ID

30249

Beschreibung

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

Stichworte

Versionen (1)
  1. 24.05.18 24.05.18 -
Rechteinhaber

GlaxoSmithKline (GSK)

Hochgeladen am

24. Mai 2018

DOI

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

Englisch

Adverse Experiences

1 Formulare  
  1. StudyEvent: ODM
    1. Adverse Experiences
Adverse Experiences
Beschreibung

Adverse Experiences

Alias
UMLS CUI-1
C0877248
None?
Beschreibung

Adverse Experiences

Datentyp

boolean

Alias
UMLS CUI [1]
C0877248
AE#
Beschreibung

AE#

Datentyp

integer

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

Adverse Experience

Datentyp

text

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

Grade per CTC

Datentyp

text

Alias
UMLS CUI [1]
C2985911
A Serious?
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1]
C1519255
Onset Date
Beschreibung

Onset Date

Datentyp

date

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

Stop Date

Datentyp

date

Alias
UMLS CUI [1]
C2697886
B Frequency
Beschreibung

B Frequency

Datentyp

integer

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

Therapeutic Measures - Drug

Datentyp

integer

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

Therapeutic Measures - Other

Datentyp

integer

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

Therapeutic Measures - Other

Datentyp

text

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

Outcome

Datentyp

integer

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

Relationship AE

Datentyp

integer

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

Relationship AE

Datentyp

integer

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

Administration

Alias
UMLS CUI-1
C1320722
Investigator Signature
Beschreibung

Investigator Signature

Datentyp

text

Alias
UMLS CUI [1]
C2346576
Date
Beschreibung

Date

Datentyp

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
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Ähnliche Modelle

Adverse Experiences

1 Formulare
  1. StudyEvent: ODM
    1. Adverse Experiences
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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