Informações:
Falhas:
ID
19223
Descrição
Study Evaluating the Tolerance and Safety of Enbrel (Etanercept) in Adults and Children; ODM derived from: https://clinicaltrials.gov/show/NCT00484809
Link
https://clinicaltrials.gov/show/NCT00484809
Palavras-chave
Versões (1)
- 13/12/2016 13/12/2016 -
Transferido a
13 de dezembro de 2016
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT00484809
Eligibility Rheumatoid Arthritis NCT00484809
- StudyEvent: Eligibility
Similar models
Eligibility Rheumatoid Arthritis NCT00484809
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Indication Disease | Package Insert
Item
inclusion in this study will be as per the approved indications in the package insert.
boolean
C3146298 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0030174 (UMLS CUI [2])
C0012634 (UMLS CUI [1,2])
C0030174 (UMLS CUI [2])
Rheumatoid arthritis moderate | Rheumatoid Arthritis Severe
Item
patients with moderately to severely active ra.
boolean
C2368567 (UMLS CUI [1])
C0003873 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0003873 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Children | Juvenile rheumatoid arthritis | Disease-Modifying Antirheumatic Drugs Quantity | Response Inadequate
Item
children with jra who have had an inadequate response to one or more dmards.
boolean
C0008059 (UMLS CUI [1])
C3714757 (UMLS CUI [2])
C0242708 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C1704632 (UMLS CUI [4,1])
C0205412 (UMLS CUI [4,2])
C3714757 (UMLS CUI [2])
C0242708 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C1704632 (UMLS CUI [4,1])
C0205412 (UMLS CUI [4,2])
Hypersensitivity Etanercept | Hypersensitivity Etanercept Component
Item
known hypersensitivity to etanercept or any of its components.
boolean
C0020517 (UMLS CUI [1,1])
C0717758 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0717758 (UMLS CUI [2,2])
C1705248 (UMLS CUI [2,3])
C0717758 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0717758 (UMLS CUI [2,2])
C1705248 (UMLS CUI [2,3])
Comorbidity Significant
Item
known significant concurrent medical disease, including:
boolean
C0009488 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0750502 (UMLS CUI [1,2])
Congestive heart failure | Angina Pectoris Uncontrolled | Myocardial Infarction
Item
congestive heart failure, uncontrolled angina pectoris, recent history of myocardial infarction
boolean
C0018802 (UMLS CUI [1])
C0002962 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0027051 (UMLS CUI [3])
C0002962 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0027051 (UMLS CUI [3])
Malignant Neoplasms
Item
cancer or history of cancer
boolean
C0006826 (UMLS CUI [1])
Communicable Disease
Item
active infection
boolean
C0009450 (UMLS CUI [1])
Sepsis | At risk for sepsis
Item
sepsis or risk of sepsis
boolean
C0243026 (UMLS CUI [1])
C4047386 (UMLS CUI [2])
C4047386 (UMLS CUI [2])
Tuberculosis
Item
active tuberculosis or a past history of tuberculosis
boolean
C0041296 (UMLS CUI [1])
Pancytopenia
Item
pancytopenia
boolean
C0030312 (UMLS CUI [1])
Pregnancy | Breast Feeding | Risk of Pregnancy | Gender Contraceptive methods
Item
females who are pregnant, breast feeding or at risk of pregnancy and not using a medically acceptable form of contraception.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C4048193 (UMLS CUI [3])
C0079399 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0006147 (UMLS CUI [2])
C4048193 (UMLS CUI [3])
C0079399 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
Elective Surgical Procedure Planned
Item
patients who are planning to undergo elective surgery during the study period.
boolean
C0206058 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,2])