ID

4954

Description

ODM derived from http://clinicaltrials.gov/show/NCT00459667

Lien

http://clinicaltrials.gov/show/NCT00459667

Mots-clés

  1. 09/12/2013 09/12/2013 - Martin Dugas
  2. 15/04/2014 15/04/2014 - Julian Varghese
  3. 20/09/2021 20/09/2021 -
Téléchargé le

15 avril 2014

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0

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Eligibility NCT00459667 Multiple Sclerosis, Relapsing-Remitting

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
age 18 Years to 55 Years
Description

age 18 Years to 55 Years

Type de données

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Completion of the BEYOND study 306440 as scheduled
Description

Completion of the BEYOND study 306440 as scheduled

Type de données

boolean

Alias
UMLS CUI 2011AA
C1554962
HL7 V3 2006_05
C
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0086960
Relapsing multiple sclerosis
Description

Relapsing multiple sclerosis

Type de données

boolean

Alias
UMLS CUI 2011AA
C0751967
SNOMED CT 2011_0131
426373005
MedDRA 14.1
10063399
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
Medical assessment by the investigator that there is no objection to the patient's participation in this trial considering the medical experience from study 306440. Special attention should be given to laboratory abnormalities and clinically relevant liver, renal and bone-marrow dysfunction.
Description

Medical assessment by the investigator that there is no objection to the patient's participation in this trial considering the medical experience from study 306440. Special attention should be given to laboratory abnormalities and clinically relevant liver, renal and bone-marrow dysfunction.

Type de données

boolean

Alias
UMLS CUI 2011AA
C0582103
SNOMED CT 2011_0131
225886003
UMLS CUI 2011AA
CL102947
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C1299586
SNOMED CT 2011_0131
52925006
UMLS CUI 2011AA
C0030705
SNOMED CT 2011_0131
116154003
UMLS CUI 2011AA
C0679823
HL7 V3 2006_05
PART
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0205476
SNOMED CT 2011_0131
74188005
UMLS CUI 2011AA
C0596545
UMLS CUI 2011AA
C0022877
SNOMED CT 2011_0131
261904005
LOINC Version 232
MTHU029808
UMLS CUI 2011AA
C1704258
UMLS CUI 2011AA
C0205210
SNOMED CT 2011_0131
58147004
UMLS CUI 2011AA
C2347946
UMLS CUI 2011AA
C0086565
SNOMED CT 2011_0131
75183008
MedDRA 14.1
10019670
UMLS CUI 2011AA
C1848822
UMLS CUI 2011AA
C0005953
SNOMED CT 2011_0131
14016003
LOINC Version 232
MTHU016536
UMLS CUI 2011AA
C0277785
SNOMED CT 2011_0131
386585008
Females of child-bearing potential:
Description

Females of child-bearing potential:

Type de données

boolean

Alias
UMLS CUI 2011AA
C0015780
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C1148523
UMLS CUI 2011AA
C0237399
Agreement to practice adequate contraception methods and
Description

Agreement to practice adequate contraception methods and

Type de données

boolean

Alias
UMLS CUI 2011AA
C0680240
UMLS CUI 2011AA
C0032893
UMLS CUI 2011AA
C0205411
SNOMED CT 2011_0131
88323005
UMLS CUI 2011AA
C0700589
SNOMED CT 2011_0131
146680009
MedDRA 14.1
10010808
UMLS CUI 2011AA
C0025663
SNOMED CT 2011_0131
260686004
LOINC Version 232
MTHU024654
Negative Pregnancy Test
Description

Negative pregnancy test and

Type de données

boolean

Alias
UMLS CUI 2011AA
C0427780
SNOMED CT 2011_0131
250425007
MedDRA 14.1
10036574
No lactation
Description

No lactation

Type de données

boolean

Alias
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0006147
MedDRA 14.1
10006247
Written informed consent
Description

Written informed consent

Type de données

boolean

Alias
UMLS CUI 2011AA
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
Serious or acute heart diseases
Description

Serious or acute heart diseases

Type de données

boolean

Alias
UMLS CUI 2011AA
C0205404
SNOMED CT 2011_0131
42745003
UMLS CUI 2011AA
C0018799
SNOMED CT 2011_0131
56265001
MedDRA 14.1
10061024
ICD-10-CM Version 2010
I51.9
ICD-9-CM Version 2011
429.9
UMLS CUI 2011AA
C1290838
SNOMED CT 2011_0131
127337006
History of severe depression or suicide attempt
Description

History of severe depression or suicide attempt

Type de données

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0588008
SNOMED CT 2011_0131
310497006
UMLS CUI 2011AA
C0038663
SNOMED CT 2011_0131
82313006
MedDRA 14.1
10042464
ICD-10-CM Version 2010
T14.91
CTCAE 1105E
E12969
Epilepsy not adequately controlled by treatment
Description

