ID

30248

Beschreibung

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

Stichworte

Versionen (1)
  1. 24.05.18 24.05.18 -
Rechteinhaber

GlaxoSmithKline (GSK)

Hochgeladen am

24. Mai 2018

DOI

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Lizenz

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

Infection Summary, Concomitant medications and Transfusions

1 Formulare  
Infection Summary
Beschreibung

Infection Summary

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

Date of visit

Datentyp

date

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

If Yes, complete the rest of this form.

Datentyp

boolean

Alias
UMLS CUI [1]
C0009450
Type of Infection
Beschreibung

Type of Infection

Datentyp

integer

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

Other Infection

Datentyp

text

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

Method of confirmation

Datentyp

integer

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

Other Method of Confirmation

Datentyp

text

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

ff Yes, complete remaining culture information.

Datentyp

boolean

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

Source Code

Datentyp

integer

Alias
UMLS CUI [1]
C1710131
Date
Beschreibung

Date

Datentyp

date

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

Result

Datentyp

integer

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

Organism code

Datentyp

integer

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

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

Datentyp

boolean

Alias
UMLS CUI [1]
C1141958
Anti-Infective
Beschreibung

Anti-Infective

Datentyp

text

Alias
UMLS CUI [1]
C0003204
Anti-Infectives
Beschreibung

Anti-Infectives

Datentyp

text

Alias
UMLS CUI [1]
C1141958
Start Date
Beschreibung

Start Date

Datentyp

date

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

Stop Date

Datentyp

date

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

Concomitant Medications & Transfusions

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

Drug or Blood Product

Datentyp

text

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

Dose

Datentyp

integer

Alias
UMLS CUI [1]
C3174092
Unit
Beschreibung

Unit

Datentyp

text

Alias
UMLS CUI [1]
C1519795
Route
Beschreibung

Route

Datentyp

text

Alias
UMLS CUI [1]
C0013153
Frequency
Beschreibung

Frequency

Datentyp

text

Alias
UMLS CUI [1]
C3476109
Start Date
Beschreibung

Start Date

Datentyp

date

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

Stop Date

Datentyp

date

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

Stop Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
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Ähnliche Modelle

Infection Summary, Concomitant medications and Transfusions

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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