Informações:
Falhas:
ID
14600
Descrição
Open-Label Safety Extension Study of Avonex; ODM derived from: https://clinicaltrials.gov/show/NCT00915460
Link
https://clinicaltrials.gov/show/NCT00915460
Palavras-chave
Versões (1)
- 23/04/2016 23/04/2016 -
Transferido a
23 de abril de 2016
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Multiple Sclerosis NCT00915460
Eligibility Multiple Sclerosis NCT00915460
- StudyEvent: Eligibility
Similar models
Eligibility Multiple Sclerosis NCT00915460
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Study participation status and inclusion Criteria
Item
must have completed (as defined below) one of the following biogen avonex® clinical studies and meet the other criteria indicated.
boolean
C2348568 (UMLS CUI [1])
C1512693 (UMLS CUI [2])
C1512693 (UMLS CUI [2])
Study completed
Item
subjects enrolled from studies c95-812 and c97-830 must have completed their respective study within 12 months prior to enrollment in c98-838. subjects enrolled from study c96-823 must have completed the study within 24 months prior to enrollment in c98-838.
boolean
C2348577 (UMLS CUI [1])
Comorbidity affecting neurologic symptoms
Item
have not been diagnosed with any other disease that accounts for their neurologic symptoms.
boolean
C0009488 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0235031 (UMLS CUI [1,3])
C0392760 (UMLS CUI [1,2])
C0235031 (UMLS CUI [1,3])
Comorbidity affecting interferon beta therapy
Item
history of any significant cardiac, hepatic, pulmonary, or renal disease; immune deficiency; or other medical conditions that would preclude therapy with interferon beta.
boolean
C0009488 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0854622 (UMLS CUI [1,3])
C0392760 (UMLS CUI [1,2])
C0854622 (UMLS CUI [1,3])
Hypersensitivity to human albumin
Item
history of severe allergic or anaphylactic reactions or history of hypersensitivity to human albumin.
boolean
C0020517 (UMLS CUI [1,1])
C0304925 (UMLS CUI [1,2])
C0304925 (UMLS CUI [1,2])
Seizure
Item
history of seizure within the 3 months prior to enrollment.
boolean
C0036572 (UMLS CUI [1])
Laboratory tests
Item
abnormal laboratory results at the screening visit:
boolean
C0022885 (UMLS CUI [1])
Suicidal ideation or severe depression
Item
history of suicidal ideation or an episode of severe depression within the 3 months prior to enrollment into this study.
boolean
C0424000 (UMLS CUI [1])
C0588008 (UMLS CUI [2])
C0588008 (UMLS CUI [2])
Inclusion or exclusion criteria
Item
other inclusion and exclusion criteria apply as per biogen idec protocol
boolean
C1512693 (UMLS CUI [1])
C0680251 (UMLS CUI [2])
C0680251 (UMLS CUI [2])