ID

31180

Description

Study ID: 104505 Clinical Study ID: BEX104505 Study Title: Phase II Study of Iodine 131 Anti B1 Antibody for 1st or 2nd Relapsed Indolent B-Cell Lymphomas or B-Cell Lymphomas That Have Transformed to a More Aggressive Histology Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00950755 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: tositumomab Trade Name: Bexxar Study Indication: Lymphoma, Non-Hodgkin

Mots-clés

Versions (1)
  1. 25/07/2018 25/07/2018 -
Détendeur de droits

see clinicaltrials.gov

Téléchargé le

25 juillet 2018

DOI

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Licence

Creative Commons BY 4.0
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Iodine 131 B1 Antibody for B-Cell Lymphomas NCT00950755

Anglais

Post-Treatment Response - Week 7

1 Formulaires  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Site Number
Description

Site number

Type de données

text

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

Patient Number

Type de données

text

Alias
UMLS CUI [1]
C1830427
Patient Initials
Description

Patient Initials

Type de données

text

Alias
UMLS CUI [1]
C2986440
Diagnostic Imaging, Head/Neck
Description

Diagnostic Imaging, Head/Neck

Alias
UMLS CUI-1
C0011923
UMLS CUI-2
C0460004
Not Done
Description

Diagnostic Imaging, Head and neck structure, Not Done

Type de données

boolean

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C0460004
UMLS CUI [1,3]
C1272696
Date
Description

Diagnostic Imaging, Head and neck structure, Date

Type de données

date

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C0460004
UMLS CUI [1,3]
C0011008
Imaging
Description

Diagnostic Imaging, Head/Neck

Type de données

text

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C0460004
Result
Description

Diagnostic Imaging, Head/Neck, Result

Type de données

text

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C0460004
UMLS CUI [1,3]
C1274040
Diagnostic Imaging; Chest
Description

Diagnostic Imaging; Chest

Alias
UMLS CUI-1
C0011923
UMLS CUI-2
C0817096
Not Done
Description

Diagnostic Imaging, Chest, Not Done

Type de données

boolean

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C0817096
UMLS CUI [1,3]
C1272696
Date
Description

Diagnostic Imaging, Chest, Date

Type de données

date

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C0817096
UMLS CUI [1,3]
C0011008
Imaging
Description

Diagnostic Imaging, Chest

Type de données

text

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C0817096
Result
Description

Diagnostic Imaging, Chest, Results

Type de données

text

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C0817096
UMLS CUI [1,3]
C1274040
Diagnostic Imaging, Abdomen
Description

Diagnostic Imaging, Abdomen

Alias
UMLS CUI-1
C0011923
UMLS CUI-2
C0000726
Not done
Description

Diagnostic Imaging, Abdomen, Not done

Type de données

boolean

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C0000726
UMLS CUI [1,3]
C1272696
Date
Description

Diagnostic Imaging, Abdomen, Date

Type de données

date

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C0000726
UMLS CUI [1,3]
C0011008
Imaging
Description

Diagnostic Imaging, Abdomen

Type de données

text

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C0000726
Result
Description

Diagnostic Imaging, Abdomen, Result

Type de données

text

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C0000726
UMLS CUI [1,3]
C1274040
Diagnostic Imaging, Pelvis
Description

Diagnostic Imaging, Pelvis

Alias
UMLS CUI-1
C0011923
UMLS CUI-2
C0030797
Not Done
Description

Diagnostic Imaging, Pelvis, Not done

Type de données

boolean

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C0030797
UMLS CUI [1,3]
C1272696
Date
Description

Diagnostic Imaging, Pelvis, Date

Type de données

date

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C0030797
UMLS CUI [1,3]
C0011008
Imaging
Description

Diagnostic Imaging, Pelvis

Type de données

text

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C0030797
Result
Description

Diagnostic Imaging, Pelvis, Result

Type de données

text

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C0030797
UMLS CUI [1,3]
C1274040
Diagnostic Imaging, Other
Description

