Viewing Study NCT01210495


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Study NCT ID: NCT01210495
Status: COMPLETED
Last Update Posted: 2019-01-09
First Post: 2010-09-22
Is NOT Gene Therapy: True
Has Adverse Events: True

Brief Title: Axitinib For The Treatment Of Advanced Hepatocellular Carcinoma
Sponsor:
Organization:

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Singapore']}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}], 'ancestors': [{'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'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077784', 'term': 'Axitinib'}], 'ancestors': [{'id': 'D001549', 'term': 'Benzamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D007191', 'term': 'Indazoles'}, {'id': 'D011720', 'term': 'Pyrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline up to follow-up visit (up to 6 years)', 'description': 'The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Child-Pugh Class A', 'description': 'Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the non-randomized portion at selected sites only at a starting axitinib dose of 5 mg BID.', 'otherNumAtRisk': 15, 'otherNumAffected': 15, 'seriousNumAtRisk': 15, 'seriousNumAffected': 10}, {'id': 'EG001', 'title': 'Child-Pugh Class B', 'description': 'Participants with Child-Pugh Class B disease (score 7) at selected sites were initially enrolled only into the non randomized portion of this study to determine the recommended starting dose of axitinib for this population.', 'otherNumAtRisk': 7, 'otherNumAffected': 7, 'seriousNumAtRisk': 7, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Axitinib', 'description': 'Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non randomized portion. Study treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles).', 'otherNumAtRisk': 133, 'otherNumAffected': 130, 'seriousNumAtRisk': 133, 'seriousNumAffected': 62}, {'id': 'EG003', 'title': 'Placebo', 'description': 'Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles). The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.', 'otherNumAtRisk': 68, 'otherNumAffected': 55, 'seriousNumAtRisk': 68, 'seriousNumAffected': 16}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 68, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v17.0)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 68, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v17.0)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 68, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v17.0)'}, {'term': 'Hydrocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 68, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v17.0)'}, {'term': 'Ear disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 68, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v17.0)'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 33}, {'groupId': 'EG003', 'numAtRisk': 68, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v17.0)'}, {'term': 'Ocular surface disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 68, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v17.0)'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 68, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v17.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 45}, {'groupId': 'EG003', 'numAtRisk': 68, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v17.0)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 68, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v17.0)'}, {'term': 'Anal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 68, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v17.0)'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 68, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v17.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 21}, {'groupId': 'EG003', 'numAtRisk': 68, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v17.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 71}, {'groupId': 'EG003', 'numAtRisk': 68, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v17.0)'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 68, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v17.0)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 68, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v17.0)'}, {'term': 'Enterocolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 68, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v17.0)'}, {'term': 'Gastritis erosive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 68, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v17.0)'}, {'term': 'Glossitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 68, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v17.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 35}, {'groupId': 'EG003', 'numAtRisk': 68, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v17.0)'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 19}, {'groupId': 'EG003', 'numAtRisk': 68, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v17.0)'}, {'term': 'Varices oesophageal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 68, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v17.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 26}, {'groupId': 'EG003', 'numAtRisk': 68, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v17.0)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 27}, {'groupId': 'EG003', 'numAtRisk': 68, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v17.0)'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 68, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v17.0)'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 68, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v17.0)'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 68, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v17.0)'}, {'term': 'Face oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 68, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v17.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 46}, {'groupId': 'EG003', 'numAtRisk': 68, 'numAffected': 18}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v17.0)'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 68, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v17.0)'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v17.0)'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 68, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v17.0)'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 68, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v17.0)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 68, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v17.0)'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 68, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v17.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 68, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v17.0)'}, {'term': 'Hyperbilirubinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 68, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v17.0)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 68, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v17.0)'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 68, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v17.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 68, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v17.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 68, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v17.0)'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 68, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 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and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v17.0)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 68, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v17.0)'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 68, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v17.0)'}, {'term': 'Lung disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 68, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v17.0)'}, {'term': 'Obstructive airways disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v17.0)'}, {'term': 'Pulmonary alveolar haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 68, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v17.0)'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 68, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v17.0)'}, {'term': 'Drug eruption', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 68, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v17.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 68, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v17.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 68, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v17.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 68, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v17.0)'}, {'term': 'Bile duct stone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 68, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v17.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Survival (OS) - Stratified Analysis, Randomized Portion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Axitinib', 'description': 'Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non randomized portion. Study treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles). The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.7', 'groupId': 'OG000', 'lowerLimit': '10.2', 'upperLimit': '14.9'}, {'value': '9.7', 'groupId': 'OG001', 'lowerLimit': '5.9', 'upperLimit': '11.8'}]}]}], 'analyses': [{'pValue': '0.2872', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.907', 'ciLowerLimit': '0.646', 'ciUpperLimit': '1.274', 'pValueComment': 'For the overall stratified analysis the p-value is from a 1-sided log-rank test of treatment stratified by tumor invasion and geographic region.', 'estimateComment': 'Assuming proportional hazards, a hazard ratio less than (\\<) 1 indicated reduction in hazard rate to favor Axitinib; hazard ratio greater than (\\>) 1 indicated reduction to favor Placebo.', 'groupDescription': 'The study was designed to test the null hypothesis that the true median OS was 5 months vs. the alternative hypothesis that the true median OS was at least 8.3 months (i.e., 66 percent \\[%\\] improvement in median OS).', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization until at least two years after the last participant has been randomized (up to 6 years)', 'description': 'OS was defined as the time from the date of randomization to the date of death due to any cause. OS (in months) was calculated as (date of death - first randomization date +1)/30.4. For participants still alive at the time of the analysis, the OS time was censored on the last date they were known to be alive. All participants were followed up for survival at least every 3 months after discontinuing study treatment until at least two years after randomization of the last participant.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants, and participants were classified according to the randomized treatment arm regardless of what treatment, if any, was received.'}, {'type': 'SECONDARY', 'title': 'Progression-Free Survival (PFS) - Stratified Analysis, Randomized Portion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Axitinib', 'description': 'Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non randomized portion. Study treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles). The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000', 'lowerLimit': '2.3', 'upperLimit': '4.6'}, {'value': '1.9', 'groupId': 'OG001', 'lowerLimit': '1.9', 'upperLimit': '3.5'}]}]}], 'analyses': [{'pValue': '0.0039', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.618', 'ciLowerLimit': '0.438', 'ciUpperLimit': '0.871', 'pValueComment': 'For the overall stratified analysis the p-value is from a 1-sided log-rank test of treatment stratified by tumor invasion and geographic region.', 'estimateComment': 'Assuming proportional hazards, a hazard ratio \\<1 indicated a reduction in hazard rate in favor of Axitinib; a hazard ratio \\>1 indicated a reduction in favor of Placebo.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Every 8 weeks until disease progression/death or start of new treatment or until at least two years after the last participant has been randomized, whatever occurs first', 'description': 'PFS was defined as time from randomization to first documented objective tumor progression or to death due to any cause, whichever occurred first. PFS (in months) was calculated as (first event date - first randomization date +1)/30.4. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease \\[PD\\]), or from adverse event (AE) data (where the outcome was death). As per response evaluation criteria in solid tumors (RECIST) 1.1, progression was defined as greater than or equal to (\\>=) 20% increase in sum of longest dimensions of target lesions or appearance of one or more new target lesions and unequivocal progression of existing non-target lesions, or appearance of 1 new non-target lesions. Participants discontinuing study treatment without documented evidence of PD were to be followed up at least every 8 weeks after discontinuing study treatment until disease progression, or initiation of another anticancer treatment.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants, and participants were classified according to the randomized treatment arm regardless of what treatment, if any, was received.'}, {'type': 'SECONDARY', 'title': 'Objective Response Rate (ORR) - Percentage of Participants With Objective Response by Stratified Analysis, Randomized Portion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Axitinib', 'description': 'Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non randomized portion. Study treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles). The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.7', 'groupId': 'OG000', 'lowerLimit': '5.3', 'upperLimit': '16.0'}, {'value': '2.9', 'groupId': 'OG001', 'lowerLimit': '0.4', 'upperLimit': '10.2'}]}]}], 'analyses': [{'pValue': '0.0914', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.172', 'ciLowerLimit': '0.759', 'ciUpperLimit': '13.265', 'pValueComment': 'ORR for the 2 treatment arms was compared with a significance level of 0.025 using Cochran-Mantel-Haenszel (CMH) test for stratified analyses.', 'estimateComment': 'Risk ratio and confidence interval (CI) were based on the Mantel-Haenszel estimator; risk ratio was adjusted for geographical region and vascular invasion and extra hepatic spread.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Every 8 weeks until at least two years after the last participant has been randomized', 'description': 'ORR was defined as the percentage of participants with confirmed complete response (CR) or confirmed partial response (PR) according to the RECIST 1.1. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must decrease to normal (short axis \\<10 millimetres \\[mm\\]). PR was defined as a 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants, and participants were classified according to the randomized treatment arm regardless of what treatment, if any, was received.'}, {'type': 'SECONDARY', 'title': 'Time to Tumor Progression (TTP) - Stratified Analysis, Randomized Portion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Axitinib', 'description': 'Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non randomized portion. Study treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles). The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.7', 'groupId': 'OG000', 'lowerLimit': '2.8', 'upperLimit': '5.6'}, {'value': '1.9', 'groupId': 'OG001', 'lowerLimit': '1.9', 'upperLimit': '3.6'}]}]}], 'analyses': [{'pValue': '0.006', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.621', 'ciLowerLimit': '0.434', 'ciUpperLimit': '0.889', 'pValueComment': 'For the overall stratified analysis the p-value is from a 1-sided log-rank test of treatment stratified by tumor invasion and geographic region.', 'estimateComment': 'Assuming proportional hazards, a hazard ratio \\<1 indicated a reduction in hazard rate in favor of Axitinib; a hazard ratio \\>1 indicated a reduction in favor of Placebo.