Information:
Fel:
ID
15301
Beskrivning
Safety and Efficacy of Teriflunomide (HMR1726) in Multiple Sclerosis With Relapses; ODM derived from: https://clinicaltrials.gov/show/NCT01487096
Länk
https://clinicaltrials.gov/show/NCT01487096
Nyckelord
Versioner (1)
- 2016-05-25 2016-05-25 -
Uppladdad den
25 maj 2016
DOI
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Licens
Creative Commons BY 4.0
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Eligibility Multiple Sclerosis NCT01487096
Eligibility Multiple Sclerosis NCT01487096
- StudyEvent: Eligibility
Similar models
Eligibility Multiple Sclerosis NCT01487096
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
MS
Item
clinically confirmed multiple sclerosis [ms];
boolean
C0026769 (UMLS CUI [1])
edss
Item
expanded disability status scale [edss] score less or equal to 6;
boolean
C0451246 (UMLS CUI [1])
two documented relapses
Item
two documented relapses in the previous 3 years, and one clinical relapse during the preceding year;
boolean
C0277556 (UMLS CUI [1])
MRI
Item
screening magnetic resonance imaging [mri] scan fulfilling the criteria for a diagnosis of ms.
boolean
C0024485 (UMLS CUI [1])
comorbidity
Item
clinically relevant cardiovascular, hepatic, hematologic, neurological, endocrine or other major systemic disease;
boolean
C0009488 (UMLS CUI [1])
pregnant or nursing woman
Item
pregnant or nursing woman;
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0006147 (UMLS CUI [2])
contraceptive use
Item
wish to parent children during the trial or following the trial (men and women were required to practice effective contraception during the trial and for 24 months after drug discontinuation);
boolean
C1999124 (UMLS CUI [1])
pharmaceutical preparations
Item
prior treatment with interferon [ifn], gamma-globulin, glatiramer acetate, or other noncorticosteroid immunomodulatory therapies in the 4 months prior to the trial;
boolean
C0279030 (UMLS CUI [1])
C0860681 (UMLS CUI [2])
C0289884 (UMLS CUI [3])
C1963758 (UMLS CUI [4])
C0860681 (UMLS CUI [2])
C0289884 (UMLS CUI [3])
C1963758 (UMLS CUI [4])
immunosuppressant agents
Item
use of cladribine, mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate or mycophenolate before enrollment;
boolean
C0021081 (UMLS CUI [1])
comorbidity limiting compliance behavior
Item
any known condition or circumstance that would prevent in the investigator's opinion compliance or completion of the study.
boolean
C0009488 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C1321605 (UMLS CUI [1,3])
C0439801 (UMLS CUI [1,2])
C1321605 (UMLS CUI [1,3])
not intended to contain all considerations
Item
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
boolean