Diagnostic Imaging, Other

Alias
UMLS CUI-1
C0011923
UMLS CUI-2
C0205394
Not Done
Description

Diagnostic Imaging, Other, Not Done

Type de données

boolean

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C1272696
Date
Description

Diagnostic Imaging, Other, Date

Type de données

date

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0011008
Imaging
Description

Diagnostic Imaging, Other

Type de données

text

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C0205394
Result
Description

Diagnostic Imaging, Other, Result

Type de données

text

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C1274040
Bone Marrow Biopsy
Description

Bone Marrow Biopsy

Alias
UMLS CUI-1
C0005954
Date of biopsy
Description

Biopsy, Date in time

Type de données

date

Alias
UMLS CUI [1,1]
C0005558
UMLS CUI [1,2]
C0011008
Bone Marrow Biopsy
Description

Bone Marrow Biopsy

Type de données

text

Alias
UMLS CUI [1]
C0005954
Marrow cellularity
Description

Bone marrow cellularity finding

Type de données

text

Alias
UMLS CUI [1]
C1561532
Tumor involvement
Description

Malignant Neoplasms, Involvement with

Type de données

integer

Unités de mesure
  • %
Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C1314939
%
Tumor involvement
Description

Malignant Neoplasms, Involvement with

Type de données

text

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C1314939
Measurable Lymphoma Disease
Description

Measurable Lymphoma Disease

Alias
UMLS CUI-1
C0024299
UMLS CUI-2
C1513041
Site
Description

Measurable Lymphoma Disease, Site

Type de données

text

Alias
UMLS CUI [1,1]
C0024299
UMLS CUI [1,2]
C1513041
UMLS CUI [1,3]
C1515974
Method of Determination
Description

Measurable Lymphoma Disease, Method of Determination

Type de données

text

Alias
UMLS CUI [1,1]
C0024299
UMLS CUI [1,2]
C1513041
UMLS CUI [1,3]
C2911685
Date
Description

Measurable Lymphoma Disease, Date

Type de données

date

Alias
UMLS CUI [1,1]
C0024299
UMLS CUI [1,2]
C1513041
UMLS CUI [1,3]
C0242485
UMLS CUI [1,4]
C0011008
Tumor Measurements
Description

Measurable Lymphoma Disease, Tumor Measurements

Type de données

integer

Unités de mesure
  • cm x cm = cm²
Alias
UMLS CUI [1,1]
C0024299
UMLS CUI [1,2]
C1513041
UMLS CUI [1,3]
C0475440
cm x cm = cm²
Non-Measurable Disease
Description

Non-Measurable Disease

Alias
UMLS CUI-1
C0012634
UMLS CUI-2
C1518373
Site
Description

Non-Measurable Disease, Site

Type de données

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1518373
UMLS CUI [1,3]
C1515974
Method of Determination
Description

Non-Measurable Disease, Method of Determination

Type de données

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1518373
UMLS CUI [1,3]
C2911685
Date
Description

Non-Measurable Disease, Date

Type de données

date

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1518373
UMLS CUI [1,3]
C0011008
Check one
Description

Non-Measurable Disease, Status

Type de données

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1518373
UMLS CUI [1,3]
C0449438
Response
Description

Response

Alias
UMLS CUI-1
C0521982
Response (check one)
Description

Response to treatment

Type de données

text

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

Response to treatment; Date of evaluation

Type de données

date

Alias
UMLS CUI [1,1]
C0521982
UMLS CUI [1,2]
C2985720
Comments
Description

Response to treatment; Comments

Type de données

text

Alias
UMLS CUI [1,1]
C0521982
UMLS CUI [1,2]
C0947611
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Similar models

