ID

31307

Beschrijving

Study ID: 104505 Clinical Study ID: BEX104505 Study Title: Phase II Study of Iodine 131 Anti B1 Antibody for 1st or 2nd Relapsed Indolent B-Cell Lymphomas or B-Cell Lymphomas That Have Transformed to a More Aggressive Histology Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00950755 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: tositumomab Trade Name: Bexxar Study Indication: Lymphoma, Non-Hodgkin Please record all presumed and confirmed invasive infections through the Week 13 visit. Record only one infection per form.

Trefwoorden

Versies (1)
  1. 12-08-18 12-08-18 -
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see clinicaltrials.gov

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12 augustus 2018

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Iodine 131 B1 Antibody for B-Cell Lymphomas NCT00950755

Engels

Infection Summary

1 Formulieren  
  1. StudyEvent: ODM
    1. Infection Summary
Administrative Data
Beschrijving

Administrative Data

Alias
UMLS CUI-1
C1320722
Site Number
Beschrijving

Site number

Datatype

text

Alias
UMLS CUI [1,1]
C0018704
UMLS CUI [1,2]
C0600091
Patient Number
Beschrijving

Patient Number

Datatype

text

Alias
UMLS CUI [1]
C1830427
Patient Initials
Beschrijving

Patient Initials

Datatype

text

Alias
UMLS CUI [1]
C2986440
Date of visit
Beschrijving

Date of visit

Datatype

date

Alias
UMLS CUI [1]
C1320303
Date of visit
Beschrijving

Date of visit

Datatype

date

Alias
UMLS CUI [1]
C1320303
Infections
Beschrijving

Infections

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

invasive infection

Datatype

boolean

Alias
UMLS CUI [1]
C0009450
Type on infection
Beschrijving

Type on infection

Datatype

text

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0332307
Method of confirmation
Beschrijving

Infection; Method of confirmation

Datatype

text

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0430022
Was a culture obtained?
Beschrijving

Infection; culture obtained

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0430400
Infection; Laboratory culture
Beschrijving

Infection; Laboratory culture

Alias
UMLS CUI-1
C0009450
UMLS CUI-2
C0430400
Source Code
Beschrijving

Infection; Laboratory Culture; Source Code

Datatype

text

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0430400
UMLS CUI [1,3]
C1710131
Date
Beschrijving

Infection; Laboratory Culture; Date

Datatype

date

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0430400
UMLS CUI [1,3]
C0011008
Result
Beschrijving

Infection; Laboratory Culture; Result

Datatype

text

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0430400
UMLS CUI [1,3]
C1274040
If positive, indicate organism code
Beschrijving

Infection; Laboratory culture; Positive; Organism Code

Datatype

text

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0430400
UMLS CUI [1,3]
C1446409
UMLS CUI [1,4]
C0029235
UMLS CUI [1,5]
C1708523
Anti-infectives
Beschrijving

Anti-infectives

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

Infection; Anti-infective agent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0003204
Anti-Infective
Beschrijving

Infection; Anti-infective agent

Datatype

text

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0003204
Empiric or Therapeutic?
Beschrijving

Infection; Anti-infective agent; type

Datatype

text

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0003204
UMLS CUI [1,3]
C0332307
Start Date
Beschrijving

Infection; Anti-infective agent; start date

Datatype

date

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0003204
UMLS CUI [1,3]
C0808070
Stop Date
Beschrijving

Infection; Anti-infective agent; end date

Datatype

date

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0003204
UMLS CUI [1,3]
C0806020
Ongoing
Beschrijving

Infection; Anti-infective agent; Continuous

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0003204
UMLS CUI [1,3]
C0549178
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Similar models

Infection Summary

1 Formulieren
  1. StudyEvent: ODM
    1. Infection Summary
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Site number
Item
Site Number
text
C0018704 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Patient Number
Item
Patient Number
text
C1830427 (UMLS CUI [1])
Patient Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Item Group
Infections
C0009450 (UMLS CUI-1)
invasive infection
Item
Has the patient had a presumed or confirmed invasive infection (e.g. sepsis, pneumonia) during study participation?
boolean
C0009450 (UMLS CUI [1])
Item
Type on infection
text
C0009450 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Type on infection
Code List
Type on infection
CL Item
Meningitis (Meningitis)
CL Item
Pyelonephritis (Pyelonephritis)
CL Item
Sepsis (Sepsis)
CL Item
Pneumonia (Pneumonia)
CL Item
Endocarditis/Pericarditis (Endocarditis/Pericarditis)
CL Item
Peritonitis (Peritonitis)
CL Item
Other (Other)
Item
Method of confirmation
text
C0009450 (UMLS CUI [1,1])
C0430022 (UMLS CUI [1,2])
Type on infection
Code List
Method of confirmation
CL Item
Other (Other)
CL Item
PE (PE)
CL Item
CT Scan (CT Scan)
CL Item
X-ray (X-ray)
Infection; culture obtained
Item
Was a culture obtained?
boolean
C0009450 (UMLS CUI [1,1])
C0430400 (UMLS CUI [1,2])
Item Group
Infection; Laboratory culture
C0009450 (UMLS CUI-1)
C0430400 (UMLS CUI-2)
Infection; Laboratory Culture; Source Code
Item
Source Code
text
C0009450 (UMLS CUI [1,1])
C0430400 (UMLS CUI [1,2])
C1710131 (UMLS CUI [1,3])
Infection; Laboratory Culture; Date
Item
Date
date
C0009450 (UMLS CUI [1,1])
C0430400 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Result
text
C0009450 (UMLS CUI [1,1])
C0430400 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Infection; Laboratory Culture; Result
Code List
Result
CL Item
Pos (Pos)
CL Item
Neg (Neg)
Infection; Laboratory culture; Positive; Organism Code
Item
If positive, indicate organism code
text
C0009450 (UMLS CUI [1,1])
C0430400 (UMLS CUI [1,2])
C1446409 (UMLS CUI [1,3])
C0029235 (UMLS CUI [1,4])
C1708523 (UMLS CUI [1,5])
Item Group
Anti-infectives
C0003204 (UMLS CUI-1)
Infection; Anti-infective agent
Item
Was an anti-infective administered?
boolean
C0009450 (UMLS CUI [1,1])
C0003204 (UMLS CUI [1,2])
Infection; Anti-infective agent
Item
Anti-Infective
text
C0009450 (UMLS CUI [1,1])
C0003204 (UMLS CUI [1,2])
Item
Empiric or Therapeutic?
text
C0009450 (UMLS CUI [1,1])
C0003204 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
Infection; Anti-infective agent
Code List
Empiric or Therapeutic?
CL Item
Empiric (Empiric)
CL Item
Therapeutic (Therapeutic)
Infection; Anti-infective agent; start date
Item
Start Date
date
C0009450 (UMLS CUI [1,1])
C0003204 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
Infection; Anti-infective agent; end date
Item
Stop Date
date
C0009450 (UMLS CUI [1,1])
C0003204 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
Infection; Anti-infective agent; Continuous
Item
Ongoing
boolean
C0009450 (UMLS CUI [1,1])
C0003204 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
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