ID

14654

Description

Does Quality of Life Improve in Multiple Sclerosis Patients Treated With Interferon Beta-1a?; ODM derived from: https://clinicaltrials.gov/show/NCT00534261

Link

https://clinicaltrials.gov/show/NCT00534261

Keywords

  1. 4/25/16 4/25/16 -
Uploaded on

April 25, 2016

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 Relapsing Remitting Multiple Sclerosis NCT00534261

Eligibility Relapsing Remitting Multiple Sclerosis NCT00534261

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
relapsing remitting multiple sclerosis
Description

Relapsing remitting multiple sclerosis

Data type

boolean

Alias
UMLS CUI [1]
C0751967
interferon naïve
Description

Interferon naïve

Data type

boolean

Alias
UMLS CUI [1,1]
C0332155
UMLS CUI [1,2]
C0751599
eligible for interferon beta-1a (avonex®) therapy as per summary of product characteristics:
Description

Eligble for interferon beta

Data type

boolean

Alias
UMLS CUI [1,1]
C0751599
UMLS CUI [1,2]
C0013893
subject has had relapsing ms for > 1 year
Description

Date of relapse

Data type

boolean

Alias
UMLS CUI [1]
C0807712
subject has had experienced 2 exacerbations in the last 2 years
Description

MS exacerbation

Data type

boolean

Alias
UMLS CUI [1]
C0581392
subject had an edss [5] score of < 5.5
Description

EDSS score

Data type

boolean

Alias
UMLS CUI [1]
C0451246
subject was ambulant
Description

Ambulant patient

Data type

boolean

Alias
UMLS CUI [1]
C0029921
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
diagnosis of ms defined as progressive
Description

Progressive MS

Data type

boolean

Alias
UMLS CUI [1]
C0751964
history of any significant cardiac, hepatic, pulmonary, or renal disease; immune deficiency; or other medical conditions that would preclude therapy with interferon beta
Description

Comorbidity affecting Interferon beta therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0751599
history of severe allergic or anaphylactic reactions or history of hypersensitivity to human albumin
Description

Allergy to human albumin

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0304925
history of seizures within the 3 months prior to starting this study
Description

Seizure

Data type

boolean

Alias
UMLS CUI [1]
C0036572
history of intolerance to acetaminophen (paracetamol), ibuprofen, naproxen or other nsaids, that would preclude use of at least one of these during the study
Description

Drug intolerance

Data type

boolean

Alias
UMLS CUI [1]
C0277585
history of intolerance to interferons
Description

Intolerance to interferons

Data type

boolean

Alias
UMLS CUI [1,1]
C0277585
UMLS CUI [1,2]
C0751599
previous use of interferon beta
Description

Previous therapy with interferon beta

Data type

boolean

Alias
UMLS CUI [1,1]
C0751599
UMLS CUI [1,2]
C2114510
female subjects who were pregnant or breast-feeding
Description

Gynaecological status

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
for female subjects, unless postmenopausal or surgically sterile, unwillingness to practice effective contraception
Description

Contraception

Data type

boolean

Alias
UMLS CUI [1]
C0700589

Similar models

Eligibility Relapsing Remitting Multiple Sclerosis NCT00534261

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Relapsing remitting multiple sclerosis
Item
relapsing remitting multiple sclerosis
boolean
C0751967 (UMLS CUI [1])
Interferon naïve
Item
interferon naïve
boolean
C0332155 (UMLS CUI [1,1])
C0751599 (UMLS CUI [1,2])
Eligble for interferon beta
Item
eligible for interferon beta-1a (avonex®) therapy as per summary of product characteristics:
boolean
C0751599 (UMLS CUI [1,1])
C0013893 (UMLS CUI [1,2])
Date of relapse
Item
subject has had relapsing ms for > 1 year
boolean
C0807712 (UMLS CUI [1])
MS exacerbation
Item
subject has had experienced 2 exacerbations in the last 2 years
boolean
C0581392 (UMLS CUI [1])
EDSS score
Item
subject had an edss [5] score of < 5.5
boolean
C0451246 (UMLS CUI [1])
Ambulant patient
Item
subject was ambulant
boolean
C0029921 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Progressive MS
Item
diagnosis of ms defined as progressive
boolean
C0751964 (UMLS CUI [1])
Comorbidity affecting Interferon beta therapy
Item
history of any significant cardiac, hepatic, pulmonary, or renal disease; immune deficiency; or other medical conditions that would preclude therapy with interferon beta
boolean
C0009488 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0751599 (UMLS CUI [1,3])
Allergy to human albumin
Item
history of severe allergic or anaphylactic reactions or history of hypersensitivity to human albumin
boolean
C0020517 (UMLS CUI [1,1])
C0304925 (UMLS CUI [1,2])
Seizure
Item
history of seizures within the 3 months prior to starting this study
boolean
C0036572 (UMLS CUI [1])
Drug intolerance
Item
history of intolerance to acetaminophen (paracetamol), ibuprofen, naproxen or other nsaids, that would preclude use of at least one of these during the study
boolean
C0277585 (UMLS CUI [1])
Intolerance to interferons
Item
history of intolerance to interferons
boolean
C0277585 (UMLS CUI [1,1])
C0751599 (UMLS CUI [1,2])
Previous therapy with interferon beta
Item
previous use of interferon beta
boolean
C0751599 (UMLS CUI [1,1])
C2114510 (UMLS CUI [1,2])
Gynaecological status
Item
female subjects who were pregnant or breast-feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Contraception
Item
for female subjects, unless postmenopausal or surgically sterile, unwillingness to practice effective contraception
boolean
C0700589 (UMLS CUI [1])

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