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Every 8 weeks until disease progression/death or start of new treatment or until at least two years after the last participant has been randomized, whatever occurs first', 'description': 'TTP was defined as the time from randomization to first documentation of objective tumor progression. If tumor progression data included more than 1 date, the first date was used. TTP (in months) was calculated as (first event date - first randomization date +1)/30.4.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants, and participants were classified according to the randomized treatment arm regardless of what treatment, if any, was received.'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DR) by Unstratified Analysis, Randomized Portion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Axitinib', 'description': 'Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non randomized portion. Study treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles). The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.4', 'groupId': 'OG000', 'lowerLimit': '3.7', 'upperLimit': '9.3'}, {'value': 'NA', 'comment': 'Not reached', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From objective response to date of progression or death', 'description': 'DR was defined as the time from the first documentation of objective tumor response (CR or PR) that was subsequently confirmed to the first documentation of PD or to death due to any cause, whichever occurs first. If tumor progression data included more than 1 date, the first date was to be used. DR (in months) was to be calculated as (the end date for DR - first CR or PR that was subsequently confirmed +1)/30.4.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants, and participants were classified according to the randomized treatment arm regardless of what treatment, if any, was received. DR was calculated for the subgroup of FAS participants with objective response.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Overall Clinical Benefit Response (CBR) - Stratified Analysis, Randomized Portion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Axitinib', 'description': 'Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non randomized portion. Study treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles). The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '31.3', 'groupId': 'OG000', 'lowerLimit': '23.6', 'upperLimit': '39.9'}, {'value': '11.8', 'groupId': 'OG001', 'lowerLimit': '5.2', 'upperLimit': '21.9'}]}]}], 'analyses': [{'pValue': '0.0025', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.650', 'ciLowerLimit': '1.319', 'ciUpperLimit': '5.326', 'pValueComment': 'For the overall stratified analysis the p-value is from Cochran-Mantel-Haenszel test of treatment stratified by geographical region and vascular invasion and extra hepatic spread.', 'estimateComment': 'Risk Ratio and CI based on the Mantel-Haenszel estimator; risk ratio was adjusted for geographical region and vascular invasion and extra hepatic spread.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline up to end of treatment', 'description': 'CBR was defined as the percentage of participants with confirmed CR or confirmed PR or a best response of stable disease \\>=8 weeks according to RECIST 1.1 criteria, relative to all randomized participants who had baseline measurable disease. Confirmed responses were defined as those that persisted on repeat imaging study \\>=4 weeks after the initial documentation of response. Participants who did not have on study radiographic tumor re-evaluation or who died, progressed, or dropped out for any reason prior to reaching a CR, PR, or stable disease were counted as non-responders in the assessment of CBR. A participant who initially met the criteria for a PR and then subsequently became a confirmed CR was to be assigned a best response of CR.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants, and participants were classified according to the randomized treatment arm regardless of what treatment, if any, was received.'}, {'type': 'SECONDARY', 'title': 'Axitinib Steady-State Pharmacokinetic (PK) Parameter - Maximum Observed Plasma Concentration (Cmax), Non-Randomized Portion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Child-Pugh Class A', 'description': 'Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the non-randomized portion at selected sites only at a starting axitinib dose of 5 mg BID.'}, {'id': 'OG001', 'title': 'Child-Pugh Class B', 'description': 'Participants with Child-Pugh Class B disease (score 7) at selected sites were initially enrolled only into the non-randomized portion of this study to determine the recommended starting dose of axitinib for this population. The initial starting dose for this group was 2 mg BID.'}], 'classes': [{'categories': [{'measurements': [{'value': '35.74', 'groupId': 'OG000', 'lowerLimit': '21.84', 'upperLimit': '58.50'}, {'value': '21.16', 'groupId': 'OG001', 'lowerLimit': '11.10', 'upperLimit': '40.33'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 15', 'description': 'Axitinib samples were to be collected from all participants on Cycle 1 Day 15 at the following time points: pre-dose, 1, 2, 3, 4, 6 and 8 hours after axitinib dosing.', 'unitOfMeasure': 'nanograms per milliliter (ng/mL)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK concentration set included all participants who were treated and had at least 1 measured concentration on at least 1 day of PK assessment. The PK parameter analysis set included all participants treated who had at least 1 estimated PK parameter of primary interest.'}, {'type': 'SECONDARY', 'title': 'Axitinib Steady-State PK Parameter - Area Under the Plasma Concentration Versus Time Curve From 0 to 24 Hour (AUC0-24), Non-Randomized Portion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Child-Pugh Class A', 'description': 'Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the non-randomized portion at selected sites only at a starting axitinib dose of 5 mg BID.'}, {'id': 'OG001', 'title': 'Child-Pugh Class B', 'description': 'Participants with Child-Pugh Class B disease (score 7) at selected sites were initially enrolled only into the non-randomized portion of this study to determine the recommended starting dose of axitinib for this population. The initial starting dose for this group was 2 mg BID.'}], 'classes': [{'categories': [{'measurements': [{'value': '310.76', 'groupId': 'OG000', 'lowerLimit': '175.02', 'upperLimit': '551.75'}, {'value': '316.20', 'groupId': 'OG001', 'lowerLimit': '162.96', 'upperLimit': '613.55'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 15', 'description': 'Axitinib samples were to be collected from all participants on Cycle 1 Day 15 at the following time points: pre-dose, 1, 2, 3, 4, 6 and 8 hours after axitinib dosing. In the below table, 4 participants in Child-Pugh A and 1 participant in Child-Pugh B were not reported due to nonestimable half-life.', 'unitOfMeasure': 'nanograms*hour per milliliter (ng*hr/mL)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK concentration set included all participants who were treated and had at least 1 measured concentration on at least 1 day of PK assessment. The PK parameter analysis set included all participants treated who had at least 1 estimated PK parameter of primary interest.'}, {'type': 'SECONDARY', 'title': 'Axitinib Steady-State Pharmacokinetic Parameter - Time to First Occurrence of Cmax (Tmax), Non-Randomized Portion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Child-Pugh Class A', 'description': 'Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the non-randomized portion at selected sites only at a starting axitinib dose of 5 mg BID.'}, {'id': 'OG001', 'title': 'Child-Pugh Class B', 'description': 'Participants with Child-Pugh Class B disease (score 7) at selected sites were initially enrolled only into the non-randomized portion of this study to determine the recommended starting dose of axitinib for this population. The initial starting dose for this group was 2 mg BID.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.50', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '7.98'}, {'value': '1.05', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '4.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cycle 1 Day 15', 'description': 'Axitinib samples were to be collected from all participants on Cycle 1 Day 15 at the following time points: pre-dose, 1, 2, 3, 4, 6 and 8 hours after axitinib dosing.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK concentration set included all participants who were treated and had at least 1 measured concentration on at least 1 day of PK assessment. The PK parameter analysis set included all participants treated who had at least 1 estimated PK parameter of primary interest.'}, {'type': 'SECONDARY', 'title': 'Axitinib Steady-State Pharmacokinetic Parameter - Apparent Oral Clearance (CL/F), Non-Randomized Portion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Child-Pugh Class A', 'description': 'Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the non-randomized portion at selected sites only at a starting axitinib dose of 5 mg BID.'}, {'id': 'OG001', 'title': 'Child-Pugh Class B', 'description': 'Participants with Child-Pugh Class B disease (score 7) at selected sites were initially enrolled only into the non-randomized portion of this study to determine the recommended starting dose of axitinib for this population. The initial starting dose for this group was 2 mg BID.'}], 'classes': [{'categories': [{'measurements': [{'value': '32.18', 'groupId': 'OG000', 'lowerLimit': '18.12', 'upperLimit': '57.13'}, {'value': '12.65', 'groupId': 'OG001', 'lowerLimit': '6.52', 'upperLimit': '24.55'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 15', 'description': 'Axitinib samples were to be collected from all participants on Cycle 1 Day 15 at the following time points: pre-dose, 1, 2, 3, 4, 6 and 8 hours after axitinib dosing. In the below table, 4 participants in Child-Pugh A and 1 participant in Child-Pugh B were not reported due to nonestimable half-life.', 'unitOfMeasure': 'liters per hour (L/hr)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK concentration set included all participants who were treated and had at least 1 measured concentration on at least 1 day of PK assessment. The PK parameter analysis set included all participants treated who had at least 1 estimated PK parameter of primary interest.'}, {'type': 'SECONDARY', 'title': 'Axitinib Steady-State Pharmacokinetic Parameter - Terminal Plasma Elimination Half-Life (t1/2), Non-Randomized Portion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Child-Pugh Class A', 'description': 'Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the non-randomized portion at selected sites only at a starting axitinib dose of 5 mg BID.'}, {'id': 'OG001', 'title': 'Child-Pugh Class B', 'description': 'Participants with Child-Pugh Class B disease (score 7) at selected sites were initially enrolled only into the non-randomized portion of this study to determine the recommended starting dose of axitinib for this population. The initial starting dose for this group was 2 mg BID.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.12', 'spread': '3.55', 'groupId': 'OG000', 'lowerLimit': '18.12', 'upperLimit': '57.13'}, {'value': '4.79', 'spread': '2.42', 'groupId': 'OG001', 'lowerLimit': '6.52', 'upperLimit': '24.55'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 Day 15', 'description': 'Axitinib samples were to be collected from all participants on Cycle 1 Day 15 at the following time points: pre-dose, 1, 2, 3, 4, 6 and 8 hours after axitinib dosing. In the below table, 4 participants in Child-Pugh A and 1 participant in Child-Pugh B were not reported due to nonestimable half-life.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK concentration set included all participants who were treated and had at least 1 measured concentration on at least 1 day of PK assessment. The PK parameter analysis set included all participants treated who had at least 1 estimated PK parameter of primary interest.'}, {'type': 'SECONDARY', 'title': 'Axitinib Steady-State Pharmacokinetic Parameter - Apparent Oral Volume of Distribution of the Drug During the Elimination Phase (Vz/F), Non-Randomized Portion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Child-Pugh Class A', 'description': 'Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the non-randomized portion at selected sites only at a starting axitinib dose of 5 mg BID.'}, {'id': 'OG001', 'title': 'Child-Pugh Class B', 'description': 'Participants with Child-Pugh Class B disease (score 7) at selected sites were initially enrolled only into the non-randomized portion of this study to determine the recommended starting dose of axitinib for this population. The initial starting dose for this group was 2 mg BID.'}], 'classes': [{'categories': [{'measurements': [{'value': '150.01', 'spread': '3.55', 'groupId': 'OG000', 'lowerLimit': '94.67', 'upperLimit': '237.68'}, {'value': '81.16', 'spread': '2.42', 'groupId': 'OG001', 'lowerLimit': '47.70', 'upperLimit': '138.08'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 15', 'description': 'Axitinib samples were to be collected from all participants on Cycle 1 Day 15 at the following time points: pre-dose, 1, 2, 3, 4, 6 and 8 hours after axitinib dosing. The PK parameter, Vz/F has been presented in this outcome measure. In the below table, 4 participants in Child-Pugh A and 1 participant in Child-Pugh B were not reported due to nonestimable half-life.', 'unitOfMeasure': 'liters', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK concentration set included all participants who were treated and had at least 1 measured concentration on at least 1 day of PK assessment. The PK parameter analysis set included all participants treated who had at least 1 estimated PK parameter of primary interest.'}, {'type': 'SECONDARY', 'title': 'Concentration of Soluble Proteins at Baseline in Randomized Portion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Axitinib', 'description': 'Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non randomized portion. Study treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles). The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.'