ID

41999

Beskrivning

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

Nyckelord

Versioner (3)
  1. 2018-07-23 2018-07-23 -
  2. 2018-08-18 2018-08-18 -
  3. 2021-03-15 2021-03-15 - Dr. rer. medic Philipp Neuhaus
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

15 mars 2021

DOI

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Creative Commons BY-NC 3.0
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Iodine-131 Anti-B1 Antibody for Non Hodgkin’s Lymphomas NCT00996593

Engelsk

Concomitant Medications and Transfusions and Adverse Experiences

1 Formulär  
Administrative
Beskrivning

Administrative

Alias
UMLS CUI-1
C1320722
Series Page
Beskrivning

Series Page

Datatyp

text

Alias
UMLS CUI [1,1]
C0205549
UMLS CUI [1,2]
C1704732
Last Page
Beskrivning

Last Page

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1704732
UMLS CUI [1,2]
C1517741
Concomitant Medications and Transfusions
Beskrivning

Concomitant Medications and Transfusions

Alias
UMLS CUI-1
C4284232
UMLS CUI-2
C0521115
UMLS CUI-3
C1879316
UMLS CUI-4
C0521115
Drug or Blood Product
Beskrivning

Drug or Blood Product

Datatyp

text

Alias
UMLS CUI [1]
C0013227
UMLS CUI [2]
C0456388
Drug or Blood Product Dose
Beskrivning

Drug or Blood Product Dose

Datatyp

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0178602
UMLS CUI [2,1]
C0456388
UMLS CUI [2,2]
C0178602
Drug or Blood Product Dose Unit
Beskrivning

Drug or Blood Product Dose Unit

Datatyp

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0439148
UMLS CUI [2,1]
C0456388
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0439148
Route of drug administration
Beskrivning

Route of drug administration

Datatyp

text

Alias
UMLS CUI [1]
C0013153
Medication and Transfusion frequency
Beskrivning

Medication frequency | Transfusion (procedure); Frequencies (time pattern)

Datatyp

text

Alias
UMLS CUI [1]
C3476109
UMLS CUI [2,1]
C1879316
UMLS CUI [2,2]
C0439603
Treatment Start Date (mm/dd/yy)
Beskrivning

Date treatment started

Datatyp

date

Alias
UMLS CUI [1]
C3173309
Treatment Stop Date (mm/dd/yy)
Beskrivning

Date treatment stopped

Datatyp

date

Alias
UMLS CUI [1]
C1531784
If treatment is continuing, please check
Beskrivning

continuing therapy

Datatyp

text

Alias
UMLS CUI [1]
C1553904
Adverse Experiences
Beskrivning

Adverse Experiences

Alias
UMLS CUI-1
C0877248
Check, if patient had no Adverse Experiences
Beskrivning

Adverse event

Datatyp

text

Alias
UMLS CUI [1]
C0877248
Adverse Experiences
Beskrivning

Adverse Experiences

Alias
UMLS CUI-1
C0877248
Number of Adverse Experience
Beskrivning

adverse event; Numbers

Datatyp

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0237753
Adverse Experience
Beskrivning

Adverse event

Datatyp

text

Alias
UMLS CUI [1]
C0877248
Grade per CTC
Beskrivning

Adverse Event Grade Code

Datatyp

text

Alias
UMLS CUI [1]
C2985911
Serious Adverse Experience?
Beskrivning

Serious: Fatal or immediately life- threatening, permanently disabling, requires of prolongs hospitalization, or congenital anomaly.

Datatyp

boolean

Alias
UMLS CUI [1]
C1519255
Adverse Experience Onset Date (mm/dd/yy)
Beskrivning

Adverse Event Onset Date

Datatyp

date

Alias
UMLS CUI [1]
C2985916
Adverse Experience Stop Date (mm/dd/yy)
Beskrivning

Adverse event; End Date

Datatyp

date

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0806020
If Adverse Experience is continuig, please check
Beskrivning

Adverse event; Continuous

Datatyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0549178
Adverse Experience Frequency
Beskrivning

Adverse event; Frequencies (time pattern)

Datatyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0439603
Therapeutic measures drug
Beskrivning

Pharmaceutical Preparations; Therapeutic procedure; Measures

Datatyp

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0079809
Other therapeutic measures
Beskrivning

Record all that apply

Datatyp

text

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0079809
UMLS CUI [1,3]
C0205394
If other therapeutic measures not listed, specify
Beskrivning

Therapeutic procedure; Measures; Other; Specification

Datatyp

text

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0079809
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C2348235
Adverse Experience Outcome
Beskrivning

Adverse Event Outcome

Datatyp

text

Alias
UMLS CUI [1]
C1705586
Relationship between Adverse Experience and Drug
Beskrivning

Adverse event; Pharmaceutical Preparations; Relationships

Datatyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0439849
Relationship between Adverse Experience and Disease
Beskrivning

Adverse event; Disease; Relationships

Datatyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0439849
Investigator Signature
Beskrivning

