Informações:
Falhas:
ID
36517
Descrição
Observational Study of Rebismart®2.0 + MSdialog™ in Subjects With Remitting Multiple Sclerosis (ADHERQOL); ODM derived from: https://clinicaltrials.gov/show/NCT02394782
Link
https://clinicaltrials.gov/show/NCT02394782
Palavras-chave
Versões (1)
- 19/05/2019 19/05/2019 -
Titular dos direitos
See clinicaltrials.gov
Transferido a
19 de maio de 2019
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Multiple Sclerosis, Relapsing-remitting NCT02394782
Eligibility Multiple Sclerosis, Relapsing-remitting NCT02394782
- StudyEvent: Eligibility
Similar models
Eligibility Multiple Sclerosis, Relapsing-remitting NCT02394782
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Multiple Sclerosis, Relapsing-Remitting
Item
diagnosed with rrms according to mcdonald criteria 2010
boolean
C0751967 (UMLS CUI [1])
Relapse Free of
Item
relapse free within 30 days before baseline data collection
boolean
C0035020 (UMLS CUI [1,1])
C0332296 (UMLS CUI [1,2])
C0332296 (UMLS CUI [1,2])
Rebif
Item
treatment with rebif for 6 months or more prior to informed consent
boolean
C0752980 (UMLS CUI [1])
Other Coding | Patient Reported Outcome Assessment
Item
already using rebismart®2.0 + msdialog™ for patient reported outcome (pro) assessments (at least once prior to informed consent)
boolean
C3846158 (UMLS CUI [1])
C2987124 (UMLS CUI [2,1])
C1516048 (UMLS CUI [2,2])
C2987124 (UMLS CUI [2,1])
C1516048 (UMLS CUI [2,2])
Childbearing Potential Contraceptive methods
Item
females of childbearing potential must be willing to use appropriate contraception for the duration of the study
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,2])
EDSS
Item
edss score less than (<) 6
boolean
C0451246 (UMLS CUI [1])
Informed Consent
Item
written informed consent obtained prior to any protocol-required data collection
boolean
C0021430 (UMLS CUI [1])
Study Subject Participation Status
Item
participation in other studies within 30 days before baseline
boolean
C2348568 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
female who is pregnant or breast feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0006147 (UMLS CUI [2])
Psychiatric symptom Impact Treatment Compliance
Item
significant psychiatric symptoms that, in the opinion of the investigator, would impact subject ability to comply with treatment (as per standard clinical practice)
boolean
C0233401 (UMLS CUI [1,1])
C4049986 (UMLS CUI [1,2])
C4319828 (UMLS CUI [1,3])
C4049986 (UMLS CUI [1,2])
C4319828 (UMLS CUI [1,3])
Medical contraindication Interferon beta-1a
Item
any contraindication for interferon (ifn) beta-1a therapy as per summary of product characteristics (spc)
boolean
C1301624 (UMLS CUI [1,1])
C0254119 (UMLS CUI [1,2])
C0254119 (UMLS CUI [1,2])
Therapy Multiple Sclerosis | Exception Rebif
Item
administration of any multiple sclerosis (ms) therapy, other than rebif, within 6 months prior to informed consent
boolean
C0087111 (UMLS CUI [1,1])
C0026769 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0752980 (UMLS CUI [2,2])
C0026769 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0752980 (UMLS CUI [2,2])