ID

31371

Description

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

Keywords

Versions (2)
  1. 7/22/18 7/22/18 -
  2. 8/18/18 8/18/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

August 18, 2018

DOI

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License

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

English

Infection Summary (Visit 8)

1 forms  
Administrative
Description

Administrative

Alias
UMLS CUI-1
C1320722
Last Page
Description

Last Page

Data type

boolean

Alias
UMLS CUI [1,1]
C1704732
UMLS CUI [1,2]
C1517741
Series page
Description

Series page

Data type

text

Alias
UMLS CUI [1,1]
C0205549
UMLS CUI [1,2]
C1704732
Date of visit
Description

Date of visit

Data type

date

Alias
UMLS CUI [1]
C1320303
Invasive infection
Description

Invasive infection

Alias
UMLS CUI-1
C0009450
UMLS CUI-2
C0205281
Has the patient had a presumed or confirmed invasive infection (e. g. sepsis, pneumonia, etc.) during study participation?
Description

Communicable Diseases; Invasive; Study; participation | Sepsis; Study; articipation | Pneumonia; Study; participation

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205281
UMLS CUI [1,3]
C2603343
UMLS CUI [1,4]
C0679823
UMLS CUI [2,1]
C0243026
UMLS CUI [2,2]
C2603343
UMLS CUI [2,3]
C0679823
UMLS CUI [3,1]
C0032285
UMLS CUI [3,2]
C2603343
UMLS CUI [3,3]
C0679823
Type of infection (If the patient had an invasive infection, complete the rest of the form)
Description

Type of infection

Data type

text

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0332307
If patient had other type of infection, please specify
Description

Communicable Diseases; Type - attribute; Other; Specification

Data type

text

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C2348235
Method of confirmation
Description

Method of confirmation

Data type

text

Alias
UMLS CUI [1,1]
C0750484
UMLS CUI [1,2]
C0025663
If other Method of confirmation, please specify
Description

Confirmation; Methods; Other; Specification

Data type

text

Alias
UMLS CUI [1,1]
C0750484
UMLS CUI [1,2]
C0025663
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C2348235
Was a culture obtained?
Description

Blood culture

Data type

boolean

Alias
UMLS CUI [1]
C0200949
Blood culture
Description

Blood culture

Alias
UMLS CUI-1
C0200949
Source Code
Description

Source Code

Data type

text

Alias
UMLS CUI [1]
C1710131
If other Source Code, please specify
Description

Source Code; Other; Specification

Data type

text

Alias
UMLS CUI [1,1]
C1710131
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
Sampling Date
Description

Sampling Date

Data type

date

Alias
UMLS CUI [1,1]
C0870078
UMLS CUI [1,2]
C0011008
Sampling Result
Description

Sampling Result

Data type

text

Alias
UMLS CUI [1,1]
C0870078
UMLS CUI [1,2]
C1274040
If positive, indicate organism code
Description

Result; Positive | Organism; Code

Data type

text

Alias
UMLS CUI [1,1]
C1274040
UMLS CUI [1,2]
C1446409
UMLS CUI [2,1]
C0029235
UMLS CUI [2,2]
C0805701
If other organism code, please specify
Description

If other organism code, please specify

Data type

text

Alias
UMLS CUI [1,1]
C0029235
UMLS CUI [1,2]
C0805701
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C2348235
Anti- infective
Description

Anti- infective

Alias
UMLS CUI-1
C0003204
Was an anti- infective administered?
Description

If yes, list here an on the Concomitant Medications form.

Data type

boolean

Alias
UMLS CUI [1]
C0003204
Anti-Infectives
Description

Anti-Infectives

Alias
UMLS CUI-1
C0003204
Anti-Infective
Description

Anti-Infective Agents

Data type

text

Alias
UMLS CUI [1]
C0003204
Empiric or therapeutic?
Description

Empiric | therapeutic

Data type

text

Alias
UMLS CUI [1]
C1880496
UMLS CUI [2]
C0302350
Start date therapy
Description

Date treatment or therapy started

Data type

date

Alias
UMLS CUI [1]
C3173309
Stop date therapy
Description

Date treatment stopped

Data type

date

Alias
UMLS CUI [1]
C1531784
Therapy ongoing?
Description

Therapeutic procedure; Continuous

Data type

text

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0549178
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Similar models

Infection Summary (Visit 8)