Post-Treatment Response - Week 7

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Site number
Item
Site Number
text
C0018704 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Patient Number
Item
Patient Number
text
C1830427 (UMLS CUI [1])
Patient Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Item Group
Diagnostic Imaging, Head/Neck
C0011923 (UMLS CUI-1)
C0460004 (UMLS CUI-2)
Diagnostic Imaging, Head and neck structure, Not Done
Item
Not Done
boolean
C0011923 (UMLS CUI [1,1])
C0460004 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Diagnostic Imaging, Head and neck structure, Date
Item
Date
date
C0011923 (UMLS CUI [1,1])
C0460004 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Imaging
text
C0011923 (UMLS CUI [1,1])
C0460004 (UMLS CUI [1,2])
Diagnostic Imaging, Head/Neck
Code List
Imaging
CL Item
CT (CT)
CL Item
MRI (MRI)
CL Item
X-ray (X-ray)
CL Item
Other (Other)
Item
Result
text
C0011923 (UMLS CUI [1,1])
C0460004 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Diagnostic Imaging, Head/Neck
Code List
Result
CL Item
Normal (Normal)
CL Item
Abnormal (specify) (Abnormal (specify))
Item Group
Diagnostic Imaging; Chest
C0011923 (UMLS CUI-1)
C0817096 (UMLS CUI-2)
Diagnostic Imaging, Chest, Not Done
Item
Not Done
boolean
C0011923 (UMLS CUI [1,1])
C0817096 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Diagnostic Imaging, Chest, Date
Item
Date
date
C0011923 (UMLS CUI [1,1])
C0817096 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Imaging
text
C0011923 (UMLS CUI [1,1])
C0817096 (UMLS CUI [1,2])
Diagnostic Imaging, Chest
Code List
Imaging
CL Item
CT (CT)
CL Item
MRI (MRI)
CL Item
X-ray (X-ray)
CL Item
Other (Other)
Item
Result
text
C0011923 (UMLS CUI [1,1])
C0817096 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Diagnostic Imaging, Chest
Code List
Result
CL Item
Normal (Normal)
CL Item
Abnormal (specify) (Abnormal (specify))
Item Group
Diagnostic Imaging, Abdomen
C0011923 (UMLS CUI-1)
C0000726 (UMLS CUI-2)
Diagnostic Imaging, Abdomen, Not done
Item
Not done
boolean
C0011923 (UMLS CUI [1,1])
C0000726 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Diagnostic Imaging, Abdomen, Date
Item
Date
date
C0011923 (UMLS CUI [1,1])
C0000726 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Imaging
text
C0011923 (UMLS CUI [1,1])
C0000726 (UMLS CUI [1,2])
Diagnostic Imaging, Abdomen
Code List
Imaging
CL Item
CT (CT)
CL Item
MRI (MRI)
CL Item
X-ray (X-ray)
CL Item
Other (Other)
Item
Result
text
C0011923 (UMLS CUI [1,1])
C0000726 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Diagnostic Imaging, Abdomen
Code List
Result
CL Item
Normal (Normal)
CL Item
Abnormal (specify) (Abnormal (specify))
Item Group
Diagnostic Imaging, Pelvis
C0011923 (UMLS CUI-1)
C0030797 (UMLS CUI-2)
Diagnostic Imaging, Pelvis, Not done
Item
Not Done
boolean
C0011923 (UMLS CUI [1,1])
C0030797 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Diagnostic Imaging, Pelvis, Date
Item
Date
date
C0011923 (UMLS CUI [1,1])
C0030797 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Imaging
text
C0011923 (UMLS CUI [1,1])
C0030797 (UMLS CUI [1,2])
Diagnostic Imaging, Pelvis
Code List
Imaging
CL Item
CT (CT)
CL Item
MRI (MRI)
CL Item
X-ray (X-ray)
CL Item
Other (Other)
Item
Result
text
C0011923 (UMLS CUI [1,1])
C0030797 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Diagnostic Imaging, Pelvis
Code List
Result
CL Item
Normal (Normal)
CL Item
Abnormal (specify) (Abnormal (specify))
Item Group
Diagnostic Imaging, Other
