ID

31384

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. 2018-08-06 2018-08-06 -
  2. 2018-08-18 2018-08-18 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

18 augusti 2018

DOI

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Licens

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

Engelsk

Independent Response Evaluation Radiologist's Assessment and Consensus Criteria

1 Formulär  
Lesion Measurements
Beskrivning

Lesion Measurements

Alias
UMLS CUI-1
C0221198
UMLS CUI-2
C0242485
Scan Date (mm/dd/yy)
Beskrivning

Scan Date

Datatyp

date

Alias
UMLS CUI [1,1]
C0441633
UMLS CUI [1,2]
C0011008
Lesion Number
Beskrivning

Lesion; Numbers;

Datatyp

integer

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0237753
Lesion Name
Beskrivning

Lesion; Name

Datatyp

text

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0027365
Lesion Measurements (cm x cm)
Beskrivning

Lesion Measurements

Datatyp

text

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0242485
Lesion Measurements (cm2)
Beskrivning

Lesion Measurements

Datatyp

float

Måttenheter
  • cm2
Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0242485
cm2
Sum of Products
Beskrivning

Sum of Products

Alias
UMLS CUI-1
C1515051
UMLS CUI-2
C1704444
Sum of Products
Beskrivning

Sum; Multiplicative Product

Datatyp

float

Måttenheter
  • cm2
Alias
UMLS CUI [1,1]
C1515051
UMLS CUI [1,2]
C1704444
cm2
Response
Beskrivning

Response

Alias
UMLS CUI-1
C0521982
Date of Response
Beskrivning

Date of Response

Datatyp

date

Alias
UMLS CUI [1,1]
C0521982
UMLS CUI [1,2]
C0011008
Response
Beskrivning

Response

Datatyp

text

Alias
UMLS CUI [1]
C0521982
Comments
Beskrivning

Comments

Datatyp

text

Alias
UMLS CUI [1]
C0947611
Consensus Criteria
Beskrivning

Consensus Criteria

Alias
UMLS CUI-1
C0376298
UMLS CUI-2
C0243161
Indicator Lesion Number
Beskrivning

Lesion; Numbers; Indicator

Datatyp

integer

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0237753
UMLS CUI [1,3]
C1522602
Response Date (mm/dd/yyyy)
Beskrivning

Response to treatment; Date in time

Datatyp

date

Alias
UMLS CUI [1,1]
C0521982
UMLS CUI [1,2]
C0011008
SPPD Indicator Lesions (cm2)
Beskrivning

Sum of Products of Perpendicular Diameters

Datatyp

float

Måttenheter
  • cm2
Alias
UMLS CUI [1]
C4318386
cm2
Consensus Response
Beskrivning

Consensus; Response to treatment

Datatyp

text

Alias
UMLS CUI [1,1]
C0376298
UMLS CUI [1,2]
C0521982
Comments
Beskrivning

Comments

Datatyp

text

Alias
UMLS CUI [1]
C0947611
Administrative
Beskrivning

Administrative

Alias
UMLS CUI-1
C1320722
Radiologist's Signature
Beskrivning

radiologist; Signature

Datatyp

text

Alias
UMLS CUI [1,1]
C0260194
UMLS CUI [1,2]
C1519316
Date of evaluation
Beskrivning

Assessment Date

Datatyp

date

Alias
UMLS CUI [1]
C2985720
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Similar models

Independent Response Evaluation Radiologist's Assessment and Consensus Criteria

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Lesion Measurements
C0221198 (UMLS CUI-1)
C0242485 (UMLS CUI-2)
Scan Date
Item
Scan Date (mm/dd/yy)
date
C0441633 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Lesion; Numbers;
Item
Lesion Number
integer
C0221198 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Lesion; Name
Item
Lesion Name
text
C0221198 (UMLS CUI [1,1])
C0027365 (UMLS CUI [1,2])
Lesion Measurements
Item
Lesion Measurements (cm x cm)
text
C0221198 (UMLS CUI [1,1])
C0242485 (UMLS CUI [1,2])
Lesion Measurements
Item
Lesion Measurements (cm2)
float
C0221198 (UMLS CUI [1,1])
C0242485 (UMLS CUI [1,2])
Item Group
Sum of Products
C1515051 (UMLS CUI-1)
C1704444 (UMLS CUI-2)
Sum; Multiplicative Product
Item
Sum of Products
float
C1515051 (UMLS CUI [1,1])
C1704444 (UMLS CUI [1,2])
Item Group
Response
C0521982 (UMLS CUI-1)
Date of Response
Item
Date of Response
date
C0521982 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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)
CL Item
NA / (baseline) (N)
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Item Group
Consensus Criteria
C0376298 (UMLS CUI-1)
C0243161 (UMLS CUI-2)
Lesion; Numbers; Indicator
Item
Indicator Lesion Number
integer
C0221198 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C1522602 (UMLS CUI [1,3])
Response to treatment; Date in time
Item
Response Date (mm/dd/yyyy)
date
C0521982 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Sum of Products of Perpendicular Diameters
Item
SPPD Indicator Lesions (cm2)
float
C4318386 (UMLS CUI [1])
Item
Consensus Response
text
C0376298 (UMLS CUI [1,1])
C0521982 (UMLS CUI [1,2])
Consensus; Response to treatment
Code List
Consensus Response
CL Item
CR (5)
CL Item
CRu (4)
CL Item
PR (3)
CL Item
SD (2)
CL Item
PD (1)
CL Item
NA (N)
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Item Group
Administrative
C1320722 (UMLS CUI-1)
radiologist; Signature
Item
Radiologist's Signature
text
C0260194 (UMLS CUI [1,1])
C1519316 (UMLS CUI [1,2])
Assessment Date
Item
Date of evaluation
date
C2985720 (UMLS CUI [1])
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