ID

19223

Descripción

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

Palabras clave

  1. 13/12/16 13/12/16 -
Subido en

13 de diciembre de 2016

DOI

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Licencia

Creative Commons BY 4.0

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Eligibility Rheumatoid Arthritis NCT00484809

Eligibility Rheumatoid Arthritis NCT00484809

Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
inclusion in this study will be as per the approved indications in the package insert.
Descripción

Indication Disease | Package Insert

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0012634
UMLS CUI [2]
C0030174
patients with moderately to severely active ra.
Descripción

Rheumatoid arthritis moderate | Rheumatoid Arthritis Severe

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2368567
UMLS CUI [2,1]
C0003873
UMLS CUI [2,2]
C0205082
children with jra who have had an inadequate response to one or more dmards.
Descripción

Children | Juvenile rheumatoid arthritis | Disease-Modifying Antirheumatic Drugs Quantity | Response Inadequate

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0008059
UMLS CUI [2]
C3714757
UMLS CUI [3,1]
C0242708
UMLS CUI [3,2]
C1265611
UMLS CUI [4,1]
C1704632
UMLS CUI [4,2]
C0205412
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
known hypersensitivity to etanercept or any of its components.
Descripción

Hypersensitivity Etanercept | Hypersensitivity Etanercept Component

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0717758
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0717758
UMLS CUI [2,3]
C1705248
known significant concurrent medical disease, including:
Descripción

Comorbidity Significant

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0750502
congestive heart failure, uncontrolled angina pectoris, recent history of myocardial infarction
Descripción

Congestive heart failure | Angina Pectoris Uncontrolled | Myocardial Infarction

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0018802
UMLS CUI [2,1]
C0002962
UMLS CUI [2,2]
C0205318
UMLS CUI [3]
C0027051
cancer or history of cancer
Descripción

Malignant Neoplasms

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0006826
active infection
Descripción

Communicable Disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0009450
sepsis or risk of sepsis
Descripción

Sepsis | At risk for sepsis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0243026
UMLS CUI [2]
C4047386
active tuberculosis or a past history of tuberculosis
Descripción

Tuberculosis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0041296
pancytopenia
Descripción

Pancytopenia

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0030312
females who are pregnant, breast feeding or at risk of pregnancy and not using a medically acceptable form of contraception.
Descripción

Pregnancy | Breast Feeding | Risk of Pregnancy | Gender Contraceptive methods

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C4048193
UMLS CUI [4,1]
C0079399
UMLS CUI [4,2]
C0700589
patients who are planning to undergo elective surgery during the study period.
Descripción

Elective Surgical Procedure Planned

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0206058
UMLS CUI [1,2]
C1301732

Similar models

Eligibility Rheumatoid Arthritis NCT00484809

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
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])
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])
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])
Item Group
C0680251 (UMLS CUI)
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])
Comorbidity Significant
Item
known significant concurrent medical disease, including:
boolean
C0009488 (UMLS CUI [1,1])
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])
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])
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])
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])

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