Informações:
Falhas:
ID
42082
Descrição
Study ID: 104512 Clinical Study ID: 104512 Study Title: Phase I, Dose-Escalation Study of Iodine-131 Anti-B1 Antibody for Patients With Previously Treated Non Hodgkin's Lymphoma With More Than 25% Bone Marrow Involvement Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00992758 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Iodine-131 Anti-B1 Antibody Trade Name: Tositumomab Study Indication: Lymphoma, Non-Hodgkin
Palavras-chave
Versões (2)
- 29/03/2021 29/03/2021 -
- 29/03/2021 29/03/2021 -
Titular dos direitos
GlaxoSmithKline
Transferido a
29 de março de 2021
DOI
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Licença
Creative Commons BY 4.0
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Iodine-131 Anti-B1 Antibody for Patients With Previously Treated Non Hodgkin's Lymphoma NCT00992758
Infection Summary; Concomitant Medications and Transfusions; Adverse Experiences
Similar models
Infection Summary; Concomitant Medications and Transfusions; Adverse Experiences
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Site Number
Item
Site Number
text
C2825164 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
Patient Number
Item
Patient Number
text
C0030705 (UMLS CUI [1,1])
C1300638 (UMLS CUI [1,2])
C1300638 (UMLS CUI [1,2])
Patient Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Series Page
Item
Series Page
text
C0205549 (UMLS CUI [1,1])
C1704732 (UMLS CUI [1,2])
C1704732 (UMLS CUI [1,2])
Has the patient had a presumed or confirmed invasive infection (e.g., sepsis, pneumonia, etc.) requiring oral or intravenous anti-infectives during study participation?
Item
Has the patient had a presumed or confirmed invasive infection (e.g., sepsis, pneumonia, etc.) requiring oral or intravenous anti-infectives during study participation?
boolean
C0009450 (UMLS CUI [1,1])
C0205281 (UMLS CUI [1,2])
C0243026 (UMLS CUI [2])
C0032285 (UMLS CUI [3])
C2603343 (UMLS CUI [4,1])
C0679823 (UMLS CUI [4,2])
C0205281 (UMLS CUI [1,2])
C0243026 (UMLS CUI [2])
C0032285 (UMLS CUI [3])
C2603343 (UMLS CUI [4,1])
C0679823 (UMLS CUI [4,2])
If no invasive infection, record date of visit
Item
If no invasive infection, record date of visit
date
C0009450 (UMLS CUI [1,1])
C0205281 (UMLS CUI [1,2])
C1320303 (UMLS CUI [2])
C0205281 (UMLS CUI [1,2])
C1320303 (UMLS CUI [2])
If invasive infection, enter date of infection
Item
If invasive infection, enter date of infection
datetime
C0009450 (UMLS CUI [1,1])
C0205281 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2])
C0205281 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2])
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)
Specify other type of infection
Item
Specify other type of infection
text
C0457463 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item
Method of confirmation
integer
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)
Specify other method of confirmation
Item
Specify other method of confirmation
text
C0750484 (UMLS CUI [1,1])
C0025663 (UMLS CUI [1,2])
C2348235 (UMLS CUI [2])
C0205394 (UMLS CUI [3])
C0025663 (UMLS CUI [1,2])
C2348235 (UMLS CUI [2])
C0205394 (UMLS CUI [3])
Was a culture obtained?
Item
Was a culture obtained?
boolean
C0430400 (UMLS CUI [1])
Item Group
Infection Summary - Culture information
C0009450 (UMLS CUI-1)
C1706244 (UMLS CUI-2)
C0430400 (UMLS CUI-3)
C1533716 (UMLS CUI-4)
C1706244 (UMLS CUI-2)
C0430400 (UMLS CUI-3)
C1533716 (UMLS CUI-4)
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 (9)
Specify other source code
Item
Specify other source code
text
C1710131 (UMLS CUI [1])
C0205394 (UMLS CUI [2])
C2348235 (UMLS CUI [3])
C0205394 (UMLS CUI [2])
C2348235 (UMLS CUI [3])
Culture Date
Item
Culture Date
date
C0430400 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
CL Item
Pos (1)
CL Item
Neg (2)
Item
If positive result, indicate organism code
integer
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
Listeria monocytogenes (8)
CL Item
Varicella-zoster (9)
CL Item
Pneumocytis carinii (10)
CL Item
Cytomegalovirus (11)
CL Item
Other, specify (12)
Specify other organism
Item
Specify other organism
text
C0029235 (UMLS CUI [1])
C0205394 (UMLS CUI [2])
C2348235 (UMLS CUI [3])
C0205394 (UMLS CUI [2])
C2348235 (UMLS CUI [3])
Item Group
Infection Summary - Anti-infective
C0009450 (UMLS CUI-1)
C1706244 (UMLS CUI-2)
C0003204 (UMLS CUI-3)
C1706244 (UMLS CUI-2)
C0003204 (UMLS CUI-3)
Was an anti-infective administered?
