Ignite Creation Date:
2025-12-24 @ 5:32 PM
Ignite Modification Date:
2025-12-27 @ 11:05 PM
Study NCT ID:
NCT00737568
Status:
COMPLETED
Last Update Posted:
2016-03-11
First Post:
2008-08-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Tenofovir Disoproxil Fumarate (Tenofovir DF) Versus Emtricitabine/Tenofovir DF in Subjects Resistant to Lamivudine
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006509', 'term': 'Hepatitis B'}, {'id': 'D019694', 'term': 'Hepatitis B, Chronic'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018347', 'term': 'Hepadnaviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D006521', 'term': 'Hepatitis, Chronic'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068698', 'term': 'Tenofovir'}, {'id': 'D000069480', 'term': 'Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination'}], 'ancestors': [{'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000225', 'term': 'Adenine'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000068679', 'term': 'Emtricitabine'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialDisclosures@gilead.com', 'title': 'Clinical Trial Disclosures', 'organization': 'Gilead Sciences, Inc.'}, 'certainAgreement': {'otherDetails': 'After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:\n\n* The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or\n* The study has been completed at all study sites for at least 2 years', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'There were no limitations affecting the analysis or results.'}}, 'adverseEventsModule': {'timeFrame': 'Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days', 'description': 'Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Tenofovir DF', 'description': 'TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily', 'otherNumAtRisk': 141, 'otherNumAffected': 109, 'seriousNumAtRisk': 141, 'seriousNumAffected': 23}, {'id': 'EG001', 'title': 'FTC/Tenofovir DF', 'description': 'FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily', 'otherNumAtRisk': 139, 'otherNumAffected': 105, 'seriousNumAtRisk': 139, 'seriousNumAffected': 21}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 15}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Seasonal allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 3}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 20}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Creatinine renal clearance decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 18}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 15}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 20}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 13}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 9}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}], 'seriousEvents': [{'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Coronary artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Middle ear inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Tympanic membrane perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Abdominal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Acarodermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Bone tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Bronchopneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Pharyngotonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Fibula fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Tendon injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Adenocarcinoma of colon', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Adenolymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Adrenal adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Adrenal neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Bladder neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Hepatocellular carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Lung neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Oesophageal adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Oesophageal carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Pancreatic carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Plasma cell myeloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Thyroid cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Tumour haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Calculus ureteric', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Dysphonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Venous thrombosis limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With HBV DNA < 400 Copies/mL at Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenofovir DF', 'description': 'TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily'}, {'id': 'OG001', 'title': 'FTC/Tenofovir DF', 'description': 'FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '89.4', 'groupId': 'OG000'}, {'value': '86.