}], 'classes': [{'title': 'IL-6', 'categories': [{'measurements': [{'value': '50.67', 'spread': '102.86', 'groupId': 'OG000'}, {'value': '50.72', 'spread': '106.74', 'groupId': 'OG001'}]}]}, {'title': 'E-Selectin', 'categories': [{'measurements': [{'value': '52313.94', 'spread': '32603.18', 'groupId': 'OG000'}, {'value': '55430.76', 'spread': '26723.43', 'groupId': 'OG001'}]}]}, {'title': 'IL-8', 'categories': [{'measurements': [{'value': '33.35', 'spread': '47.72', 'groupId': 'OG000'}, {'value': '27.23', 'spread': '44.46', 'groupId': 'OG001'}]}]}, {'title': 'HGF', 'categories': [{'measurements': [{'value': '478.84', 'spread': '712.43', 'groupId': 'OG000'}, {'value': '406.06', 'spread': '376.04', 'groupId': 'OG001'}]}]}, {'title': 'MMP-2', 'categories': [{'measurements': [{'value': '355715.66', 'spread': '137663.04', 'groupId': 'OG000'}, {'value': '350979.72', 'spread': '146323.29', 'groupId': 'OG001'}]}]}, {'title': 'SCF', 'categories': [{'measurements': [{'value': '1352.75', 'spread': '1534.41', 'groupId': 'OG000'}, {'value': '1439.71', 'spread': '2260.89', 'groupId': 'OG001'}]}]}, {'title': 'Ang-2', 'categories': [{'measurements': [{'value': '662.40', 'spread': '623.87', 'groupId': 'OG000'}, {'value': '577.82', 'spread': '354.42', 'groupId': 'OG001'}]}]}, {'title': 'VEGF-A', 'categories': [{'measurements': [{'value': '102.56', 'spread': '128.09', 'groupId': 'OG000'}, {'value': '173.59', 'spread': '472.19', 'groupId': 'OG001'}]}]}, {'title': 'VEGF-C', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Not available as the % \\< LLQ (lower limit of quantification) was greater than 75%.', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not available as the % \\< LLQ was greater than 75%.', 'groupId': 'OG001'}]}]}, {'title': 'sVEGFR2', 'categories': [{'measurements': [{'value': '17675.76', 'spread': '7218.95', 'groupId': 'OG000'}, {'value': '18273.65', 'spread': '6836.16', 'groupId': 'OG001'}]}]}, {'title': 'sVEGFR3', 'categories': [{'measurements': [{'value': '287429.28', 'spread': '117583.24', 'groupId': 'OG000'}, {'value': '290338.69', 'spread': '97830.36', 'groupId': 'OG001'}]}]}, {'title': 'SDF1', 'categories': [{'measurements': [{'value': '1190.08', 'spread': '823.03', 'groupId': 'OG000'}, {'value': '1150.10', 'spread': '681.04', 'groupId': 'OG001'}]}]}, {'title': 'NGAL', 'categories': [{'measurements': [{'value': '134861.80', 'spread': '152492.96', 'groupId': 'OG000'}, {'value': '141383.00', 'spread': '121747.35', 'groupId': 'OG001'}]}]}, {'title': 'MIF', 'categories': [{'measurements': [{'value': '33057.15', 'spread': '28256.00', 'groupId': 'OG000'}, {'value': '32302.99', 'spread': '21485.01', 'groupId': 'OG001'}]}]}, {'title': 'c-MET ELISA', 'categories': [{'measurements': [{'value': '1664.96', 'spread': '834.36', 'groupId': 'OG000'}, {'value': '1641.08', 'spread': '704.38', 'groupId': 'OG001'}]}]}, {'title': 'RANTES', 'categories': [{'measurements': [{'value': '26412.12', 'spread': '38682.81', 'groupId': 'OG000'}, {'value': '26917.76', 'spread': '27094.12', 'groupId': 'OG001'}]}]}, {'title': 'MCP-3', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Not available as the % \\< LLQ was greater than 75%.', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not available as the % \\< LLQ was greater than 75%.', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Plasma soluble proteins interleukin-6 (IL-6), E-Selectin, interleukin-8 (IL-8), hepatocyte growth factor (HGF), matrix metalloproteinase-2 (MMP-2), stem cell factor (SCF), angiopoietin-2 (Ang-2), vascular endothelial growth factor-A (VEGF-A), vascular endothelial growth factor-C (VEGF-C), soluble vascular endothelial growth factor receptor 2 (sVEGFR2), soluble vascular endothelial growth factor receptor 3 (sVEGFR3), stromal cell-derived factor-1 (SDF1), neutrophil gelatinase-associated lipocalin (NGAL), migration inhibitory factor (MIF), c-MET, regulated upon activation normal T cell expressed and presumably secreted (RANTES), and monocyte chemotactic protein-3 (MCP-3) were only measured in randomized participants.', 'unitOfMeasure': 'picograms per milliliter (pg/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The soluble protein analysis set included all participants in the safety analysis set who had a Baseline soluble protein assessment. Safety analysis population included all randomized participants who received at least 1 dose of study drug with treatment assignments designated according to actual study treatment received.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Specific Micro-Ribonucleic Acid (miRNA) Transcript Present in Circulation in Randomized Portion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Axitinib', 'description': 'Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non randomized portion. Study treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles). The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.'}], 'classes': [{'title': 'hsa-let-7a-5p', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-let-7b-5p', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-let-7c', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-let-7d-5p', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-let-7f-5p', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-let-7g-5p', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-let-7i-5p', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-103a-3p', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-106b-5p', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-107', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-1202', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-1207-5p', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-1225-5p', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-1234-5p', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-1246', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-125b-5p', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-126-3p', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-1260a', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-1260b', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-1268a', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-1273g-3p', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-1275', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-128', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-130a-3p', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-130b-3p', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-140-3p', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-142-3p', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-145-5p', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-148a-3p', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-148b-3p', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-150-5p', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-151a-3p', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-151a-5p', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-151b', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-1587', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-15a-5p', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-15b-5p', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-16-5p', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-17-5p', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-181a-5p', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-182-5p', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-183-5p', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-185-5p', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-186-5p', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-191-5p', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-1914-3p', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-1915-3p', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-192-5p', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-194-5p', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-197-3p', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-197-5p', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-19a-3p', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-19b-3p', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-20a-5p', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-20b-5p', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-21-5p', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-210', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-215', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-22-3p', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-222-3p', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-223-3p', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-23a-3p', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-23b-3p', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-24-3p', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-25-3p', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-26a-5p', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-26b-5p', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, 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{'title': 'hsa-miR-4286', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4299', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4306', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4318', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4323', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4428', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4442', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4443', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4454', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4459', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4466', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4497', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4505', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4507', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4516', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-451a', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4530', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4687-3p', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4713-3p', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4721', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4728-5p', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4732-3p', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4739', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4763-3p', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4787-5p', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4788', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-484', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-486-5p', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-494', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-5001-5p', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-500a-3p', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-500a-5p', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-501-3p', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-501-5p', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-502-3p', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-505-5p', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-5100', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-532-3p', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-532-5p', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-550a-3-5p', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-550a-3p', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-5739', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-574-3p', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-574-5p', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-5787', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-584-5p', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-6085', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-6087', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-6088', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-6089', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-6090', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-6125', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-6127', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-625-5p', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-638', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-642a-3p', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-642b-3p', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-652-3p', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-660-5p', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-664a-3p', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-664b-3p', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-6717-5p', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-6724-5p', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-7-5p', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-762', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-766-3p', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-92a-3p', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-93-3p', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-93-5p', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-937-5p', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-940', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-1228-3p', 'categories': [{'measurements': [{'value': '99.1', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-1268b', 'categories': [{'measurements': [{'value': '99.1', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-142-5p', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '98.3', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-27a-3p', 'categories': [{'measurements': [{'value': '99.1', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-296-5p', 'categories': [{'measurements': [{'value': '99.1', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-3196', 'categories': [{'measurements': [{'value': '99.1', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-3198', 'categories': [{'measurements': [{'value': '99.1', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-342-5p', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '98.3', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-3653', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '98.3', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4465', 'categories': [{'measurements': [{'value': '99.1', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4515', 'categories': [{'measurements': [{'value': '99.1', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4653-3p', 'categories': [{'measurements': [{'value': '99.1', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4665-3p', 'categories': [{'measurements': [{'value': '99.1', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4746-3p', 'categories': [{'measurements': [{'value': '99.1', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-505-3p', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '98.3', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-6073', 'categories': [{'measurements': [{'value': '99.1', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-6126', 'categories': [{'measurements': [{'value': '99.1', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-6132', 'categories': [{'measurements': [{'value': '99.1', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-6165', 'categories': [{'measurements': [{'value': '99.1', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 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{'title': 'hsa-miR-10a-5p', 'categories': [{'measurements': [{'value': '58.6', 'groupId': 'OG000'}, {'value': '59.3', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-3176', 'categories': [{'measurements': [{'value': '56.8', 'groupId': 'OG000'}, {'value': '62.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-1224-5p', 'categories': [{'measurements': [{'value': '56.8', 'groupId': 'OG000'}, {'value': '61.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4462', 'categories': [{'measurements': [{'value': '55.9', 'groupId': 'OG000'}, {'value': '62.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4728-3p', 'categories': [{'measurements': [{'value': '58.6', 'groupId': 'OG000'}, {'value': '57.6', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-193a-5p', 'categories': [{'measurements': [{'value': '59.5', 'groupId': 'OG000'}, {'value': '54.2', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-664b-5p', 'categories': [{'measurements': [{'value': '55.9', 'groupId': 'OG000'}, {'value': '61.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-3141', 'categories': [{'measurements': [{'value': '53.2', 'groupId': 'OG000'}, {'value': '64.4', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-6075', 'categories': [{'measurements': [{'value': '55.9', 'groupId': 'OG000'}, {'value': '59.3', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-6086', 'categories': [{'measurements': [{'value': '55.0', 'groupId': 'OG000'}, {'value': '61.