Investigator Signature

Alias
UMLS CUI-1
C2346576
Investigator Signature
Beskrivning

Investigator Signature

Datatyp

text

Alias
UMLS CUI [1]
C2346576
Assessment Date
Beskrivning

Assessment Date

Datatyp

date

Alias
UMLS CUI [1]
C2985720
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Similar models

Concomitant Medications and Transfusions and Adverse Experiences

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Series Page
Item
Series Page
text
C0205549 (UMLS CUI [1,1])
C1704732 (UMLS CUI [1,2])
Last Page
Item
Last Page
boolean
C1704732 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
Item Group
Concomitant Medications and Transfusions
C4284232 (UMLS CUI-1)
C0521115 (UMLS CUI-2)
C1879316 (UMLS CUI-3)
C0521115 (UMLS CUI-4)
Drug or Blood Product
Item
Drug or Blood Product
text
C0013227 (UMLS CUI [1])
C0456388 (UMLS CUI [2])
Drug or Blood Product Dose
Item
Drug or Blood Product Dose
text
C0013227 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0456388 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
Drug or Blood Product Dose Unit
Item
Drug or Blood Product Dose Unit
text
C0013227 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0439148 (UMLS CUI [1,3])
C0456388 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0439148 (UMLS CUI [2,3])
Route of drug administration
Item
Route of drug administration
text
C0013153 (UMLS CUI [1])
Medication frequency | Transfusion (procedure); Frequencies (time pattern)
Item
Medication and Transfusion frequency
text
C3476109 (UMLS CUI [1])
C1879316 (UMLS CUI [2,1])
C0439603 (UMLS CUI [2,2])
Date treatment started
Item
Treatment Start Date (mm/dd/yy)
date
C3173309 (UMLS CUI [1])
Date treatment stopped
Item
Treatment Stop Date (mm/dd/yy)
date
C1531784 (UMLS CUI [1])
Item
If treatment is continuing, please check
text
C1553904 (UMLS CUI [1])
continuing therapy
Code List
If treatment is continuing, please check
CL Item
continuing therapy (C)
Item Group
Adverse Experiences
C0877248 (UMLS CUI-1)
Item
Check, if patient had no Adverse Experiences
text
C0877248 (UMLS CUI [1])
Adverse event
Code List
Check, if patient had no Adverse Experiences
CL Item
None (N)
Item Group
Adverse Experiences
C0877248 (UMLS CUI-1)
adverse event; Numbers
Item
Number of Adverse Experience
integer
C0877248 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Adverse event
Item
Adverse Experience
text
C0877248 (UMLS CUI [1])
Adverse Event Grade Code
Item
Grade per CTC
text
C2985911 (UMLS CUI [1])
Serious Adverse Event
Item
Serious Adverse Experience?
boolean
C1519255 (UMLS CUI [1])
Adverse Event Onset Date
Item
Adverse Experience Onset Date (mm/dd/yy)
date
C2985916 (UMLS CUI [1])
Adverse event; End Date
Item
Adverse Experience Stop Date (mm/dd/yy)
date
C0877248 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
If Adverse Experience is continuig, please check
text
C0877248 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
undefined item
Code List
If Adverse Experience is continuig, please check
CL Item
continuing AE (C)
Item
Adverse Experience Frequency
text
C0877248 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
Adverse event; Frequencies (time pattern)
Code List
Adverse Experience Frequency
CL Item
Single (1)
CL Item
Intermittent (2)
CL Item
Continious (3)
Item
Therapeutic measures drug
text
C0013227 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0079809 (UMLS CUI [1,3])
Therapeutic procedure; Measures
Code List
Therapeutic measures drug
CL Item
None (1)
CL Item
infusion rate slowed (2)
CL Item
infusion stopped permanently (3)
Item
Other therapeutic measures
text
C0087111 (UMLS CUI [1,1])
C0079809 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Therapeutic procedure; Measures; Other
Code List
Other therapeutic measures
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- prescription drug therapy (7)
CL Item
Hospitalization (8)
CL Item
IV Fluids (9)
CL Item
Other (99)
Therapeutic procedure; Measures; Other; Specification
Item
If other therapeutic measures not listed, specify
text
C0087111 (UMLS CUI [1,1])
C0079809 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Item
Adverse Experience Outcome
text
C1705586 (UMLS CUI [1])
Adverse Event Outcome
Code List
Adverse Experience 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 between Adverse Experience and Drug
text
C0877248 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Adverse event; Pharmaceutical Preparations; Relationships
Code List
Relationship between Adverse Experience and Drug
CL Item
None (1)
CL Item
Remote (2)
CL Item
Possible (3)
CL Item
Probable (4)
Item
Relationship between Adverse Experience and Disease
text
C0877248 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Adverse event; Disease; Relationships
Code List
Relationship between Adverse Experience and Disease
CL Item
None (1)
CL Item
Remote (2)
CL Item
Possible (3)
CL Item
Probable (4)
Item Group
Investigator Signature
C2346576 (UMLS CUI-1)
Investigator Signature
Item
Investigator Signature
text
C2346576 (UMLS CUI [1])
Assessment Date
Item
Assessment Date
date
C2985720 (UMLS CUI [1])
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