Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2026-01-02 @ 5:29 AM
Study NCT ID:
NCT02224456
Status:
COMPLETED
Last Update Posted:
2022-02-14
First Post:
2014-08-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety Study of Tenofovir Disoproxil Fumarate (TDF) in Chinese Chronic Hepatitis B (CHB) Subjects With Advanced Fibrosis & Compensated Cirrhosis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019694', 'term': 'Hepatitis B, Chronic'}, {'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}, {'id': 'D005355', 'term': 'Fibrosis'}], 'ancestors': [{'id': 'D006509', 'term': 'Hepatitis B'}, {'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': 'D006521', 'term': 'Hepatitis, Chronic'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068698', 'term': 'Tenofovir'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'GSKClinicalSupportHD@gsk.com', 'phone': '866-435-7343', 'title': 'GSK Reponse Center', 'organization': 'GlaxoSmithKline'}, 'certainAgreement': {'otherDetails': 'GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.', 'description': 'Safety analysis population was used to collect the adverse events', 'eventGroups': [{'id': 'EG000', 'title': 'Tenofovir Disoproxil Fumarate 300 mg', 'description': 'Participants received Tenofovir Disoproxil Fumarate 300 mg tablet once daily (QD) orally for 240 weeks.', 'otherNumAtRisk': 195, 'deathsNumAtRisk': 195, 'otherNumAffected': 129, 'seriousNumAtRisk': 195, 'deathsNumAffected': 2, 'seriousNumAffected': 34}], 'otherEvents': [{'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 36}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pulmonary tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Urethritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Vulvovaginal mycotic infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Myringitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Herpes virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Tonsillitis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Vaginal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Epigastric discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Gastric ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Chronic gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Haemorrhoidal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Gastrointestinal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Abdominal mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Dysbacteriosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Duodenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Haemorrhoids thrombosed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Intestinal polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Protein urine present', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Blood phosphorus decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Alpha 1 foetoprotein increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Blood urine present', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Blood uric acid increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Red blood cells urine positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hepatitis B DNA increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Glomerular filtration rate decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Creatinine renal clearance decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Blood urine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Blood lactate dehydrogenase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hypophosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 15}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hyperuricaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hypermagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 9}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Splenomegaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Coagulopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 5}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hepatic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Liver injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hyperbilirubinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hepatic steatosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hepatic function abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Gallbladder polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Renal injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Renal cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hypertonic bladder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Osteoporosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Spinal osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Animal bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Ligament sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Joint injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Ligament injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Thermal burn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Skin wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Rhinitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Nasal dryness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Nasal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Psoriasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Leukoderma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Menstruation irregular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Uterine enlargement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pelvic fluid collection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Breast hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Menstruation delayed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Sleep disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hepatocellular carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Uterine leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Vitreous floaters', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Retinal vein occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Transaminases increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}], 'seriousEvents': [{'term': 'Hepatocellular carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 13}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Malignant melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Ovarian germ cell teratoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Foot fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Lower limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Post procedural bile leak', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Radius fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Spinal compression fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Tibia fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Bile duct stone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hepatic cirrhosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Rheumatic fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Synovial cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Nasal polyps', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Nasal septum deviation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Rhinitis hypertrophic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Vertigo positional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Uterine adhesions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Ureterolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hypersplenism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Rheumatic heart disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Chronic gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Chest X-ray abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Incidence Rate of Newly Diagnosed Hepatocellular Carcinoma (HCC) at Week 240', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenofovir Disoproxil Fumarate 300 mg', 'description': 'Participants received Tenofovir Disoproxil Fumarate 300 mg tablet once daily (QD) orally for 240 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.045', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 240', 'description': 'The newly diagnosed HCC was defined as HCC cases from Week 24 to Week 240 and the participants were required to meet one of the following criteria: without HCC before Week 24; a histological diagnosis of HCC (i.e. by biopsy or at post-mortem); participants with nodules \\>2 centimeter (cm), identification of typical HCC characteristics (hyper-vascular in the arterial phase with washout in the portal venous or delayed phases) by 4-phase multi-detector computed tomography (CT) scan or dynamic contrast-enhanced magnetic resonance imaging (MRI); participants with nodules \\>1 cm, identification of typical HCC characteristics by both techniques (4-phase multi-detector CT and dynamic contrast-enhanced MRI).', 'unitOfMeasure': 'Events per person-year', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-treat (mITT) Population consisted of all recruited participants who received at least one dose of study medication.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Disease Progression at Week 240', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenofovir Disoproxil Fumarate 300 mg', 'description': 'Participants received Tenofovir Disoproxil Fumarate 300 mg tablet once daily (QD) orally for 240 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 240', 'description': 'Disease progression was defined as the first occurrence of any one of the following criteria: 1) an increase in Childs-Pugh score of 2 or more points from Baseline; 2) an increase in Childs-Pugh score of 2 or more points, solely based on laboratory parameters (i.e. bilirubin, prothrombin time and/or albumin) confirmed between two consecutive visits at least one month apart; 3) spontaneous bacterial peritonitis (with proven sepsis); 4) renal insufficiency; 5) bleeding gastric/esophageal varices; 6) hepatocellular carcinoma; 7)liver-related death.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Newly Diagnosed Hepatocellular Carcinoma (HCC) at Week 48, Week 96, Week 144 and Week 192', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenofovir Disoproxil Fumarate 300 mg', 'description': 'Participants received Tenofovir Disoproxil Fumarate 300 mg tablet once daily (QD) orally for 240 weeks.'