Informações:
Falhas:
ID
39635
Descrição
Efficacy, Safety, and Tolerability of Plovamer Acetate (Pathway 1); ODM derived from: https://clinicaltrials.gov/show/NCT01963611
Link
https://clinicaltrials.gov/show/NCT01963611
Palavras-chave
Versões (2)
- 19/01/2019 19/01/2019 -
- 06/02/2020 06/02/2020 - Christian Arras
Titular dos direitos
EMD Serono
Transferido a
6 de fevereiro de 2020
DOI
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Licença
Creative Commons BY-NC 3.0
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Eligibility Relapsing Remitting Multiple Sclerosis NCT01963611
Eligibility Relapsing Remitting Multiple Sclerosis NCT01963611
- StudyEvent: Eligibility
Similar models
Eligibility Relapsing Remitting Multiple Sclerosis NCT01963611
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Gender, Age
Item
male or female, between the ages of 18 and 60 years
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0001779 (UMLS CUI [2])
Subcutaneous injections, self-administration, ability | administration procedure, caregiver
Item
subject is able to learn and self-administer subcutaneous injections or a care-giver may be trained to inject the subject
boolean
C0021499 (UMLS CUI [1,1])
C0036589 (UMLS CUI [1,2])
C0085732 (UMLS CUI [1,3])
C0021499 (UMLS CUI [2,1])
C1533734 (UMLS CUI [2,2])
C0085537 (UMLS CUI [2,3])
C0036589 (UMLS CUI [1,2])
C0085732 (UMLS CUI [1,3])
C0021499 (UMLS CUI [2,1])
C1533734 (UMLS CUI [2,2])
C0085537 (UMLS CUI [2,3])
Relapsing remitting multiple sclerosis, current diagnosis, McDonald diagnostic criteria
Item
subjects must have a current diagnosis of relapsing remitting multiple sclerosis (rrms) (according to the 2010 mcdonald ms diagnostic criteria)
boolean
C0751967 (UMLS CUI [1,1])
C0679228 (UMLS CUI [1,2])
C0679228 (UMLS CUI [1,2])
Inclusion criteria, Study protocol
Item
other protocol defined inclusion criteria could apply
boolean
C1512693 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,2])
Multiple Sclerosis Primary Progressive, Multiple Sclerosis Secondary Progressive, Multiple Sclerosis Progressive Relapsing
Item
any multiple sclerosis categorized as primary progressive, secondary progressive or progressive relapsing
boolean
C0751964 (UMLS CUI [1])
C0751965 (UMLS CUI [2])
C0393666 (UMLS CUI [3])
C0751965 (UMLS CUI [2])
C0393666 (UMLS CUI [3])
Hypersensitivity, Mannitol, Plovamer acetate, Copaxone, Gadolinium
Item
allergy to mannitol, plovamer acetate, copaxone (glatiramer acetate), gd contrast for mri
boolean
C0020517 (UMLS CUI [1,1])
C0024730 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C3272845 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0528175 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0016911 (UMLS CUI [4,2])
C0024730 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C3272845 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0528175 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0016911 (UMLS CUI [4,2])
Glucocorticoid therapy, Clinical trial period
Item
any requirement for continuous systemic glucocorticoid administration during the trial period.
boolean
C0744425 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
C0205373 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
Contraindiction Copaxone
Item
contraindication to copaxone use
boolean
C1301624 (UMLS CUI [1,1])
C0528175 (UMLS CUI [1,2])
C0528175 (UMLS CUI [1,2])
Exclusion criteria
Item
other protocol defined exclusion criteria could apply
boolean
C0680251 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,2])