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-99b-5p', 'categories': [{'measurements': [{'value': '55.9', 'groupId': 'OG000'}, {'value': '59.3', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-1307-3p', 'categories': [{'measurements': [{'value': '58.6', 'groupId': 'OG000'}, {'value': '52.5', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-148b-5p', 'categories': [{'measurements': [{'value': '56.8', 'groupId': 'OG000'}, {'value': '55.9', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-15a-3p', 'categories': [{'measurements': [{'value': '59.5', 'groupId': 'OG000'}, {'value': '50.8', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-6513-3p', 'categories': [{'measurements': [{'value': '61.3', 'groupId': 'OG000'}, {'value': '47.5', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-590-5p', 'categories': [{'measurements': [{'value': '54.1', 'groupId': 'OG000'}, {'value': '57.6', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-199a-3p', 'categories': [{'measurements': [{'value': '52.3', 'groupId': 'OG000'}, {'value': '59.3', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-301a-3p', 'categories': [{'measurements': [{'value': '55.0', 'groupId': 'OG000'}, {'value': '52.5', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4698', 'categories': [{'measurements': [{'value': '51.4', 'groupId': 'OG000'}, {'value': '59.3', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-491-5p', 'categories': [{'measurements': [{'value': '56.8', 'groupId': 'OG000'}, {'value': '49.2', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4701-5p', 'categories': [{'measurements': [{'value': '53.2', 'groupId': 'OG000'}, {'value': '54.2', 'groupId': 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'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4312', 'categories': [{'measurements': [{'value': '26.1', 'groupId': 'OG000'}, {'value': '37.3', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-6076', 'categories': [{'measurements': [{'value': '25.2', 'groupId': 'OG000'}, {'value': '35.6', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-5585-3p', 'categories': [{'measurements': [{'value': '28.8', 'groupId': 'OG000'}, {'value': '27.1', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-125b-1-3p', 'categories': [{'measurements': [{'value': '25.2', 'groupId': 'OG000'}, {'value': '32.2', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4632-5p', 'categories': [{'measurements': [{'value': '27.0', 'groupId': 'OG000'}, {'value': '28.8', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-139-5p', 'categories': [{'measurements': [{'value': '27.9', 'groupId': 'OG000'}, {'value': '25.4', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4767', 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}, {'value': '15.3', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-34a-5p', 'categories': [{'measurements': [{'value': '27.9', 'groupId': 'OG000'}, {'value': '22.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4455', 'categories': [{'measurements': [{'value': '25.2', 'groupId': 'OG000'}, {'value': '27.1', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-330-3p', 'categories': [{'measurements': [{'value': '28.8', 'groupId': 'OG000'}, {'value': '18.6', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-1180', 'categories': [{'measurements': [{'value': '25.2', 'groupId': 'OG000'}, {'value': '23.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-193b-3p', 'categories': [{'measurements': [{'value': '28.8', 'groupId': 'OG000'}, {'value': '16.9', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4784', 'categories': [{'measurements': [{'value': '20.7', 'groupId': 'OG000'}, {'value': '30.5', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4667-5p', 'categories': [{'measurements': [{'value': '23.4', 'groupId': 'OG000'}, {'value': '23.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-660-3p', 'categories': [{'measurements': [{'value': '23.4', 'groupId': 'OG000'}, {'value': '23.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4731-3p', 'categories': [{'measurements': [{'value': '22.5', 'groupId': 'OG000'}, {'value': '23.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-503-5p', 'categories': [{'measurements': [{'value': '24.3', 'groupId': 'OG000'}, {'value': '20.3', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-378g', 'categories': [{'measurements': [{'value': '18.0', 'groupId': 'OG000'}, {'value': '27.1', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4481', 'categories': [{'measurements': [{'value': '19.8', 'groupId': 'OG000'}, {'value': '23.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-138-2-3p', 'categories': [{'measurements': [{'value': '18.9', 'groupId': 'OG000'}, {'value': '23.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-1469', 'categories': [{'measurements': [{'value': '20.7', 'groupId': 'OG000'}, {'value': '20.3', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4327', 'categories': [{'measurements': [{'value': '21.6', 'groupId': 'OG000'}, {'value': '18.6', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-1236-5p', 'categories': [{'measurements': [{'value': '17.1', 'groupId': 'OG000'}, {'value': '23.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-152', 'categories': [{'measurements': [{'value': '18.0', 'groupId': 'OG000'}, {'value': '22.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-21-3p', 'categories': [{'measurements': [{'value': '18.9', 'groupId': 'OG000'}, {'value': '20.3', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4697-3p', 'categories': [{'measurements': [{'value': '16.2', 'groupId': 'OG000'}, {'value': '25.4', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-548aa', 'categories': [{'measurements': [{'value': '17.1', 'groupId': 'OG000'}, {'value': '23.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-636', 'categories': [{'measurements': [{'value': '19.8', 'groupId': 'OG000'}, {'value': '18.6', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-767-3p', 'categories': [{'measurements': [{'value': '18.0', 'groupId': 'OG000'}, {'value': '22.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4689', 'categories': [{'measurements': [{'value': '23.4', 'groupId': 'OG000'}, {'value': '8.5', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-3679-3p', 'categories': [{'measurements': [{'value': '19.8', 'groupId': 'OG000'}, {'value': '13.6', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4326', 'categories': [{'measurements': [{'value': '15.3', 'groupId': 'OG000'}, {'value': '22.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-2276', 'categories': [{'measurements': [{'value': '17.1', 'groupId': 'OG000'}, {'value': '16.9', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-3137', 'categories': [{'measurements': [{'value': '17.1', 'groupId': 'OG000'}, {'value': '16.9', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4734', 'categories': [{'measurements': [{'value': '16.2', 'groupId': 'OG000'}, {'value': '18.6', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-181c-5p', 'categories': [{'measurements': [{'value': '18.0', 'groupId': 'OG000'}, {'value': '13.6', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-921', 'categories': [{'measurements': [{'value': '17.1', 'groupId': 'OG000'}, {'value': '15.3', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-3688-3p', 'categories': [{'measurements': [{'value': '15.3', 'groupId': 'OG000'}, {'value': '16.9', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4274', 'categories': [{'measurements': [{'value': '15.3', 'groupId': 'OG000'}, {'value': '16.9', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4758-5p', 'categories': [{'measurements': [{'value': '16.2', 'groupId': 'OG000'}, {'value': '13.6', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-5010-5p', 'categories': [{'measurements': [{'value': '15.3', 'groupId': 'OG000'}, {'value': '15.3', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4488', 'categories': [{'measurements': [{'value': '13.5', 'groupId': 'OG000'}, {'value': '16.9', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-483-5p', 'categories': [{'measurements': [{'value': '14.4', 'groupId': 'OG000'}, {'value': '15.3', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-542-5p', 'categories': [{'measurements': [{'value': '15.3', 'groupId': 'OG000'}, {'value': '13.6', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-623', 'categories': [{'measurements': [{'value': '11.7', 'groupId': 'OG000'}, {'value': '20.3', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-650', 'categories': [{'measurements': [{'value': '9.9', 'groupId': 'OG000'}, {'value': '23.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-3188', 'categories': [{'measurements': [{'value': '11.7', 'groupId': 'OG000'}, {'value': '18.6', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-378b', 'categories': [{'measurements': [{'value': '10.8', 'groupId': 'OG000'}, {'value': '20.3', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-576-5p', 'categories': [{'measurements': [{'value': '12.6', 'groupId': 'OG000'}, {'value': '16.9', 'groupId': 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'OG001'}]}]}, {'title': 'hsa-miR-3615', 'categories': [{'measurements': [{'value': '10.8', 'groupId': 'OG000'}, {'value': '13.6', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-424-3p', 'categories': [{'measurements': [{'value': '10.8', 'groupId': 'OG000'}, {'value': '13.6', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4636', 'categories': [{'measurements': [{'value': '11.7', 'groupId': 'OG000'}, {'value': '11.9', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4646-5p', 'categories': [{'measurements': [{'value': '9.0', 'groupId': 'OG000'}, {'value': '16.9', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-3610', 'categories': [{'measurements': [{'value': '12.6', 'groupId': 'OG000'}, {'value': '8.5', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-557', 'categories': [{'measurements': [{'value': '9.9', 'groupId': 'OG000'}, {'value': '13.6', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-718', 'categories': [{'measurements': [{'value': '14.4', 'groupId': 'OG000'}, {'value': '5.1', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-193b-5p', 'categories': [{'measurements': [{'value': '9.0', 'groupId': 'OG000'}, {'value': '13.6', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-3692-5p', 'categories': [{'measurements': [{'value': '12.6', 'groupId': 'OG000'}, {'value': '6.8', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-509-3-5p', 'categories': [{'measurements': [{'value': '11.7', 'groupId': 'OG000'}, {'value': '8.5', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-1470', 'categories': [{'measurements': [{'value': '10.8', 'groupId': 'OG000'}, {'value': '8.5', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-28-3p', 'categories': [{'measurements': [{'value': '8.1', 'groupId': 'OG000'}, {'value': '13.6', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-378f', 'categories': [{'measurements': [{'value': '10.8', 'groupId': 'OG000'}, {'value': '8.5', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4252', 'categories': [{'measurements': [{'value': '6.3', 'groupId': 'OG000'}, {'value': '16.9', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4417', 'categories': [{'measurements': [{'value': '11.7', 'groupId': 'OG000'}, {'value': '6.8', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4498', 'categories': [{'measurements': [{'value': '10.8', 'groupId': 'OG000'}, {'value': '8.5', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-491-3p', 'categories': [{'measurements': [{'value': '8.1', 'groupId': 'OG000'}, {'value': '13.6', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-495-3p', 'categories': [{'measurements': [{'value': '7.2', 'groupId': 'OG000'}, {'value': '15.3', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-5096', 'categories': [{'measurements': [{'value': '12.6', 'groupId': 'OG000'}, {'value': '5.1', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-1229-3p', 'categories': [{'measurements': [{'value': '6.3', 'groupId': 'OG000'}, {'value': '15.3', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-299-5p', 'categories': [{'measurements': [{'value': '6.3', 'groupId': 'OG000'}, {'value': '15.3', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-3138', 'categories': [{'measurements': [{'value': '6.3', 'groupId': 'OG000'}, {'value': '15.3', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-335-3p', 'categories': [{'measurements': [{'value': '8.1', 'groupId': 'OG000'}, {'value': '11.9', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-3682-3p', 'categories': [{'measurements': [{'value': '8.1', 'groupId': 'OG000'}, {'value': '11.9', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-485-3p', 'categories': [{'measurements': [{'value': '8.1', 'groupId': 'OG000'}, {'value': '11.9', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-630', 'categories': [{'measurements': [{'value': '7.2', 'groupId': 'OG000'}, {'value': '13.6', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-936', 'categories': [{'measurements': [{'value': '9.0', 'groupId': 'OG000'}, {'value': '10.2', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-101-5p', 'categories': [{'measurements': [{'value': '10.8', 'groupId': 'OG000'}, {'value': '5.1', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-122-5p', 'categories': [{'measurements': [{'value': '9.9', 'groupId': 'OG000'}, {'value': '6.8', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4446-3p', 'categories': [{'measurements': [{'value': '5.4', 'groupId': 'OG000'}, {'value': '15.3', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4518', 'categories': [{'measurements': [{'value': '8.1', 'groupId': 'OG000'}, {'value': '10.2', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4640-3p', 'categories': [{'measurements': [{'value': '6.3', 'groupId': 'OG000'}, {'value': '13.6', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-5189', 'categories': [{'measurements': [{'value': '8.1', 'groupId': 'OG000'}, {'value': '10.2', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-6129', 'categories': [{'measurements': [{'value': '8.1', 'groupId': 'OG000'}, {'value': '10.2', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-1471', 'categories': [{'measurements': [{'value': '8.1', 'groupId': 'OG000'}, {'value': '8.5', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-29b-2-5p', 'categories': [{'measurements': [{'value': '8.1', 'groupId': 'OG000'}, {'value': '8.5', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-5003-5p', 'categories': [{'measurements': [{'value': '5.4', 'groupId': 'OG000'}, {'value': '13.6', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-1273c', 'categories': [{'measurements': [{'value': '6.3', 'groupId': 'OG000'}, {'value': '10.2', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-190a', 'categories': [{'measurements': [{'value': '9.0', 'groupId': 'OG000'}, {'value': '5.1', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-3675-3p', 'categories': [{'measurements': [{'value': '8.1', 'groupId': 'OG000'}, {'value': '6.8', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-6511b-5p', 'categories': [{'measurements': [{'value': '5.4', 'groupId': 'OG000'}, {'value': '11.9', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-1291', 'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000'}, {'value': '11.9', 'groupId': 'OG001'}]}]}, {'title': 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[{'measurements': [{'value': '2.7', 'groupId': 'OG000'}, {'value': '8.5', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4673', 'categories': [{'measurements': [{'value': '5.4', 'groupId': 'OG000'}, {'value': '3.4', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4730', 'categories': [{'measurements': [{'value': '6.3', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-489', 'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000'}, {'value': '5.1', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-584-3p', 'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000'}, {'value': '5.1', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-6720-3p', 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}, {'value': '10.2', 'groupId': 'OG001'}]}]}, {'title': 'hsa-let-7i-3p', 'categories': [{'measurements': [{'value': '5.4', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-1307-5p', 'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000'}, {'value': '5.1', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-204-5p', 'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000'}, {'value': '3.4', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-218-5p', 'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000'}, {'value': '3.4', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-378e', 'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000'}, {'value': '5.1', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-3911', 