Gender
Item
males or females
boolean
C0079399 (UMLS CUI [1])
Age
Item
age >= 18 years old
boolean
C0001779 (UMLS CUI [1])
Demyelinating disorder First Suggestive of Multiple Sclerosis | Betaferon | Multiple Sclerosis, Relapsing-Remitting | Rebif
Item
patients after a first demyelinating event suggestive of ms (only for betaferon) as well as patients with a definite diagnosis of rrms (betaferon et rebif)
boolean
C0947925 (UMLS CUI [1,1])
C0205435 (UMLS CUI [1,2])
C0332299 (UMLS CUI [1,3])
C0026769 (UMLS CUI [1,4])
C0592527 (UMLS CUI [2])
C0751967 (UMLS CUI [3])
C0752980 (UMLS CUI [4])
Interferon-beta Subcutaneous Firstly | Betaferon | Rebif
Item
first justified prescription of one interferon beta by subcutaneous route (as described in summary of product characteristics [smpc] of betaferon or rebif)
boolean
C0015980 (UMLS CUI [1,1])
C1522438 (UMLS CUI [1,2])
C1279901 (UMLS CUI [1,3])
C0592527 (UMLS CUI [2])
C0752980 (UMLS CUI [3])
Childbearing Potential Contraceptive methods
Item
females of child-bearing potential must agree to practice adequate contraceptive methods over the duration of the study (not applicable for men)
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Protocol Compliance
Item
patient can follow and comply with all study procedures of the trial protocol
boolean
C0525058 (UMLS CUI [1])
Laboratory data interpretation | Evaluation Liver enzyme Gamma glutamyl transferase measurement | Complete Blood Count | Differential white blood cell count procedure | Normal Laboratory Test Result
Item
laboratory evaluations (i.e., evaluation of hepatic enzyme gamma-gt, full blood count and differential white blood cell count [wbc]) must be available and the results must be normal.
boolean
C0262707 (UMLS CUI [1])
C1261322 (UMLS CUI [2,1])
C0443764 (UMLS CUI [2,2])
C0202035 (UMLS CUI [2,3])
C0009555 (UMLS CUI [3])
C0162401 (UMLS CUI [4])
C0438214 (UMLS CUI [5])
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Medical contraindication Betaferon | Medical contraindication Rebif
Item
any contraindication to the prescription of betaferon or rebif, as described in the smpc of products:
boolean
C1301624 (UMLS CUI [1,1])
C0592527 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0752980 (UMLS CUI [2,2])
Pregnancy | Breast Feeding
Item
pregnancy or lactation
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Hypersensitivity Interferon-beta | Hypersensitivity Recombinant Interferon Beta | Mannitol allergy | Hypersensitivity Albumin Human | Hypersensitivity Excipient
Item
known hypersensitivity to natural or recombinant interferon beta, to mannitol, to human albumin or any other excipients used
boolean
C0020517 (UMLS CUI [1,1])
C0015980 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0751599 (UMLS CUI [2,2])
C0571922 (UMLS CUI [3])
C0020517 (UMLS CUI [4,1])
C0304925 (UMLS CUI [4,2])
C0020517 (UMLS CUI [5,1])
C0015237 (UMLS CUI [5,2])
Severe depression | Suicide attempt | Feeling suicidal
Item
history of severe depression or suicide attempt or current suicidal ideation.
boolean
C0588008 (UMLS CUI [1])
C0038663 (UMLS CUI [2])
C0424000 (UMLS CUI [3])
Decompensated liver disease
Item
patient with decompensated liver disease
boolean
C4075847 (UMLS CUI [1])
Epilepsy control poor
Item
epilepsy not adequately controlled by treatment
boolean
C1278398 (UMLS CUI [1])
Study Subject Participation Status
Item
patient previously included in this study.
boolean
C2348568 (UMLS CUI [1])
Betaferon Subcutaneous | Rebif Subcutaneous
Item
patient previously treated by sub-cutaneous route with either betaferon or rebif.
boolean
C0592527 (UMLS CUI [1,1])
C1522438 (UMLS CUI [1,2])
C0752980 (UMLS CUI [2,1])
C1522438 (UMLS CUI [2,2])
Study Subject Participation Status | Investigational New Drugs
Item
participation in any clinical trial within the past 30 days involving the investigational drug intake.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Medical condition compromises Comprehension Patient Information | Medical condition compromises Informed Consent | Medical condition compromises Protocol Compliance | Medical condition compromises Clinical Trial Completion | Mental disorder compromises Comprehension Patient Information | Mental disorder compromises Informed Consent | Mental disorder compromises Protocol Compliance | Mental disorder compromises Clinical Trial Completion | Condition compromises Comprehension Patient Information | Condition compromises Informed Consent | Condition compromises Protocol Compliance | Condition compromises Clinical Trial Completion
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
C3843040 (UMLS CUI [1,1])
C2945640 (UMLS CUI [1,2])
C0162340 (UMLS CUI [1,3])
C1955348 (UMLS CUI [1,4])
C3843040 (UMLS CUI [2,1])
C2945640 (UMLS CUI [2,2])
C0021430 (UMLS CUI [2,3])
C3843040 (UMLS CUI [3,1])
C2945640 (UMLS CUI [3,2])
C0525058 (UMLS CUI [3,3])
C3843040 (UMLS CUI [4,1])
C2945640 (UMLS CUI [4,2])
C0008976 (UMLS CUI [4,3])
C0205197 (UMLS CUI [4,4])
C0004936 (UMLS CUI [5,1])
C2945640 (UMLS CUI [5,2])
C0162340 (UMLS CUI [5,3])
C1955348 (UMLS CUI [5,4])
C0004936 (UMLS CUI [6,1])
C2945640 (UMLS CUI [6,2])
C0021430 (UMLS CUI [6,3])
C0004936 (UMLS CUI [7,1])
C2945640 (UMLS CUI [7,2])
C0525058 (UMLS CUI [7,3])
C0004936 (UMLS CUI [8,1])
C2945640 (UMLS CUI [8,2])
C0008976 (UMLS CUI [8,3])
C0205197 (UMLS CUI [8,4])
C0348080 (UMLS CUI [9,1])
C2945640 (UMLS CUI [9,2])
C0162340 (UMLS CUI [9,3])
C1955348 (UMLS CUI [9,4])
C0348080 (UMLS CUI [10,1])
C2945640 (UMLS CUI [10,2])
C0021430 (UMLS CUI [10,3])
C0348080 (UMLS CUI [11,1])
C2945640 (UMLS CUI [11,2])
C0525058 (UMLS CUI [11,3])
C0348080 (UMLS CUI [12,1])
C2945640 (UMLS CUI [12,2])
C0008976 (UMLS CUI [12,3])
C0205197 (UMLS CUI [12,4])