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Last Page
Item
Last Page
boolean
C1704732 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
Series page
Item
Series page
text
C0205549 (UMLS CUI [1,1])
C1704732 (UMLS CUI [1,2])
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Item Group
Invasive infection
C0009450 (UMLS CUI-1)
C0205281 (UMLS CUI-2)
Communicable Diseases; Invasive; Study; participation | Sepsis; Study; articipation | Pneumonia; Study; participation
Item
Has the patient had a presumed or confirmed invasive infection (e. g. sepsis, pneumonia, etc.) during study participation?
boolean
C0009450 (UMLS CUI [1,1])
C0205281 (UMLS CUI [1,2])
C2603343 (UMLS CUI [1,3])
C0679823 (UMLS CUI [1,4])
C0243026 (UMLS CUI [2,1])
C2603343 (UMLS CUI [2,2])
C0679823 (UMLS CUI [2,3])
C0032285 (UMLS CUI [3,1])
C2603343 (UMLS CUI [3,2])
C0679823 (UMLS CUI [3,3])
Item
Type of infection (If the patient had an invasive infection, complete the rest of the form)
text
C0009450 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Type of infection
Code List
Type of infection (If the patient had an invasive infection, complete the rest of the form)
CL Item
Meningitis (1)
CL Item
Pyelonephritis (2)
CL Item
Sepsis (3)
CL Item
Pneumonia (4)
CL Item
Endocarditis / Pericarditis (5)
CL Item
Peritonitis (6)
CL Item
Other (7)
Communicable Diseases; Type - attribute; Other; Specification
Item
If patient had other type of infection, please specify
text
C0009450 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Item
Method of confirmation
text
C0750484 (UMLS CUI [1,1])
C0025663 (UMLS CUI [1,2])
Method of confirmation
Code List
Method of confirmation
CL Item
PE (1)
CL Item
CT Scan (2)
CL Item
X-Ray (3)
CL Item
Other (4)
Confirmation; Methods; Other; Specification
Item
If other Method of confirmation, please specify
text
C0750484 (UMLS CUI [1,1])
C0025663 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Blood culture
Item
Was a culture obtained?
boolean
C0200949 (UMLS CUI [1])
Item Group
Blood culture
C0200949 (UMLS CUI-1)
Item
Source Code
text
C1710131 (UMLS CUI [1])
Source Code
Code List
Source Code
CL Item
Sputum (1)
CL Item
Blood (2)
CL Item
Throat (3)
CL Item
Skin (4)
CL Item
CSF (5)
CL Item
Urine (6)
CL Item
Stool (7)
CL Item
Abscess (8)
CL Item
Other (9)
Source Code; Other; Specification
Item
If other Source Code, please specify
text
C1710131 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Sampling Date
Item
Sampling Date
date
C0870078 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Sampling Result
text
C0870078 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Sampling Result
Code List
Sampling Result
CL Item
Positive (1)
CL Item
Negative (2)
Item
If positive, indicate organism code
text
C1274040 (UMLS CUI [1,1])
C1446409 (UMLS CUI [1,2])
C0029235 (UMLS CUI [2,1])
C0805701 (UMLS CUI [2,2])
Result; Positive | Organism
Code List
If positive, indicate organism code
CL Item
Herpes simplex (1)
CL Item
Staph. aureus (2)
CL Item
Staph. epidermis (3)
CL Item
E. coli (4)
CL Item
Candida albicans (5)
CL Item
Strep. pneumoniae (6)
CL Item
Pseudomonas aeruginosa (7)
CL Item
Other (8)
If other organism code, please specify
Item
If other organism code, please specify
text
C0029235 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Item Group
Anti- infective
C0003204 (UMLS CUI-1)
Anti-Infective Agents
Item
Was an anti- infective administered?
boolean
C0003204 (UMLS CUI [1])
Item Group
Anti-Infectives
C0003204 (UMLS CUI-1)
Anti-Infective Agents
Item
Anti-Infective
text
C0003204 (UMLS CUI [1])
Item
Empiric or therapeutic?
text
C1880496 (UMLS CUI [1])
C0302350 (UMLS CUI [2])
Empiric | therapeutic
Code List
Empiric or therapeutic?
CL Item
empiric (1)
CL Item
therapeutic (2)
Date treatment or therapy started
Item
Start date therapy
date
C3173309 (UMLS CUI [1])
Date treatment stopped
Item
Stop date therapy
date
C1531784 (UMLS CUI [1])
Item
Therapy ongoing?
text
C0087111 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
undefined item
Code List
Therapy ongoing?
CL Item
yes (1)
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