Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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