Childbearing Potential Contraceptive methods Quantity | Childbearing Potential Sexual Abstinence | Childbearing Potential Partner Male sterilization
Item
females of childbearing potential must agree to use two effective methods of birth control, practice complete abstinence, or confirm sterilization of monogamous male partner
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0036899 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0682323 (UMLS CUI [3,2])
C0024559 (UMLS CUI [3,3])
Gender Vasectomy | Gender Sexual Abstinence | Gender Use of Condom | Gender Avoidance Sperm
Item
males must have had a documented vasectomy, practice complete abstinence or use a condom and refrain from sperm.
boolean
C0079399 (UMLS CUI [1,1])
C0042387 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C0036899 (UMLS CUI [2,2])
C0079399 (UMLS CUI [3,1])
C1524063 (UMLS CUI [3,2])
C0009653 (UMLS CUI [3,3])
C0079399 (UMLS CUI [4,1])
C0870186 (UMLS CUI [4,2])
C0037868 (UMLS CUI [4,3])
Disease Free Medical History | Disease Free History of surgical procedures | Disease Free Physical Examination | Disease Free 12 lead ECG | Disease Free Laboratory Procedures
Item
participant is free from clinically significant illness or disease as determined by medical and surgical history, physical examination, 12-lead electrocardiogram (ecg) and clinical laboratory assessments.
boolean
C0012634 (UMLS CUI [1,1])
C0332296 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C0332296 (UMLS CUI [2,2])
C0489540 (UMLS CUI [2,3])
C0012634 (UMLS CUI [3,1])
C0332296 (UMLS CUI [3,2])
C0031809 (UMLS CUI [3,3])
C0012634 (UMLS CUI [4,1])
C0332296 (UMLS CUI [4,2])
C0430456 (UMLS CUI [4,3])
C0012634 (UMLS CUI [5,1])
C0332296 (UMLS CUI [5,2])
C0022885 (UMLS CUI [5,3])
Informed Consent
Item
able to understand and sign the written informed consent form
boolean
C0021430 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
female subjects who are pregnant or lactating.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Cardiovascular Disease | Liver disease | Kidney Disease | Lung disease | Hematological Disease | Gastrointestinal Disease | Endocrine System Disease | Immune System Disease | Dermatologic disorder | Nervous system disorder | Metabolic Diseases | Psychological disease | Musculoskeletal Disease | Malignant Neoplasms | Exception Clinical Significance Absent
Item
history of any significant cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, metabolic, psychological, musculoskeletal disease or malignancies unless deemed not clinically significant by the principal investigator.
boolean
C0007222 (UMLS CUI [1])
C0023895 (UMLS CUI [2])
C0022658 (UMLS CUI [3])
C0024115 (UMLS CUI [4])
C0018939 (UMLS CUI [5])
C0017178 (UMLS CUI [6])
C0014130 (UMLS CUI [7])
C0021053 (UMLS CUI [8])
C0037274 (UMLS CUI [9])
C0027765 (UMLS CUI [10])
C0025517 (UMLS CUI [11])
C1658764 (UMLS CUI [12])
C0026857 (UMLS CUI [13])
C0006826 (UMLS CUI [14])
C1705847 (UMLS CUI [15,1])
C2826293 (UMLS CUI [15,2])
C0332197 (UMLS CUI [15,3])
Interferon | Interferon Use Investigational
Item
previous treatment with any interferon product, including investigational use.
boolean
C3652465 (UMLS CUI [1])
C3652465 (UMLS CUI [2,1])
C0457083 (UMLS CUI [2,2])
C1517586 (UMLS CUI [2,3])
Malignant Neoplasms | Solid Neoplasm | Hematologic Neoplasms | Exception Complete excision Basal cell carcinoma | Exception Complete excision Squamous cell carcinoma of skin | Exception Basal cell carcinoma Cured | Exception Squamous cell carcinoma of skin Cured
Item
participants with a history of malignant disease, including solid tumours and hematologic malignancies (except basal cell and squamous cell carcinomas of the skin that have been completely excised and are considered cured).
boolean
C0006826 (UMLS CUI [1])
C0280100 (UMLS CUI [2])
C0376545 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C0015250 (UMLS CUI [4,2])
C0007117 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0015250 (UMLS CUI [5,2])
C0553723 (UMLS CUI [5,3])
C1705847 (UMLS CUI [6,1])
C0007117 (UMLS CUI [6,2])
C1880198 (UMLS CUI [6,3])
C1705847 (UMLS CUI [7,1])
C0553723 (UMLS CUI [7,2])
C1880198 (UMLS CUI [7,3])
HIV Seropositivity
Item
positive screening test for human immunodeficiency virus (hiv).
