ID

31371

Beschreibung

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

Stichworte

Versionen (2)
  1. 22.07.18 22.07.18 -
  2. 18.08.18 18.08.18 -
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GlaxoSmithKline

Hochgeladen am

18. August 2018

DOI

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Iodine-131 Anti-B1 Antibody for Non Hodgkin’s Lymphomas NCT00996593

Englisch

Infection Summary (Visit 8)

1 Formulare  
Administrative
Beschreibung

Administrative

Alias
UMLS CUI-1
C1320722
Last Page
Beschreibung

Last Page

Datentyp

boolean

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

Series page

Datentyp

text

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

Date of visit

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Invasive infection
Beschreibung

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?
Beschreibung

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

Datentyp

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)
Beschreibung

Type of infection

Datentyp

text

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

Communicable Diseases; Type - attribute; Other; Specification

Datentyp

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
Beschreibung

Method of confirmation

Datentyp

text

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

Confirmation; Methods; Other; Specification

Datentyp

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?
Beschreibung

Blood culture

Datentyp

boolean

Alias
UMLS CUI [1]
C0200949
Blood culture
Beschreibung

Blood culture

Alias
UMLS CUI-1
C0200949
Source Code
Beschreibung

Source Code

Datentyp

text

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

Source Code; Other; Specification

Datentyp

text

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

Sampling Date

Datentyp

date

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

Sampling Result

Datentyp

text

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

Result; Positive | Organism; Code

Datentyp

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
Beschreibung

If other organism code, please specify

Datentyp

text

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

Anti- infective

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

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

Datentyp

boolean

Alias
UMLS CUI [1]
C0003204
Anti-Infectives
Beschreibung

Anti-Infectives

Alias
UMLS CUI-1
C0003204
Anti-Infective
Beschreibung

Anti-Infective Agents

Datentyp

text

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

Empiric | therapeutic

Datentyp

text

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

Date treatment or therapy started

Datentyp

date

Alias
UMLS CUI [1]
C3173309
Stop date therapy
Beschreibung

Date treatment stopped

Datentyp

date

Alias
UMLS CUI [1]
C1531784
Therapy ongoing?
Beschreibung

Therapeutic procedure; Continuous

Datentyp

text

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0549178
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Ähnliche Modelle

Infection Summary (Visit 8)

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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