}], 'classes': [{'title': 'Week 48', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 96', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 144', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Week 192', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 48, Week 96, Week 144 and Week 192', 'description': 'The newly diagnosed HCC was defined as HCC cases from Week 24 to Week 240 and the participants were required to meet one of the following criteria: without HCC before Week 24; a histological diagnosis of HCC (i.e. by biopsy or at post-mortem); participants with nodules \\>2 centimeter (cm), identification of typical HCC characteristics (hyper-vascular in the arterial phase with washout in the portal venous or delayed phases) by 4-phase multi-detector computed tomography (CT) scan or dynamic contrast-enhanced magnetic resonance imaging (MRI); participants with nodules \\>1 cm, identification of typical HCC characteristics by both techniques (4-phase multi-detector CT and dynamic contrast-enhanced MRI).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Newly Diagnosed Hepatocellular Carcinoma (HCC) at Week 48, Week 96, Week 144, Week 192 and Week 240', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenofovir Disoproxil Fumarate 300 mg', 'description': 'Participants received Tenofovir Disoproxil Fumarate 300 mg tablet once daily (QD) orally for 240 weeks.'}], 'classes': [{'title': 'Week 48', 'categories': [{'measurements': [{'value': '0', 'comment': 'NA indicates that 95% CI could not be calculated due to insufficient participants with events', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Week 96', 'categories': [{'measurements': [{'value': '0', 'comment': 'NA indicates that 95% CI could not be calculated due to insufficient participants with events', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Week 144', 'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '4.3'}]}]}, {'title': 'Week 192', 'categories': [{'measurements': [{'value': '4.6', 'groupId': 'OG000', 'lowerLimit': '1.4', 'upperLimit': '7.8'}]}]}, {'title': 'Week 240', 'categories': [{'measurements': [{'value': '5.6', 'groupId': 'OG000', 'lowerLimit': '2.1', 'upperLimit': '9.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 48, Week 96, Week 144, Week 192 and Week 240', 'description': 'The newly diagnosed HCC was defined as HCC cases from Week 24 to Week 240 and the participants were required to meet one of the following criteria: without HCC before Week 24; a histological diagnosis of HCC (i.e. by biopsy or at post-mortem); participants with nodules \\>2 centimeter (cm), identification of typical HCC characteristics (hyper-vascular in the arterial phase with washout in the portal venous or delayed phases) by 4-phase multi-detector computed tomography (CT) scan or dynamic contrast-enhanced magnetic resonance imaging (MRI); participants with nodules \\>1 cm, identification of typical HCC characteristics by both techniques (4-phase multi-detector CT and dynamic contrast-enhanced MRI).The cumulative percentage of participants with newly diagnosed Hepatocellular Carcinoma has been presented along with 95% confidence interval (CI) (Wald method).', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Disease Progression at Week 48, Week 96, Week 144, Week 192 and Week 240', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenofovir Disoproxil Fumarate 300 mg', 'description': 'Participants received Tenofovir Disoproxil Fumarate 300 mg tablet once daily (QD) orally for 240 weeks.'}], 'classes': [{'title': 'Week 48', 'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '4.3'}]}]}, {'title': 'Week 96', 'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '5.0'}]}]}, {'title': 'Week 144', 'categories': [{'measurements': [{'value': '4.1', 'groupId': 'OG000', 'lowerLimit': '1.1', 'upperLimit': '7.1'}]}]}, {'title': 'Week 192', 'categories': [{'measurements': [{'value': '7.2', 'groupId': 'OG000', 'lowerLimit': '3.3', 'upperLimit': '11.1'}]}]}, {'title': 'Week 240', 'categories': [{'measurements': [{'value': '7.2', 'groupId': 'OG000', 'lowerLimit': '3.3', 'upperLimit': '11.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 48, Week 96, Week 144, Week 192 and Week 240', 'description': 'Disease progression was defined as the first occurrence of any one of the following criteria: 1) an increase in Childs-Pugh score of 2 or more points from Baseline; 2) an increase in Childs-Pugh score of 2 or more points, solely based on laboratory parameters (i.e. bilirubin, prothrombin time and/or albumin) confirmed between two consecutive visits at least one month apart; 3) spontaneous bacterial peritonitis (with proven sepsis); 4) renal insufficiency; 5) bleeding gastric/oesophageal varices; 6) hepatocellular carcinoma; 7) liver-related death. The cumulative percentage of participants with disease progression has been presented along with 95% CI (Wald method).', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Liver Stiffness Measure at Week 48, Week 96, Week 144, Week 192 and Week 240', 'denoms': [{'units': 'Participants', 'counts': [{'value': '182', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenofovir Disoproxil Fumarate 300 mg', 'description': 'Participants received Tenofovir Disoproxil Fumarate 300 mg tablet once daily (QD) orally for 240 weeks.'}], 'classes': [{'title': 'Week 48, n=182', 'denoms': [{'units': 'Participants', 'counts': [{'value': '182', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.3', 'spread': '4.84', 'groupId': 'OG000'}]}]}, {'title': 'Week 96, n= 176', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.7', 'spread': '5.60', 'groupId': 'OG000'}]}]}, {'title': 'Week 144, n= 175', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.1', 'spread': '5.85', 'groupId': 'OG000'}]}]}, {'title': 'Week 192, n=167', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.1', 'spread': '7.82', 'groupId': 'OG000'}]}]}, {'title': 'Week 240, n= 131', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-6.2', 'spread': '5.55', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 0), Week 48, Week 96, Week 144, Week 192 and Week 240', 'description': 'Liver stiffness measure was obtained by a non-invasive transient elastography using FibroScan. Baseline is defined as the last assessment (Day 0) before administration of the study drug. Change from Baseline is defined as post-dose visit value minus Baseline value', 'unitOfMeasure': 'Kilopascals', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Serum Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) <20 International Units Per Milliliter (IU/mL) at Weeks 48, 96, 144, 192 and 240', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenofovir Disoproxil Fumarate 300 mg', 'description': 'Participants received Tenofovir Disoproxil Fumarate 300 mg tablet once daily (QD) orally for 240 weeks.'}], 'classes': [{'title': 'Week 48, n=191', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '81.2', 'groupId': 'OG000', 'lowerLimit': '75.3', 'upperLimit': '87.0'}]}]}, {'title': 'Week 96, n=188', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '88.8', 'groupId': 'OG000', 'lowerLimit': '84.1', 'upperLimit': '93.6'}]}]}, {'title': 'Week 144, n=185', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '94.1', 'groupId': 'OG000', 'lowerLimit': '90.4', 'upperLimit': '97.7'}]}]}, {'title': 'Week 192, n=174', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '97.7', 'groupId': 'OG000', 'lowerLimit': '95.2', 'upperLimit': '100.0'}]}]}, {'title': 'Week 240, n=160', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '99.4', 'groupId': 'OG000', 'lowerLimit': '97.8', 'upperLimit': '100.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 48, Week 96, Week 144, Week 192 and Week 240', 'description': 'Serum samples were collected for the analysis of HBV DNA levels using Roche Cobas Taqman HBV test. Confidence interval was calculated by normal approximation and continuity correction method.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Logarithm to the Base 10 (Log 10) Serum HBV DNA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenofovir Disoproxil Fumarate 300 mg', 'description': 'Participants received Tenofovir Disoproxil Fumarate 300 mg tablet once daily (QD) orally for 240 weeks.'}], 'classes': [{'title': 'Week 48, n=191', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.2', 'spread': '1.40', 'groupId': 'OG000'}]}]}, {'title': 'Week 96, n=188', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.3', 'spread': '1.44', 'groupId': 'OG000'}]}]}, {'title': 'Week 144, n=185', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.3', 'spread': '1.48', 'groupId': 'OG000'}]}]}, {'title': 'Week 192, n=174', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.2', 'spread': '1.50', 'groupId': 'OG000'}]}]}, {'title': 'Week 240, n=160', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.3', 'spread': '1.46', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 0) and Week 48, Week 96, Week 144, Week 192 and Week 240', 'description': 'Serum samples were collected for the analysis of HBV DNA levels. Baseline is defined as the last assessment (Day 0) before administration of the study drug. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.', 'unitOfMeasure': 'Log 10 (IU/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Week 48, Week 96, Week 144, Week 192 and Week 240 in Participants Who Had Abnormal ALT at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenofovir Disoproxil Fumarate 300 mg', 'description': 'Participants received Tenofovir Disoproxil Fumarate 300 mg tablet once daily (QD) orally for 240 weeks.'}], 'classes': [{'title': 'Week 48, n=97', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '63.9', 'groupId': 'OG000', 'lowerLimit': '53.8', 'upperLimit': '74.0'}]}]}, {'title': 'Week 96, n= 97', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '66.0', 'groupId': 'OG000', 'lowerLimit': '56.0', 'upperLimit': '75.9'}]}]}, {'title': 'Week 144, n=96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '70.8', 'groupId': 'OG000', 'lowerLimit': '61.2', 'upperLimit': '80.4'}]}]}, {'title': 'Week 192, n=93', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '82.8', 'groupId': 'OG000', 'lowerLimit': '74.6', 'upperLimit': '91.0'}]}]}, {'title': 'Week 240, n=87', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '82.8', 'groupId': 'OG000', 'lowerLimit': '74.2', 'upperLimit': '91.