Informações:
Falhas:
ID
31877
Descrição
Long-term Treatment Study of Certolizumab Pegol Without Coadministration of Methotrexate in Japanese Rheumatoid Arthritis (RA) Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00850343
Link
https://clinicaltrials.gov/show/NCT00850343
Palavras-chave
Versões (1)
- 06/10/2018 06/10/2018 -
Titular dos direitos
See clinicaltrials.gov
Transferido a
6 de outubro de 2018
DOI
Para um pedido faça login.
Licença
Creative Commons BY 4.0
Comentários do modelo :
Aqui pode comentar o modelo. Pode comentá-lo especificamente através dos balões de texto nos grupos de itens e itens.
Comentários do grupo de itens para :
Comentários do item para :
Para descarregar formulários, precisa de ter uma sessão iniciada. Por favor faça login ou registe-se gratuitamente.
Eligibility Rheumatoid Arthritis NCT00850343
Eligibility Rheumatoid Arthritis NCT00850343
- StudyEvent: Eligibility
Similar models
Eligibility Rheumatoid Arthritis NCT00850343
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Study Subject Participation Status | Clinical Trial Specified | Criteria Fulfill
Item
subjects who participated in study 275-08-003 and meet all of the criteria described below.
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2,1])
C0205369 (UMLS CUI [2,2])
C0243161 (UMLS CUI [3,1])
C1550543 (UMLS CUI [3,2])
C0008976 (UMLS CUI [2,1])
C0205369 (UMLS CUI [2,2])
C0243161 (UMLS CUI [3,1])
C1550543 (UMLS CUI [3,2])
ACR Criteria failed | Clinical Trial Specified Premature Discontinued | Clinical Trial Specified Completed
Item
patients who did not reach acr20, and prematurely discontinued study 275-08-003 at week 16 or completed study 275-08-003 by week 24.
boolean
C3273747 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
C0008976 (UMLS CUI [2,1])
C0205369 (UMLS CUI [2,2])
C4018905 (UMLS CUI [2,3])
C1444662 (UMLS CUI [2,4])
C0008976 (UMLS CUI [3,1])
C0205369 (UMLS CUI [3,2])
C0205197 (UMLS CUI [3,3])
C0231175 (UMLS CUI [1,2])
C0008976 (UMLS CUI [2,1])
C0205369 (UMLS CUI [2,2])
C4018905 (UMLS CUI [2,3])
C1444662 (UMLS CUI [2,4])
C0008976 (UMLS CUI [3,1])
C0205369 (UMLS CUI [3,2])
C0205197 (UMLS CUI [3,3])
Protocol Deviation Important
Item
patients who experienced an important protocol deviation as mentioned below during study 275-08-003.
boolean
C1705236 (UMLS CUI [1,1])
C3898777 (UMLS CUI [1,2])
C3898777 (UMLS CUI [1,2])
Live Vaccine | Exception Influenza | Exception Pneumococcal vaccine
Item
patients who received live or attenuated vaccines during study 275-08-003 (except for influenza or pneumococcal vaccines).
boolean
C0042211 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0021400 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0358314 (UMLS CUI [3,2])
C1705847 (UMLS CUI [2,1])
C0021400 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0358314 (UMLS CUI [3,2])
Tuberculosis Chest X-ray
Item
patients who were found to have tuberculosis on a chest x-ray during study 275-08-003.
boolean
C0041296 (UMLS CUI [1,1])
C0039985 (UMLS CUI [1,2])
C0039985 (UMLS CUI [1,2])
Communicable Disease Same | Treatment required for Quantity
Item
patients who required treatment for the same infection at two or more different times during study 275-08-003
boolean
C0009450 (UMLS CUI [1,1])
C0445247 (UMLS CUI [1,2])
C0332121 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0445247 (UMLS CUI [1,2])
C0332121 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
Pregnancy | Breast Feeding | Childbearing Potential Planned Pregnancy
Item
women who are pregnant, are lactating, of childbearing potential and wish to conceive during the study and post-study 3 months.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0032992 (UMLS CUI [3,2])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0032992 (UMLS CUI [3,2])
Study Subject Participation Status Inappropriate
Item
patients whom the investigator has decided to be inappropriate for participation in the study
boolean
C2348568 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C1548788 (UMLS CUI [1,2])