ID

34549

Beschreibung

Efficacy, Safety, and Tolerability of Plovamer Acetate (Pathway 1); ODM derived from: https://clinicaltrials.gov/show/NCT01963611

Link

https://clinicaltrials.gov/show/NCT01963611

Stichworte

  1. 19.01.19 19.01.19 -
  2. 06.02.20 06.02.20 - Christian Arras
Rechteinhaber

see on clinicaltrials.gov

Hochgeladen am

19. Januar 2019

DOI

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Lizenz

Creative Commons BY-NC 3.0

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Eligibility Relapsing Remitting Multiple Sclerosis NCT01963611

Eligibility Relapsing Remitting Multiple Sclerosis NCT01963611

Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female, between the ages of 18 and 60 years
Beschreibung

ID.1

Datentyp

boolean

subject is able to learn and self-administer subcutaneous injections (a care-giver may be trained to inject the subject)
Beschreibung

ID.2

Datentyp

boolean

subjects must have a current diagnosis of relapsing remitting multiple sclerosis (rrms) (according to the 2010 mcdonald ms diagnostic criteria)
Beschreibung

ID.3

Datentyp

boolean

other protocol defined inclusion criteria could apply
Beschreibung

ID.4

Datentyp

boolean

Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
any multiple sclerosis categorized as primary progressive, secondary progressive or progressive relapsing
Beschreibung

ID.5

Datentyp

boolean

allergy to mannitol, plovamer acetate, copaxone (glatiramer acetate), gd contrast for mri
Beschreibung

ID.6

Datentyp

boolean

any requirement for continuous systemic glucocorticoid administration during the trial period. (note: treatment with interferons such as avonex®, rebif®, or betaseron® will be allowed until the baseline visit, as no wash-out period is needed)
Beschreibung

ID.7

Datentyp

boolean

contraindication to copaxone use
Beschreibung

ID.8

Datentyp

boolean

other protocol defined exclusion criteria could apply
Beschreibung

ID.9

Datentyp

boolean

Ähnliche Modelle

Eligibility Relapsing Remitting Multiple Sclerosis NCT01963611

Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
male or female, between the ages of 18 and 60 years
boolean
ID.2
Item
subject is able to learn and self-administer subcutaneous injections (a care-giver may be trained to inject the subject)
boolean
ID.3
Item
subjects must have a current diagnosis of relapsing remitting multiple sclerosis (rrms) (according to the 2010 mcdonald ms diagnostic criteria)
boolean
ID.4
Item
other protocol defined inclusion criteria could apply
boolean
Item Group
C0680251 (UMLS CUI)
ID.5
Item
any multiple sclerosis categorized as primary progressive, secondary progressive or progressive relapsing
boolean
ID.6
Item
allergy to mannitol, plovamer acetate, copaxone (glatiramer acetate), gd contrast for mri
boolean
ID.7
Item
any requirement for continuous systemic glucocorticoid administration during the trial period. (note: treatment with interferons such as avonex®, rebif®, or betaseron® will be allowed until the baseline visit, as no wash-out period is needed)
boolean
ID.8
Item
contraindication to copaxone use
boolean
ID.9
Item
other protocol defined exclusion criteria could apply
boolean

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