ID

30249

Description

https://clinicaltrials.gov/show/NCT00989664 Adverse Experiences Study ID: 104504 Clinical Study ID: BEX104504 Study Title: Multicenter, Pivotal Phase III Study of Iodine-131 Anti-B1 Antibody (Murine) Radioimmunotherapy for Chemotherapy Refractory Low Grade B Cell Lymphomas and Low Grade Lymphomas that have Transformed to Higher Grade Histologies Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00989664 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: tositumomab Trade Name: Bexxar Study Indication: Lymphoma, Non-Hodgkin

Link

https://clinicaltrials.gov/show/NCT00989664

Keywords

Versions (1)
  1. 5/24/18 5/24/18 -
Copyright Holder

GlaxoSmithKline (GSK)

Uploaded on

May 24, 2018

DOI

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License

Creative Commons BY-NC 3.0
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Multicenter, Pivotal Phase III Study of Iodine-131 Anti-B1 Antibody (Murine) Radioimmunotherapy NCT00989664

English

Adverse Experiences

1 forms  
  1. StudyEvent: ODM
    1. Adverse Experiences
Adverse Experiences
Description

Adverse Experiences

Alias
UMLS CUI-1
C0877248
None?
Description

Adverse Experiences

Data type

boolean

Alias
UMLS CUI [1]
C0877248
AE#
Description

AE#

Data type

integer

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

Adverse Experience

Data type

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C2348235
Grade per CTC
Description

Grade per CTC

Data type

text

Alias
UMLS CUI [1]
C2985911
A Serious?
Description

A. SERIOUS: Fatal or Immediately life-threatening, permanently disabling, requires or prolongs hospitalization, or congenital anomaly.

Data type

boolean

Alias
UMLS CUI [1]
C1519255
Onset Date
Description

Onset Date

Data type

date

Alias
UMLS CUI [1]
C2985916
Stop Date or 'C' if continuing.
Description

Stop Date

Data type

date

Alias
UMLS CUI [1]
C2697886
B Frequency
Description

B Frequency

Data type

integer

Alias
UMLS CUI [1,1]
C3476109
UMLS CUI [1,2]
C1519255
Therapeutic Measures - Drug
Description

Therapeutic Measures - Drug

Data type

integer

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0013227
Therapeutic Measures - Other
Description

Therapeutic Measures - Other

Data type

integer

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0205394
Therapeutic Measures - If Other specify here:
Description

Therapeutic Measures - Other

Data type

text

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0205394
E Outcome
Description

Outcome

Data type

integer

Alias
UMLS CUI [1]
C1705586
Relationship AE - Drug
Description

Relationship AE

Data type

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0439849
Relationship AE - Disease
Description

Relationship AE

Data type

integer

Alias
UMLS CUI [1,1]
C0439849
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0012634
Administration
Description

Administration

Alias
UMLS CUI-1
C1320722
Investigator Signature
Description

Investigator Signature

Data type

text

Alias
UMLS CUI [1]
C2346576
Date
Description

Date

Data type

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
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Similar models

Adverse Experiences

1 forms
  1. StudyEvent: ODM
    1. Adverse Experiences
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Adverse Experiences
C0877248 (UMLS CUI-1)
Adverse Experiences
Item
None?
boolean
C0877248 (UMLS CUI [1])
AE#
Item
AE#
integer
C0877248 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Adverse Experience
Item
Adverse Experience (one experience per Line)
text
C0877248 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Grade per CTC
Item
Grade per CTC
text
C2985911 (UMLS CUI [1])
A Serious?
Item
A Serious?
boolean
C1519255 (UMLS CUI [1])
Onset Date
Item
Onset Date
date
C2985916 (UMLS CUI [1])
Stop Date
Item
Stop Date or 'C' if continuing.
date
C2697886 (UMLS CUI [1])
Item
B Frequency
integer
C3476109 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
B Frequency
Code List
B Frequency
CL Item
Single (1)
CL Item
Intermittent (2)
CL Item
Continuous (3)
Item
Therapeutic Measures - Drug
integer
C0087111 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Therapeutic Measures - Drug
Code List
Therapeutic Measures - Drug
CL Item
1 None (1)
CL Item
2 Infusion rate slowed (2)
CL Item
3 Infusion slopped permanently (3)
Item
Therapeutic Measures - Other
integer
C0087111 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Therapeutic Measures - Other
Code List
Therapeutic Measures - Other
CL Item
None (1)
CL Item
Uncertain (2)
CL Item
Procedure or physical therapy (3)
CL Item
Blood or blood products (4)
CL Item
Withdrawn from study (5)
CL Item
Prescription drug therapy (6)
CL Item
Non-prescriptlon drug therapy (7)
CL Item
Hospitalizatlon (8)
CL Item
IV Fluids (9)
CL Item
Other (specify above) (10)
Therapeutic Measures - Other
Item
Therapeutic Measures - If Other specify here:
text
C0087111 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Item
E Outcome
integer
C1705586 (UMLS CUI [1])
Outcome
Code List
E Outcome
CL Item
Complete recovery (1)
CL Item
Death (2)
CL Item
Unknown/lost to follow-up (3)
CL Item
AE persisting (4)
Item
Relationship AE - Drug
integer
C1518404 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Relationship AE
Code List
Relationship AE - Drug
CL Item
None (1)
CL Item
Remote (2)
CL Item
Possible (3)
CL Item
Probable (4)
Item
Relationship AE - Disease
integer
C0439849 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,3])
Relationship AE
Code List
Relationship AE - Disease
CL Item
None (1)
CL Item
Remote (2)
CL Item
Possible (3)
CL Item
Probable (4)
Item Group
Administration
C1320722 (UMLS CUI-1)
Investigator Signature
Item
Investigator Signature
text
C2346576 (UMLS CUI [1])
Date
Item
Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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