Item
Was an anti-infective administered?
boolean
C0003204 (UMLS CUI [1])
Item Group
Infection Summary - Anti-infective
C0009450 (UMLS CUI-1)
C1706244 (UMLS CUI-2)
C0003204 (UMLS CUI-3)
C1706244 (UMLS CUI-2)
C0003204 (UMLS CUI-3)
Anti-Infective
Item
Anti-Infective
text
C0003204 (UMLS CUI [1])
CL Item
IV (1)
CL Item
PO (2)
Item
Empiric or therapeutic?
integer
C1880496 (UMLS CUI [1])
C0302350 (UMLS CUI [2])
C0302350 (UMLS CUI [2])
CL Item
Empiric (1)
CL Item
Therapeutic (2)
Anti-infective therapy start date
Item
Anti-infective therapy start date
date
C1141958 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
Anti-infective therapy stop date
Item
Anti-infective therapy stop date
date
C1141958 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
Item
Anti-infective therapy ongoing?
integer
C1141958 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
CL Item
ongoing (1)
Item Group
Concomitant Medications and Transfusions
C2347852 (UMLS CUI-1)
C1879316 (UMLS CUI-2)
C1879316 (UMLS CUI-2)
Drug or Blood Product
Item
Drug or Blood Product
text
C0013227 (UMLS CUI [1])
C0456388 (UMLS CUI [2])
C0456388 (UMLS CUI [2])
Medication Dose
Item
Medication Dose
text
C3174092 (UMLS CUI [1])
Medication Unit
Item
Medication Unit
text
C2826646 (UMLS CUI [1])
Medication Route
Item
Medication Route
text
C0013153 (UMLS CUI [1])
Medication Frequency
Item
Medication Frequency
text
C3476109 (UMLS CUI [1])
Medication Start Date
Item
Medication Start Date
date
C2826734 (UMLS CUI [1])
Medication Stop Date
Item
Medication Stop Date
date
C2826744 (UMLS CUI [1])
CL Item
Continuing (C)
CL Item
No Adverse Experience (1)
Adverse Experience Number
Item
Adverse Experience Number
integer
C0877248 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
Adverse Experience
Item
Adverse Experience
text
C0877248 (UMLS CUI [1])
Adverse Experience Grade
Item
Adverse Experience Grade
text
C2985911 (UMLS CUI [1])
SAE?
Item
SAE?
boolean
C1519255 (UMLS CUI [1])
Adverse Experience Onset Date
Item
Adverse Experience Onset Date
date
C2985916 (UMLS CUI [1])
Adverse Experience Stop Date
Item
Adverse Experience Stop Date
date
C0877248 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
CL Item
Continuing (C)
Item
Therapeutic Measures - Drug
integer
C0087111 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
CL Item
None (1)
CL Item
Infusion rate slowed (2)
CL Item
Infusion stopped permanently (3)
Item
Other therapeutic measures
integer
C0087111 (UMLS CUI [1,1])
C0079809 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0079809 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
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, specify (99)
Specify other therapeutic measure
Item
Specify other therapeutic measure
text
C0087111 (UMLS CUI [1,1])
C0079809 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [2])
C0079809 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [2])
CL Item
Complete recovery (1)
CL Item
Death (2)
CL Item
Unknown/ lost to follow-up (3)
CL Item
AE persisting (4)
Item
Adverse Experience Relationship to Drug
integer
C0877248 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C0013227 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
CL Item
None (1)
CL Item
Remote (2)
CL Item
Possible (3)
CL Item
Probable (4)
CL Item
Highly Probable (5)
Item Group
Adverse Experiences - Investigator Signature
C0877248 (UMLS CUI-1)
C2346576 (UMLS CUI-2)
C2346576 (UMLS CUI-2)
Investigator Signature
Item
Investigator Signature
text
C2346576 (UMLS CUI [1])
Investigator Signature Date
Item
Investigator Signature Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])