Information:
Error:
ID
12178
Description
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
Keywords
Versions (1)
- 10/7/15 10/7/15 - Julian Varghese
Uploaded on
October 7, 2015
DOI
To request one please log in.
License
Creative Commons BY 4.0
Model comments :
You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.
Itemgroup comments for :
Item comments for :
In order to download data models you must be logged in. Please log in or register for free.
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)
Data type
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])