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.43', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'The p-value for the two-sided Cochran-Mantel-Haenszel test was controlled for strata (HBeAg status and ALT level).', 'groupDescription': 'The null hypothesis is that there is no difference between the FTC/TDF and TDF treatment groups. The alternative hypothesis is that there is a difference between the FTC/TDF and TDF treatment groups. These hypotheses were evaluated using a Cochran-Mantel-Haenszel (CMH) test, controlling for randomization strata, with the missing = failure method in which participants with missing data were considered to have failed to achieve the endpoint.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 96', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: participants were randomized and received at least 1 dose of study drug. The missing = failure method was used in which participants with missing data were considered to have failed to achieve the endpoint.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 48, 144, 192, and 240', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenofovir DF', 'description': 'TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily'}, {'id': 'OG001', 'title': 'FTC/Tenofovir DF', 'description': 'FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily'}], 'classes': [{'title': 'Week 48', 'categories': [{'measurements': [{'value': '81.6', 'groupId': 'OG000'}, {'value': '84.2', 'groupId': 'OG001'}]}]}, {'title': 'Week 144', 'categories': [{'measurements': [{'value': '87.2', 'groupId': 'OG000'}, {'value': '84.9', 'groupId': 'OG001'}]}]}, {'title': 'Week 192', 'categories': [{'measurements': [{'value': '86.5', 'groupId': 'OG000'}, {'value': '85.6', 'groupId': 'OG001'}]}]}, {'title': 'Week 240', 'categories': [{'measurements': [{'value': '83.0', 'groupId': 'OG000'}, {'value': '82.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 48, 144, 192, and 240', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set, missing = failure method'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HBV DNA < 169 Copies/mL at Weeks 48, 96, 144, 192, and 240', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenofovir DF', 'description': 'TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily'}, {'id': 'OG001', 'title': 'FTC/Tenofovir DF', 'description': 'FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily'}], 'classes': [{'title': 'Week 48', 'categories': [{'measurements': [{'value': '76.6', 'groupId': 'OG000'}, {'value': '77.7', 'groupId': 'OG001'}]}]}, {'title': 'Week 96', 'categories': [{'measurements': [{'value': '85.8', 'groupId': 'OG000'}, {'value': '83.5', 'groupId': 'OG001'}]}]}, {'title': 'Week 144', 'categories': [{'measurements': [{'value': '86.5', 'groupId': 'OG000'}, {'value': '84.9', 'groupId': 'OG001'}]}]}, {'title': 'Week 192', 'categories': [{'measurements': [{'value': '85.1', 'groupId': 'OG000'}, {'value': '84.2', 'groupId': 'OG001'}]}]}, {'title': 'Week 240', 'categories': [{'measurements': [{'value': '81.6', 'groupId': 'OG000'}, {'value': '82.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 48, 96, 144, 192, and 240', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set, missing = failure method'}, {'type': 'SECONDARY', 'title': 'HBV DNA Level at Weeks 48, 96, 144, 192, and 240', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenofovir DF', 'description': 'TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily'}, {'id': 'OG001', 'title': 'FTC/Tenofovir DF', 'description': 'FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily'}], 'classes': [{'title': 'Week 48 (TDF: n=130; FTC/TDF: n=133)', 'categories': [{'measurements': [{'value': '2.42', 'spread': '0.542', 'groupId': 'OG000'}, {'value': '2.48', 'spread': '0.887', 'groupId': 'OG001'}]}]}, {'title': 'Week 96 (TDF: n=132; FTC/TDF: n=127)', 'categories': [{'measurements': [{'value': '2.29', 'spread': '0.254', 'groupId': 'OG000'}, {'value': '2.28', 'spread': '0.241', 'groupId': 'OG001'}]}]}, {'title': 'Week 144 (TDF: n=128; FTC/TDF: n=123)', 'categories': [{'measurements': [{'value': '2.26', 'spread': '0.173', 'groupId': 'OG000'}, {'value': '2.29', 'spread': '0.541', 'groupId': 'OG001'}]}]}, {'title': 'Week 192 (TDF: n=126; FTC/TDF: n=119)', 'categories': [{'measurements': [{'value': '2.25', 'spread': '0.135', 'groupId': 'OG000'}, {'value': '2.23', 'spread': '0.027', 'groupId': 'OG001'}]}]}, {'title': 'Week 240 (TDF: n=118; FTC/TDF: n=116)', 'categories': [{'measurements': [{'value': '2.23', 'spread': '0.052', 'groupId': 'OG000'}, {'value': '2.26', 'spread': '0.376', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 48, 96, 144, 192, and 240', 'unitOfMeasure': 'log10 copies/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set; participants with HBV DNA measurements at the given time point were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Normal ALT at Weeks 48, 96, 144, 192, and 240', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenofovir