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Informações:
Falhas:
ID
31138
Descrição
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
Palavras-chave
Versões (2)
- 22/07/2018 22/07/2018 -
- 18/08/2018 18/08/2018 -
Titular dos direitos
see clinicaltrials.gov
Transferido a
22 de julho de 2018
DOI
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Licença
Creative Commons BY-NC 3.0
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Iodine-131 Anti-B1 Antibody for Non Hodgkin’s Lymphomas NCT00996593
Infection Summary (Visit 8)
- StudyEvent: ODM
Similar models
Infection Summary (Visit 8)
- StudyEvent: ODM
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Last Page
Item
Last Page
boolean
C1704732 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,2])
Series page
Item
Series page
text
C0205549 (UMLS CUI [1,1])
C1704732 (UMLS CUI [1,2])
C1704732 (UMLS CUI [1,2])
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Communicable Diseases; Invasive; Study; participation | Sepsis; Study; articipation | Pneumonia; Study; participation
Item
Has the patient had a presumed or confirmed invasive infection (e. g. sepsis, pneumonia, etc.) during study participation?
boolean
C0009450 (UMLS CUI [1,1])
C0205281 (UMLS CUI [1,2])
C2603343 (UMLS CUI [1,3])
C0679823 (UMLS CUI [1,4])
C0243026 (UMLS CUI [2,1])
C2603343 (UMLS CUI [2,2])
C0679823 (UMLS CUI [2,3])
C0032285 (UMLS CUI [3,1])
C2603343 (UMLS CUI [3,2])
C0679823 (UMLS CUI [3,3])
C0205281 (UMLS CUI [1,2])
C2603343 (UMLS CUI [1,3])
C0679823 (UMLS CUI [1,4])
C0243026 (UMLS CUI [2,1])
C2603343 (UMLS CUI [2,2])
C0679823 (UMLS CUI [2,3])
C0032285 (UMLS CUI [3,1])
C2603343 (UMLS CUI [3,2])
C0679823 (UMLS CUI [3,3])
Item
Type of infection (If the patient had an invasive infection, complete the rest of the form)
text
C0009450 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,2])
Code List
Type of infection (If the patient had an invasive infection, complete the rest of the form)
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)
Communicable Diseases; Type - attribute; Other; Specification
Item
If patient had other type of infection, please specify
text
C0009450 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C0332307 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Item
Method of confirmation
text
C0750484 (UMLS CUI [1,1])
C0025663 (UMLS CUI [1,2])
C0025663 (UMLS CUI [1,2])
CL Item
PE (1)
CL Item
CT Scan (2)
CL Item
X-Ray (3)
CL Item
Other (4)
Confirmation; Methods; Other; Specification
Item
If other Method of confirmation, please specify
text
C0750484 (UMLS CUI [1,1])
C0025663 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C0025663 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Blood culture
Item
Was a culture obtained?
boolean
C0200949 (UMLS CUI [1])
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 (9)
Source Code; Other; Specification
Item
If other Source Code, please specify
text
C1710131 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Sampling Date
Item
Sampling Date
date
C0870078 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
CL Item
Positive (1)
CL Item
Negative (2)
Item
If positive, indicate organism code
text
C1274040 (UMLS CUI [1,1])
C1446409 (UMLS CUI [1,2])
C0029235 (UMLS CUI [2,1])
C0805701 (UMLS CUI [2,2])
C1446409 (UMLS CUI [1,2])
C0029235 (UMLS CUI [2,1])
C0805701 (UMLS CUI [2,2])
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 (8)
If other organism code, please specify
Item
If other organism code, please specify
text
C0029235 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C0805701 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Anti-Infective Agents
Item
Was an anti- infective administered?
boolean
C0003204 (UMLS CUI [1])
Anti-Infective Agents
Item
Anti-Infective
text
C0003204 (UMLS CUI [1])
Item
Empiric or therapeutic?
text
C1880496 (UMLS CUI [1])
C0302350 (UMLS CUI [2])
C0302350 (UMLS CUI [2])
CL Item
empiric (1)
CL Item
therapeutic (2)
Date treatment or therapy started
Item
Start date therapy
date
C3173309 (UMLS CUI [1])
Date treatment stopped
Item
Stop date therapy
date
C1531784 (UMLS CUI [1])
Item
Therapy ongoing?
text
C0087111 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
CL Item
yes (1)