boolean
C0019699 (UMLS CUI [1])
Hepatitis C antibody test positive | Hepatitis B | Hepatitis B surface antigen positive
Item
positive screening test for hepatitis c antibody (hcv ab) or current hepatitis b infection (defined as positive for hepatitis surface antigen [hbsag] at screening). participants with immunity to hepatitis b (defined as negative hbsag and positive hepatitis b surface antibody [hbsab]) are eligible to participate in the study.
boolean
C1277805 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0149709 (UMLS CUI [3])
Epilepsy | Blackout Unexplained
Item
history of epilepsy, seizure disorder or any unexplained black-outs.
boolean
C0014544 (UMLS CUI [1])
C0312422 (UMLS CUI [2,1])
C4288071 (UMLS CUI [2,2])
Allergy to acetaminophen | Intolerance to Acetaminophen | Allergy to nonsteroidal anti-inflammatory agents | Intolerance to Non-Steroidal Anti-Inflammatory Agents
Item
history of hypersensitivity or intolerance to paracetamol or non-steroidal anti-inflammatory drugs (nsaid) that would preclude the use of at least 1 of these during the study.
boolean
C0570513 (UMLS CUI [1])
C1744706 (UMLS CUI [2,1])
C0000970 (UMLS CUI [2,2])
C0746949 (UMLS CUI [3])
C1744706 (UMLS CUI [4,1])
C0003211 (UMLS CUI [4,2])
Severe allergic reaction | Anaphylaxis Severe | Hypersensitivity Interferon beta-1b Component
Item
history of severe allergic or anaphylactic reactions or a known allergy to any component of the interferon β-1b formulation.
boolean
C2220378 (UMLS CUI [1])
C0002792 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0244713 (UMLS CUI [3,2])
C1705248 (UMLS CUI [3,3])
Substance Use Disorders
Item
history of drug or alcohol abuse less than or equal to 12 months prior to screening.
boolean
C0038586 (UMLS CUI [1])
Tobacco use
Item
history of tobacco use less than or equal to 6 months prior to screening.
boolean
C0543414 (UMLS CUI [1])
Presence of drugs of abuse | Blood alcohol test positive
Item
a positive test for drugs of abuse or alcohol during screening or prior to dosing.
boolean
C0428264 (UMLS CUI [1])
C0948726 (UMLS CUI [2])
Alcohol Abstinence Unwilling | Alcohol Abstinence Unable
Item
unwilling or unable to abstain from alcohol from 7 days prior to dosing until end-of-study assessments.
boolean
C0678274 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0678274 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
Medication use During Screening | Use of Non-Prescription Drugs During Screening | Use of Herbal Supplements During Screening | Use of Herbal product During Screening | Medication use During Clinical Trial | Use of Non-Prescription Drugs During Clinical Trial | Use of Herbal Supplements During Clinical Trial | Use of Herbal product During Clinical Trial
Item
use of any prescription medication, over-the-counter medication, or herbal supplements/products during screening or throughout study, unless approved by both the principal investigator and the sponsor.
boolean
C0240320 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0220908 (UMLS CUI [1,3])
C1524063 (UMLS CUI [2,1])
C0013231 (UMLS CUI [2,2])
C0347984 (UMLS CUI [2,3])
C0220908 (UMLS CUI [2,4])
C1524063 (UMLS CUI [3,1])
C1504473 (UMLS CUI [3,2])
C0347984 (UMLS CUI [3,3])
C0220908 (UMLS CUI [3,4])
C1524063 (UMLS CUI [4,1])
C2240391 (UMLS CUI [4,2])
C0347984 (UMLS CUI [4,3])
C0220908 (UMLS CUI [4,4])
C0240320 (UMLS CUI [5,1])
C0347984 (UMLS CUI [5,2])
C0008976 (UMLS CUI [5,3])
C1524063 (UMLS CUI [6,1])
C0013231 (UMLS CUI [6,2])
C0347984 (UMLS CUI [6,3])
C0008976 (UMLS CUI [6,4])
C1524063 (UMLS CUI [7,1])
C1504473 (UMLS CUI [7,2])
C0347984 (UMLS CUI [7,3])
C0008976 (UMLS CUI [7,4])
C1524063 (UMLS CUI [8,1])
C2240391 (UMLS CUI [8,2])
C0347984 (UMLS CUI [8,3])
C0008976 (UMLS CUI [8,4])