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ID
12178
Beschrijving
Vaccination Response in Tecfidera-Treated Versus Interferon-Treated Participants With Relapsing Forms of Multiple Sclerosis.; ODM derived from: https://clinicaltrials.gov/show/NCT02097849
Link
https://clinicaltrials.gov/show/NCT02097849
Trefwoorden
Versies (1)
- 07-10-15 07-10-15 - Julian Varghese
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7 oktober 2015
DOI
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Licentie
Creative Commons BY 4.0
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Eligibility Relapsing Forms of Multiple Sclerosis NCT02097849
Eligibility Relapsing Forms of Multiple Sclerosis NCT02097849
- StudyEvent: Eligibility
Similar models
Eligibility Relapsing Forms of Multiple Sclerosis NCT02097849
- StudyEvent: Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
confirmed diagnosis of rrms
Item
must have a confirmed diagnosis of rrms per the 2010 mcdonald criteria.
boolean
C0751967 (UMLS CUI [1])
tetanus immunization
Item
must have a known tetanus immunization history with most recent tetanus vaccination given 2 to 15 years prior to screening and an anti-tetanus igg titer at screening that is less than or equal to one-half the upper limit of detection for the assay.
boolean
C0199807 (UMLS CUI [1])
C0305058 (UMLS CUI [2])
C0305058 (UMLS CUI [2])
Tecfidera | Avonex | Betaseron | Rebif | Extavia
Item
must have been on a stable approved dose of tecfidera (240 mg twice daily [bid]) [group 1] for ≥6 months or on a stable approved dose of a non-pegylated ifn (e.g., avonex, betaseron, rebif, extavia) [group 2] for ≥3 months prior to day 1.
boolean
C3556178 (UMLS CUI [1])
C0594372 (UMLS CUI [2])
C0284968 (UMLS CUI [3])
C0752980 (UMLS CUI [4])
C2719461 (UMLS CUI [5])
C0594372 (UMLS CUI [2])
C0284968 (UMLS CUI [3])
C0752980 (UMLS CUI [4])
C2719461 (UMLS CUI [5])
clinical relapse requiring treatment
Item
clinical relapse requiring treatment within 30 days prior to day 1.
boolean
C0856120 (UMLS CUI [1,1])
C0815189 (UMLS CUI [1,2])
C0815189 (UMLS CUI [1,2])
pneumococcal vaccination; screening
Item
pneumococcal vaccination within 5 years prior to screening.
boolean
C0419707 (UMLS CUI [1])
meningococcal vaccines; exposure
Item
previous exposure to meningococcal vaccines.
boolean
C0700144 (UMLS CUI [1])
C0332157 (UMLS CUI [2])
C0332157 (UMLS CUI [2])
hypersensitivity to td, ppsv23, or mcv4 or their components.
Item
known hypersensitivity to td, ppsv23, or mcv4 or their components.
boolean
C0020517 (UMLS CUI [1,1])
C3272755 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0358314 (UMLS CUI [2,2])
C3272755 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0358314 (UMLS CUI [2,2])
other protocol-defined inclusion/exclusion criteria may apply
Item
note: other protocol-defined inclusion/exclusion criteria may apply.
boolean
C2827031 (UMLS CUI [1])