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000'}, {'value': '6.8', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-543', 'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000'}, {'value': '5.1', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-5703', 'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000'}, {'value': '5.1', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-589-3p', 'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000'}, {'value': '5.1', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-885-5p', 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}, {'value': '8.5', 'groupId': 'OG001'}]}]}, {'title': 'hsa-let-7g-3p', 'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000'}, {'value': '3.4', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-1185-2-3p', 'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-1238-5p', 'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000'}, {'value': '3.4', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-19b-1-5p', 'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000'}, {'value': '3.4', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-3130-5p', 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000'}, {'value': '5.1', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-3163', 'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000'}, {'value': '3.4', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-377-3p', 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000'}, {'value': '5.1', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-421', 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000'}, {'value': '5.1', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4419a', 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000'}, {'value': '5.1', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4425', 'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000'}, {'value': '3.4', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4470', 'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000'}, {'value': '3.4', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4539', 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000'}, {'value': '5.1', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-516a-5p', 'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000'}, {'value': '3.4', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-610', 'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-628-5p', 'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000'}, {'value': '3.4', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-99b-3p', 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000'}, {'value': '5.1', 'groupId': 'OG001'}]}]}, {'title': 'hsa-let-7f-2-3p', 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000'}, {'value': '3.4', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-193a-3p', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '6.8', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-195-3p', 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000'}, {'value': '3.4', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-221-5p', 'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-223-5p', 'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-23a-5p', 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}, {'value': '5.1', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-25-5p', 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}, {'value': '5.1', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-3616-3p', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '6.8', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-376c-3p', 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}, {'value': '5.1', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4701-3p', 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000'}, {'value': '3.4', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4743-5p', 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}, {'value': '5.1', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-5008-5p', 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}, {'value': '5.1', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-570-3p', 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000'}, {'value': '3.4', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-595', 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}, {'value': '5.1', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-6716-3p', 'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-887', 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000'}, {'value': '3.4', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-1299', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '5.1', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-133a', 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-198', 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}, {'value': '3.4', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-3622b-5p', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '5.1', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-373-5p', 'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-3917', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '5.1', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-409-5p', 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}, {'value': '3.4', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4440', 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4514', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '5.1', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4535', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '5.1', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4668-5p', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '5.1', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4776-5p', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '5.1', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4793-3p', 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-542-3p', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '5.1', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-548am-5p', 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}, {'value': '3.4', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-548q', 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}, {'value': '3.4', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-582-5p', 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-654-5p', 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}, {'value': '3.4', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-758-3p', 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-760', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '6.8', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-765', 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}, {'value': '3.4', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-875-5p', 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}, {'value': '3.4', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-106a-3p', 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-1236-3p', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '5.1', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-1255b-5p', 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-181c-3p', 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-26a-2-3p', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '3.4', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-298', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '3.4', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-3194-5p', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '3.4', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-3620-3p', 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-374a-3p', 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-411-3p', 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4475', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '3.4', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4476', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '3.4', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4716-5p', 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4762-3p', 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-544a', 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-548d-5p', 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-561-3p', 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-5695', 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-580', 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-612', 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-622', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '3.4', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-670', 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-744-3p', 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-let-7a-3p', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-1255a', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-1270', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-185-3p', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '3.4', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-186-3p', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '3.4', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-187-5p', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-194-3p', 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-200b-5p', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-2052', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '3.4', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-224-5p', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-2964a-5p', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-29b-1-5p', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-30d-3p', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '3.4', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-3150b-5p', 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-3184-3p', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-32-3p', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-323a-3p', 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-3663-5p', 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-370', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-376a-5p', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-381-3p', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 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'OG001'}]}]}, {'title': 'hsa-miR-548at-5p', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-556-3p', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-559', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '3.4', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-5686', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-5692a', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '3.4', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-586', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-590-3p', 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-601', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-607', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-619', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '3.4', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-624-3p', 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-642a-5p', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-645', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-668', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-6722-3p', 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-675-5p', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-888-3p', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-937-3p', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-939-3p', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-10b-3p', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-10b-5p', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-1183', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-1208', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-1226-3p', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-1228-5p', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-124-3p', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-124-5p', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-1247-3p', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-1261', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-1269a', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-1273d', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-1285-5p', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-1287', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-1296', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-143-3p', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-1538', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-16-1-3p', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-184', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-188-3p', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-1909-5p', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-1910', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-196a-3p', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-19a-5p', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-19b-2-5p', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-205-5p', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-206', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-20b-3p', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-2115-5p', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-218-1-3p', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-218-2-3p', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-2277-3p', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-2681-3p', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-26a-1-3p', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-27b-5p', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-297', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-29a-5p', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-300', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-301b', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-302b-3p', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-30a-3p', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-3132', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-3149', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-3157-5p', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-3161', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-32-5p', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-330-5p', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-33a-3p', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-33b-5p', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-34c-3p', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-3591-3p', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-3607-3p', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-3654', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-3666', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-367-5p', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-374b-3p', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-379-3p', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-380-5p', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-3935', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-3937', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-3942-3p', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-3976', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-410', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4259', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4272', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4290', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4294', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-431-5p', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4420', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4422', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4489', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4500', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-450a-5p', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-450b-3p', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-451b', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4520b-3p', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4639-3p', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4648', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4657', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4677-3p', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4677-5p', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4685-3p', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4694-3p', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4695-3p', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4707-5p', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4710', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4723-3p', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4726-5p', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4733-3p', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4733-5p', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4736', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4740-5p', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4755-3p', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4762-5p', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4763-5p', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4785', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4792', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-4800-3p', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-493-5p', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-5007-3p', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-5011-5p', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-5087', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-5093', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-513a-3p', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-513c-3p', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-517c-3p', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-518a-5p', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-5196-3p', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-520c-3p', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-541-3p', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-548a-3p', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-548ap-3p', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-548d-3p', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-548e', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-552', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-558', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-5591-3p', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-5681b', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-5692b', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-5692c', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-571', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-588', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-589-5p', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-593-3p', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-597', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-609', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-615-3p', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-615-5p', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-616-5p', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-618', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-621', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-631', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-633', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-637', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-639', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-642b-5p', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-646', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-6509-3p', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-651', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-6511a-3p', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-657', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-6722-5p', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-708-5p', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-767-5p', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-875-3p', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-876-5p', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-877-5p', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-891a', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-920', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-922', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-924', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-92a-2-5p', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-935', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-938', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-943', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'hsa-miR-423-5p', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline', 'description': 'A 5 millilitres (mL) whole blood sample was collected from all randomized participants to evaluate the miRNA transcripts.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The miRNA analysis set included all participants in the safety analysis set who had a baseline miRNA assessment. Safety analysis population included all randomized participants who received at least 1 dose of study drug with treatment assignments designated according to actual study treatment received.'}, {'type': 'SECONDARY', 'title': 'Functional Assessment of Cancer Therapy - Hepatobiliary Questionnaire (FACT-Hep) in Randomized Portion: Overall Between-Treatment Comparison Based on the Repeated Measures Mixed Effects Model', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Axitinib', 'description': 'Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non randomized portion. Study treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles). The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '123.33', 'groupId': 'OG000', 'lowerLimit': '120.17', 'upperLimit': '126.50'}, {'value': '135.22', 'groupId': 'OG001', 'lowerLimit': '129.17', 'upperLimit': '141.27'}]}]}], 'analyses': [{'pValue': '0.0006', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-11.89', 'ciLowerLimit': '-18.70', 'ciUpperLimit': '-5.08', 'pValueComment': 'No adjustment made for multiple comparisons.', 'groupDescription': 'Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.', 'statisticalMethod': 'Longitudinal mixed effect analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Cycle 1 Day 1 pre-dose and before any other clinical assessments, every 4 weeks thereafter while on study, at end of study treatment/withdrawal, and follow-up and at Day 28 after last dose date', 'description': "FACT-Hep consists of 27-item FACT-G, and 18-item Hepatobiliary Subscale. FACT-Hep questionnaire uses 5-point Likert rating scale, range '0'-not at all to '4'. FACT-Hep total score ranges from 0 to 180, where highest score represents maximum achievable quality of life. Domains of FACT-G include Physical Well-Being (PWB), Social/Family Well-Being (SWB), Emotional Well-Being (EWB) and Functional Well-Being (FWB). Hepatobiliary disease specific items include: swelling or cramps, losing weight, gastrointestinal (GI)-related questions, lack of energy, side effects, pain, fatigue, usual activities, jaundice, fevers, itching, taste of food and chills. Eight of the items (pain, back pain, stomach pain/discomfort, lack of energy, fatigue, nausea, weight loss and jaundice) make up FACT-Hepatobiliary Symptom Index (FHSI-8), and are considered to be symptoms specific to hepatobiliary cancer. Table below included mixed effect model estimated average based on all observed values/time points.", 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants, and participants were classified according to the randomized treatment arm regardless of what treatment, if any, was received.'}, {'type': 'SECONDARY', 'title': 'Functional Assessment of Cancer Therapy - General (FACT-G) in Randomized Portion: Overall Between-Treatment Comparison Based on the Repeated Measures Mixed Effects Model', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Axitinib', 'description': 'Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non randomized portion. Study treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles). The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '71.20', 'groupId': 'OG000', 'lowerLimit': '69.00', 'upperLimit': '73.41'}, {'value': '78.81', 'groupId': 'OG001', 'lowerLimit': '74.68', 'upperLimit': '82.93'}]}]}], 'analyses': [{'pValue': '0.0014', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.60', 'ciLowerLimit': '-12.27', 'ciUpperLimit': '-2.94', 'pValueComment': 'No adjustment made for multiple comparisons.', 'groupDescription': 'Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.', 'statisticalMethod': 'Longitudinal mixed effect analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Cycle 1 Day 1 pre-dose and before any other clinical assessments, every 4 weeks thereafter while on study, at end of study treatment/withdrawal, and follow-up and at Day 28 after last dose date', 'description': 'FACT-G is core questionnaire of Functional Assessment of Chronic Illness Therapy (FACIT) measurement system to evaluate QoL in cancer population. FACT-G consisted of 27 questions grouped in 4 domains of general Health-Related QoL (HRQoL): PWB, SWB, EWB and FWB; each ranging from 0 (not at all) to 4 (very much). FACT-G ranged between 0 and 108. Since questions could be reversed coded, as appropriate, before calculating FACT-G, 0 and 108 could be considered worst and best health states. The below table included the model estimated average based on all the observed values/time points. The mixed effect model was used.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants, and participants were classified according to the randomized treatment arm regardless of what treatment, if any, was received.'}, {'type': 'SECONDARY', 'title': 'Functional Assessment of Cancer Therapy (FACT)-Hepatobiliary Symptom Index-8 (FHSI-8) in Randomized Portion: Overall Between-Treatment Comparison Based on the Repeated Measures Mixed Effects Model', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Axitinib', 'description': 'Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non randomized portion. Study treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles). The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '23.42', 'groupId': 'OG000', 'lowerLimit': '22.77', 'upperLimit': '24.07'}, {'value': '26.69', 'groupId': 'OG001', 'lowerLimit': '25.35', 'upperLimit': '28.03'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.27', 'ciLowerLimit': '-4.76', 'ciUpperLimit': '-1.78', 'pValueComment': 'No adjustment made for multiple comparisons.', 'groupDescription': 'Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.', 'statisticalMethod': 'Longitudinal mixed effect analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Cycle 1 Day 1 pre-dose and before any other clinical assessments, every 4 weeks thereafter while on study, at end of study treatment/withdrawal, and follow-up and at Day 28 after last dose date', 'description': 'The FACT-Hep includes the FACT-G and a hepatobiliary module. The hepatobiliary disease specific items include: swelling or cramps, losing weight, GI related questions, lack of energy, side effects, pain, fatigue, usual activities, jaundice, fevers, itching, taste of food and chills. Eight of the items (pain, back pain, stomach pain/discomfort, lack of energy, fatigue, nausea, weight loss, and jaundice) make up the FHSI-8, and are considered to be symptoms specific to hepatobiliary cancer. FHSI-8 total score ranges from 0 to 32 where "0" is a severely symptomatic participant and the highest score indicates an asymptomatic participant. The below table included the model estimated average based on all the observed values/time points. The mixed effect model was used.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants, and participants were classified according to the randomized treatment arm regardless of what treatment, if any, was received.'}, {'type': 'SECONDARY', 'title': 'Functional Assessment of Cancer Therapy-G (FACT-G) Subscales in Randomized Portion: Overall Between-Treatment Comparison Based on the Repeated Measures Mixed Effects Model', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Axitinib', 'description': 'Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non randomized portion. Study treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles). The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.'}], 'classes': [{'title': 'PWB', 'categories': [{'measurements': [{'value': '19.39', 'groupId': 'OG000', 'lowerLimit': '18.72', 'upperLimit': '20.07'}, {'value': '23.13', 'groupId': 'OG001', 'lowerLimit': '21.76', 'upperLimit': '24.50'}]}]}, {'title': 'SWB', 'categories': [{'measurements': [{'value': '18.94', 'groupId': 'OG000', 'lowerLimit': '18.05', 'upperLimit': '19.83'}, {'value': '20.21', 'groupId': 'OG001', 'lowerLimit': '18.66', 'upperLimit': '21.77'}]}]}, {'title': 'EWB', 'categories': [{'measurements': [{'value': '17.23', 'groupId': 'OG000', 'lowerLimit': '16.63', 'upperLimit': '17.84'}, {'value': '17.71', 'groupId': 'OG001', 'lowerLimit': '16.54', 'upperLimit': '18.89'}]}]}, {'title': 'FWB', 'categories': [{'measurements': [{'value': '15.76', 'groupId': 'OG000', 'lowerLimit': '14.88', 'upperLimit': '16.65'}, {'value': '17.83', 'groupId': 'OG001', 'lowerLimit': '16.19', 'upperLimit': '19.47'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.74', 'ciLowerLimit': '-5.26', 'ciUpperLimit': '-2.21', 'pValueComment': 'No adjustment made for multiple comparisons.', 'groupDescription': 'Analysis presented above is for FACT-G PWB. Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.', 'statisticalMethod': 'Longitudinal mixed effect analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.1642', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.27', 'ciLowerLimit': '-3.07', 'ciUpperLimit': '0.52', 'pValueComment': 'No adjustment made for multiple comparisons.', 'groupDescription': 'Analysis presented above is for FACT-G SWB. Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.', 'statisticalMethod': 'Longitudinal mixed effect analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.4759', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.48', 'ciLowerLimit': '-1.80', 'ciUpperLimit': '0.84', 'pValueComment': 'No adjustment made for multiple comparisons.', 'groupDescription': 'Analysis presented above is for FACT-G EWB. Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.', 'statisticalMethod': 'Longitudinal mixed effect analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.0288', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.07', 'ciLowerLimit': '-3.92', 'ciUpperLimit': '-0.21', 'pValueComment': 'No adjustment made for multiple comparisons.', 'groupDescription': 'Analysis presented above is for FACT-G FWB. Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.', 'statisticalMethod': 'Longitudinal mixed effect analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Cycle 1 Day 1 pre-dose and before any other clinical assessments, every 4 weeks thereafter while on study, at end of study treatment/withdrawal, and follow-up and at Day 28 after last dose date', 'description': 'FACT-G is core questionnaire of Functional Assessment of Chronic Illness Therapy (FACIT) measurement system to evaluate QoL in cancer population. FACT-G consisted of 27 questions grouped in 4 domains of general HRQoL: PWB, SWB, EWB and FWB. Each of the individual subscale, except EWB has 7 items and each integer scored 0 to 4 making a maximum possible score of 28 (range 0 to 28). EWB has 6 items and each integer scored 0 to 4 making a maximum possible score of 24 (range 0 to 24). For all the 4 scales, higher values correspond to better health. The below table included the model estimated average based on all the observed values/time points. The mixed effect model was used.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants, and participants were classified according to the randomized treatment arm regardless of what treatment, if any, was received.'