ID

30941

Description

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

Link

https://clinicaltrials.gov/show/NCT00751881

Keywords

  1. 7/5/18 7/5/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 5, 2018

DOI

To request one please log in.

License

Creative Commons BY 4.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Multiple Sclerosis NCT00751881

Eligibility Multiple Sclerosis NCT00751881

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
relapsing multiple sclerosis,
Description

Multiple Sclerosis, Acute Relapsing

Data type

boolean

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

Relapse Quantity Timespan

Data type

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

Data type

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

Data type

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

Data type

boolean

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

Substance Use Disorders

Data type

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

Data type

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

Data type

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

Data type

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

Data type

boolean

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

Similar models

Eligibility Multiple Sclerosis NCT00751881

Name
Type
Description | Question | Decode (Coded Value)
Data type
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])

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial