ID

30226

Beschreibung

Disease Staging and Laboratory Tests 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

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  1. 22.05.18 22.05.18 -
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GlaxoSmithKline (GSK)

Hochgeladen am

22. Mai 2018

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

Englisch

Disease Staging and Laboratory Tests

1 Formulare  
CT or other Radiological Imaging Results
Beschreibung

CT or other Radiological Imaging Results

Alias
UMLS CUI-1
C0011923
UMLS CUI-2
C1274040
Anatomic site
Beschreibung

Anatomic site

Datentyp

integer

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C0011923
Not done?
Beschreibung

Not done

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C1272696
Date
Beschreibung

Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C0011008
Radiological Imaging Method
Beschreibung

Radiological Imaging Method

Datentyp

integer

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C1275506
Specify other Imaging:
Beschreibung

Other Imaging

Datentyp

text

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C0079595
UMLS CUI [1,3]
C0205394
Imaging Findings
Beschreibung

Imaging Findings

Datentyp

integer

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C0243095
Specify Abnormal Finding
Beschreibung

Abnormal Finding

Datentyp

text

Alias
UMLS CUI [1,1]
C2826279
UMLS CUI [1,2]
C0011923
Bone Marrow Biopsy
Beschreibung

Bone Marrow Biopsy

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

integer

Maßeinheiten
  • %
Alias
UMLS CUI [1]
C1517677
%
Side
Beschreibung

Side

Datentyp

integer

Alias
UMLS CUI [1,1]
C0441987
UMLS CUI [1,2]
C0475445
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 [1,1]
C0011008
UMLS CUI [1,2]
C1148554
Tumor Measurements
Beschreibung

Tumor Measurements

Datentyp

integer

Maßeinheiten
  • cm x cm = cm²
Alias
UMLS CUI [1,1]
C0205485
UMLS CUI [1,2]
C0242485
UMLS CUI [1,3]
C1300072
cm x cm = cm²
Non-Measurable Dlsease
Beschreibung

Non-Measurable Dlsease

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 [1,1]
C0011008
UMLS CUI [1,2]
C1148554
Status of Non-Measurable Disease
Beschreibung

Status

Datentyp

integer

Alias
UMLS CUI [1,1]
C0449438
UMLS CUI [1,2]
C1334988
Administration
Beschreibung

Administration

Alias
UMLS CUI-1
C1320722
Signature of lnvestigator
Beschreibung

Signature of lnvestigator

Datentyp

text

Alias
UMLS CUI [1]
C2346576
Date
Beschreibung

Date

Datentyp

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Laboratory Results
Beschreibung

Laboratory Results

Alias
UMLS CUI-1
C1254595
Hematology Date
Beschreibung

Hematology Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C0011008
Lab # (Worksheet B)
Beschreibung

Lab #

Datentyp

integer

Alias
UMLS CUI [1,1]
C0022877
UMLS CUI [1,2]
C0600091
Hematologic tests
Beschreibung

Hematologic tests

Datentyp

integer

Alias
UMLS CUI [1]
C0018941
Hematologic test result
Beschreibung

Hematologic test result

Datentyp

float

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C0587081
Chemistry Date
Beschreibung

Chemistry Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0007996
UMLS CUI [1,2]
C0022877
UMLS CUI [1,3]
C0011008
Lab # (Worksheet B)
Beschreibung

Lab #

Datentyp

integer

Alias
UMLS CUI [1,1]
C0022877
UMLS CUI [1,2]
C0600091
Chemistry tests
Beschreibung

Chemistry tests

Datentyp

integer

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0022885
Chemistry test results
Beschreibung

Chemistry test results

Datentyp

float

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C0005774
Pregnancy Test Date
Beschreibung

Must be obtained within 7 days of study entry

Datentyp

date

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C0011008
Pregnancy test material
Beschreibung

Pregnancy test material

Datentyp

integer

Alias
UMLS CUI [1]
C0032976
Pregnancy test result
Beschreibung

Pregnancy test result

Datentyp

integer

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C1274040
Beta-2 Microglobulin (Serum) Date
Beschreibung

Beta-2 Microglobulin (Serum) Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0005149
UMLS CUI [1,2]
C0011008
Result
Beschreibung

Beta-2 Microglobulin (Serum)

Datentyp

float

Alias
UMLS CUI [1,1]
C1274040
UMLS CUI [1,2]
C0022885
UMLS CUI [1,3]
C1522609
UMLS CUI [1,4]
C0005149
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Ähnliche Modelle

