ID

18292

Descripción

Efficacy and Safety of FTY720 in Patients With Relapsing Multiple Sclerosis; ODM derived from: https://clinicaltrials.gov/show/NCT00333138

Link

https://clinicaltrials.gov/show/NCT00333138

Palabras clave

Versiones (1)
  1. 28/10/16 28/10/16 -
Subido en

28 de octubre de 2016

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Multiple Sclerosis NCT00333138

Inglés

Eligibility Multiple Sclerosis NCT00333138

1 formularios  
Criteria
Descripción

Criteria

Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of relapsing multiple sclerosis (ms)
Descripción

Multiple Sclerosis, Acute Relapsing

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0393664
patients with at least two documented relapses in the previous 2 years or one documented relapse in the last year
Descripción

Relapse Quantity Period

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0035020
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C1948053
patients with an expanded disability status scale (edss) score of 0-6
Descripción

EDSS

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0451246
extension study
Descripción

Extension Clinical Trial

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0231448
UMLS CUI [1,2]
C0008976
a positive gd-enhanced mri scan at screening (in case the first mri scan obtained at screening was negative, a second scan could have been obtained 1 month later)
Descripción

Nuclear magnetic resonance imaging gadolinium-enhanced Positive | Magnetic Resonance Imaging

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0855566
UMLS CUI [1,2]
C1514241
UMLS CUI [2]
C0024485
neurologically stable with no evidence of relapse within 30 days prior to randomization,or during the screening and baseline periods.
Descripción

Neurologic Stable | Relapse Evidence

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0205494
UMLS CUI [1,2]
C0205360
UMLS CUI [2,1]
C0035020
UMLS CUI [2,2]
C3887511
female patients either post-menopausal, surgically incapable of bearing children, or practicing an acceptable method of birth control. females of childbearing potential with a negative pregnancy test at baseline prior to entry into the treatment period.
Descripción

Gender | Postmenopausal state | Female Sterilization | Contraceptive methods | Childbearing Potential Pregnancy test negative

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0232970
UMLS CUI [3]
C0015787
UMLS CUI [4]
C0700589
UMLS CUI [5,1]
C3831118
UMLS CUI [5,2]
C0427780
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
core study
Descripción

Clinical Trial Main

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C1542147
patients with other chronic disease of the immune system, malignancies, pulmonary or heart disease, etc
Descripción

Chronic disease of immune system | Malignant Neoplasms | Lung diseases | Heart Diseases

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1290894
UMLS CUI [2]
C0006826
UMLS CUI [3]
C0024115
UMLS CUI [4]
C0018799
pregnant or nursing women
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
extension study
Descripción

Extension Clinical Trial

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0231448
UMLS CUI [1,2]
C0008976
patients who had permanently discontinued study drug prior to the month 6 visit of the core study
Descripción

Investigational New Drug Discontinued Permanent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C1444662
UMLS CUI [1,3]
C0205355
patients with diabetes mellitus (to reduce the risk of me), and therefore ongoing patients with diabetes mellitus or who developed diabetes mellitus were discontinued from the study)
Descripción

Diabetes Mellitus

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011849
other protocol-defined inclusion/exclusion criteria may apply
Descripción

Clinical Trial Eligibility Criteria Study Protocol

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348563
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Similar models

Eligibility Multiple Sclerosis NCT00333138

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Item Group
C1512693 (UMLS CUI)
Multiple Sclerosis, Acute Relapsing
Item
diagnosis of relapsing multiple sclerosis (ms)
boolean
C0393664 (UMLS CUI [1])
Relapse Quantity Period
Item
patients with at least two documented relapses in the previous 2 years or one documented relapse in the last year
boolean
C0035020 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1948053 (UMLS CUI [1,3])
EDSS
Item
patients with an expanded disability status scale (edss) score of 0-6
boolean
C0451246 (UMLS CUI [1])
Extension Clinical Trial
Item
extension study
boolean
C0231448 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
Nuclear magnetic resonance imaging gadolinium-enhanced Positive | Magnetic Resonance Imaging
Item
a positive gd-enhanced mri scan at screening (in case the first mri scan obtained at screening was negative, a second scan could have been obtained 1 month later)
boolean
C0855566 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
C0024485 (UMLS CUI [2])
Neurologic Stable | Relapse Evidence
Item
neurologically stable with no evidence of relapse within 30 days prior to randomization,or during the screening and baseline periods.
boolean
C0205494 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0035020 (UMLS CUI [2,1])
C3887511 (UMLS CUI [2,2])
Gender | Postmenopausal state | Female Sterilization | Contraceptive methods | Childbearing Potential Pregnancy test negative
Item
female patients either post-menopausal, surgically incapable of bearing children, or practicing an acceptable method of birth control. females of childbearing potential with a negative pregnancy test at baseline prior to entry into the treatment period.
boolean
C0079399 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
C0015787 (UMLS CUI [3])
C0700589 (UMLS CUI [4])
C3831118 (UMLS CUI [5,1])
C0427780 (UMLS CUI [5,2])
Item Group
C0680251 (UMLS CUI)
Clinical Trial Main
Item
core study
boolean
C0008976 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Chronic disease of immune system | Malignant Neoplasms | Lung diseases | Heart Diseases
Item
patients with other chronic disease of the immune system, malignancies, pulmonary or heart disease, etc
boolean
C1290894 (UMLS CUI [1])
C0006826 (UMLS CUI [2])
C0024115 (UMLS CUI [3])
C0018799 (UMLS CUI [4])
Pregnancy | Breast Feeding
Item
pregnant or nursing women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Extension Clinical Trial
Item
extension study
boolean
C0231448 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
Investigational New Drug Discontinued Permanent
Item
patients who had permanently discontinued study drug prior to the month 6 visit of the core study
boolean
C0013230 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0205355 (UMLS CUI [1,3])
Diabetes Mellitus
Item
patients with diabetes mellitus (to reduce the risk of me), and therefore ongoing patients with diabetes mellitus or who developed diabetes mellitus were discontinued from the study)
boolean
C0011849 (UMLS CUI [1])
Clinical Trial Eligibility Criteria Study Protocol
Item
other protocol-defined inclusion/exclusion criteria may apply
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
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