DF', 'description': 'TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily'}, {'id': 'OG001', 'title': 'FTC/Tenofovir DF', 'description': 'FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily'}], 'classes': [{'title': 'Week 48', 'categories': [{'measurements': [{'value': '67.4', 'groupId': 'OG000'}, {'value': '69.8', 'groupId': 'OG001'}]}]}, {'title': 'Week 96', 'categories': [{'measurements': [{'value': '70.2', 'groupId': 'OG000'}, {'value': '69.8', 'groupId': 'OG001'}]}]}, {'title': 'Week 144', 'categories': [{'measurements': [{'value': '70.2', 'groupId': 'OG000'}, {'value': '75.5', 'groupId': 'OG001'}]}]}, {'title': 'Week 192', 'categories': [{'measurements': [{'value': '75.9', 'groupId': 'OG000'}, {'value': '76.3', 'groupId': 'OG001'}]}]}, {'title': 'Week 240', 'categories': [{'measurements': [{'value': '71.6', 'groupId': 'OG000'}, {'value': '71.9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 48, 96, 144, 192, and 240', 'description': 'Normal ALT was defined as having a value less than or equal to the ULN. The ULN was 43 U/L for males and 34 U/L for females aged 18 to \\< 69, and 35 U/L for males and 32 U/L for females aged ≥ 69.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set, missing = failure method'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HBeAg Loss at Weeks 48, 96, 144, 192, and 240', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenofovir DF', 'description': 'TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily'}, {'id': 'OG001', 'title': 'FTC/Tenofovir DF', 'description': 'FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily'}], 'classes': [{'title': 'Week 48', 'categories': [{'measurements': [{'value': '9.2', 'groupId': 'OG000'}, {'value': '5.9', 'groupId': 'OG001'}]}]}, {'title': 'Week 96', 'categories': [{'measurements': [{'value': '15.4', 'groupId': 'OG000'}, {'value': '13.2', 'groupId': 'OG001'}]}]}, {'title': 'Week 144', 'categories': [{'measurements': [{'value': '23.1', 'groupId': 'OG000'}, {'value': '17.6', 'groupId': 'OG001'}]}]}, {'title': 'Week 192', 'categories': [{'measurements': [{'value': '21.5', 'groupId': 'OG000'}, {'value': '14.7', 'groupId': 'OG001'}]}]}, {'title': 'Week 240', 'categories': [{'measurements': [{'value': '24.6', 'groupId': 'OG000'}, {'value': '19.1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline; Weeks 48, 96, 144, 192, and 240', 'description': 'The percentage of participants who were HBeAg positive at baseline and who had HBeAg Loss at the given time point was summarized. Loss of HBeAg was defined as change of detectable HBeAg from positive to negative.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set who were HBeAg positive at baseline were analyzed using the missing = failure method.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Seroconversion to Antibody Against HBeAg (Anti-HBe) at Weeks 48, 96, 144, 192, and 240', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenofovir DF', 'description': 'TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily'}, {'id': 'OG001', 'title': 'FTC/Tenofovir DF', 'description': 'FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily'}], 'classes': [{'title': 'Week 48', 'categories': [{'measurements': [{'value': '6.2', 'groupId': 'OG000'}, {'value': '4.4', 'groupId': 'OG001'}]}]}, {'title': 'Week 96', 'categories': [{'measurements': [{'value': '10.8', 'groupId': 'OG000'}, {'value': '10.3', 'groupId': 'OG001'}]}]}, {'title': 'Week 144', 'categories': [{'measurements': [{'value': '12.3', 'groupId': 'OG000'}, {'value': '11.8', 'groupId': 'OG001'}]}]}, {'title': 'Week 192', 'categories': [{'measurements': [{'value': '10.8', 'groupId': 'OG000'}, {'value': '10.3', 'groupId': 'OG001'}]}]}, {'title': 'Week 240', 'categories': [{'measurements': [{'value': '12.3', 'groupId': 'OG000'}, {'value': '10.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline; Weeks 48, 96, 144, 192, and 240', 'description': 'The percentage of participants who were HBeAg positive at baseline and who had seroconversion to anti-HBe at the given time point was summarized. Seroconversion to anti-HBe was defined as change of detectable antibody to HBeAg from negative to positive.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set who were HBeAg positive at baseline were analyzed using the missing = failure method.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HBV Surface Antigen (HBsAg) Loss at Weeks 48, 96, 144, 192, and 240', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenofovir DF', 'description': 'TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily'}, {'id': 'OG001', 'title': 'FTC/Tenofovir DF', 'description': 'FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily'}], 'classes': [{'title': 'Week 48', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.7', 'groupId': 'OG001'}]}]}, {'title': 'Week 96', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.7', 'groupId': 'OG001'}]}]}, {'title': 'Week 144', 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000'}, {'value': '1.4', 'groupId': 'OG001'}]}]}, {'title': 'Week 192', 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000'}, {'value': '2.9', 'groupId': 'OG001'}]}]}, {'title': 'Week 240', 'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000'}, {'value': '2.9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline; Weeks 48, 96, 144, 192, and 240', 'description': 'The percentage of participants with HBsAg Loss at the given time point was summarized. Loss of HBsAg was defined as change of detectable HBsAg from positive to negative.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set, missing = failure method'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Seroconversion to Antibody Against HBV Surface Antigen (Anti-HBs) at Weeks 48, 96, 144, 192, and 240', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenofovir DF', 'description': 'TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily'}, {'id': 'OG001', 'title': 'FTC/Tenofovir DF', 'description': 'FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily'}], 'classes': [{'title': 'Week 48', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Week 96', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Week 144', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.7', 'groupId': 'OG001'}]}]}, {'title': 'Week 192', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.7', 'groupId': 'OG001'}]}]}, {'title': 'Week 240', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline; Weeks 48, 96, 144, 192, and 240', 'description': 'The percentage of participants with seroconversion to anti-HBs at the given time point was summarized. Seroconversion to anti-HBs was defined as change of detectable antibody to HBsAg from negative to positive.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set, missing = failure method'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Virologic Breakthrough at Weeks 48, 96, 144, 192, and 240', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenofovir DF', 'description': 'TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily'}, {'id': 'OG001', 'title': 'FTC/Tenofovir DF', 'description': 'FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily'}], 'classes': [{'title': 'Week 48 (TDF: n=130; FTC/TDF: n=133)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.8', 'groupId': 'OG001'}]}]}, {'title': 'Week 96 (TDF: n=132; FTC/TDF: n=127)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Week 144 (TDF: n=128; FTC/TDF: n=123)', 'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000'}, {'value': '0.8', 'groupId': 'OG001'}]}]}, {'title': 'Week 192 (TDF: n=126; FTC/TDF: n=119)', 'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Week 240 (TDF: n=118; FTC/TDF: n=116)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline; Weeks 48, 96, 144, 192, and 240', 'description': 'The percentage of participants with virologic breakthrough at the given time point was summarized. Virologic breakthrough was defined as having two consecutive 1.0 log10 or greater increases in serum HBV DNA from on-treatment nadir, or two consecutive HBV DNA values ≥ 400 copies/mL after being \\< 400 copies/mL.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set; the missing-equals-excluded method was used in which participants with missing data were excluded from the analysis.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Bone Mineral Density (BMD) of the Spine at Weeks 24, 48, 72, 96, 144, 192, and 240', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenofovir DF', 'description': 'TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily'}, {'id': 'OG001', 'title': 'FTC/Tenofovir DF', 'description': 'FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily'}], 'classes': [{'title': '% Change at Week 24 (TDF: n=132; FTC/TDF: n=127)', 'categories': [{'measurements': [{'value': '-1.74', 'spread': '2.867', 'groupId': 'OG000'}, {'value': '-1.83', 'spread': '2.565', 'groupId': 'OG001'}]}]}, {'title': '% Change at Week 48 (TDF: n=126; FTC/TDF: n=121)', 'categories': [{'measurements': [{'value': '-1.68', 'spread': '3.094', 'groupId': 'OG000'}, {'value': '-1.73', 'spread': '2.944', 'groupId': 'OG001'}]}]}, {'title': '% Change at Week 72 (TDF: n=123; FTC/TDF: n=119)', 'categories': [{'measurements': [{'value': '-1.35', 'spread': '3.337', 'groupId': 'OG000'}, {'value': '-1.95', 'spread': '2.977', 'groupId': 'OG001'}]}]}, {'title': '% Change at Week 96 (TDF: n=126; FTC/TDF: n=114)', 'categories': [{'measurements': [{'value': '-1.24', 'spread': '3.761', 'groupId': 'OG000'}, {'value': '-1.72', 'spread': '3.269', 'groupId': 'OG001'}]}]}, {'title': '% Change at Week 144 (TDF: n=123; FTC/TDF: n=110)', 'categories': [{'measurements': [{'value': '-1.36', 'spread': '3.810', 'groupId': 'OG000'}, {'value': '-1.63', 'spread': '3.591', 'groupId': 'OG001'}]}]}, {'title': '% Change at