C0011923 (UMLS CUI-1)
C0205394 (UMLS CUI-2)
Diagnostic Imaging, Other, Not Done
Item
Not Done
boolean
C0011923 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Diagnostic Imaging, Other, Date
Item
Date
date
C0011923 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Imaging
text
C0011923 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Diagnostic Imaging, Other
Code List
Imaging
CL Item
CT (CT)
CL Item
MRI (MRI)
CL Item
X-ray (X-ray)
CL Item
Other (Other)
Item
Result
text
C0011923 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Diagnostic Imaging, Other
Code List
Result
CL Item
Normal (Normal)
CL Item
Abnormal (specify) (Abnormal (specify))
Item Group
Bone Marrow Biopsy
C0005954 (UMLS CUI-1)
Biopsy, Date in time
Item
Date of biopsy
date
C0005558 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Bone Marrow Biopsy
text
C0005954 (UMLS CUI [1])
Bone Marrow Biopsy
Code List
Bone Marrow Biopsy
CL Item
Not done (Not done)
CL Item
Not indicated (BM not positive at baseline) (Not indicated (BM not positive at baseline))
CL Item
Not indicated (patient not in CR) (Not indicated (patient not in CR))
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)
Malignant Neoplasms, Involvement with
Item
Tumor involvement
integer
C0006826 (UMLS CUI [1,1])
C1314939 (UMLS CUI [1,2])
Item
Tumor involvement
text
C0006826 (UMLS CUI [1,1])
C1314939 (UMLS CUI [1,2])
Malignant Neoplasms, Involvement with
Code List
Tumor involvement
CL Item
Unilateral (1)
CL Item
Bilateral (2)
Item Group
Measurable Lymphoma Disease
C0024299 (UMLS CUI-1)
C1513041 (UMLS CUI-2)
Measurable Lymphoma Disease, Site
Item
Site
text
C0024299 (UMLS CUI [1,1])
C1513041 (UMLS CUI [1,2])
C1515974 (UMLS CUI [1,3])
Measurable Lymphoma Disease, Method of Determination
Item
Method of Determination
text
C0024299 (UMLS CUI [1,1])
C1513041 (UMLS CUI [1,2])
C2911685 (UMLS CUI [1,3])
Measurable Lymphoma Disease, Date
Item
Date
date
C0024299 (UMLS CUI [1,1])
C1513041 (UMLS CUI [1,2])
C0242485 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Measurable Lymphoma Disease, Tumor Measurements
Item
Tumor Measurements
integer
C0024299 (UMLS CUI [1,1])
C1513041 (UMLS CUI [1,2])
C0475440 (UMLS CUI [1,3])
Item Group
Non-Measurable Disease
C0012634 (UMLS CUI-1)
C1518373 (UMLS CUI-2)
Non-Measurable Disease, Site
Item
Site
text
C0012634 (UMLS CUI [1,1])
C1518373 (UMLS CUI [1,2])
C1515974 (UMLS CUI [1,3])
Non-Measurable Disease, Method of Determination
Item
Method of Determination
text
C0012634 (UMLS CUI [1,1])
C1518373 (UMLS CUI [1,2])
C2911685 (UMLS CUI [1,3])
Non-Measurable Disease, Date
Item
Date
date
C0012634 (UMLS CUI [1,1])
C1518373 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Check one
text
C0012634 (UMLS CUI [1,1])
C1518373 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,3])
Non-Measurable Disease, Status
Code List
Check one
CL Item
New (New)
CL Item
Increased (Increased)
CL Item
Stable (Stable)
CL Item
Decreased (Decreased)
Item Group
Response
C0521982 (UMLS CUI-1)
Item
Response (check one)
text
C0521982 (UMLS CUI [1])
Response to treatment
Code List
Response (check one)
CL Item
CR (CR)
CL Item
CCR (CCR)
CL Item
PR (PR)
CL Item
SD (SD)
CL Item
PD (PD)
Response to treatment; Date of evaluation
Item
Date of Response Evaluation
date
C0521982 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
Response to treatment; Comments
Item
Comments
text
C0521982 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
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