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 48, Week 96, Week 144, Week 192 and Week 240', 'description': 'Blood samples were collected for evaluation of ALT at indicated time points. ALT normalization is defined as ALT outside the normal range at Baseline and within the normal range at Week 48, Week 96, Week 144, Week 192 and Week 240. Normal range of ALT is 7 to 56 International Units per liter. Percentage of participants with ALT normalization at Weeks 48, 96, 144, 192 and 240 in participants who had abnormal ALT at Baseline (Day 0) have been presented. Confidence interval was calculated using normal approximation and continuity correction method.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles.'}, {'type': 'SECONDARY', 'title': 'Percentage of Hepatitis B e Antigen (HBeAg) Positive Participants Achieving HBeAg Loss, HBeAg Seroconversion at Week 48, Week 96, Week 144, Week 192 and Week 240.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenofovir Disoproxil Fumarate 300 mg', 'description': 'Participants received Tenofovir Disoproxil Fumarate 300 mg tablet once daily (QD) orally for 240 weeks.'}], 'classes': [{'title': 'Week 48, HBeAg Loss, n=94', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '18.1', 'groupId': 'OG000', 'lowerLimit': '9.8', 'upperLimit': '26.4'}]}]}, {'title': 'Week 48, HBeAg Seroconversion, n=94', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.6', 'groupId': 'OG000', 'lowerLimit': '3.1', 'upperLimit': '16.1'}]}]}, {'title': 'Week 96, HBeAg , n=94', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '33.0', 'groupId': 'OG000', 'lowerLimit': '22.9', 'upperLimit': '43.0'}]}]}, {'title': 'Week 96, HBeAg Seroconversion, n=94', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14.9', 'groupId': 'OG000', 'lowerLimit': '7.2', 'upperLimit': '22.6'}]}]}, {'title': 'Week 144, HBeAg Loss, n=90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '35.6', 'groupId': 'OG000', 'lowerLimit': '24.5', 'upperLimit': '45.1'}]}]}, {'title': 'Week 144, HBeAg Seroconversion, n=90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14.4', 'groupId': 'OG000', 'lowerLimit': '6.5', 'upperLimit': '21.8'}]}]}, {'title': 'Week 192, HBeAg Loss, n=90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '47.8', 'groupId': 'OG000', 'lowerLimit': '36.4', 'upperLimit': '58.1'}]}]}, {'title': 'Week 192, HBeAg Seroconversion, n=90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000', 'lowerLimit': '8.3', 'upperLimit': '24.7'}]}]}, {'title': 'Week 240, HBeAg Loss, n=82', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '51.2', 'groupId': 'OG000', 'lowerLimit': '38.7', 'upperLimit': '61.3'}]}]}, {'title': 'Week 240, HBeAg Seroconversion, n=82', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '23.2', 'groupId': 'OG000', 'lowerLimit': '13.1', 'upperLimit': '32.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 48, Week 96, Week 144, Week 192 and Week 240', 'description': 'Serological response was assessed at Week 48, Week 96, Week 144, Week 192 and Week 240 in participants with Positive HBeAg at Baseline (Day 0). It was presented as HBeAg Loss and HBeAg Seroconversion. HBeAg Loss was defined as HBeAg changed to be negative. HBeAg seroconversion was defined as HBeAg changed to negative and HBeAb was positive. Confidence interval was calculated using normal approximation and continuity correction method.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles.)'}, {'type': 'SECONDARY', 'title': 'Percentage of HBeAg Negative Participants Achieving HBsAg Loss and HBsAg Seroconversion at Week 48, Week 96, Week 144, Week 192 and Week 240', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenofovir Disoproxil Fumarate 300 mg', 'description': 'Participants received Tenofovir Disoproxil Fumarate 300 mg tablet once daily (QD) orally for 240 weeks.'}], 'classes': [{'title': 'Week 48, HBsAg Loss, n=97', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '3.6'}]}]}, {'title': 'Week 48, HBsAg Seroconversion, n=97', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '3.6'}]}]}, {'title': 'Week 96, HBsAg , n=93', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.5'}]}]}, {'title': 'Week 96, HBsAg Seroconversion, n=93', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.5'}]}]}, {'title': 'Week 144, HBsAg Loss, n=93', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.2', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '7.4'}]}]}, {'title': 'Week 144, HBsAg Seroconversion, n=93', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.5'}]}]}, {'title': 'Week 192, HBsAg Loss, n=89', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '9.4'}]}]}, {'title': 'Week 192, HBsAg Seroconversion, n=89', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '5.9'}]}]}, {'title': 'Week 240, HBsAg Loss, n=77', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.2', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '10.8'}]}]}, {'title': 'Week 240, HBsAg Seroconversion, n=77', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '4.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 48, Week 96, Week 144, Week 192 and Week 240', 'description': 'Serological response was assessed at Week 48, Week 96, Week 144, Week 192 and Week 240 in participants with negative HBeAg at Baseline (Day 0). HBsAg Loss was defined as HBsAg changed to be negative. HBsAg seroconversion was defined as HBsAg changed to negative and HBsAb was positive.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles.)'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Experienced Viral Breakthrough', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenofovir Disoproxil Fumarate 300 mg', 'description': 'Participants received Tenofovir Disoproxil Fumarate 300 mg tablet once daily (QD) orally for 240 weeks.'}], 'classes': [{'title': 'Week 48, n=195', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'comment': 'NA indicates that 95% CI could not be calculated due to insufficient participants with events', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Week 96, n=195', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'comment': 'NA indicates that 95% CI could not be calculated due to insufficient participants with events', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Week 144, n=185', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.9'}]}]}, {'title': 'Week 192, n=180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.9'}]}]}, {'title': 'Week 240, n=161', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 48, Week 96, Week 144, Week 192 and Week 240', 'description': 'Viral breakthrough was defined as \\>=1 log10 increase in HBV DNA from nadir determined by two sequential HBV DNA measurements. Percentage of Participants who experienced viral breakthrough at Week 48, Week 96, Week 144, Week 192 and Week 240 is presented.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles.)'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Histological Improvement at Week 216', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenofovir Disoproxil Fumarate 300 mg', 'description': 'Participants received Tenofovir Disoproxil Fumarate 300 mg tablet once daily (QD) orally for 240 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '45.2', 'groupId': 'OG000', 'lowerLimit': '26.0', 'upperLimit': '64.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 216', 'description': 'The Knodell scoring system, also called the Histologic Activity Index (HAI), classifies liver biopsy specimens according to scores into 4 categories of histologic features: (I) Periportal or periseptal interface hepatitis (piecemeal necrosis) (scores from 0, 1, 2, 3, 4 or 10); (II) Confluent necrosis (scores from 0, 1, 3, 4, 5, 6 or 10); (III) Focal (spotty) lytic necrosis, apoptosis and focal inflammation (scores from 0, 1, 2, 3, 4 or 10); (IV) Portal inflammation (scores from 0, 1, 2, 3, 4 or 10). Histological improvement is considered as a reduction of two or more points in the Knodell necroinflammatory score with no increase in fibrosis.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population. Only those participants with data available at the specified data points were analyzed'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Cirrhosis Reversal at Week 216', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenofovir Disoproxil Fumarate 300 mg', 'description': 'Participants received Tenofovir Disoproxil Fumarate 300 mg tablet once daily (QD) orally for 240 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '41.9', 'groupId': 'OG000', 'lowerLimit': '23.0', 'upperLimit': '60.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 216', 'description': 'Cirrhosis reversal was defined as a reduction of one or more points in the Ishak score with no evidence of cirrhosis. The Ishak liver fibrosis score ranges from 0 indicating no fibrosis to 6 indicating cirrhosis.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population. Only those participants with data available at the specified data points were analyzed'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and Non-serious TEAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenofovir Disoproxil Fumarate 300 mg', 'description': 'Participants received Tenofovir Disoproxil Fumarate 300 mg tablet once daily (QD) orally for 240 weeks.'}], 'classes': [{'title': 'Any TEAEs', 'categories': [{'measurements': [{'value': '139', 'groupId': 'OG000'}]}]}, {'title': 'Serious TEAE', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}]}]}, {'title': 'Non-serious TEAE', 'categories': [{'measurements': [{'value': '129', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 240', 'description': 'An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAE is defined as AE that occurred on or after the first dose date of study drug. SAE is any untoward medical occurrence that results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, is a congenital anomaly/birth defect and other situations according to medical or scientific judgement or events possible drug-induced liver injury with hyperbilirubinemia.