Week 192 (TDF: n=120; FTC/TDF: n=106)', 'categories': [{'measurements': [{'value': '-1.32', 'spread': '4.237', 'groupId': 'OG000'}, {'value': '-1.60', 'spread': '4.628', 'groupId': 'OG001'}]}]}, {'title': '% Change at Week 240 (TDF: n=115; FTC/TDF: n=102)', 'categories': [{'measurements': [{'value': '-0.83', 'spread': '4.490', 'groupId': 'OG000'}, {'value': '-1.15', 'spread': '5.130', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Weeks 24, 48, 72, 96, 144, 192, and 240', 'description': 'BMD is calculated as grams per cubic centimeter (g/cm\\^2); the mean (SD) percentage change is presented.', 'unitOfMeasure': 'percentage change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Safety Analysis Set (randomized and received at least 1 dose of study drug) with spine BMD measurements at the given time point were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in BMD of the Hip at Weeks 24, 48, 72, 96, 144, 192, and 240', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenofovir DF', 'description': 'TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily'}, {'id': 'OG001', 'title': 'FTC/Tenofovir DF', 'description': 'FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily'}], 'classes': [{'title': '% Change at Week 24 (TDF: n=130; FTC/TDF: n=127)', 'categories': [{'measurements': [{'value': '-0.71', 'spread': '1.724', 'groupId': 'OG000'}, {'value': '-0.59', 'spread': '1.835', 'groupId': 'OG001'}]}]}, {'title': '% Change at Week 48 (TDF: n=126; FTC/TDF: n=118)', 'categories': [{'measurements': [{'value': '-1.15', 'spread': '2.120', 'groupId': 'OG000'}, {'value': '-1.00', 'spread': '2.063', 'groupId': 'OG001'}]}]}, {'title': '% Change at Week 72 (TDF: n=121; FTC/TDF: n=115)', 'categories': [{'measurements': [{'value': '-1.59', 'spread': '2.507', 'groupId': 'OG000'}, {'value': '-1.61', 'spread': '2.525', 'groupId': 'OG001'}]}]}, {'title': '% Change at Week 96 (TDF: n=125; FTC/TDF: n=112)', 'categories': [{'measurements': [{'value': '-1.70', 'spread': '2.617', 'groupId': 'OG000'}, {'value': '-1.77', 'spread': '2.801', 'groupId': 'OG001'}]}]}, {'title': '% Change at Week 144 (TDF: n=120; FTC/TDF: n=107)', 'categories': [{'measurements': [{'value': '-2.02', 'spread': '3.030', 'groupId': 'OG000'}, {'value': '-1.91', 'spread': '3.281', 'groupId': 'OG001'}]}]}, {'title': '% Change at Week 192 (TDF: n=116; FTC/TDF: n=105)', 'categories': [{'measurements': [{'value': '-2.33', 'spread': '3.190', 'groupId': 'OG000'}, {'value': '-2.41', 'spread': '3.783', 'groupId': 'OG001'}]}]}, {'title': '% Change at Week 240 (TDF: n=111; FTC/TDF: n=100)', 'categories': [{'measurements': [{'value': '-2.46', 'spread': '3.191', 'groupId': 'OG000'}, {'value': '-2.63', 'spread': '3.872', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Weeks 24, 48, 72, 96, 144, 192, and 240', 'description': 'BMD is calculated as g/cm\\^2; the mean (SD) percentage change is presented.', 'unitOfMeasure': 'percentage change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Safety Analysis Set with hip BMD measurements at the given time point were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Development of Drug-resistant Mutations (DRMs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenofovir DF', 'description': 'TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily'}, {'id': 'OG001', 'title': 'FTC/Tenofovir DF', 'description': 'FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily'}], 'classes': [{'title': 'New tenofovir DF DRMs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Enrichment of tenofovir DF DRMs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'New FTC DRMs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Enrichment of FTC DRMs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 240', 'description': 'The development of DRMs was summarized, either as development of new DRMs or enrichment of existing DRMs.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tenofovir DF', 'description': 'Tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg tablet once daily plus emtricitabine (FTC)/TDF placebo tablet once daily'}, {'id': 'FG001', 'title': 'FTC/Tenofovir DF', 'description': 'FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily'}], 'periods': [{'title': 'Treatment Period Through Week 240', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '141'}, {'groupId': 'FG001', 'numSubjects': '139'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '121'}, {'groupId': 'FG001', 'numSubjects': '118'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '21'}]}], 'dropWithdraws': [{'type': "Investigator's Discretion", 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Withdrew Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Safety, Tolerability, or Efficacy Reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Study Discontinued by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Treatment-Free Follow-up (TFFU) Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '1 participant not completing the 240 week treatment period enrolled in the TFFU period.', 'groupId': 'FG000', 'numSubjects': '38'}, {'comment': '4 participants not completing the 240 week treatment period enrolled in the TFFU period.', 'groupId': 'FG001', 'numSubjects': '37'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '18'}]}], 'dropWithdraws': [{'type': 'Started Commercial Therapy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrew Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were enrolled at study sites in North America, Europe, and New Zealand. The first participant was screened on 30 September 2008. The last study visit occurred on 09 February 2015.', 'preAssignmentDetails': '752 participants were screened. Randomization was stratified by hepatitis B e antigen (HBeAg) status (negative or positive) and alanine aminotransferase (ALT) level (≥ 2 × upper limit of normal \\[ULN\\] or \\< 2 × ULN) at screening.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'BG000'}, {'value': '139', 'groupId': 'BG001'}, {'value': '280', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Tenofovir DF', 'description': 'TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily'}, {'id': 'BG001', 'title': 'FTC/Tenofovir DF', 'description': 'FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '47.1', 'spread': '13.63', 'groupId': 'BG000'}, {'value': '46.3', 'spread': '13.56', 'groupId': 'BG001'}, {'value': '46.7', 'spread': '13.58', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '104', 'groupId': 'BG000'}, {'value': '107', 'groupId': 'BG001'}, {'value': '211', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '138', 'groupId': 'BG000'}, {'value': '137', 'groupId': 'BG001'}, {'value': '275', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '172', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Austria', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Bulgaria', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}]}, {'title': 'Czech Republic', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Greece', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Hungary', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'New Zealand', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}, {'title': 'Romania', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}, {'title': 'Serbia', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Turkey', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'ALT Normal at Baseline', 'classes': [{'title': 'Abnormal', 'categories': [{'measurements': [{'value': '79', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '162', 'groupId': 'BG002'}]}]}, {'title': 'Normal', 'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'The ULN was 43 U/L for males and 34 U/L for females aged 18 to \\< 69, and 35 U/L for males and 32 U/L for females aged ≥ 69.', 'unitOfMeasure': 'participants'}, {'title': 'Hepatitis B Virus (HBV) DNA Level at Baseline', 'classes': [{'categories': [{'measurements': [{'value': '6.40', 'spread': '1.826', 'groupId': 'BG000'}, {'value': '6.53', 'spread': '1.968', 'groupId': 'BG001'}, {'value': '6.46', 'spread': '1.896', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'log_10 copies/mL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'HBV e Antigen (HBeAg) Status at Baseline', 'classes': [{'title': 'Negative', 'categories': [{'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '147', 'groupId': 'BG002'}]}]}, {'title': 'Positive', 'categories': [{'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 280}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-09', 'studyFirstSubmitDate': '2008-08-15', 'resultsFirstSubmitDate': '2012-11-15', 'studyFirstSubmitQcDate': '2008-08-15', 'lastUpdatePostDateStruct': {'date': '2016-03-11', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-03-01', 'studyFirstPostDateStruct': {'date': '2008-08-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-04-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With HBV DNA < 400 Copies/mL at Week 96', 'timeFrame': 'Week 96'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 48, 144, 192, and 240', 'timeFrame': 'Weeks 48, 144, 192, and 240'}, {'measure': 'Percentage of Participants With HBV DNA < 169 Copies/mL at Weeks 48, 96, 144, 192, and 240', 'timeFrame': 'Weeks 48, 96, 144, 192, and 240'}, {'measure': 'HBV DNA Level at Weeks 48, 96, 144, 192, and 240', 'timeFrame': 'Weeks 48, 96, 144, 192, and 240'}, {'measure': 'Percentage of Participants With Normal ALT at Weeks 48, 96, 144, 192, and 240', 'timeFrame': 'Weeks 48, 96, 144, 192, and 240', 'description': 'Normal ALT was defined as having a value less than or equal to the ULN. The ULN was 43 U/L for males and 34 U/L for females aged 18 to \\< 69, and 35 U/L for males and 32 U/L for females aged ≥ 69.'}, {'measure': 'Percentage of Participants With HBeAg Loss at Weeks 48, 96, 144, 192, and 240', 'timeFrame': 'Baseline; Weeks 48, 96, 144, 192, and 240', 'description': 'The percentage of participants who were HBeAg positive at baseline and who had HBeAg Loss at the given time point was summarized. Loss of HBeAg was defined as change of detectable HBeAg from positive to negative.'}, {'measure': 'Percentage of Participants With Seroconversion to Antibody Against HBeAg (Anti-HBe) at Weeks 48, 96, 144, 192, and 240', 'timeFrame': 'Baseline; Weeks 48, 96, 144, 192, and 240', 'description': 'The percentage of participants who were HBeAg positive at baseline and who had seroconversion to anti-HBe at the given time point was summarized. Seroconversion to anti-HBe was defined as change of detectable antibody to HBeAg from negative to positive.'}, {'measure': 'Percentage of Participants With HBV Surface Antigen (HBsAg) Loss at Weeks 48, 96, 144, 192, and 240', 'timeFrame': 'Baseline; Weeks 48, 96, 144, 192, and 240', 'description': 'The percentage of participants with HBsAg Loss at the given time point was summarized. Loss of HBsAg was defined as change of detectable HBsAg from positive to negative.'}, {'measure': 'Percentage of Participants With Seroconversion to Antibody Against HBV Surface Antigen (Anti-HBs) at Weeks 48, 96, 144, 192, and 240', 'timeFrame': 'Baseline; Weeks 48, 96, 144, 192, and 240', 'description': 'The percentage of participants with seroconversion to anti-HBs at the given time point was summarized. Seroconversion to anti-HBs was defined as change of detectable antibody to HBsAg from negative to positive.'}, {'measure': 'Percentage of Participants With Virologic Breakthrough at Weeks 48, 96, 144, 192, and 240', 'timeFrame': 'Baseline; Weeks 48, 96, 144, 192, and 240', 'description': 'The percentage of participants with virologic breakthrough at the given time point was summarized. Virologic breakthrough was defined as having two consecutive 1.0 log10 or greater increases in serum HBV DNA from on-treatment nadir, or two consecutive HBV DNA values ≥ 400 copies/mL after being \\< 400 copies/mL.'}, {'measure': 'Percent Change From Baseline in Bone Mineral Density (BMD) of the Spine at Weeks 24, 48, 72, 96, 144, 192, and 240', 'timeFrame': 'Baseline; Weeks 24, 48, 72, 96, 144, 192, and 240', 'description': 'BMD is calculated as grams per cubic centimeter (g/cm\\^2); the mean (SD) percentage change is presented.'}, {'measure': 'Percent Change From Baseline in BMD of the Hip at Weeks 24, 48, 72, 96, 144, 192, and 240', 'timeFrame': 'Baseline; Weeks 24, 48, 72, 96, 144, 192, and 240', 'description': 'BMD is calculated as g/cm\\^2; the mean (SD) percentage change is presented.'}, {'measure': 'Development of Drug-resistant Mutations (DRMs)', 'timeFrame': 'Baseline to Week 240', 'description': 'The development of DRMs was summarized, either as development of new DRMs or enrichment of existing DRMs.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Tenofovir DF', 'Emtricitabine', 'Chronic hepatitis B', 'Combination therapy'], 'conditions': ['Hepatitis B']}, 'referencesModule': {'references': [{'pmid': '24929235', 'type': 'RESULT', 'citation': 'Corsa AC, Liu Y, Flaherty JF, Mitchell B, Fung SK, Gane E, Miller MD, Kitrinos KM. No resistance to tenofovir disoproxil fumarate through 96 weeks of treatment in patients with lamivudine-resistant chronic hepatitis B. Clin Gastroenterol Hepatol. 2014 Dec;12(12):2106-12.e1. doi: 10.1016/j.cgh.2014.05.024. Epub 2014 Jun 11.'}, {'pmid': '24861361', 'type': 'RESULT', 'citation': 'Liu Y, Fung S, Gane EJ, Dinh P, Flaherty JF, Svarovskaia ES, Miller MD, Kitrinos KM. Evaluation of HBV DNA decay kinetics in patients containing both rtM204V/I mutant and wild-type HBV subpopulations during tenofovir DF (TDF) monotherapy or combination therapy with emtricitabine (FTC)/TDF. J Med Virol. 2014 Sep;86(9):1473-81. doi: 10.1002/jmv.23982. Epub 2014 May 23.'}, {'pmid': '24368224', 'type': 'RESULT', 'citation': 'Fung S, Kwan P, Fabri M, Horban A, Pelemis M, Hann HW, Gurel S, Caruntu FA, Flaherty JF, Massetto B, Dinh P, Corsa A, Subramanian GM, McHutchison JG, Husa P, Gane E. Randomized comparison of tenofovir disoproxil fumarate vs emtricitabine and tenofovir disoproxil fumarate in patients with lamivudine-resistant chronic hepatitis B. Gastroenterology. 2014 Apr;146(4):980-8. doi: 10.1053/j.gastro.2013.12.028. Epub 2013 Dec 22.'}, {'pmid': '27545497', 'type': 'DERIVED', 'citation': 'Fung S, Kwan P, Fabri M, Horban A, Pelemis M, Hann HW, Gurel S, Caruntu FA, Flaherty JF, Massetto B, Kim K, Kitrinos KM, Subramanian GM, McHutchison JG, Yee LJ, Elkhashab M, Berg T, Sporea I, Yurdaydin C, Husa P, Jablkowski MS, Gane E. Tenofovir disoproxil fumarate (TDF) vs. emtricitabine (FTC)/TDF in lamivudine resistant hepatitis B: A 5-year randomised study. J Hepatol. 2017 Jan;66(1):11-18. doi: 10.1016/j.jhep.2016.08.008. Epub 2016 Aug 18.'