ID

30941

Description

An Efficacy Study of Teriflunomide in Patients With Relapsing Multiple Sclerosis; ODM derived from: https://clinicaltrials.gov/show/NCT00751881

Lien

https://clinicaltrials.gov/show/NCT00751881

Mots-clés

Versions (1)
  1. 05/07/2018 05/07/2018 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

5 juillet 2018

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
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Eligibility Multiple Sclerosis NCT00751881

Anglais

Eligibility Multiple Sclerosis NCT00751881

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
relapsing multiple sclerosis,
Description

Multiple Sclerosis, Acute Relapsing

Type de données

boolean

Alias
UMLS CUI [1]
C0393664
two relapses in prior 2 years or one relapse in prior year.
Description

Relapse Quantity Timespan

Type de données

boolean

Alias
UMLS CUI [1,1]
C0035020
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0872291
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
clinically relevant cardiovascular, hepatic, neurological, endocrine or other major systemic disease,
Description

Cardiovascular Diseases | Liver diseases | Nervous system disorder | Endocrine System Diseases | Systemic disease Major

Type de données

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0023895
UMLS CUI [3]
C0027765
UMLS CUI [4]
C0014130
UMLS CUI [5,1]
C0442893
UMLS CUI [5,2]
C0205164
significantly impaired bone marrow function or, significant anemia, leukopenia or thrombocytopenia,
Description

Bone Marrow function Impaired | Anemia | Leukopenia | Thrombocytopenia

Type de données

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [1,3]
C0221099
UMLS CUI [2]
C0002871
UMLS CUI [3]
C0023530
UMLS CUI [4]
C0040034
pregnant or nursing woman,
Description

Pregnancy | Breast Feeding

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
alcohol or drug abuse,
Description

Substance Use Disorders

Type de données

boolean

Alias
UMLS CUI [1]
C0038586
prior or concomitant use of cladribine, mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate or mycophenolate,
Description

Cladribine | Mitoxantrone | Immunosuppressive Agents | Azathioprine | Cyclophosphamide | Cyclosporine | Methotrexate | MYCOPHENOLATE

Type de données

boolean

Alias
UMLS CUI [1]
C0092801
UMLS CUI [2]
C0026259
UMLS CUI [3]
C0021081
UMLS CUI [4]
C0004482
UMLS CUI [5]
C0010583
UMLS CUI [6]
C0010592
UMLS CUI [7]
C0025677
UMLS CUI [8]
C0883242
human immunodeficiency virus (hiv) positive,
Description

HIV Seropositivity

Type de données

boolean

Alias
UMLS CUI [1]
C0019699
any known condition or circumstance that would prevent, in the investigator's opinion, compliance or completion of the study.
Description

Condition Preventing Compliance behavior | Condition Preventing Completion of clinical trial

Type de données

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C1321605
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C1292733
UMLS CUI [2,3]
C2732579
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Description

Eligibility Criteria Additional

Type de données

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C1524062
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Similar models

Eligibility Multiple Sclerosis NCT00751881

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Sclerosis, Acute Relapsing
Item
relapsing multiple sclerosis,
boolean
C0393664 (UMLS CUI [1])
Relapse Quantity Timespan
Item
two relapses in prior 2 years or one relapse in prior year.
boolean
C0035020 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0872291 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Cardiovascular Diseases | Liver diseases | Nervous system disorder | Endocrine System Diseases | Systemic disease Major
Item
clinically relevant cardiovascular, hepatic, neurological, endocrine or other major systemic disease,
boolean
C0007222 (UMLS CUI [1])
C0023895 (UMLS CUI [2])
C0027765 (UMLS CUI [3])
C0014130 (UMLS CUI [4])
C0442893 (UMLS CUI [5,1])
C0205164 (UMLS CUI [5,2])
Bone Marrow function Impaired | Anemia | Leukopenia | Thrombocytopenia
Item
significantly impaired bone marrow function or, significant anemia, leukopenia or thrombocytopenia,
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0221099 (UMLS CUI [1,3])
C0002871 (UMLS CUI [2])
C0023530 (UMLS CUI [3])
C0040034 (UMLS CUI [4])
Pregnancy | Breast Feeding
Item
pregnant or nursing woman,
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Substance Use Disorders
Item
alcohol or drug abuse,
boolean
C0038586 (UMLS CUI [1])
Cladribine | Mitoxantrone | Immunosuppressive Agents | Azathioprine | Cyclophosphamide | Cyclosporine | Methotrexate | MYCOPHENOLATE
Item
prior or concomitant use of cladribine, mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate or mycophenolate,
boolean
C0092801 (UMLS CUI [1])
C0026259 (UMLS CUI [2])
C0021081 (UMLS CUI [3])
C0004482 (UMLS CUI [4])
C0010583 (UMLS CUI [5])
C0010592 (UMLS CUI [6])
C0025677 (UMLS CUI [7])
C0883242 (UMLS CUI [8])
HIV Seropositivity
Item
human immunodeficiency virus (hiv) positive,
boolean
C0019699 (UMLS CUI [1])
Condition Preventing Compliance behavior | Condition Preventing Completion of clinical trial
Item
any known condition or circumstance that would prevent, in the investigator's opinion, compliance or completion of the study.
boolean
C0348080 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C1321605 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C2732579 (UMLS CUI [2,3])
Eligibility Criteria Additional
Item
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
boolean
C1516637 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
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