}, {'type': 'SECONDARY', 'title': 'Functional Assessment of Cancer Therapy - Hepatobiliary Cancer Subscale (FACT Hep-CS18) Questionnaire in Randomized Portion: Overall Between-Treatment Comparison Based on the Repeated Measures Mixed Effects Model', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Axitinib', 'description': 'Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non randomized portion. Study treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles). The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '51.78', 'groupId': 'OG000', 'lowerLimit': '50.46', 'upperLimit': '53.10'}, {'value': '56.74', 'groupId': 'OG001', 'lowerLimit': '54.08', 'upperLimit': '59.39'}]}]}], 'analyses': [{'pValue': '0.0011', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.96', 'ciLowerLimit': '-7.93', 'ciUpperLimit': '-1.99', 'pValueComment': 'No adjustment made for multiple comparisons.', 'groupDescription': 'Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.', 'statisticalMethod': 'Longitudinal mixed effect analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Cycle 1 Day 1 pre-dose and before any other clinical assessments, every 4 weeks thereafter while on study, at end of study treatment/withdrawal, and follow-up and at Day 28 after last dose date', 'description': "This subscale consists of 18 items rated on a scale from '0' - not at all to '4' - very much regarding how much each item was present in the last 7 days. FACT-Hep-CS18 total score ranges from 0 to 72. The higher score reflects better QoL or fewer symptoms. The 18 items of this scale are associated with hepatocellular carcinoma. The below table included the model estimated average based on all the observed values/time points. The mixed effect model was used.", 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants, and participants were classified according to the randomized treatment arm regardless of what treatment, if any, was received.'}, {'type': 'SECONDARY', 'title': 'Functional Assessment of Cancer Therapy - Hepatobiliary Cancer Trial Outcome Index (FACT Hep-TOI) Questionnaire in Randomized Portion: Overall Between-Treatment Comparison Based on the Repeated Measures Mixed Effects Model', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Axitinib', 'description': 'Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non randomized portion. Study treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles). The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '87.28', 'groupId': 'OG000', 'lowerLimit': '84.98', 'upperLimit': '89.58'}, {'value': '97.73', 'groupId': 'OG001', 'lowerLimit': '93.24', 'upperLimit': '102.23'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-10.45', 'ciLowerLimit': '-15.49', 'ciUpperLimit': '-5.42', 'pValueComment': 'No adjustment made for multiple comparisons.', 'groupDescription': 'Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.', 'statisticalMethod': 'Longitudinal mixed effect analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Cycle 1 Day 1 pre-dose and before any other clinical assessments, every 4 weeks thereafter while on study, at end of study treatment/withdrawal, and follow-up and at Day 28 after last dose date', 'description': "The trial outcome index is defined to be the sum (PWB+FWB+HepCS), making it 32 items altogether. Each ranges from '0' - not at all to '4' - very much regarding how much each item was present in the last 7 days. FACT Hep -TOI total score ranges from 0 to 128, where the highest score represents a maximum achievable quality of life. The below table included the model estimated average based on all the observed values/time points. The mixed effect model was used.", 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants, and participants were classified according to the randomized treatment arm regardless of what treatment, if any, was received.'}, {'type': 'SECONDARY', 'title': 'Time to Deterioration (TTD) Based on the Composite Endpoint in Randomized Portion: Overall Between-Treatment Comparison Based on the Repeated Measures Mixed Effects Model', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Axitinib', 'description': 'Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non randomized portion. Study treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles). The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000', 'lowerLimit': '1.8', 'upperLimit': '1.9'}, {'value': '1.9', 'groupId': 'OG001', 'lowerLimit': '1.8', 'upperLimit': '2.7'}]}]}], 'analyses': [{'pValue': '0.9182', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.252', 'ciLowerLimit': '0.923', 'ciUpperLimit': '1.698', 'pValueComment': 'The p-value is from a 1-sided log-rank test.', 'estimateComment': 'Assuming proportional hazards, a hazard ratio \\<1 indicates reduction in hazard rate to favor Axitinib, hazard ratio \\>1 indicates reduction to favor Placebo.', 'statisticalMethod': '1-sided, unstratified log-rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization to death or tumor progression or FHSI-8 mean score decrease >=3 points, whichever comes first', 'description': 'TTD analysis was performed for FHSI-8. Time to deterioration was defined as the time between date of randomization and date of the event.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants, and participants were classified according to the randomized treatment arm regardless of what treatment, if any, was received.'}, {'type': 'SECONDARY', 'title': 'EuroQoL (EQ-5D)- Health State Profile Utility Score in Randomized Portion: Overall Between-Treatment Comparison Based on the Repeated Measures Mixed Effects Model', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Axitinib', 'description': 'Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non randomized portion. Study treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles). The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.67', 'groupId': 'OG000', 'lowerLimit': '0.63', 'upperLimit': '0.70'}, {'value': '0.79', 'groupId': 'OG001', 'lowerLimit': '0.72', 'upperLimit': '0.86'}]}]}], 'analyses': [{'pValue': '0.0024', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.12', 'ciLowerLimit': '-0.20', 'ciUpperLimit': '-0.04', 'groupDescription': 'Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.', 'statisticalMethod': 'Longitudinal mixed effect analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Cycle 1 Day 1 pre-dose and before any other clinical assessments, every 4 weeks thereafter while on study, at end of study treatment/withdrawal, and follow-up and at Day 28 after last dose date', 'description': 'EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. The below table included the model estimated average based on all the observed values/time points. The mixed effect model was used.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants, and participants were classified according to the randomized treatment arm regardless of what treatment, if any, was received.'}, {'type': 'SECONDARY', 'title': 'EuroQoL Visual Analogue Scale (EQ-VAS) in Randomized Portion: Overall Between-Treatment Comparison Based on the Repeated Measures Mixed Effects Model', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Axitinib', 'description': 'Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non randomized portion. Study treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles). The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '68.67', 'groupId': 'OG000', 'lowerLimit': '66.11', 'upperLimit': '71.23'}, {'value': '75.70', 'groupId': 'OG001', 'lowerLimit': '70.40', 'upperLimit': '81.00'}]}]}], 'analyses': [{'pValue': '0.0193', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.03', 'ciLowerLimit': '-12.91', 'ciUpperLimit': '-1.15', 'groupDescription': 'Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.', 'statisticalMethod': 'Longitudinal mixed effect analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Cycle 1 Day 1 pre-dose and before any other clinical assessments, every 4 weeks thereafter while on study, at end of study treatment/withdrawal, and follow-up and at Day 28 after last dose date', 'description': "EQ-5D VAS in rates the participant's overall health status using values from 0 (worst imaginable) to 100 (best imaginable). The below table included the model estimated average based on all the observed values/time points. The mixed effect model was used.", 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants, and participants were classified according to the randomized treatment arm regardless of what treatment, if any, was received.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Dose-Limiting Toxicities (DLTs) in Non-Randomized Portion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Child-Pugh Class A', 'description': 'Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the non-randomized portion at selected sites only at a starting axitinib dose of 5 mg BID.'}, {'id': 'OG001', 'title': 'Child-Pugh Class B', 'description': 'Participants with Child-Pugh Class B disease (score 7) at selected sites were initially enrolled only into the non-randomized portion of this study to determine the recommended starting dose of axitinib for this population. The initial starting dose for this group was 2 mg BID.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Cycle 1 (4 weeks)', 'description': 'Number of Child-Pugh Class B (score 7) participants with DLT was evaluated during Cycle 1 of treatment in the non-randomized portion of the study.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with Child-Pugh Class B, score 7 are only included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-Emergent Adverse Events (AEs) in Non-Randomized Portion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Child-Pugh Class A', 'description': 'Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the non-randomized portion at selected sites only at a starting axitinib dose of 5 mg BID.'}, {'id': 'OG001', 'title': 'Child-Pugh Class B', 'description': 'Participants with Child-Pugh Class B disease (score 7) at selected sites were initially enrolled only into the non-randomized portion of this study to determine the recommended starting dose of axitinib for this population. The initial starting dose for this group was 2 mg BID.'}], 'classes': [{'title': 'Participants with AEs', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Participants with SAEs', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Participants >=Grade 3 AEs', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Participants Grade 5 AEs', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 28 days after last dose of study drug (up to 6 years)', 'description': 'An AE was an untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes: death, initial or prolonged inpatient hospitalization, life-threatening experience, persistent or significant disability/incapacity, congenital anomaly. Treatment-emergent AEs were those with initial onset or that worsen in severity after the first dose of study medication. The grade of an AE was determined according to Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis population included participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-Related Adverse Events (AEs) in Non-Randomized Portion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Child-Pugh Class A', 'description': 'Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the non-randomized portion at selected sites only at a starting axitinib dose of 5 mg BID.'}, {'id': 'OG001', 'title': 'Child-Pugh Class B', 'description': 'Participants with Child-Pugh Class B disease (score 7) at selected sites were initially enrolled only into the non-randomized portion of this study to determine the recommended starting dose of axitinib for this population. The initial starting dose for this group was 2 mg BID.'}], 'classes': [{'title': 'Participants with AEs', 'categories': [{'measurements': [{'value': '14', 'spread': '3.55', 'groupId': 'OG000', 'lowerLimit': '94.67', 'upperLimit': '237.68'}, {'value': '6', 'spread': '2.42', 'groupId': 'OG001', 'lowerLimit': '47.70', 'upperLimit': '138.08'}]}]}, {'title': 'Participants with SAEs', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Participants ≥Grade 3 AEs', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Participants Grade 5 AEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 28 days after last dose of study drug (up to 6 years)', 'description': 'Treatment-related AE was any untoward medical occurrence in a participant with causal relationship to the study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The grade of an AE was determined according to CTCAE Version 3.0.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis population included participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-Emergent Adverse Events (AEs) in Randomized Portion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Axitinib', 'description': 'Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non randomized portion. Study treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles). The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.'}], 'classes': [{'title': 'Participants with AEs', 'categories': [{'measurements': [{'value': '131', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}]}, {'title': 'Participants with SAEs', 'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Participants with Grade >=3 AEs', 'categories': [{'measurements': [{'value': '109', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}, {'title': 'Participants with Grade 5 AEs', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 28 days after last dose of study drug (up to 6 years)', 'description': 'An AE was an untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes: death, initial or prolonged inpatient hospitalization, life-threatening experience, persistent or significant disability/incapacity, congenital anomaly. Treatment-emergent AEs were those with initial onset or that worsen in severity after the first dose of study medication. The grade of an AE was determined according to CTCAE Version 3.0.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis population included all randomized participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-Related Adverse Events (AEs) in Randomized Portion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Axitinib', 'description': 'Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non randomized portion. Study treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles). The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.'}], 'classes': [{'title': 'Participants with AEs', 'categories': [{'measurements': [{'value': '128', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}, {'title': 'Participants with SAEs', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Participants with Grade >=3 AEs', 'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Participants with Grade 5 AEs', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 28 days after last dose of study drug (up to 6 years)', 'description': 'Treatment-related AE was any untoward medical occurrence in a participant with causal relationship to the study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The grade of an AE was determined according to CTCAE Version 3.0.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis population included all randomized participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Child-Pugh Class A', 'description': 'Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the non-randomized portion at selected sites only at a starting axitinib dose of 5 milligrams (mg) twice daily (BID).'}, {'id': 'FG001', 'title': 'Child-Pugh Class B', 'description': 'Participants with Child-Pugh Class B disease (score 7) at selected sites were initially enrolled only into the non-randomized portion of this study to determine the recommended starting dose of axitinib for this population. The initial starting dose for this group was 2 mg BID.'}, {'id': 'FG002', 'title': 'Axitinib', 'description': 'Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non-randomized portion. Study treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles).'