item
Please check the appropriate visit week
text
C0545082 (UMLS CUI [1,1])
C0439230 (UMLS CUI [1,2])
visit week
Code List
Please check the appropriate visit week
CL Item
Week 52 (1 year) (1)
CL Item
Week 78 (1,5 years) (2)
CL Item
Week 104 (2 years) (3)
Visit; Week; Other
Item
Other Visit Week
text
C0545082 (UMLS CUI [1,1])
C0439230 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Item Group
CT or other Radiological Imaging Results
C0040405 (UMLS CUI-1)
C1274040 (UMLS CUI-2)
C0011923 (UMLS CUI-3)
C0205483 (UMLS CUI-4)
C1274040 (UMLS CUI-5)
Item
Imaging Location
text
C0011923 (UMLS CUI [1,1])
C0450429 (UMLS CUI [1,2])
Location
Code List
Imaging Location
CL Item
Head/ Neck (2)
CL Item
Chest (3)
CL Item
Abdomen (4)
CL Item
Pelvis (5)
CL Item
Other (99)
Item
Imaging Finding
text
C0011923 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
Finding
Code List
Imaging Finding
CL Item
Normal (1)
CL Item
Abnormal (Specify) (2)
CL Item
Not done (0)
If abnormal, please specify
Item
If abnormal finding, please specify
text
C0243095 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item
Imaging Type
text
C0011923 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Imaging Type
Code List
Imaging Type
CL Item
CT (10)
CL Item
MRI (12)
CL Item
X-ray (1)
CL Item
Other (99)
Date of Imaging
Item
Date of Imaging
date
C0011923 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Bone Marrow Biopsy
C0005954 (UMLS CUI-1)
Item
Bone Marrow Biopsy
text
C0005954 (UMLS CUI [1])
Bone Marrow Biopsy
Code List
Bone Marrow Biopsy
CL Item
Not Done (2)
CL Item
Not indicated (BM not possible at baseline) (4)
CL Item
Not indicated (patient not in CR) (3)
Date of Biopsy
Item
Date of Biopsy
date
C0005558 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Marrow cellularity
text
C1561532 (UMLS CUI [1])
Marrow cellularity
Code List
Marrow cellularity
CL Item
Normal (1)
CL Item
Hypocellular (2)
CL Item
Hypercellular (3)
Tumor involvement
Item
Tumor involvement
text
C1517677 (UMLS CUI [1])
Item
Tumor Involvement Dimension
text
C1517677 (UMLS CUI [1,1])
C0439534 (UMLS CUI [1,2])
Dimension
Code List
Tumor Involvement Dimension
CL Item
Unilateral (1)
CL Item
Bilateral (2)
Item Group
Measurable Lymphoma Disease
C0024299 (UMLS CUI-1)
C1513041 (UMLS CUI-2)
Site
Item
Disease Site
text
C0012634 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
Method of Determination
Item
Method of Determination
text
C2911685 (UMLS CUI [1])
Date
Item
Evaluation Date (mm/dd/yy)
date
C0220825 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Tumor Measurements
Item
Tumor Measurements (cm x cm)
text
C0242485 (UMLS CUI [1,1])
C0027651 (UMLS CUI [1,2])
Tumor Measurements
Item
Tumor Measurements
float
C0242485 (UMLS CUI [1,1])
C0027651 (UMLS CUI [1,2])
Item Group
Non- Measurable Disease
C1334988 (UMLS CUI-1)
Item
Non- Measurable Disease
text
C1334988 (UMLS CUI [1])
Non- Measurable Disease
Code List
Non- Measurable Disease
CL Item
None (1)
CL Item
Not done (2)
Site
Item
Disease Site
text
C0012634 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
Method of Determination
Item
Method of Determination
text
C2911685 (UMLS CUI [1])
Date
Item
Evaluation Date (mm/dd/yy)
date
C0220825 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Finding
text
C0243095 (UMLS CUI [1])
Finding
Code List
Finding
CL Item
New (1)
CL Item
Increased (2)
CL Item
Stable (3)
CL Item
Decreased (4)
Item Group
Response
C0521982 (UMLS CUI-1)
Item
Response
text
C0521982 (UMLS CUI [1])
Response
Code List
Response
CL Item
CR (5)
CL Item
CCR (4)
CL Item
PR (3)
CL Item
SD (2)
CL Item
PD (1)
Date of Response Evaluation
Item
Date of Response Evaluation
date
C0521982 (UMLS CUI [1,1])
C0220825 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Item Group
Administrative
C1320722 (UMLS CUI-1)
Series page
Item
Series page
text
C0205549 (UMLS CUI [1,1])
C1704732 (UMLS CUI [1,2])
Last Page
Item
Last Page
boolean
C1704732 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
Signature of Investigator
Item
Signature of Investigator
text
C2346576 (UMLS CUI [1])
Date
Item
Evaluation Date
date
C0220825 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Tillbaka till toppen 

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