Epilepsy not adequately controlled by treatment

Type de données

boolean

Alias
UMLS CUI 2011AA
C0014544
SNOMED CT 2011_0131
84757009
MedDRA 14.1
10015037
LOINC Version 232
MTHU020586
ICD-10-CM Version 2010
G40.9
ICD-9-CM Version 2011
345.9
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0205411
SNOMED CT 2011_0131
88323005
UMLS CUI 2011AA
C2587213
SNOMED CT 2011_0131
31509003
UMLS CUI 2011AA
C0039798
Known allergy to IFNs, to human albumin or to mannitol
Description

Known allergy to IFNs, to human albumin or to mannitol

Type de données

boolean

Alias
UMLS CUI 2011AA
C0020517
SNOMED CT 2011_0131
257550005
ICD-10-CM Version 2010
T78.40
UMLS CUI 2011AA
C0021747
SNOMED CT 2011_0131
49327004
LOINC Version 232
MTHU021353
UMLS CUI 2011AA
C0086418
SNOMED CT 2011_0131
278412004
UMLS CUI 2011AA
C0001924
SNOMED CT 2011_0131
52454007
LOINC Version 232
MTHU001929
UMLS CUI 2011AA
C0024730
SNOMED CT 2011_0131
387168006
LOINC Version 232
MTHU015736
Medical, psychiatric or other conditions that compromise the patient's ability to understand the patient information, to give informed consent, to comply with the trial protocol, or to complete the study
Description

Medical, psychiatric or other conditions that compromise the patient's ability to understand the patient information, to give informed consent, to comply with the trial protocol, or to complete the study

Type de données

boolean

Alias
UMLS CUI 2011AA
C0205476
SNOMED CT 2011_0131
74188005
UMLS CUI 2011AA
C0205487
SNOMED CT 2011_0131
27296002
LOINC Version 232
MTHU002618
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0348080
SNOMED CT 2011_0131
260905004
HL7 V3 2006_05
COND
UMLS CUI 2011AA
C0221099
SNOMED CT 2011_0131
260379002
UMLS CUI 2011AA
C0030705
SNOMED CT 2011_0131
116154003
UMLS CUI 2011AA
C1273101
SNOMED CT 2011_0131
395659009
UMLS CUI 2011AA
C1955348
LOINC Version 232
MTHU029792
UMLS CUI 2011AA
C1999230
UMLS CUI 2011AA
C0021430
UMLS CUI 2011AA
C0525058
UMLS CUI 2011AA
C1554962
HL7 V3 2006_05
C
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008

