Placebo given Clinical Trial l-fmau
Item
1. patients who received placebo in l-fmau-201 study
boolean
C0420256 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0045212 (UMLS CUI [1,3])
Childbearing Potential Serum pregnancy test negative | Childbearing Potential Serum Beta-HCG Test Negative
Item
2. female of childbearing potential with a negative serum (beta-hcg) pregnancy test within 14 days of starting therapy.
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C1255526 (UMLS CUI [2,2])
C1513916 (UMLS CUI [2,3])
Informed Consent | Protocol Compliance
Item
3. patients who were able to give written informed consent prior to study start and to comply with the study requirements.
boolean
C0021430 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
Patient Visit Complete | Follow-up visit Additional
Item
4. patients who met the following criteria after completion of the week 48 visit were to have additional follow-up visits at weeks 54 and 60:
boolean
C1512346 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0589121 (UMLS CUI [2,1])
C1524062 (UMLS CUI [2,2])
Clevudine | HBV DNA decreased
Item
1)had received no additional therapy since completion of 24-week treatment of clevudine and 2)experienced a >= 1 log10 decrease from baseline in hbv dna at week 48
boolean
C0045212 (UMLS CUI [1])
C1262160 (UMLS CUI [2])
Hepatitis B e Antigens Seroconversion Antibody to hepatitis Be antigen
Item
1. patient with hbeag seroconverted to anti-hbe at the last 2 consecutive visits (one month apart) in l-fmau-201 study.
boolean
C0019167 (UMLS CUI [1,1])
C4042908 (UMLS CUI [1,2])
C0312634 (UMLS CUI [1,3])
Antiviral Therapy | Biological Response Modifier Therapy | Steroid therapy
Item
2. patient who was currently receiving antiviral, immunomodulatory or corticosteroid therapy.
boolean
C0280274 (UMLS CUI [1])
C0005527 (UMLS CUI [2])
C0149783 (UMLS CUI [3])
Lamivudine | lobucavir | famciclovir | adefovir | Nucleoside Investigational | Therapeutic procedure Hepatitis B
Item
3. patient who was treated with lamivudine, lobucavir, famciclovir, adefovir or any other investigational nucleoside for hbv infection after cessation of treatment in l-fmau-201 study.
boolean
C0209738 (UMLS CUI [1])
C0286536 (UMLS CUI [2])
C0209227 (UMLS CUI [3])
C0050175 (UMLS CUI [4])
C0028621 (UMLS CUI [5,1])
C1517586 (UMLS CUI [5,2])
C0087111 (UMLS CUI [6,1])
C0019163 (UMLS CUI [6,2])
Ascites | Bleeding varices | Hepatic Encephalopathy
Item
4. patient who had a history of ascites, variceal hemorrhage or hepatic encephalopathy.
boolean
C0003962 (UMLS CUI [1])
C0333106 (UMLS CUI [2])
C0019151 (UMLS CUI [3])
HCV coinfection | Coinfection HDV | HIV coinfection
Item
5. patient who was co-infected with hcv, hdv or hiv.
boolean
C1698259 (UMLS CUI [1])
C0275524 (UMLS CUI [2,1])
C0011220 (UMLS CUI [2,2])
C4062778 (UMLS CUI [3])
Liver Cirrhosis Evidence of | Liver carcinoma Evidence of | Alpha-fetoprotein measurement | Ultrasonography
Item
6. patient with clinical evidence of cirrhosis or hepatocellular carcinoma (®-fetoprotein)evaluation was based on alpha-fetoprotein primarily. if alpha-fetoprotein level was suggestive of cirrhosis or hepatocellular carcinoma, confirmation was made with ultrasonography etc.
boolean
C0023890 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C2239176 (UMLS CUI [2,1])
C0332120 (UMLS CUI [2,2])
C0201539 (UMLS CUI [3])
C0041618 (UMLS CUI [4])
Pregnancy | Breast Feeding
Item
7. patient who was pregnant or breast-feeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Contraceptive methods Unwilling | Condoms, Male | Female Sterilization | Hysterectomy | Bilateral tubal ligation | Postmenopausal state | Contraception, Barrier | Intrauterine Devices | Vaginal Spermicides | Sexual Abstinence
Item
8. patient who was unwilling to use an "effective" method of contraception during treatment period and for up to 3 months after cessation of therapy. for males, condoms should be used. females must be surgically sterile (via hysterectomy or bilateral tubal ligation), post-menopausal or using at least a medically acceptable barrier method of contraception (i.e., iud, barrier methods with supermicide or abstinence)
boolean
C0700589 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0009653 (UMLS CUI [2])
C0015787 (UMLS CUI [3])
C0020699 (UMLS CUI [4])
C0589114 (UMLS CUI [5])
C0232970 (UMLS CUI [6])
C0004764 (UMLS CUI [7])
C0021900 (UMLS CUI [8])
C0087145 (UMLS CUI [9])
C0036899 (UMLS CUI [10])
Substance Use Disorders
Item
9. patient who had a clinically relevant history of abuse of alcohol or drugs.
boolean
C0038586 (UMLS CUI [1])
Gastrointestinal Diseases Significant | Kidney Diseases | Decompensated liver disease | Bronchopulmonary disease | nervous system disorder | Cardiovascular Diseases | Malignant Neoplasms | Hypersensitivity
Item
10. patient who had a significant gastrointestinal, renal, hepatic (decompensated), bronchopulmonary, neurological, cardiovascular, oncologic or allergic disease.
boolean
C0017178 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0022658 (UMLS CUI [2])
C4075847 (UMLS CUI [3])
C1096000 (UMLS CUI [4])
C0027765 (UMLS CUI [5])
C0007222 (UMLS CUI [6])
C0006826 (UMLS CUI [7])
C0020517 (UMLS CUI [8])
Estimation of creatinine clearance by Cockcroft-Gault formula
Item
11. patient who had creatinine clearance less than 60ml/min as estimated by the following formula:
boolean
C2711451 (UMLS CUI [1])
Age | Body Weight | Creatinine measurement, serum | Gender
Item
(140-age in years) (body weight [kg])/(72) (serum creatinine [mg/dl]) [note: multiply estimates by 0.85 for women]
boolean
C0001779 (UMLS CUI [1])
C0005910 (UMLS CUI [2])
C0201976 (UMLS CUI [3])
C0079399 (UMLS CUI [4])