Disease Staging and Laboratory Tests

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
CT or other Radiological Imaging Results
C0011923 (UMLS CUI-1)
C1274040 (UMLS CUI-2)
Item
Anatomic site
integer
C1515974 (UMLS CUI [1,1])
C0011923 (UMLS CUI [1,2])
Anatomic site
Code List
Anatomic site
CL Item
Head/Neck (1)
CL Item
Chest (2)
CL Item
Abdomen (3)
CL Item
Pelvis (4)
CL Item
Other (5)
Not done
Item
Not done?
boolean
C0011923 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
Date
Item
Date
date
C0011923 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Radiological Imaging Method
integer
C0011923 (UMLS CUI [1,1])
C1275506 (UMLS CUI [1,2])
Radiological Imaging Method
Code List
Radiological Imaging Method
CL Item
CT (1)
CL Item
MRI (2)
CL Item
X-Ray (3)
CL Item
Other (4)
Other Imaging
Item
Specify other Imaging:
text
C0011923 (UMLS CUI [1,1])
C0079595 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Item
Imaging Findings
integer
C0011923 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
Imaging Findings
Code List
Imaging Findings
CL Item
Normal (1)
CL Item
Abnormal (2)
Abnormal Finding
Item
Specify Abnormal Finding
text
C2826279 (UMLS CUI [1,1])
C0011923 (UMLS CUI [1,2])
Item Group
Bone Marrow Biopsy
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
1 Normal (1)
CL Item
1 Hypercellular (2)
CL Item
2 Hypocellular (3)
Tumor involvement
Item
Tumor involvement
integer
C1517677 (UMLS CUI [1])
Item
Side
integer
C0441987 (UMLS CUI [1,1])
C0475445 (UMLS CUI [1,2])
Side
Code List
Side
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 [1,1])
C1148554 (UMLS CUI [1,2])
Tumor Measurements
Item
Tumor Measurements
integer
C0205485 (UMLS CUI [1,1])
C0242485 (UMLS CUI [1,2])
C1300072 (UMLS CUI [1,3])
Item Group
Non-Measurable Dlsease
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 [1,1])
C1148554 (UMLS CUI [1,2])
Item
Status of Non-Measurable Disease
integer
C0449438 (UMLS CUI [1,1])
C1334988 (UMLS CUI [1,2])
Status
Code List
Status of Non-Measurable Disease
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 lnvestigator
Item
Signature of lnvestigator
text
C2346576 (UMLS CUI [1])
Date
Item
Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Laboratory Results
C1254595 (UMLS CUI-1)
Hematology Date
Item
Hematology Date
date
C0474523 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Lab #
Item
Lab # (Worksheet B)
integer
C0022877 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Item
Hematologic tests
integer
C0018941 (UMLS CUI [1])
Hematologic tests
Code List
Hematologic tests
CL Item
WBC (1)
CL Item
RBC (2)
CL Item
Hemoglobin (3)
CL Item
Hematocrit (4)
CL Item
Platelets (5)
CL Item
Neutrophils (segs + bands) (6)
CL Item
Lymphocytes (7)
CL Item
Monocytes (8)
CL Item
Eosinophils (9)
CL Item
Basophils (10)
CL Item
Other differential (11)
CL Item
ANC (10³/mm³) (12)
Hematologic test result
Item
Hematologic test result
float
C0018941 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Chemistry Date
Item
Chemistry Date
date
C0007996 (UMLS CUI [1,1])
C0022877 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Lab #
Item
Lab # (Worksheet B)
integer
C0022877 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Item
Chemistry tests
integer
C0008000 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
Chemistry tests
Code List
Chemistry tests
CL Item
Sodium (1)
CL Item
Potassium (2)
CL Item
Chloride (3)
CL Item
BUN (4)
CL Item
Creatinine (5)
CL Item
AST(SGOT) (6)
CL Item
ALT (SGPT) (7)
CL Item
Al.l<.P+f (8)
CL Item
Alkaline Phosphatase (9)
CL Item
LDH (10)
CL Item
Total Bilirubin (11)
CL Item
TSH (12)
CL Item
Total T3 (13)
CL Item
Free T4 (14)
Chemistry test results
Item
Chemistry test results
float
C1254595 (UMLS CUI [1,1])
C0005774 (UMLS CUI [1,2])
Pregnancy Test Date
Item
Pregnancy Test Date
date
C0032976 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Pregnancy test material
integer
C0032976 (UMLS CUI [1])
Pregnancy test material
Code List
Pregnancy test material
CL Item
Urine (1)
CL Item
Serum (2)
Item
Pregnancy test result
integer
C0032976 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Pregnancy test result
Code List
Pregnancy test result
CL Item
Positive (1)
CL Item
Negative (2)
Beta-2 Microglobulin (Serum) Date
Item
Beta-2 Microglobulin (Serum) Date
date
C0005149 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Beta-2 Microglobulin (Serum)
Item
Result
float
C1274040 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
C1522609 (UMLS CUI [1,3])
C0005149 (UMLS CUI [1,4])
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