Protocol Compliance | Informed Consent
Item
demonstrate willingness to participate in the study and comply with its procedures by signing a written informed consent.
boolean
C0525058 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Age
Item
equal to or greater than 18 years.
boolean
C0001779 (UMLS CUI [1])
Hepatitis C, Chronic | Hepatitis C RNA positive Plasma
Item
confirmed chronic hepatitis c with hepatitis c virus (hcv) rna positive in plasma.
boolean
C0524910 (UMLS CUI [1])
C0855842 (UMLS CUI [2,1])
C0032105 (UMLS CUI [2,2])
Pen Pegintron Absent
Item
no previous use of pegintron pen.
boolean
C4058415 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Hypersensitivity Investigational New Drugs | Hypersensitivity Interferon | Hypersensitivity Excipient
Item
hypersensitivity to the active substance or to any interferon or to any of the excipients.
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C3652465 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0015237 (UMLS CUI [3,2])
Pregnancy
Item
pregnant women.
boolean
C0032961 (UMLS CUI [1])
Breast Feeding
Item
women who are breastfeeding.
boolean
C0006147 (UMLS CUI [1])
Mental condition Severe | Severe depression | Feeling suicidal | Suicide attempt
Item
existence of or a history of severe psychiatric condition, particularly severe depression, suicidal ideation or suicide attempt.
boolean
C3840291 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0588008 (UMLS CUI [2])
C0424000 (UMLS CUI [3])
C0038663 (UMLS CUI [4])
Heart Disease Pre-existing | Heart Disease Unstable | Heart Disease Uncontrolled
Item
a history of severe pre-existing cardiac disease, including unstable or uncontrolled cardiac disease in the previous six months.
boolean
C0018799 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C0018799 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C0018799 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
Medical condition Debilitation Severe | Kidney Failure, Chronic | Creatinine clearance measurement
Item
severe debilitating medical condition, including patients with chronic renal failure or creatinine clearance < 50 ml/minute.
boolean
C3843040 (UMLS CUI [1,1])
C0742985 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,3])
C0022661 (UMLS CUI [2])
C0373595 (UMLS CUI [3])
Hepatitis, Autoimmune | Autoimmune Diseases
Item
auto immune hepatitis or a history of autoimmune disease.
boolean
C0241910 (UMLS CUI [1])
C0004364 (UMLS CUI [2])
Liver Dysfunction Severe | Decompensated cirrhosis of liver
Item
severe hepatic dysfunction or decompensated cirrhosis of the liver.
boolean
C0086565 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1619727 (UMLS CUI [2])
Thyroid Disease Pre-existing | Exception Disease control Standard of Care
Item
pre-existing thyroid disease unless it can be controlled with conventional treatment.
boolean
C0040128 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0920467 (UMLS CUI [2,2])
C2936643 (UMLS CUI [2,3])
Epilepsy | Central nervous system function Impaired
Item
epilepsy and/or compromised central nervous system (cns) function.
boolean
C0014544 (UMLS CUI [1])
C0683212 (UMLS CUI [2,1])
C0221099 (UMLS CUI [2,2])