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Population was defined as all participants who received at least one dose of study medication and have at least one post Baseline safety assessment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenofovir Disoproxil Fumarate 300 mg', 'description': 'Participants received Tenofovir Disoproxil Fumarate 300 mg tablet once daily (QD) orally for 240 weeks.'}], 'classes': [{'title': 'Week 48, WBC, n=191', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.02', 'spread': '1.264', 'groupId': 'OG000'}]}]}, {'title': 'Week 96, WBC, n=188', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.09', 'spread': '1.380', 'groupId': 'OG000'}]}]}, {'title': 'Week 144, WBC, n=185', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.12', 'spread': '1.378', 'groupId': 'OG000'}]}]}, {'title': 'Week 192, WBC, n=179', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.12', 'spread': '1.412', 'groupId': 'OG000'}]}]}, {'title': 'Week 240, WBC, n=160', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.06', 'spread': '1.434', 'groupId': 'OG000'}]}]}, {'title': 'Week 48, Neutrophils, n=191', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.08', 'spread': '1.051', 'groupId': 'OG000'}]}]}, {'title': 'Week 96, Neutrophils, n=188', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.21', 'spread': '1.184', 'groupId': 'OG000'}]}]}, {'title': 'Week 144, Neutrophils, n=185', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.07', 'spread': '1.162', 'groupId': 'OG000'}]}]}, {'title': 'Week 192, Neutrophils, n=179', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.26', 'spread': '1.197', 'groupId': 'OG000'}]}]}, {'title': 'Week 240, Neutrophils, n=160', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.28', 'spread': '1.194', 'groupId': 'OG000'}]}]}, {'title': 'Week 48, Lymphocytes, n=191', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.438', 'groupId': 'OG000'}]}]}, {'title': 'Week 96, Lymphocytes, n=188', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.06', 'spread': '0.511', 'groupId': 'OG000'}]}]}, {'title': 'Week 144, Lymphocytes, n=185', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.13', 'spread': '0.422', 'groupId': 'OG000'}]}]}, {'title': 'Week 192, Lymphocytes, n=179', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.10', 'spread': '0.442', 'groupId': 'OG000'}]}]}, {'title': 'Week 240, Lymphocytes, n=160', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.15', 'spread': '0.483', 'groupId': 'OG000'}]}]}, {'title': 'Week 48, Monocytes, n=191', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.032', 'spread': '0.1056', 'groupId': 'OG000'}]}]}, {'title': 'Week 96, Monocytes, n=188', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.033', 'spread': '0.1113', 'groupId': 'OG000'}]}]}, {'title': 'Week 144, Monocytes, n=185', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.035', 'spread': '0.1244', 'groupId': 'OG000'}]}]}, {'title': 'Week 192, Monocytes, n=179', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.025', 'spread': '0.1162', 'groupId': 'OG000'}]}]}, {'title': 'Week 240, Monocytes, n=160', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.005', 'spread': '0.1664', 'groupId': 'OG000'}]}]}, {'title': 'Week 48, Eosinophils, n=191', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.114', 'groupId': 'OG000'}]}]}, {'title': 'Week 96, Eosinophils, n=188', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.164', 'groupId': 'OG000'}]}]}, {'title': 'Week 144, Eosinophils, n=185', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.04', 'spread': '0.237', 'groupId': 'OG000'}]}]}, {'title': 'Week 192, Eosinophils, n=179', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.03', 'spread': '0.248', 'groupId': 'OG000'}]}]}, {'title': 'Week 240, Eosinophils, n=160', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.03', 'spread': '0.251', 'groupId': 'OG000'}]}]}, {'title': 'Week 48, Basophils, n=191', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.017', 'groupId': 'OG000'}]}]}, {'title': 'Week 96, Basophils, n=188', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.019', 'groupId': 'OG000'}]}]}, {'title': 'Week 144, Basophils, n=184', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.01', 'spread': '0.025', 'groupId': 'OG000'}]}]}, {'title': 'Week 192, Basophils, n=179', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.01', 'spread': '0.021', 'groupId': 'OG000'}]}]}, {'title': 'Week 240, Basophils, n=160', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.01', 'spread': '0.033', 'groupId': 'OG000'}]}]}, {'title': 'Week 48, Platelets, n=191', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.8', 'spread': '31.45', 'groupId': 'OG000'}]}]}, {'title': 'Week 96, Platelets, n=188', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14.1', 'spread': '32.46', 'groupId': 'OG000'}]}]}, {'title': 'Week 144, Platelets, n=185', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '20.6', 'spread': '42.02', 'groupId': 'OG000'}]}]}, {'title': 'Week 192, Platelets, n=179', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '25.7', 'spread': '42.56', 'groupId': 'OG000'}]}]}, {'title': 'Week 240, Platelets, n=160', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '26.6', 'spread': '38.39', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 0) and at Week 48, Week 96, Week 144, Week 192 and Week 240', 'description': 'Blood samples were collected to analyze the hematology parameters: basophils, eosinophils, WBC, lymphocytes, monocytes, neutrophils and platelets. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.', 'unitOfMeasure': '10^9 cells per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Hemoglobin (Hb)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenofovir Disoproxil Fumarate 300 mg', 'description': 'Participants received Tenofovir Disoproxil Fumarate 300 mg tablet once daily (QD) orally for 240 weeks.'}], 'classes': [{'title': 'Week 48, n=191', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.6', 'spread': '10.12', 'groupId': 'OG000'}]}]}, {'title': 'Week 96, n=188', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '11.63', 'groupId': 'OG000'}]}]}, {'title': 'Week 144, n=185', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.9', 'spread': '11.26', 'groupId': 'OG000'}]}]}, {'title': 'Week 192, n=179', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'spread': '12.61', 'groupId': 'OG000'}]}]}, {'title': 'Week 240, n=160', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.2', 'spread': '12.71', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 0) and at Week 48, Week 96, Week 144, Week 192 and Week 240', 'description': 'Blood samples were collected to analyze Hb values. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.', 'unitOfMeasure': 'Grams per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Red Blood Cells (RBC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenofovir Disoproxil Fumarate 300 mg', 'description': 'Participants received Tenofovir Disoproxil Fumarate 300 mg tablet once daily (QD) orally for 240 weeks.'}], 'classes': [{'title': 'Week 48, n=191', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.11', 'spread': '0.306', 'groupId': 'OG000'}]}]}, {'title': 'Week 96, n=188', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.13', 'spread': '0.344', 'groupId': 'OG000'}]}]}, {'title': 'Week 144, n=185', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.15', 'spread': '0.340', 'groupId': 'OG000'}]}]}, {'title': 'Week 192, n=179', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.10', 'spread': '0.363', 'groupId': 'OG000'}]}]}, {'title': 'Week 240, n=160', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.12', 'spread': '0.341', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 0) and at Week 48, Week 96, Week 144, Week 192 and Week 240', 'description': 'Blood samples were collected to analyze RBC values. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.', 'unitOfMeasure': 'Trillion cells per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenofovir Disoproxil Fumarate 300 mg', 'description': 'Participants received Tenofovir Disoproxil Fumarate 300 mg tablet once daily (QD) orally for 240 weeks.'}], 'classes': [{'title': 'Week 48, ALT, n=190', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-23.98', 'spread': '59.452', 'groupId': 'OG000'}]}]}, {'title': 'Week 96, ALT, n=187', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-28.99', 'spread': '56.983', 'groupId': 'OG000'}]}]}, {'title': 'Week 144, ALT, n=185', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-28.99', 'spread': '56.983', 'groupId': 'OG000'}]}]}, {'title': 'Week 192, ALT, n=178', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-31.79', 'spread': '57.955', 'groupId': 'OG000'}]}]}, {'title': 'Week 240, ALT, n=158', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-32.02', 'spread': '63.157', 'groupId': 'OG000'}]}]}, {'title': 'Week 48, AST, n=191', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-14.69', 'spread': '36.674', 'groupId': 'OG000'}]}]}, {'title': 'Week 96, AST, n=188', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-17.97', 'spread': '36.057', 'groupId': 'OG000'}]}]}, {'title': 'Week 144, AST, n=184', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-18.10', 'spread': '36.809', 'groupId': 'OG000'}]}]}, {'title': 'Week 192, AST, n=178', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-19.82', 'spread': '36.312', 'groupId': 'OG000'}]}]}, {'title': 'Week 240, AST, n=158', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-20.24', 'spread': '43.908', 'groupId': 'OG000'}]}]}, {'title': 'Week 48, ALP, n=190', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10.18', 'spread': '20.288', 'groupId': 'OG000'}]}]}, {'title': 'Week 96, ALP, n=188', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.60', 'spread': '28.233', 'groupId': 'OG000'}]}]}, {'title': 'Week 144, ALP, n=185', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.20', 'spread': '26.555', 'groupId': 'OG000'}]}]}, {'title': 'Week 192, ALP, n=177', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.94', 'spread': '31.604', 'groupId': 'OG000'}]}]}, {'title': 'Week 240, ALP, n=158', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.68', 'spread': '27.596', 'groupId': 'OG000'}]}]}, {'title': 'Week 48, GGT, n=190', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-17.88', 'spread': '32.753', 'groupId': 'OG000'}]}]}, {'title': 'Week 96, GGT, n=188', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-22.20', 'spread': '34.866', 'groupId': 'OG000'}]}]}, {'title': 'Week 144, GGT, n=185', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-24.69', 'spread': '39.764', 'groupId': 'OG000'}]}]}, {'title': 'Week 192, GGT, n=175', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-24.07', 'spread': '38.609', 'groupId': 'OG000'}]}]}, {'title': 'Week 240, GGT, n=152', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-27.26', 'spread': '42.932', 'groupId': 'OG000'}]}]}, {'title': 'Week 48 CK, n=188', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10.51', 'spread': '103.515', 'groupId': 'OG000'}]}]}, {'title': 'Week 96, CK, n=185', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '16.77', 'spread': '141.961', 'groupId': 'OG000'}]}]}, {'title': 'Week 144, CK, n=182', 'denoms': [{'units': 'Participants', 'counts': [{'value': '182', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.96', 'spread': '101.897', 'groupId': 'OG000'}]}]}, {'title': 'Week 192, CK, n=173', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13.72', 'spread': '106.986', 'groupId': 'OG000'}]}]}, {'title': 'Week 240, CK, n=156', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.79', 'spread': '105.349', 'groupId': 'OG000'}]}]}, {'title': 'Week 48, LDH, n=187', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-10.62', 'spread': '52.851', 'groupId': 'OG000'}]}]}, {'title': 'Week 96, LDH, n=185', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-10.21', 'spread': '48.112', 'groupId': 'OG000'}]}]}, {'title': 'Week 144, LDH, n=180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.34', 'spread': '73.047', 'groupId': 'OG000'}]}]}, {'title': 'Week 192, LDH, n=172', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-18.45', 'spread': '87.931', 'groupId': 'OG000'}]}]}, {'title': 'Week 240, LDH, n=155', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '25.79', 'spread': '87.464', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 0) and at Week 48, Week 96, Week 144, Week 192 and Week 240', 'description': 'Blood samples were collected to analyze the chemistry parameters: ALT, ALP, AST, GGT, CK, LDH. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.', 'unitOfMeasure': 'Units per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Serum Creatinine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenofovir Disoproxil Fumarate 300 mg', 'description': 'Participants received Tenofovir Disoproxil Fumarate 300 mg tablet once daily (QD) orally for 240 weeks.'}], 'classes': [{'title': 'Week 48, total bilirubin, n=191', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.485', 'spread': '7.1347', 'groupId': 'OG000'}]}]}, {'title': 'Week 96, total bilirubin, n=188', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.823', 'spread': '6.7167', 'groupId': 'OG000'}]}]}, {'title': 'Week 144, total bilirubin, n=185', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.665', 'spread': '7.1281', 'groupId': 'OG000'}]}]}, {'title': 'Week 192, total bilirubin, n=177', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.791', 'spread': '6.9230', 'groupId': 'OG000'}]}]}, {'title': 'Week 240, total bilirubin, n=158', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.772', 'spread': '6.9786', 'groupId': 'OG000'}]}]}, {'title': 'Week 48, direct bilirubin, n=191', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.296', 'spread': '3.1229', 'groupId': 'OG000'}]}]}, {'title': 'Week 96, direct bilirubin, n=188', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.462', 'spread': '3.1875', 'groupId': 'OG000'}]}]}, {'title': 'Week 144, direct bilirubin, n=185', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.713', 'spread': '3.4898', 'groupId': 'OG000'}]}]}, {'title': 'Week 192, direct bilirubin, n=178', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.780', 'spread': '3.5942', 'groupId': 'OG000'}]}]}, {'title': 'Week 240, direct bilirubin, n=157', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.599', 'spread': '3.5608', 'groupId': 'OG000'}]}]}, {'title': 'Week 48, serum creatinine, n=191', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.03', 'spread': '7.020', 'groupId': 'OG000'}]}]}, {'title': 'Week 96, serum creatinine, n=188', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.10', 'spread': '7.597', 'groupId': 'OG000'}]}]}, {'title': 'Week 144, serum creatinine, n=184', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.76', 'spread': '9.122', 'groupId': 'OG000'}]}]}, {'title': 'Week 192, serum creatinine, n=178', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.37', 'spread': '8.591', 'groupId': 'OG000'}]}]}, {'title': 'Week 240, serum creatinine, n=159', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.35', 'spread': '9.879', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 0) and at Week 48, Week 96, Week 144, Week 192 and Week 240', 'description': 'Blood samples were collected to analyze the chemistry parameters: total billirubin,direct bilirubin and serum creatinine. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.', 'unitOfMeasure': 'Micromoles per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Chemistry Parameters: Albumin and Total Protein', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenofovir Disoproxil Fumarate 300 mg', 'description': 'Participants received Tenofovir Disoproxil Fumarate 300 mg tablet once daily (QD) orally for 240 weeks.'}], 'classes': [{'title': 'Week 48, albumin, n=191', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.06', 'spread': '3.063', 'groupId': 'OG000'}]}]}, {'title': 'Week 96, albumin, n=188', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.23', 'spread': '3.313', 'groupId': 'OG000'}]}]}, {'title': 'Week 144, albumin, n=185', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.86', 'spread': '3.675', 'groupId': 'OG000'}]}]}, {'title': 'Week 192, albumin, n=175', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.65', 'spread': '3.780', 'groupId': 'OG000'}]}]}, {'title': 'Week 240, albumin, n=158', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.81', 'spread': '3.790', 'groupId': 'OG000'}]}]}, {'title': 'Week 48, total protein, n=191', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.01', 'spread': '5.273', 'groupId': 'OG000'}]}]}, {'title': 'Week 96, total protein, n=188', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.21', 'spread': '5.397', 'groupId': 'OG000'}]}]}, {'title': 'Week 144, total protein, n=185', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.27', 'spread': '5.065', 'groupId': 'OG000'}]}]}, {'title': 'Week 192, total protein, n=175', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.94', 'spread': '5.175', 'groupId': 'OG000'}]}]}, {'title': 'Week 240, total protein, n=158', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.61', 'spread': '5.829', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 0) and at Week 48, Week 96, Week 144, Week 192 and Week 240', 'description': 'Blood samples were collected to analyze the chemistry parameters: albumin and total protein. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.', 'unitOfMeasure': 'Grams per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridion, Phosphorus, Calcium and Fasting Blood Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenofovir Disoproxil Fumarate 300 mg', 'description': 'Participants received Tenofovir Disoproxil Fumarate 300 mg tablet once daily (QD) orally for 240 weeks.'}], 'classes': [{'title': 'Week 48, BUN, n=191', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.046', 'spread': '1.1067', 'groupId': 'OG000'}]}]}, {'title': 'Week 96, BUN, n=188', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.000', 'spread': '1.1875', 'groupId': 'OG000'}]}]}, {'title': 'Week 144, BUN, n=184', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.037', 'spread': '1.0892', 'groupId': 'OG000'}]}]}, {'title': 'Week 192, BUN, n=178', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.143', 'spread': '1.1234', 'groupId': 'OG000'}]}]}, {'title': 'Week 240, BUN, n=155', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.131', 'spread': '1.1358', 'groupId': 'OG000'}]}]}, {'title': 'Week 48, Potassium, n=191', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.001', 'spread': '0.3703', 'groupId': 'OG000'}]}]}, {'title': 'Week 96, Potassium, n=186', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.002', 'spread': '0.3230', 'groupId': 'OG000'}]}]}, {'title': 'Week 144, Potassium, n=184', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.039', 'spread': '0.3871', 'groupId': 'OG000'}]}]}, {'title': 'Week 192, Potassium, n=178', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.015', 'spread': '0.4223', 'groupId': 'OG000'}]}]}, {'title': 'Week 240, Potassium, n=158', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.013', 'spread': '0.3946', 'groupId': 'OG000'}]}]}, {'title': 'Week 48, Sodium, n=191', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.21', 'spread': '3.495', 'groupId': 'OG000'}]}]}, {'title': 'Week 96, Sodium, n=186', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.02', 'spread': '3.121', 'groupId': 'OG000'}]}]}, {'title': 'Week 144, Sodium, n=184', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.35', 'spread': '2.730', 'groupId': 'OG000'}]}]}, {'title': 'Week 192, Sodium, n=178', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.38', 'spread': '2.998', 'groupId': 'OG000'}]}]}, {'title': 'Week 240, Sodium, n=158', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.13', 'spread': '2.707', 'groupId': 'OG000'}]}]}, {'title': 'Week 48, Chloridion, n=191', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.13', 'spread': '3.600', 'groupId': 'OG000'}]}]}, {'title': 'Week 96, Chloridion, n=186', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.40', 'spread': '3.535', 'groupId': 'OG000'}]}]}, {'title': 'Week 144, Chloridion, n=183', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.35', 'spread': '3.492', 'groupId': 'OG000'}]}]}, {'title': 'Week 192, Chloridion, n=178', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.77', 'spread': '3.142', 'groupId': 'OG000'}]}]}, {'title': 'Week 240, Chloridion, n=158', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.49', 