ID

16663

Descripción

Tolerability of Rebif® Injection With and Without the Use of Rebiject™Mini in Relapsing-Remitting Multiple Sclerosis Subjects; ODM derived from: https://clinicaltrials.gov/show/NCT00292253

Link

https://clinicaltrials.gov/show/NCT00292253

Palabras clave

Versiones (1)
  1. 30/7/16 30/7/16 -
Subido en

30 de julio de 2016

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Multiple Sclerosis, Relapsing-remitting NCT00292253

Inglés

Eligibility Multiple Sclerosis, Relapsing-remitting NCT00292253

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
greater than or equal to 18 years of age
Descripción

age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
has relapsing-remitting ms
Descripción

relapsing-remitting ms

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0751967
are willing and able to comply with the protocol for the duration of the study
Descripción

study compliance

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1321605
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
has significant leukopenia/lymphopenia (white blood cell count less than (<) 0.5 times the lower limit of normal)
Descripción

leukopenia/lymphopenia

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0023530
UMLS CUI [1,2]
C0023508
UMLS CUI [2]
C0024312
has elevated liver function tests (aspartate aminotransferase [ast], alanine transaminase [alt], or alkaline phosphatase greater than (>) 2 times the upper limit of normal or total bilirubin > 1.5 times the upper limit of normal)
Descripción

has elevated liver function tests

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
UMLS CUI [3]
C1561546
UMLS CUI [4]
C0201913
has an allergy to human serum albumin or mannitol
Descripción

has an allergy to human serum albumin or mannitol

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0071512
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0024730
had treatment with an investigational product or procedure within 3 months
Descripción

had treatment with an investigational product or procedure within 3 months

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0013230
has the presence of systemic disease or abnormal laboratory findings that might interfere with subject safety, compliance or evaluation of the condition under study
Descripción

systemic disease interfering with study protocol compliance

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
has concomitant use of avonex®, betaseron®, copaxone®, or novantrone®
Descripción

concomitant medication

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0594372
UMLS CUI [2,1]
C2347852
UMLS CUI [2,2]
C0284968
UMLS CUI [3,1]
C2347852
UMLS CUI [3,2]
C0282248
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Similar models

Eligibility Multiple Sclerosis, Relapsing-remitting NCT00292253

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
age
Item
greater than or equal to 18 years of age
boolean
C0001779 (UMLS CUI [1])
relapsing-remitting ms
Item
has relapsing-remitting ms
boolean
C0751967 (UMLS CUI [1])
study compliance
Item
are willing and able to comply with the protocol for the duration of the study
boolean
C1321605 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
leukopenia/lymphopenia
Item
has significant leukopenia/lymphopenia (white blood cell count less than (<) 0.5 times the lower limit of normal)
boolean
C0023530 (UMLS CUI [1,1])
C0023508 (UMLS CUI [1,2])
C0024312 (UMLS CUI [2])
has elevated liver function tests
Item
has elevated liver function tests (aspartate aminotransferase [ast], alanine transaminase [alt], or alkaline phosphatase greater than (>) 2 times the upper limit of normal or total bilirubin > 1.5 times the upper limit of normal)
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C1561546 (UMLS CUI [3])
C0201913 (UMLS CUI [4])
has an allergy to human serum albumin or mannitol
Item
has an allergy to human serum albumin or mannitol
boolean
C0020517 (UMLS CUI [1,1])
C0071512 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0024730 (UMLS CUI [2,2])
had treatment with an investigational product or procedure within 3 months
Item
had treatment with an investigational product or procedure within 3 months
boolean
C1514463 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
systemic disease interfering with study protocol compliance
Item
has the presence of systemic disease or abnormal laboratory findings that might interfere with subject safety, compliance or evaluation of the condition under study
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
concomitant medication
Item
has concomitant use of avonex®, betaseron®, copaxone®, or novantrone®
boolean
C2347852 (UMLS CUI [1,1])
C0594372 (UMLS CUI [1,2])
C2347852 (UMLS CUI [2,1])
C0284968 (UMLS CUI [2,2])
C2347852 (UMLS CUI [3,1])
C0282248 (UMLS CUI [3,2])
Volver a la parte superior de la página 

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