ID

31306

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 Any adverse experience is defined as a new or worsening pre-existing medical condition or complication occurring while on study, regardless of its perceived relationship to the drug. Please record all adverse experiences from the time of study entry through the Week 13 visit.

Trefwoorden

Versies (1)
  1. 12-08-18 12-08-18 -
Houder van rechten

see clinicaltrials.gov

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12 augustus 2018

DOI

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Creative Commons BY 4.0
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Iodine 131 B1 Antibody for B-Cell Lymphomas NCT00950755

Engels

Adverse Experiences

1 Formulieren  
  1. StudyEvent: ODM
    1. Adverse Experiences
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
Adverse Experiences
Beschrijving

Adverse Experiences

Alias
UMLS CUI-1
C0877248
AE #
Beschrijving

Adverse Event; Number

Datatype

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0237753
Adverse Experience (one experience per line)
Beschrijving

Adverse Event

Datatype

text

Alias
UMLS CUI [1]
C0877248
Grade per CTC (per Appx F)
Beschrijving

Adverse Event; CTC grade

Datatype

text

Alias
UMLS CUI [1]
C2985911
Serious
Beschrijving

Adverse event, serious

Datatype

boolean

Alias
UMLS CUI [1]
C1519255
Onset Date
Beschrijving

Adverse event; start date

Datatype

date

Alias
UMLS CUI [1]
C2697888
Stop Date
Beschrijving

Adverse event; end date

Datatype

date

Alias
UMLS CUI [1]
C2697886
Frequency
Beschrijving

Adverse event; frequency

Datatype

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0439603
Therapeutic Measures: Drugs
Beschrijving

Adverse event; Therapeutic Measures; Drugs

Datatype

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0013227
Therapeutic Measures: Other
Beschrijving

Adverse event; Therapeutic Measures; Other

Datatype

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0205394
Therapeutic Measures: If Other, specify here
Beschrijving

Adverse event; Therapeutic Measures; Other; Specification

Datatype

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C2348235
Outcome
Beschrijving

Adverse event; Outcome

Datatype

text

Alias
UMLS CUI [1]
C1705586
Relationship: Drug
Beschrijving

Adverse event; Relationship; Drug

Datatype

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0013227
Relationship: Disease
Beschrijving

Adverse event; Relationship; Disease

Datatype

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0012634
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Similar models

Adverse Experiences

1 Formulieren
  1. StudyEvent: ODM
    1. Adverse Experiences
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])
Item Group
Adverse Experiences
C0877248 (UMLS CUI-1)
Adverse Event; Number
Item
AE #
integer
C0877248 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Adverse Event
Item
Adverse Experience (one experience per line)
text
C0877248 (UMLS CUI [1])
Adverse Event; CTC grade
Item
Grade per CTC (per Appx F)
text
C2985911 (UMLS CUI [1])
Adverse event, serious
Item
Serious
boolean
C1519255 (UMLS CUI [1])
Adverse event; start date
Item
Onset Date
date
C2697888 (UMLS CUI [1])
Adverse event; end date
Item
Stop Date
date
C2697886 (UMLS CUI [1])
Adverse event; frequency
Item
Frequency
text
C0877248 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
Adverse event; Therapeutic Measures; Drugs
Item
Therapeutic Measures: Drugs
text
C0877248 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
Adverse event; Therapeutic Measures; Other
Item
Therapeutic Measures: Other
text
C0877248 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Adverse event; Therapeutic Measures; Other; Specification
Item
Therapeutic Measures: If Other, specify here
text
C0877248 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Adverse event; Outcome
Item
Outcome
text
C1705586 (UMLS CUI [1])
Adverse event; Relationship; Drug
Item
Relationship: Drug
text
C0877248 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
Adverse event; Relationship; Disease
Item
Relationship: Disease
text
C0877248 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,3])
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