ID

30171

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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30170_29981_Multicenter Pivotal Phase III Study of Iodine-131 Anti-B1 Antibody (Murine) Radioimmunotherapy

Englisch

Disease Staging Baseline

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
CT or other Radiological Imaging Results (within 28 days of entry)
Beschreibung

CT or other Radiological Imaging Results (within 28 days of entry)

Alias
UMLS CUI-1
C0011923
UMLS CUI-2
C1274040
Imaging Site
Beschreibung

Imaging Site

Datentyp

text

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C1704254
Not done
Beschreibung

Not done

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1272696
UMLS CUI [1,2]
C0011923
Imaging Type
Beschreibung

Imaging Type

Datentyp

text

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C0332307
Result
Beschreibung

Result

Datentyp

text

Alias
UMLS CUI [1,1]
C1274040
UMLS CUI [1,2]
C0011923
Date
Beschreibung

Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0011923
Bone Marrow Biopsy (within 42 days of entry)
Beschreibung

Bone Marrow Biopsy (within 42 days of entry)

Alias
UMLS CUI-1
C0005954
Bone Marrow Biopsy (Done or not done)
Beschreibung

Bone Marrow Biopsy

Datentyp

boolean

Alias
UMLS CUI [1]
C0005954
Date of biopsy
Beschreibung

Date of biopsy

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0005954
Marrow Cellularity
Beschreibung

Marrow Cellularity

Datentyp

integer

Alias
UMLS CUI [1]
C1561532
Tumor Involvement %
Beschreibung

Tumor Involvement

Datentyp

float

Alias
UMLS CUI [1,1]
C1517677
UMLS CUI [1,2]
C0368761
Tumor Involvement
Beschreibung

Tumor Involvement

Datentyp

integer

Alias
UMLS CUI [1]
C1517677
Measurable Lymphoma Disease
Beschreibung

Measurable Lymphoma Disease

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

Site

Datentyp

text

Alias
UMLS CUI [1]
C1515974
Method of Determination
Beschreibung

Method of Determination

Datentyp

text

Alias
UMLS CUI [1]
C2911685
Date
Beschreibung

Date

Datentyp

date

Alias
UMLS CUI [1]
C0011008
Tumor Measurement-1
Beschreibung

Tumor Measurement-1

Datentyp

float

Maßeinheiten
  • cm
Alias
UMLS CUI [1,1]
C0242485
UMLS CUI [1,2]
C0024299
cm
Tumor Measurement-2
Beschreibung

Tumor Measurement-2

Datentyp

float

Maßeinheiten
  • cm
Alias
UMLS CUI [1,1]
C0242485
UMLS CUI [1,2]
C0024299
cm
Tumor Measurement in cm2
Beschreibung

Tumor Measurement in cm2

Datentyp

float

Maßeinheiten
  • cm2
Alias
UMLS CUI [1,1]
C0242485
UMLS CUI [1,2]
C0024299
cm2
Non-Measurable Disease
Beschreibung

Non-Measurable Disease

Alias
UMLS CUI-1
C1334988
Non-Measurable Disease (Done/not done)
Beschreibung

Non-Measurable Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C1334988
Site
Beschreibung

Site

Datentyp

text

Alias
UMLS CUI [1]
C1515974
Method of Determination
Beschreibung

Method of Determination

Datentyp

text

Alias
UMLS CUI [1]
C2911685
Date
Beschreibung

Date

Datentyp

date

Alias
UMLS CUI [1]
C0011008
Check one
Beschreibung

Check one

Datentyp

integer

Alias
UMLS CUI [1,1]
C0332307
UMLS CUI [1,2]
C1334988
Administration
Beschreibung

Administration

Alias
UMLS CUI-1
C1320722
Signature of Investigator
Beschreibung

Signature of Investigator

Datentyp

text

Alias
UMLS CUI [1]
C2346576
Date
Beschreibung

Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C2346576
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Ähnliche Modelle

Disease Staging Baseline

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
CT or other Radiological Imaging Results (within 28 days of entry)
C0011923 (UMLS CUI-1)
C1274040 (UMLS CUI-2)
Item
Imaging Site
text
C1515974 (UMLS CUI [1,1])
C1704254 (UMLS CUI [1,2])
Imaging Site
Code List
Imaging Site
CL Item
Head and Neck (2)
CL Item
Chest (3)
CL Item
Abdomen (4)
CL Item
Pelvis (5)
CL Item
Other (99)
Not done
Item
Not done
boolean
C1272696 (UMLS CUI [1,1])
C0011923 (UMLS CUI [1,2])
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)
Item
Result
text
C1274040 (UMLS CUI [1,1])
C0011923 (UMLS CUI [1,2])
Result
Code List
Result
CL Item
Not Done (0)
CL Item
Normal (1)
CL Item
Abnormal, specify.......... (2)
Date
Item
Date
date
C0011008 (UMLS CUI [1,1])
C0011923 (UMLS CUI [1,2])
Item Group
Bone Marrow Biopsy (within 42 days of entry)
C0005954 (UMLS CUI-1)
Bone Marrow Biopsy
Item
Bone Marrow Biopsy (Done or not done)
boolean
C0005954 (UMLS CUI [1])
Date of biopsy
Item
Date of biopsy
date
C0011008 (UMLS CUI [1,1])
C0005954 (UMLS CUI [1,2])
Item
Marrow Cellularity
integer
C1561532 (UMLS CUI [1])
Marrow Cellularity
Code List
Marrow Cellularity
CL Item
Normal (1)
CL Item
Hypocellular (2)
CL Item
Hypercellular (3)
CL Item
NA (0)
Tumor Involvement
Item
Tumor Involvement %
float
C1517677 (UMLS CUI [1,1])
C0368761 (UMLS CUI [1,2])
Item
Tumor Involvement
integer
C1517677 (UMLS CUI [1])
Tumor Involvement
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)
Site
Item
Site
text
C1515974 (UMLS CUI [1])
Method of Determination
Item
Method of Determination
text
C2911685 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Tumor Measurement-1
Item
Tumor Measurement-1
float
C0242485 (UMLS CUI [1,1])
C0024299 (UMLS CUI [1,2])
Tumor Measurement-2
Item
Tumor Measurement-2
float
C0242485 (UMLS CUI [1,1])
C0024299 (UMLS CUI [1,2])
Tumor Measurement in cm2
Item
Tumor Measurement in cm2
float
C0242485 (UMLS CUI [1,1])
C0024299 (UMLS CUI [1,2])
Item Group
Non-Measurable Disease
C1334988 (UMLS CUI-1)
Non-Measurable Disease
Item
Non-Measurable Disease (Done/not done)
boolean
C1334988 (UMLS CUI [1])
Site
Item
Site
text
C1515974 (UMLS CUI [1])
Method of Determination
Item
Method of Determination
text
C2911685 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Item
Check one
integer
C0332307 (UMLS CUI [1,1])
C1334988 (UMLS CUI [1,2])
Check one
Code List
Check one
CL Item
New (1)
CL Item
Increased (2)
CL Item
Stable (3)
CL Item
Decreased (4)
Item Group
Administration
C1320722 (UMLS CUI-1)
Signature of Investigator
Item
Signature of Investigator
text
C2346576 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1,1])
C2346576 (UMLS CUI [1,2])
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