'spread': '3.364', 'groupId': 'OG000'}]}]}, {'title': 'Week 48, Phosphorus, n=190', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.044', 'spread': '0.1724', 'groupId': 'OG000'}]}]}, {'title': 'Week 96, Phosphorus, n=187', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.038', 'spread': '0.1632', 'groupId': 'OG000'}]}]}, {'title': 'Week 144, Phosphorus, n=184', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.037', 'spread': '0.1955', 'groupId': 'OG000'}]}]}, {'title': 'Week 192, Phosphorus, n=175', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.059', 'spread': '0.1876', 'groupId': 'OG000'}]}]}, {'title': 'Week 240, Phosphorus, n=159', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.042', 'spread': '0.2009', 'groupId': 'OG000'}]}]}, {'title': 'Week 48, Calcium, n=190', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.023', 'spread': '0.1513', 'groupId': 'OG000'}]}]}, {'title': 'Week 96, Calcium, n=187', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.006', 'spread': '0.1652', 'groupId': 'OG000'}]}]}, {'title': 'Week 144, Calcium, n=184', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.022', 'spread': '0.1605', 'groupId': 'OG000'}]}]}, {'title': 'Week 192, Calcium, n=178', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.004', 'spread': '0.1470', 'groupId': 'OG000'}]}]}, {'title': 'Week 240, Calcium, n=158', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.006', 'spread': '0.1558', 'groupId': 'OG000'}]}]}, {'title': 'Week 48, Fasting Blood Glucose, n=191', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.162', 'spread': '0.7154', 'groupId': 'OG000'}]}]}, {'title': 'Week 96, Fasting Blood Glucose, n=188', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.109', 'spread': '0.7139', 'groupId': 'OG000'}]}]}, {'title': 'Week 144, Fasting Blood Glucose, n=185', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.094', 'spread': '0.8979', 'groupId': 'OG000'}]}]}, {'title': 'Week 192, Fasting Blood Glucose, n=177', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.052', 'spread': '0.7548', 'groupId': 'OG000'}]}]}, {'title': 'Week 240, Fasting Blood Glucose, n=158', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.052', 'spread': '1.2197', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 0) and at Week 48, Week 96, Week 144, Week 192 and Week 240', 'description': 'Blood samples were collected to analyze the chemistry parameters: BUN, potassium, sodium, chloridion, phosphorus,calcium and fasting blood glucose. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.', 'unitOfMeasure': 'Millimoles per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Chemistry Parameters: Creatinine Clearance Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenofovir Disoproxil Fumarate 300 mg', 'description': 'Participants received Tenofovir Disoproxil Fumarate 300 mg tablet once daily (QD) orally for 240 weeks.'}], 'classes': [{'title': 'Week 48, n=190', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.064', 'spread': '11.5995', 'groupId': 'OG000'}]}]}, {'title': 'Week 96, n=188', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.214', 'spread': '12.7883', 'groupId': 'OG000'}]}]}, {'title': 'Week 144, n=184', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.324', 'spread': '15.3937', 'groupId': 'OG000'}]}]}, {'title': 'Week 192, n=177', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-6.599', 'spread': '13.8858', 'groupId': 'OG000'}]}]}, {'title': 'Week 240, n=155', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-6.658', 'spread': '16.5351', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 0) and at Week 48, Week 96, Week 144, Week 192 and Week 240', 'description': 'Blood samples were collected to analyze the chemistry parameters: creatinine clearance rate. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.', 'unitOfMeasure': 'Milliliter per minute (mL/min)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Chemistry Parameters: Estimated Glomerular Filtration Rate (eGFR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenofovir Disoproxil Fumarate 300 mg', 'description': 'Participants received Tenofovir Disoproxil Fumarate 300 mg tablet once daily (QD) orally for 240 weeks.'}], 'classes': [{'title': 'Week 48, n=191', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.86', 'spread': '6.581', 'groupId': 'OG000'}]}]}, {'title': 'Week 96, n=188', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.87', 'spread': '7.078', 'groupId': 'OG000'}]}]}, {'title': 'Week 144, n=185', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.68', 'spread': '8.368', 'groupId': 'OG000'}]}]}, {'title': 'Week 192, n=180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.06', 'spread': '8.442', 'groupId': 'OG000'}]}]}, {'title': 'Week 240, n=161', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.42', 'spread': '9.609', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 0) and at Week 48, Week 96, Week 144, Week 192 and Week 240', 'description': 'Blood samples were collected to analyze the chemistry parameters: eGFR. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.', 'unitOfMeasure': 'mL/minute per 1.73 square meter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tenofovir Disoproxil Fumarate 300 mg', 'description': 'Participants received Tenofovir Disoproxil Fumarate 300 mg tablet once daily (QD) orally for 240 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '197'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '161'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Treatment Interruptions of ≥28 days', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'This study was conducted to evaluate the efficacy and safety of 300 milligram (mg) Tenofovir Disoproxil Fumarate (TDF) therapy in Chinese chronic hepatitis B (CHB) participants with advanced fibrosis and compensated cirrhosis', 'preAssignmentDetails': 'A total of 266 participants were screened, of which 197 entered the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Tenofovir Disoproxil Fumarate 300 mg', 'description': 'Participants received Tenofovir Disoproxil Fumarate 300 mg tablet once daily (QD) orally for 240 weeks.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '42.3', 'spread': '9.80', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Baseline characteristics is presented for mITT Population which consisted of all participants who received at least one dose of study medication. 2 participants did not receive TDF treatment thus excluded from mITT Population', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '47', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '148', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Baseline characteristics is presented for mITT Population which consisted of all participants who received at least one dose of study medication. 2 participants did not receive TDF treatment thus excluded from mITT Population', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '195', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Baseline characteristics is presented for mITT Population which consisted of all participants who received at least one dose of study medication. 2 participants did not receive TDF treatment thus excluded from mITT Population', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Baseline characteristics is presented for modified Intent-to-treat (mITT) Population which consisted of all participants who received at least one dose of study medication. 2 participants did not receive TDF treatment thus excluded from mITT Population'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-09-09', 'size': 1594280, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-10-19T09:00', 'hasProtocol': True}, {'date': '2021-02-26', 'size': 630628, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-09-24T08:23', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 197}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2020-12-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-26', 'studyFirstSubmitDate': '2014-08-21', 'resultsFirstSubmitDate': '2021-11-26', 'studyFirstSubmitQcDate': '2014-08-21', 'lastUpdatePostDateStruct': {'date': '2022-02-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-11-26', 'studyFirstPostDateStruct': {'date': '2014-08-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-02-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence Rate of Newly Diagnosed Hepatocellular Carcinoma (HCC) at Week 240', 'timeFrame': 'Week 240', 'description': 'The newly diagnosed HCC was defined as HCC cases from Week 24 to Week 240 and the participants were required to meet one of the following criteria: without HCC before Week 24; a histological diagnosis of HCC (i.e. by biopsy or at post-mortem); participants with nodules \\>2 centimeter (cm), identification of typical HCC characteristics (hyper-vascular in the arterial phase with washout in the portal venous or delayed phases) by 4-phase multi-detector computed tomography (CT) scan or dynamic contrast-enhanced magnetic resonance imaging (MRI); participants with nodules \\>1 cm, identification of typical HCC characteristics by both techniques (4-phase multi-detector CT and dynamic contrast-enhanced MRI).'}, {'measure': 'Percentage of Participants With Disease Progression at Week 240', 'timeFrame': 'Week 240', 'description': 'Disease progression was defined as the first occurrence of any one of the following criteria: 1) an increase in Childs-Pugh score of 2 or more points from Baseline; 2) an increase in Childs-Pugh score of 2 or more points, solely based on laboratory parameters (i.e. bilirubin, prothrombin time and/or albumin) confirmed between two consecutive visits at least one month apart; 3) spontaneous bacterial peritonitis (with proven sepsis); 4) renal insufficiency; 5) bleeding gastric/esophageal varices; 6) hepatocellular carcinoma; 7)liver-related death.