}]}, 'descriptionModule': {'briefSummary': 'The aim of therapy for the treatment of chronic hepatitis B virus (HBV) is to maintain suppression of viral replication to prevent the emergence of complications, which requires long-term therapy. Durable suppression of viral replication is achieved in the treatment of chronic viral diseases by preventing of the emergence of drug-resistant mutations. The clinical guidelines for the management of lamivudine resistant patients are variable. Some recommend switching to another agent without cross-resistance, while others recommend adding on another agent without cross-resistance. Limited clinical data exists to demonstrate whether tenofovir disoproxil fumarate (tenofovir DF; TDF) is an effective monotherapy for lamivudine resistant patients or if it should be used as part of a combination therapy regimen.\n\nThis study is designed to evaluate the effectiveness, safety, and tolerability of tenofovir DF monotherapy versus emtricitabine (FTC)/tenofovir DF combination therapy in participants with chronic HBV with lamivudine resistance (presence of the rtM204I/V mutation with or without the rtL180M mutation) over a 240-week period. Participants in this study must be receiving lamivudine treatment at the time of enrollment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Chronic HBV infection, defined as positive serum HBsAg for at least 6 months\n* 18 through 75 years of age, inclusive\n* HBV DNA ≥ 10\\^3 IU/mL\n* Receiving treatment with lamivudine with confirmation of HBV reverse transcriptase mutation(s) known to confer resistance to lamivudine (rtM204I/V with or without rtL180M) by central laboratory assessment prior to randomization; adefovir dipivoxil treatment of ≤ 48 weeks at the time of screening (inclusive of combination adefovir dipivoxil + lamivudine at entry) was allowed\n* Willing and able to provide written informed consent\n* Negative serum pregnancy test (for females of childbearing potential only)\n* Calculated creatinine clearance ≥ 50 mL/min\n* Hemoglobin ≥ 10 g/dL\n* Neutrophils ≥ 1000 /mm\\^3\n* No prior oral HBV therapy with approved nucleotide and/or nucleoside therapy or other investigational agents for HBV infection other than lamivudine or adefovir dipivoxil\n\nExclusion Criteria\n\n* Pregnant women, women who are breast feeding or who believe they may wish to become pregnant during the course of the study\n* Males and females of reproductive potential who are not willing to use an effective method of contraception during the study\n* Alanine aminotransferase (ALT) ≥ 10 × the upper limit of the normal range (ULN)\n* Decompensated liver disease\n* Interferon or pegylated interferon therapy within 6 months of the screening visit\n* Alpha fetoprotein \\> 50 ng/mL\n* Evidence of hepatocellular carcinoma\n* Coinfection with hepatitis C virus, HIV, or hepatitis D virus\n* Significant renal, cardiovascular, pulmonary, or neurological disease\n* Received solid organ or bone marrow transplantation\n* Receiving therapy with immunomodulators (eg, corticosteroids, etc.), investigational agents, nephrotoxic agents, or agents susceptible of modifying renal excretion\n* Proximal tubulopathy\n* Known hypersensitivity to the study drugs, the metabolites or formulation excipients'}, 'identificationModule': {'nctId': 'NCT00737568', 'briefTitle': 'Tenofovir Disoproxil Fumarate (Tenofovir DF) Versus Emtricitabine/Tenofovir DF in Subjects Resistant to Lamivudine', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gilead Sciences'}, 'officialTitle': 'A Phase 3b, Randomized, Double-Blind, Double-Dummy Study Evaluating the Antiviral Efficacy, Safety, and Tolerability of Tenofovir Disoproxil Fumarate (DF) Monotherapy Versus Emtricitabine Plus Tenofovir DF Fixed-Dose Combination Therapy in Subjects With Chronic Hepatitis B Who Are Resistant to Lamivudine', 'orgStudyIdInfo': {'id': 'GS-US-174-0121'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tenofovir DF', 'description': 'TDF plus placebo to match FTC/TDF', 'interventionNames': ['Drug: TDF', 'Drug: FTC/TDF Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'FTC/TDF', 'description': 'FTC/TDF plus placebo to match TDF', 'interventionNames': ['Drug: FTC/TDF', 'Drug: TDF Placebo']}], 'interventions': [{'name': 'TDF', 'type': 'DRUG', 'otherNames': ['Viread®'], 'description': 'Tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg tablet administered orally once daily', 'armGroupLabels': ['Tenofovir DF']}, {'name': 'FTC/TDF', 'type': 'DRUG', 'otherNames': ['Truvada®'], 'description': 'Emtricitabine (FTC)/TDF 200/300 mg fixed-dose combination tablet administered orally once daily', 'armGroupLabels': ['FTC/TDF']}, {'name': 'TDF Placebo', 'type': 'DRUG', 'description': 'TDF placebo tablet administered orally once daily', 'armGroupLabels': ['FTC/TDF']}, {'name': 'FTC/TDF Placebo', 'type': 'DRUG', 'description': 'FTC/TDF placebo tablet administered orally once daily', 'armGroupLabels': ['Tenofovir DF']}]}, 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