Similar models

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Inclusion Criteria
CL425202 (UMLS CUI 2011AA)
age 18 Years to 55 Years
Item
age 18 Years to 55 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Completion of the BEYOND study 306440 as scheduled
Item
Completion of the BEYOND study 306440 as scheduled
boolean
C1554962 (UMLS CUI 2011AA)
C (HL7 V3 2006_05)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0086960 (UMLS CUI 2011AA)
Relapsing multiple sclerosis
Item
Relapsing multiple sclerosis
boolean
C0751967 (UMLS CUI 2011AA)
426373005 (SNOMED CT 2011_0131)
10063399 (MedDRA 14.1)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
Medical assessment by the investigator that there is no objection to the patient's participation in this trial considering the medical experience from study 306440. Special attention should be given to laboratory abnormalities and clinically relevant liver, renal and bone-marrow dysfunction.
Item
Medical assessment by the investigator that there is no objection to the patient's participation in this trial considering the medical experience from study 306440. Special attention should be given to laboratory abnormalities and clinically relevant liver, renal and bone-marrow dysfunction.
boolean
C0582103 (UMLS CUI 2011AA)
225886003 (SNOMED CT 2011_0131)
CL102947 (UMLS CUI 2011AA)
C1518422 (UMLS CUI 2011AA)
C1299586 (UMLS CUI 2011AA)
52925006 (SNOMED CT 2011_0131)
C0030705 (UMLS CUI 2011AA)
116154003 (SNOMED CT 2011_0131)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0205476 (UMLS CUI 2011AA)
74188005 (SNOMED CT 2011_0131)
C0596545 (UMLS CUI 2011AA)
C0022877 (UMLS CUI 2011AA)
261904005 (SNOMED CT 2011_0131)
MTHU029808 (LOINC Version 232)
C1704258 (UMLS CUI 2011AA)
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C2347946 (UMLS CUI 2011AA)
C0086565 (UMLS CUI 2011AA)
75183008 (SNOMED CT 2011_0131)
10019670 (MedDRA 14.1)
C1848822 (UMLS CUI 2011AA)
C0005953 (UMLS CUI 2011AA)
14016003 (SNOMED CT 2011_0131)
MTHU016536 (LOINC Version 232)
C0277785 (UMLS CUI 2011AA)
386585008 (SNOMED CT 2011_0131)
Females of child-bearing potential:
Item
Females of child-bearing potential:
boolean
C0015780 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
Agreement to practice adequate contraception methods and
Item
Agreement to practice adequate contraception methods and
boolean
C0680240 (UMLS CUI 2011AA)
C0032893 (UMLS CUI 2011AA)
C0205411 (UMLS CUI 2011AA)
88323005 (SNOMED CT 2011_0131)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
C0025663 (UMLS CUI 2011AA)
260686004 (SNOMED CT 2011_0131)
MTHU024654 (LOINC Version 232)
Negative pregnancy test and
Item
Negative Pregnancy Test
boolean
C0427780 (UMLS CUI 2011AA)
250425007 (SNOMED CT 2011_0131)
10036574 (MedDRA 14.1)
No lactation
Item
No lactation
boolean
C1518422 (UMLS CUI 2011AA)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
Written informed consent
Item
Written informed consent
boolean
C0021430 (UMLS CUI 2011AA)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Serious or acute heart diseases
Item
Serious or acute heart diseases
boolean
C0205404 (UMLS CUI 2011AA)
42745003 (SNOMED CT 2011_0131)
C0018799 (UMLS CUI 2011AA)
56265001 (SNOMED CT 2011_0131)
10061024 (MedDRA 14.1)
I51.9 (ICD-10-CM Version 2010)
429.9 (ICD-9-CM Version 2011)
C1290838 (UMLS CUI 2011AA)
127337006 (SNOMED CT 2011_0131)
History of severe depression or suicide attempt
Item
History of severe depression or suicide attempt
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0588008 (UMLS CUI 2011AA)
310497006 (SNOMED CT 2011_0131)
C0038663 (UMLS CUI 2011AA)
82313006 (SNOMED CT 2011_0131)
10042464 (MedDRA 14.1)
T14.91 (ICD-10-CM Version 2010)
E12969 (CTCAE 1105E)
Epilepsy not adequately controlled by treatment
Item
Epilepsy not adequately controlled by treatment
boolean
C0014544 (UMLS CUI 2011AA)
84757009 (SNOMED CT 2011_0131)
10015037 (MedDRA 14.1)
MTHU020586 (LOINC Version 232)
G40.9 (ICD-10-CM Version 2010)
345.9 (ICD-9-CM Version 2011)
C1518422 (UMLS CUI 2011AA)
C0205411 (UMLS CUI 2011AA)
88323005 (SNOMED CT 2011_0131)
C2587213 (UMLS CUI 2011AA)
31509003 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
Known allergy to IFNs, to human albumin or to mannitol
Item
Known allergy to IFNs, to human albumin or to mannitol
boolean
C0020517 (UMLS CUI 2011AA)
257550005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C0021747 (UMLS CUI 2011AA)
49327004 (SNOMED CT 2011_0131)
MTHU021353 (LOINC Version 232)
C0086418 (UMLS CUI 2011AA)
278412004 (SNOMED CT 2011_0131)
C0001924 (UMLS CUI 2011AA)
52454007 (SNOMED CT 2011_0131)
MTHU001929 (LOINC Version 232)
C0024730 (UMLS CUI 2011AA)
387168006 (SNOMED CT 2011_0131)
MTHU015736 (LOINC Version 232)
Medical, psychiatric or other conditions that compromise the patient's ability to understand the patient information, to give informed consent, to comply with the trial protocol, or to complete the study
Item
Medical, psychiatric or other conditions that compromise the patient's ability to understand the patient information, to give informed consent, to comply with the trial protocol, or to complete the study
boolean
C0205476 (UMLS CUI 2011AA)
74188005 (SNOMED CT 2011_0131)
C0205487 (UMLS CUI 2011AA)
27296002 (SNOMED CT 2011_0131)
MTHU002618 (LOINC Version 232)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0348080 (UMLS CUI 2011AA)
260905004 (SNOMED CT 2011_0131)
COND (HL7 V3 2006_05)
C0221099 (UMLS CUI 2011AA)
260379002 (SNOMED CT 2011_0131)
C0030705 (UMLS CUI 2011AA)
116154003 (SNOMED CT 2011_0131)
C1273101 (UMLS CUI 2011AA)
395659009 (SNOMED CT 2011_0131)
C1955348 (UMLS CUI 2011AA)
MTHU029792 (LOINC Version 232)
C1999230 (UMLS CUI 2011AA)
C0021430 (UMLS CUI 2011AA)
C0525058 (UMLS CUI 2011AA)
C1554962 (UMLS CUI 2011AA)
C (HL7 V3 2006_05)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)

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