ID

30248

Description

https://clinicaltrials.gov/show/NCT00989664 Infection Summary, Concomitant medications and Transfusions 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

Infection Summary, Concomitant medications and Transfusions

1 forms  
Infection Summary
Description

Infection Summary

Alias
UMLS CUI-1
C0009450
UMLS CUI-2
C1706244
Date of visit
Description

Date of visit

Data type

date

Alias
UMLS CUI [1]
C1320303
Has the patient had a presumed or confirmed invasive infection (e.g., sepsis, pneumonia, etc.) during study participation?
Description

If Yes, complete the rest of this form.

Data type

boolean

Alias
UMLS CUI [1]
C0009450
Type of Infection
Description

Type of Infection

Data type

integer

Alias
UMLS CUI [1,1]
C0332307
UMLS CUI [1,2]
C0009450
Other Infection
Description

Other Infection

Data type

text

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205394
Method of confirmation
Description

Method of confirmation

Data type

integer

Alias
UMLS CUI [1,1]
C0750484
UMLS CUI [1,2]
C2911685
UMLS CUI [1,3]
C0009450
Other Method of Confirmation
Description

Other Method of Confirmation

Data type

text

Alias
UMLS CUI [1,1]
C0750484
UMLS CUI [1,2]
C2911685
UMLS CUI [1,3]
C0009450
Was a culture obtained?
Description

ff Yes, complete remaining culture information.

Data type

boolean

Alias
UMLS CUI [1,1]
C0430400
UMLS CUI [1,2]
C0009450
Source Code
Description

Source Code

Data type

integer

Alias
UMLS CUI [1]
C1710131
Date
Description

Date

Data type

date

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

Result

Data type

integer

Alias
UMLS CUI [1,1]
C1274040
UMLS CUI [1,2]
C0430400
UMLS CUI [1,3]
C0009450
If positive, Indicate organism code:
Description

Organism code

Data type

integer

Alias
UMLS CUI [1,1]
C0029235
UMLS CUI [1,2]
C0430400
Was an anti-infective administered?
Description

If Yes, list here and on the Concomitant Medications form.

Data type

boolean

Alias
UMLS CUI [1]
C1141958
Anti-Infective
Description

Anti-Infective

Data type

text

Alias
UMLS CUI [1]
C0003204
Anti-Infectives
Description

Anti-Infectives

Data type

text

Alias
UMLS CUI [1]
C1141958
Start Date
Description

Start Date

Data type

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0808070
UMLS CUI [1,3]
C1141958
Stop Date, or check box if ongoing.
Description

Stop Date

Data type

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
UMLS CUI [1,3]
C1141958
Concomitant Medications & Transfusions
Description

Concomitant Medications & Transfusions

Alias
UMLS CUI-1
C2347852
UMLS CUI-2
C0013227
Drug or Blood Product
Description

Drug or Blood Product

Data type

text

Alias
UMLS CUI [1]
C0456388
UMLS CUI [2]
C0013227
Dose
Description

Dose

Data type

integer

Alias
UMLS CUI [1]
C3174092
Unit
Description

Unit

Data type

text

Alias
UMLS CUI [1]
C1519795
Route
Description

Route

Data type

text

Alias
UMLS CUI [1]
C0013153
Frequency
Description

Frequency

Data type

text

Alias
UMLS CUI [1]
C3476109
Start Date
Description

Start Date

Data type

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0808070
Stop Date, or C for continuing.
Description

Stop Date

Data type

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
Stop Date, or C for continuing.
Description

Stop Date

Data type

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
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Similar models

Infection Summary, Concomitant medications and Transfusions

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Infection Summary
C0009450 (UMLS CUI-1)
C1706244 (UMLS CUI-2)
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Presumed or confirmed invasive infection
Item
Has the patient had a presumed or confirmed invasive infection (e.g., sepsis, pneumonia, etc.) during study participation?
boolean
C0009450 (UMLS CUI [1])
Item
Type of Infection
integer
C0332307 (UMLS CUI [1,1])
C0009450 (UMLS CUI [1,2])
Type of Infection
Code List
Type of Infection
CL Item
Meningitis (1)
CL Item
Pyelonephritis (2)
CL Item
Sepsis (3)
CL Item
Pneumonia (4)
CL Item
Endocarditis/Pericarditis (5)
CL Item
Peritonitis (6)
CL Item
Other (7)
Other Infection
Item
Other Infection
text
C0009450 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Item
Method of confirmation
integer
C0750484 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
C0009450 (UMLS CUI [1,3])
Method of confirmation
Code List
Method of confirmation
CL Item
PE (1)
CL Item
CT Scan (2)
CL Item
X-ray (3)
CL Item
Other (4)
Other Method of Confirmation
Item
Other Method of Confirmation
text
C0750484 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
C0009450 (UMLS CUI [1,3])
Culture
Item
Was a culture obtained?
boolean
C0430400 (UMLS CUI [1,1])
C0009450 (UMLS CUI [1,2])
Item
Source Code
integer
C1710131 (UMLS CUI [1])
Source Code
Code List
Source Code
CL Item
Sputum (1)
CL Item
Blood (2)
CL Item
Throat (3)
CL Item
Skin (4)
CL Item
CSF (5)
CL Item
Urine (6)
CL Item
Stool (7)
CL Item
Abscess (8)
CL Item
Other (specify in source code box) (9)
Date
Item
Date
date
C0011008 (UMLS CUI [1,1])
C0430400 (UMLS CUI [1,2])
C0009450 (UMLS CUI [1,3])
Item
Result
integer
C1274040 (UMLS CUI [1,1])
C0430400 (UMLS CUI [1,2])
C0009450 (UMLS CUI [1,3])
Result
Code List
Result
CL Item
Positive (1)
CL Item
Negative (2)
Item
If positive, Indicate organism code:
integer
C0029235 (UMLS CUI [1,1])
C0430400 (UMLS CUI [1,2])
Organism code
Code List
If positive, Indicate organism code:
CL Item
Herpes simplex (1)
CL Item
Staph. aureus (2)
CL Item
Staph. epidermis (3)
CL Item
E. coli (4)
CL Item
Candida albicans (5)
CL Item
Strep. pneumoniae (6)
CL Item
Pseudomonas aeruginosa (7)
CL Item
Other (specify in organism code box) (8)
Anti-Infectives
Item
Was an anti-infective administered?
boolean
C1141958 (UMLS CUI [1])
Anti-Infective
Item
Anti-Infective
text
C0003204 (UMLS CUI [1])
Item
Anti-Infectives
text
C1141958 (UMLS CUI [1])
Anti-Infectives
Code List
Anti-Infectives
CL Item
Empiric (E)
CL Item
Therapeutic (T)
Start Date
Item
Start Date
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C1141958 (UMLS CUI [1,3])
Stop Date
Item
Stop Date, or check box if ongoing.
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C1141958 (UMLS CUI [1,3])
Item Group
Concomitant Medications & Transfusions
C2347852 (UMLS CUI-1)
C0013227 (UMLS CUI-2)
Drug or Blood Product
Item
Drug or Blood Product
text
C0456388 (UMLS CUI [1])
C0013227 (UMLS CUI [2])
Dose
Item
Dose
integer
C3174092 (UMLS CUI [1])
Unit
Item
Unit
text
C1519795 (UMLS CUI [1])
Route
Item
Route
text
C0013153 (UMLS CUI [1])
Frequency
Item
Frequency
text
C3476109 (UMLS CUI [1])
Start Date
Item
Start Date
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Stop Date
Item
Stop Date, or C for continuing.
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Stop Date
Item
Stop Date, or C for continuing.
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
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