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Newly Diagnosed Hepatocellular Carcinoma (HCC) at Week 48, Week 96, Week 144 and Week 192', 'timeFrame': 'Week 48, Week 96, Week 144 and Week 192', 'description': 'The newly diagnosed HCC was defined as HCC cases from Week 24 to Week 240 and the participants were required to meet one of the following criteria: without HCC before Week 24; a histological diagnosis of HCC (i.e. by biopsy or at post-mortem); participants with nodules \\>2 centimeter (cm), identification of typical HCC characteristics (hyper-vascular in the arterial phase with washout in the portal venous or delayed phases) by 4-phase multi-detector computed tomography (CT) scan or dynamic contrast-enhanced magnetic resonance imaging (MRI); participants with nodules \\>1 cm, identification of typical HCC characteristics by both techniques (4-phase multi-detector CT and dynamic contrast-enhanced MRI).'}, {'measure': 'Percentage of Participants With Newly Diagnosed Hepatocellular Carcinoma (HCC) at Week 48, Week 96, Week 144, Week 192 and Week 240', 'timeFrame': 'Week 48, Week 96, Week 144, Week 192 and Week 240', 'description': 'The newly diagnosed HCC was defined as HCC cases from Week 24 to Week 240 and the participants were required to meet one of the following criteria: without HCC before Week 24; a histological diagnosis of HCC (i.e. by biopsy or at post-mortem); participants with nodules \\>2 centimeter (cm), identification of typical HCC characteristics (hyper-vascular in the arterial phase with washout in the portal venous or delayed phases) by 4-phase multi-detector computed tomography (CT) scan or dynamic contrast-enhanced magnetic resonance imaging (MRI); participants with nodules \\>1 cm, identification of typical HCC characteristics by both techniques (4-phase multi-detector CT and dynamic contrast-enhanced MRI).The cumulative percentage of participants with newly diagnosed Hepatocellular Carcinoma has been presented along with 95% confidence interval (CI) (Wald method).'}, {'measure': 'Percentage of Participants With Disease Progression at Week 48, Week 96, Week 144, Week 192 and Week 240', 'timeFrame': 'Week 48, Week 96, Week 144, Week 192 and Week 240', 'description': 'Disease progression was defined as the first occurrence of any one of the following criteria: 1) an increase in Childs-Pugh score of 2 or more points from Baseline; 2) an increase in Childs-Pugh score of 2 or more points, solely based on laboratory parameters (i.e. bilirubin, prothrombin time and/or albumin) confirmed between two consecutive visits at least one month apart; 3) spontaneous bacterial peritonitis (with proven sepsis); 4) renal insufficiency; 5) bleeding gastric/oesophageal varices; 6) hepatocellular carcinoma; 7) liver-related death. The cumulative percentage of participants with disease progression has been presented along with 95% CI (Wald method).'}, {'measure': 'Mean Change From Baseline in Liver Stiffness Measure at Week 48, Week 96, Week 144, Week 192 and Week 240', 'timeFrame': 'Baseline (Day 0), Week 48, Week 96, Week 144, Week 192 and Week 240', 'description': 'Liver stiffness measure was obtained by a non-invasive transient elastography using FibroScan. Baseline is defined as the last assessment (Day 0) before administration of the study drug. Change from Baseline is defined as post-dose visit value minus Baseline value'}, {'measure': 'Percentage of Participants With Serum Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) <20 International Units Per Milliliter (IU/mL) at Weeks 48, 96, 144, 192 and 240', 'timeFrame': 'Week 48, Week 96, Week 144, Week 192 and Week 240', 'description': 'Serum samples were collected for the analysis of HBV DNA levels using Roche Cobas Taqman HBV test. Confidence interval was calculated by normal approximation and continuity correction method.'}, {'measure': 'Change From Baseline in Logarithm to the Base 10 (Log 10) Serum HBV DNA', 'timeFrame': 'Baseline (Day 0) and Week 48, Week 96, Week 144, Week 192 and Week 240', 'description': 'Serum samples were collected for the analysis of HBV DNA levels. Baseline is defined as the last assessment (Day 0) before administration of the study drug. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.'}, {'measure': 'Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Week 48, Week 96, Week 144, Week 192 and Week 240 in Participants Who Had Abnormal ALT at Baseline', 'timeFrame': 'Week 48, Week 96, Week 144, Week 192 and Week 240', 'description': 'Blood samples were collected for evaluation of ALT at indicated time points. ALT normalization is defined as ALT outside the normal range at Baseline and within the normal range at Week 48, Week 96, Week 144, Week 192 and Week 240. Normal range of ALT is 7 to 56 International Units per liter. Percentage of participants with ALT normalization at Weeks 48, 96, 144, 192 and 240 in participants who had abnormal ALT at Baseline (Day 0) have been presented. Confidence interval was calculated using normal approximation and continuity correction method.'}, {'measure': 'Percentage of Hepatitis B e Antigen (HBeAg) Positive Participants Achieving HBeAg Loss, HBeAg Seroconversion at Week 48, Week 96, Week 144, Week 192 and Week 240.', 'timeFrame': 'Week 48, Week 96, Week 144, Week 192 and Week 240', 'description': 'Serological response was assessed at Week 48, Week 96, Week 144, Week 192 and Week 240 in participants with Positive HBeAg at Baseline (Day 0). It was presented as HBeAg Loss and HBeAg Seroconversion. HBeAg Loss was defined as HBeAg changed to be negative. HBeAg seroconversion was defined as HBeAg changed to negative and HBeAb was positive. Confidence interval was calculated using normal approximation and continuity correction method.'}, {'measure': 'Percentage of HBeAg Negative Participants Achieving HBsAg Loss and HBsAg Seroconversion at Week 48, Week 96, Week 144, Week 192 and Week 240', 'timeFrame': 'Week 48, Week 96, Week 144, Week 192 and Week 240', 'description': 'Serological response was assessed at Week 48, Week 96, Week 144, Week 192 and Week 240 in participants with negative HBeAg at Baseline (Day 0). HBsAg Loss was defined as HBsAg changed to be negative. HBsAg seroconversion was defined as HBsAg changed to negative and HBsAb was positive.'}, {'measure': 'Percentage of Participants Who Experienced Viral Breakthrough', 'timeFrame': 'Week 48, Week 96, Week 144, Week 192 and Week 240', 'description': 'Viral breakthrough was defined as \\>=1 log10 increase in HBV DNA from nadir determined by two sequential HBV DNA measurements. Percentage of Participants who experienced viral breakthrough at Week 48, Week 96, Week 144, Week 192 and Week 240 is presented.'}, {'measure': 'Percentage of Participants With Histological Improvement at Week 216', 'timeFrame': 'Week 216', 'description': 'The Knodell scoring system, also called the Histologic Activity Index (HAI), classifies liver biopsy specimens according to scores into 4 categories of histologic features: (I) Periportal or periseptal interface hepatitis (piecemeal necrosis) (scores from 0, 1, 2, 3, 4 or 10); (II) Confluent necrosis (scores from 0, 1, 3, 4, 5, 6 or 10); (III) Focal (spotty) lytic necrosis, apoptosis and focal inflammation (scores from 0, 1, 2, 3, 4 or 10); (IV) Portal inflammation (scores from 0, 1, 2, 3, 4 or 10). Histological improvement is considered as a reduction of two or more points in the Knodell necroinflammatory score with no increase in fibrosis.'}, {'measure': 'Percentage of Participants With Cirrhosis Reversal at Week 216', 'timeFrame': 'Week 216', 'description': 'Cirrhosis reversal was defined as a reduction of one or more points in the Ishak score with no evidence of cirrhosis. The Ishak liver fibrosis score ranges from 0 indicating no fibrosis to 6 indicating cirrhosis.'}, {'measure': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and Non-serious TEAEs', 'timeFrame': 'Up to Week 240', 'description': 'An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAE is defined as AE that occurred on or after the first dose date of study drug. SAE is any untoward medical occurrence that results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, is a congenital anomaly/birth defect and other situations according to medical or scientific judgement or events possible drug-induced liver injury with hyperbilirubinemia.'}, {'measure': 'Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets', 'timeFrame': 'Baseline (Day 0) and at Week 48, Week 96, Week 144, Week 192 and Week 240', 'description': 'Blood samples were collected to analyze the hematology parameters: basophils, eosinophils, WBC, lymphocytes, monocytes, neutrophils and platelets. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.'}, {'measure': 'Change From Baseline in Hemoglobin (Hb)', 'timeFrame': 'Baseline (Day 0) and at Week 48, Week 96, Week 144, Week 192 and Week 240', 'description': 'Blood samples were collected to analyze Hb values. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.'}, {'measure': 'Change From Baseline in Red Blood Cells (RBC)', 'timeFrame': 'Baseline (Day 0) and at Week 48, Week 96, Week 144, Week 192 and Week 240', 'description': 'Blood samples were collected to analyze RBC values. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.'}, {'measure': 'Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH)', 'timeFrame': 'Baseline (Day 0) and at Week 48, Week 96, Week 144, Week 192 and Week 240', 'description': 'Blood samples were collected to analyze the chemistry parameters: ALT, ALP, AST, GGT, CK, LDH. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.'}, {'measure': 'Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Serum Creatinine', 'timeFrame': 'Baseline (Day 0) and at Week 48, Week 96, Week 144, Week 192 and Week 240', 'description': 'Blood samples were collected to analyze the chemistry parameters: total billirubin,direct bilirubin and serum creatinine. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.'}, {'measure': 'Change From Baseline in Chemistry Parameters: Albumin and Total Protein', 'timeFrame': 'Baseline (Day 0) and at Week 48, Week 96, Week 144, Week 192 and Week 240', 'description': 'Blood samples were collected to analyze the chemistry parameters: albumin and total protein. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.'}, {'measure': 'Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridion, Phosphorus, Calcium and Fasting Blood Glucose', 'timeFrame': 'Baseline (Day 0) and at Week 48, Week 96, Week 144, Week 192 and Week 240', 'description': 'Blood samples were collected to analyze the chemistry parameters: BUN, potassium, sodium, chloridion, phosphorus,calcium and fasting blood glucose. