Informed Consent
Item
ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (phi) in accordance with national and local subject privacy regulations.
boolean
C0021430 (UMLS CUI [1])
Age
Item
male or female aged 18- to 60-years-old, inclusive, at the time of informed consent.
boolean
C0001779 (UMLS CUI [1])
Multiple Sclerosis, Acute Relapsing
Item
must have a diagnosis of relapsing ms.
boolean
C0393664 (UMLS CUI [1])
EDSS
Item
must have a screening expanded disability status scale (edss) score between 0 and 6.0, inclusive.
boolean
C0451246 (UMLS CUI [1])
Females & males of reproductive potential Contraceptive methods
Item
all male subjects and female participants of child-bearing potential must practice effective contraception during the study and be willing and able to continue contraception for 30 days after their last study dose of avonex.
boolean
C4034483 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Severe allergic reaction | Anaphylaxis Severe
Item
history of severe allergic or anaphylactic reactions.
boolean
C2220378 (UMLS CUI [1])
C0002792 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Multiple Sclerosis, Primary Progressive | Multiple Sclerosis, Secondary Progressive | Multiple Sclerosis, Progressive Relapsing
Item
diagnosed with primary progressive, secondary progressive, or progressive relapsing ms.
boolean
C0751964 (UMLS CUI [1])
C0751965 (UMLS CUI [2])
C0393666 (UMLS CUI [3])
Hypersensitivity Avonex Component
Item
known allergy to any component of the avonex formulation.
boolean
C0020517 (UMLS CUI [1,1])
C0594372 (UMLS CUI [1,2])
C1705248 (UMLS CUI [1,3])
Heart Diseases | Endocrine System Diseases | Hematological Disease | Liver diseases | Immune System Diseases | Metabolic Diseases | Urologic Diseases | Lung diseases | Nervous system disorder | Dermatologic disorders | Mental disorders | Kidney Diseases | Disease Major
Item
history of any clinically significant (as determined by the investigator) cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric renal, or other major disease.
boolean
C0018799 (UMLS CUI [1])
C0014130 (UMLS CUI [2])
C0018939 (UMLS CUI [3])
C0023895 (UMLS CUI [4])
C0021053 (UMLS CUI [5])
C0025517 (UMLS CUI [6])
C0042075 (UMLS CUI [7])
C0024115 (UMLS CUI [8])
C0027765 (UMLS CUI [9])
C0037274 (UMLS CUI [10])
C0004936 (UMLS CUI [11])
C0022658 (UMLS CUI [12])
C0012634 (UMLS CUI [13,1])
C0205164 (UMLS CUI [13,2])
Malignant Neoplasms | Solid Neoplasm | Hematologic Neoplasms
Item
subjects with history of malignant disease, including solid tumors and hematologic malignancies.
boolean
C0006826 (UMLS CUI [1])
C0280100 (UMLS CUI [2])
C0376545 (UMLS CUI [3])
Epilepsy | Blackout Unexplained | Seizure
Item
history of seizure disorder or unexplained blackouts or history of a seizure within 3 months prior to day 1.
boolean
C0014544 (UMLS CUI [1])
C0039070 (UMLS CUI [2,1])
C4288071 (UMLS CUI [2,2])
C0036572 (UMLS CUI [3])
Feeling suicidal | Severe depression Episode | Severe depression Hospitalization Required | Initiation Antidepressant therapy | Antidepressant therapy Dose Increased
Item
history of suicidal ideation within 3 months prior to day 1 or an episode of severe depression within 3 months prior to day 1. severe depression is defined as any episode of depression that requires hospitalization, or the initiation of antidepressant therapy, or an increase in the dose of an existing regimen of antidepressant therapy.
boolean
C0424000 (UMLS CUI [1])
C0588008 (UMLS CUI [2,1])
C0332189 (UMLS CUI [2,2])
C0588008 (UMLS CUI [3,1])
C1708385 (UMLS CUI [3,2])
C1704686 (UMLS CUI [4,1])
C1096649 (UMLS CUI [4,2])
C1096649 (UMLS CUI [5,1])
C1707810 (UMLS CUI [5,2])
Electrocardiogram abnormal
Item
clinically significant abnormal electrocardiogram (ecg) values as determined by the investigator.
boolean
C0522055 (UMLS CUI [1])
HIV Infection | HIV Seropositivity
Item
known history of, or a positive test result for, human immunodeficiency virus (hiv).
boolean
C0019693 (UMLS CUI [1])
C0019699 (UMLS CUI [2])
Hepatitis C | Hepatitis C Virus Positive
Item
known history of, or a positive test result for hepatitis c virus.
boolean
C0019196 (UMLS CUI [1])
C4330254 (UMLS CUI [2])
Abnormal blood test
Item
abnormal screening blood tests exceeding any of the limits defined below:
boolean
C0854146 (UMLS CUI [1])
Alanine aminotransferase increased | Aspartate aminotransferase increased | Elevated total bilirubin
Item
1. alanine transaminase/serum glutamate pyruvate transaminase (alt/sgpt) greater than 2 times the upper limit of normal or aspartate transaminase/serum glutamic oxaloacetic transaminase or bilirubin.
boolean
C0151905 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
C0741494 (UMLS CUI [3])
White Blood Cell Count procedure
Item
2. total white blood cell count (wbc) <3700 cells/mm
boolean
C0023508 (UMLS CUI [1])
Platelet Count measurement
Item
3. platelet count <150,000 cells/mm
boolean
C0032181 (UMLS CUI [1])
Hemoglobin measurement | Gender
Item
4. hemoglobin <10 g/dl in female subjects; <11 g/dl in male subjects
boolean
C0518015 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Serum creatinine raised
Item
5. serum creatinine >upper limit of normal (uln)
boolean
C0700225 (UMLS CUI [1])
Elevated prothrombin time | Partial thromboplastin time increased
Item
6. prothrombin time (pt) or activated partial thromboplastin time (aptt) > 1.2*uln
boolean
C2674387 (UMLS CUI [1])
C0240671 (UMLS CUI [2])