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.'}, {'measure': 'Change From Baseline in Chemistry Parameters: Creatinine Clearance Rate', 'timeFrame': 'Baseline (Day 0) and at Week 48, Week 96, Week 144, Week 192 and Week 240', 'description': 'Blood samples were collected to analyze the chemistry parameters: creatinine clearance rate. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.'}, {'measure': 'Change From Baseline in Chemistry Parameters: Estimated Glomerular Filtration Rate (eGFR)', 'timeFrame': 'Baseline (Day 0) and at Week 48, Week 96, Week 144, Week 192 and Week 240', 'description': 'Blood samples were collected to analyze the chemistry parameters: eGFR. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Tenofovir disoproxil fumarate', 'hepatocellular carcinoma', 'chronic hepatitis B', 'Cirrhosis'], 'conditions': ['Hepatitis B, Chronic']}, 'descriptionModule': {'briefSummary': 'Chronic Hepatitis B infection (CHB) is known as the most frequently identified cause of liver disease that predisposes patients to the development of hepatocellular carcinoma (HCC). Active hepatitis B virus (HBV) replication is the key driver of liver injury and disease progression. Majority of Chinese patients are infected with genotype B and C HBV, which is different from Caucasian counterparts. This prospective multi-center cohort open-label study is designed to investigate the long-term effect of TDF on prevention of HCC and disease progression as well as to evaluate the efficacy and safety of long-term TDF in Chinese CHB subjects with advanced liver diseases. The study will enrol 240 subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-60 years(inclusive);\n* Presence of HBsAg in serum at screening and for at least 6 months before screening assessment;\n* Serum HBV DNA\\>=2000 IU/mL if HBeAg positive at screening (with or without ALT elevation); or serum HBV DNA\\>=200IU/mL if HBeAg negative at screening (with or without ALT elevation);\n* Clinically diagnosed as advanced fibrosis or compensated cirrhosis defined as both of following : liver stiffness measure (LSM) \\>12.4 kiloPascals (kpa) (ALT\\> Upper limit of normal \\[ULN\\]) or LSM\\>9.0 kpa (ALT\\<=ULN); One of following: Liver biopsy showing advanced fibrosis or cirrhosis (Ishak score \\>=4, within the previous 6 months before screening and provided that no treatment likely to improve liver histology has been taken since). The slides must be available for review by an independent histopathologist; Endoscopy-proven gastroesophageal or gastric varices, non-cirrhotic portal hypertension excluded; Abdominal ultrasound or CT found changes indicating cirrhosis, irregular liver surface or nodularity, with/without splenomegaly (depth of spleen\\>4.0cm or spleen length\\>13cm); Blood platelets \\<100 x10\\^9/L (and other causes of thrombocytopenia excluded);\n* Ability to give written informed consent;\n* A female is eligible to enter and participate in this study if she is of: non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post-menopausal), or Child-bearing potential, has a negative urine pregnancy test at screening, and agrees to one of the following methods for avoidance of pregnancy during the period of the study and until 30 days after last dose of study medication: Oral contraceptive, either combined or progestogen alone; Injectable progestogen; Implants of levonorgestrel; Oestrogenic vaginal ring; Percutaneous contraceptive patches; Intrauterine device (IUD) or intrauterine system (IUS) showing that the expected failure rate is less than 1% per year as stated in the IUD or IUS product label; Has a male partner who is sterilised; Double barrier method: condom and an occlusive cap (diaphragm orcervical/vault caps) with a vaginal spermicidal agent (foam/gel/film /cream/suppository).\n* Agreement not to participate in any other investigational trials or to undertake other HBV systemic antiviral or interferon (IFN) regimens during participation in this study.\n\nExclusion Criteria:\n\n* Hepatocellular carcinoma as evidenced by one of the following: Suspicious foci on ultrasound or radiological examination; Normal ultrasound serum alpha-fetoprotein \\>50 nanograms (ng)/mL at screening.\n* Serum ALT \\>10 times ULN at screening or history of acute exacerbation leading to transient decompensation;\n* Documented co-infection with hepatitis A (HAV), hepatitis C (HCV), hepatitis delta virus (HDV), hepatitis E virus (HEV) or human immunodeficiency virus (HIV). For HCV co-infection, subjects who are anti-HCV positive and in whom HCV ribonucleic acid (RNA) is undetectable are considered to be not eligible for enrolment.\n* Evidence of active liver disease due to autoimmune hepatitis (antinuclear antibody (ANA) titre \\>1:160).\n* Decompensated liver disease as indicated by any of the following: serum bilirubin \\>1.5 xULN prothrombin time activity \\<60% or International normalized ratio (INR)\\>1.5; serum albumin \\<32 grams per liter (g/L); history of previous clinical hepatic decompensation (e.g., ascites, variceal bleeding, or encephalopathy);\n* Planned for liver transplantation or previous liver transplantation;\n* Creatinine clearance less than 70 mL/minute (min);\n* Haemoglobin \\<10 g/deciliter (dL), white blood cell (WBC) count \\<1.5 x 10\\^9/liter (L), platelets \\<=50 x 10\\^9/L;\n* Any serious or active medical or psychiatric illnesses other than hepatitis B which, in the opinion of the Investigator, would interfere with subject treatment, assessment or compliance with the protocol. This would include any uncontrolled clinically significant renal, cardiac, pulmonary, vascular, neurogenic, digestive, metabolic (diabetes, thyroid disorders, adrenal disease), immunodeficiency disorders, pathological fractures or cancer;\n* Active alcohol or drug abuse or history of alcohol or drug abuse considered by the Investigator to be sufficient to hinder compliance with treatment, participation in the study or interpretation of results;\n* A female who is breastfeeding or plan to breastfeed;\n* Use of immunosuppressive therapy, immunomodulatory therapy (including IFN or thymosin alpha), systemic cytotoxic agents, chronic antiviral agents including Chinese herbal medicines known to have activity against HBV (e.g., lamivudine (LAM), adefovir, entecavir (ETV), telbivudine (LdT) or hepatitis B immunoglobulin (HBIg)) within the previous 6 months prior to screening into this study;\n* Have ever received TDF or any medicinal products containing the above mentioned antiviral agents or any investigative anti-HBV treatments (e.g., emtricitabine (FTC), (2R,4R)-4-(2,6-Diaminopurin-9-yl)-1,3-dioxolan-2-yl\\]methanol (DAPD) and 1-(2-fluoro-5-methyl-beta, Larabinofuranosyl) uracil (L-FMAU));\n* History of hypersensitivity to nucleoside and/or nucleotide analogues and/or any component of study medication;\n* Therapy with nephrotoxic drugs (e.g., aminoglycosides, amphotercin B, vancomycin, cidofovir, foscarnet, cis-platinum, pentamidine etc.) or competitors of renal excretion (e.g., probenecid) within 2 months prior to study screening or the expectation that subject will receive any of these during the course of the study;\n* Inability to comply with study requirements as determined by the study Investigator'}, 'identificationModule': {'nctId': 'NCT02224456', 'briefTitle': 'Efficacy and Safety Study of Tenofovir Disoproxil Fumarate (TDF) in Chinese Chronic Hepatitis B (CHB) Subjects With Advanced Fibrosis & Compensated Cirrhosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A Prospective, Multi-center, Cohort Study to Evaluate the Efficacy and Safety of Tenofovir Disoproxil Fumarate (TDF) Therapy in Chinese Chronic Hepatitis B (CHB) Subjects With Advanced Fibrosis & Compensated Cirrhosis', 'orgStudyIdInfo': {'id': '201213'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tenofovir', 'description': "Subjects will receive TDF 300 milligrams (mg) tablet once daily for 240 weeks in the study. Subjects who receive add-on rescue treatment may take LAM 100 mg, ETV 0.5 mg or LdT 600 mg per day upon investigator's decision in addition to TDF tablet.", 'interventionNames': ['Drug: Tenofovir disoproxil fumarate']}], 'interventions': [{'name': 'Tenofovir disoproxil fumarate', 'type': 'DRUG', 'description': 'White, almond-shaped, film-coated tablet containing 300 mg of TDF, debossed with "GILEAD" and "4331" on one side of the tablet.', 'armGroupLabels': ['Tenofovir']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510060', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '430022', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '210002', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '210003', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '130000', 'city': 'Changchun', 'state': 'Jilin', 'country': 'China', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}, {'zip': '710038', 'city': 'Xian', 'state': 'Shanxi', 'country': 'China', 'facility': 'GSK Investigational Site'}, {'zip': '610041', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'zip': '100044', 'city': 'Beijing', 'country': 'China', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100050', 'city': 'Beijing', 'country': 'China', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100069', 'city': 'Beijing', 'country': 'China', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '400038', 'city': 'Chongqing', 'country': 'China', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'zip': '310000', 'city': 'Hangzhou', 'country': 'China', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'zip': '250021', 'city': 'Jinan', 'country': 'China', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'zip': '200025', 'city': 'Shanghai', 'country': 'China', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200040', 'city': 'Shanghai', 'country': 'China', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '201508', 'city': 'Shanghai', 'country': 'China', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '030001', 'city': 'Taiyuan', 'country': 'China', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 37.86944, 'lon': 112.56028}}, {'zip': '710061', 'city': "Xi'an", 'country': 'China', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}, {'zip': '450000', 'city': 'Zhengzhou', 'country': 'China', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}