}, {'id': 'FG003', 'title': 'Placebo', 'description': 'Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles). The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child-Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '134'}, {'groupId': 'FG003', 'numSubjects': '68'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '134'}, {'groupId': 'FG003', 'numSubjects': '68'}]}], 'dropWithdraws': [{'type': 'Participant Refused Further Follow-Up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '112'}, {'groupId': 'FG003', 'numSubjects': '54'}]}, {'type': 'Study Terminated by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '11'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Other unspecified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Total 224 participants were enrolled in the study. Randomized portion enrolled 202 participants in 2 arms (134 in axitinib, 68 in placebo) in 70 centers (13 countries). Non-randomized portion enrolled 22 participants in 2 cohorts (15 in Child-Pugh Class A, 7 in Child-Pugh Class B score 7) according to Child-Pugh score in 13 centers (4 countries).', 'preAssignmentDetails': 'Participants with Child-Pugh Class A (score 5 or 6) could have been enrolled into either non-randomized or to randomized portion. Participants with Child-Pugh Class B (score 7) were initially enrolled into non-randomized portion but following determination of recommended axitinib starting dose they could have been enrolled in randomized portion.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '134', 'groupId': 'BG002'}, {'value': '68', 'groupId': 'BG003'}, {'value': '224', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Child-Pugh Class A', 'description': 'Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the non-randomized portion at selected sites only at a starting axitinib dose of 5 mg BID.'}, {'id': 'BG001', 'title': 'Child-Pugh Class B', 'description': 'Participants with Child-Pugh Class B disease (score 7) at selected sites were initially enrolled only into the non-randomized portion of this study to determine the recommended starting dose of axitinib for this population. The initial starting dose for this group was 2 mg BID.'}, {'id': 'BG002', 'title': 'Axitinib', 'description': 'Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non randomized portion. Study treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles).'}, {'id': 'BG003', 'title': 'Placebo', 'description': 'Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles). The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<18 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}, {'title': '18-44 years', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}]}]}, {'title': '45-64 years', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}, {'value': '116', 'groupId': 'BG004'}]}]}, {'title': '>=65 years', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}, {'value': '93', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '41', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '110', 'groupId': 'BG002'}, {'value': '56', 'groupId': 'BG003'}, {'value': '183', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full analysis set (FAS) included all randomized participants, and participants were classified according to the randomized treatment arm regardless of what treatment, if any, was received.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 224}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-12-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'dispFirstSubmitDate': '2014-03-04', 'completionDateStruct': {'date': '2016-12-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-20', 'studyFirstSubmitDate': '2010-09-22', 'dispFirstSubmitQcDate': '2014-03-04', 'resultsFirstSubmitDate': '2015-03-03', 'studyFirstSubmitQcDate': '2010-09-27', 'dispFirstPostDateStruct': {'date': '2014-04-02', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2019-01-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-05-11', 'studyFirstPostDateStruct': {'date': '2010-09-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-05-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival (OS) - Stratified Analysis, Randomized Portion', 'timeFrame': 'From randomization until at least two years after the last participant has been randomized (up to 6 years)', 'description': 'OS was defined as the time from the date of randomization to the date of death due to any cause. OS (in months) was calculated as (date of death - first randomization date +1)/30.4. For participants still alive at the time of the analysis, the OS time was censored on the last date they were known to be alive. All participants were followed up for survival at least every 3 months after discontinuing study treatment until at least two years after randomization of the last participant.'}], 'secondaryOutcomes': [{'measure': 'Progression-Free Survival (PFS) - Stratified Analysis, Randomized Portion', 'timeFrame': 'Every 8 weeks until disease progression/death or start of new treatment or until at least two years after the last participant has been randomized, whatever occurs first', 'description': 'PFS was defined as time from randomization to first documented objective tumor progression or to death due to any cause, whichever occurred first. PFS (in months) was calculated as (first event date - first randomization date +1)/30.4. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease \\[PD\\]), or from adverse event (AE) data (where the outcome was death). As per response evaluation criteria in solid tumors (RECIST) 1.1, progression was defined as greater than or equal to (\\>=) 20% increase in sum of longest dimensions of target lesions or appearance of one or more new target lesions and unequivocal progression of existing non-target lesions, or appearance of 1 new non-target lesions. Participants discontinuing study treatment without documented evidence of PD were to be followed up at least every 8 weeks after discontinuing study treatment until disease progression, or initiation of another anticancer treatment.'}, {'measure': 'Objective Response Rate (ORR) - Percentage of Participants With Objective Response by Stratified Analysis, Randomized Portion', 'timeFrame': 'Every 8 weeks until at least two years after the last participant has been randomized', 'description': 'ORR was defined as the percentage of participants with confirmed complete response (CR) or confirmed partial response (PR) according to the RECIST 1.1. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must decrease to normal (short axis \\<10 millimetres \\[mm\\]). PR was defined as a 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.'}, {'measure': 'Time to Tumor Progression (TTP) - Stratified Analysis, Randomized Portion', 'timeFrame': 'Every 8 weeks until disease progression/death or start of new treatment or until at least two years after the last participant has been randomized, whatever occurs first', 'description': 'TTP was defined as the time from randomization to first documentation of objective tumor progression. If tumor progression data included more than 1 date, the first date was used. TTP (in months) was calculated as (first event date - first randomization date +1)/30.4.'}, {'measure': 'Duration of Response (DR) by Unstratified Analysis, Randomized Portion', 'timeFrame': 'From objective response to date of progression or death', 'description': 'DR was defined as the time from the first documentation of objective tumor response (CR or PR) that was subsequently confirmed to the first documentation of PD or to death due to any cause, whichever occurs first. If tumor progression data included more than 1 date, the first date was to be used. DR (in months) was to be calculated as (the end date for DR - first CR or PR that was subsequently confirmed +1)/30.4.'}, {'measure': 'Percentage of Participants With Overall Clinical Benefit Response (CBR) - Stratified Analysis, Randomized Portion', 'timeFrame': 'From Baseline up to end of treatment', 'description': 'CBR was defined as the percentage of participants with confirmed CR or confirmed PR or a best response of stable disease \\>=8 weeks according to RECIST 1.1 criteria, relative to all randomized participants who had baseline measurable disease. Confirmed responses were defined as those that persisted on repeat imaging study \\>=4 weeks after the initial documentation of response. Participants who did not have on study radiographic tumor re-evaluation or who died, progressed, or dropped out for any reason prior to reaching a CR, PR, or stable disease were counted as non-responders in the assessment of CBR. A participant who initially met the criteria for a PR and then subsequently became a confirmed CR was to be assigned a best response of CR.'}, {'measure': 'Axitinib Steady-State Pharmacokinetic (PK) Parameter - Maximum Observed Plasma Concentration (Cmax), Non-Randomized Portion', 'timeFrame': 'Cycle 1 Day 15', 'description': 'Axitinib samples were to be collected from all participants on Cycle 1 Day 15 at the following time points: pre-dose, 1, 2, 3, 4, 6 and 8 hours after axitinib dosing.'}, {'measure': 'Axitinib Steady-State PK Parameter - Area Under the Plasma Concentration Versus Time Curve From 0 to 24 Hour (AUC0-24), Non-Randomized Portion', 'timeFrame': 'Cycle 1 Day 15', 'description': 'Axitinib samples were to be collected from all participants on Cycle 1 Day 15 at the following time points: pre-dose, 1, 2, 3, 4, 6 and 8 hours after axitinib dosing. In the below table, 4 participants in Child-Pugh A and 1 participant in Child-Pugh B were not reported due to nonestimable half-life.'}, {'measure': 'Axitinib Steady-State Pharmacokinetic Parameter - Time to First Occurrence of Cmax (Tmax), Non-Randomized Portion', 'timeFrame': 'Cycle 1 Day 15', 'description': 'Axitinib samples were to be collected from all participants on Cycle 1 Day 15 at the following time points: pre-dose, 1, 2, 3, 4, 6 and 8 hours after axitinib dosing.'}, {'measure': 'Axitinib Steady-State Pharmacokinetic Parameter - Apparent Oral Clearance (CL/F), Non-Randomized Portion', 'timeFrame': 'Cycle 1 Day 15', 'description': 'Axitinib samples were to be collected from all participants on Cycle 1 Day 15 at the following time points: pre-dose, 1, 2, 3, 4, 6 and 8 hours after axitinib dosing. In the below table, 4 participants in Child-Pugh A and 1 participant in Child-Pugh B were not reported due to nonestimable half-life.'}, {'measure': 'Axitinib Steady-State Pharmacokinetic Parameter - Terminal Plasma Elimination Half-Life (t1/2), Non-Randomized Portion', 'timeFrame': 'Cycle 1 Day 15', 'description': 'Axitinib samples were to be collected from all participants on Cycle 1 Day 15 at the following time points: pre-dose, 1, 2, 3, 4, 6 and 8 hours after axitinib dosing. In the below table, 4 participants in Child-Pugh A and 1 participant in Child-Pugh B were not reported due to nonestimable half-life.'}, {'measure': 'Axitinib Steady-State Pharmacokinetic Parameter - Apparent Oral Volume of Distribution of the Drug During the Elimination Phase (Vz/F), Non-Randomized Portion', 'timeFrame': 'Cycle 1 Day 15', 'description': 'Axitinib samples were to be collected from all participants on Cycle 1 Day 15 at the following time points: pre-dose, 1, 2, 3, 4, 6 and 8 hours after axitinib dosing. The PK parameter, Vz/F has been presented in this outcome measure. In the below table, 4 participants in Child-Pugh A and 1 participant in Child-Pugh B were not reported due to nonestimable half-life.'}, {'measure': 'Concentration of Soluble Proteins at Baseline in Randomized Portion', 'timeFrame': 'Baseline', 'description': 'Plasma soluble proteins interleukin-6 (IL-6), E-Selectin, interleukin-8 (IL-8), hepatocyte growth factor (HGF), matrix metalloproteinase-2 (MMP-2), stem cell factor (SCF), angiopoietin-2 (Ang-2), vascular endothelial growth factor-A (VEGF-A), vascular endothelial growth factor-C (VEGF-C), soluble vascular endothelial growth factor receptor 2 (sVEGFR2), soluble vascular endothelial growth factor receptor 3 (sVEGFR3), stromal cell-derived factor-1 (SDF1), neutrophil gelatinase-associated lipocalin (NGAL), migration inhibitory factor (MIF), c-MET, regulated upon activation normal T cell expressed and presumably secreted (RANTES), and monocyte chemotactic protein-3 (MCP-3) were only measured in randomized participants.'}, {'measure': 'Percentage of Participants With Specific Micro-Ribonucleic Acid (miRNA) Transcript Present in Circulation in Randomized Portion', 'timeFrame': 'Baseline', 'description': 'A 5 millilitres (mL) whole blood sample was collected from all randomized participants to evaluate the miRNA transcripts.'}, {'measure': 'Functional Assessment of Cancer Therapy - Hepatobiliary Questionnaire (FACT-Hep) in Randomized Portion: Overall Between-Treatment Comparison Based on the Repeated Measures Mixed Effects Model', 'timeFrame': 'Cycle 1 Day 1 pre-dose and before any other clinical assessments, every 4 weeks thereafter while on study, at end of study treatment/withdrawal, and follow-up and at Day 28 after last dose date', 'description': "FACT-Hep consists of 27-item FACT-G, and 18-item Hepatobiliary Subscale. FACT-Hep questionnaire uses 5-point Likert rating scale, range '0'-not at all to '4'. FACT-Hep total score ranges from 0 to 180, where highest score represents maximum achievable quality of life. Domains of FACT-G include Physical Well-Being (PWB), Social/Family Well-Being (SWB), Emotional Well-Being (EWB) and Functional Well-Being (FWB). Hepatobiliary disease specific items include: swelling or cramps, losing weight, gastrointestinal (GI)-related questions, lack of energy, side effects, pain, fatigue, usual activities, jaundice, fevers, itching, taste of food and chills. Eight of the items (pain, back pain, stomach pain/discomfort, lack of energy, fatigue, nausea, weight loss and jaundice) make up FACT-Hepatobiliary Symptom Index (FHSI-8), and are considered to be symptoms specific to hepatobiliary cancer. Table below included mixed effect model estimated average based on all observed values/time points."}, {'measure': 'Functional Assessment of Cancer Therapy - General (FACT-G) in Randomized Portion: Overall Between-Treatment Comparison Based on the Repeated Measures Mixed Effects Model', 'timeFrame': 'Cycle 1 Day 1 pre-dose and before any other clinical assessments, every 4 weeks thereafter while on study, at end of study treatment/withdrawal, and follow-up and at Day 28 after last dose date', 'description': 'FACT-G is core questionnaire of Functional Assessment of Chronic Illness Therapy (FACIT) measurement system to evaluate QoL in cancer population. FACT-G consisted of 27 questions grouped in 4 domains of general Health-Related QoL (HRQoL): PWB, SWB, EWB and FWB; each ranging from 0 (not at all) to 4 (very much). FACT-G ranged between 0 and 108. Since questions could be reversed coded, as appropriate, before calculating FACT-G, 0 and 108 could be considered worst and best health states. The below table included the model estimated average based on all the observed values/time points. The mixed effect model was used.'}, {'measure': 'Functional Assessment of Cancer Therapy (FACT)-Hepatobiliary Symptom Index-8 (FHSI-8) in Randomized Portion: Overall Between-Treatment Comparison Based on the Repeated Measures Mixed Effects Model', 'timeFrame': 'Cycle 1 Day 1 pre-dose and before any other clinical assessments, every 4 weeks thereafter while on study, at end of study treatment/withdrawal, and follow-up and at Day 28 after last dose date', 'description': 'The FACT-Hep includes the FACT-G and a hepatobiliary module. The hepatobiliary disease specific items include: swelling or cramps, losing weight, GI related questions, lack of energy, side effects, pain, fatigue, usual activities, jaundice, fevers, itching, taste of food and chills. Eight of the items (pain, back pain, stomach pain/discomfort, lack of energy, fatigue, nausea, weight loss, and jaundice) make up the FHSI-8, and are considered to be symptoms specific to hepatobiliary cancer. FHSI-8 total score ranges from 0 to 32 where "0" is a severely symptomatic participant and the highest score indicates an asymptomatic participant. The below table included the model estimated average based on all the observed values/time points. The mixed effect model was used.'}, {'measure': 'Functional Assessment of Cancer Therapy-G (FACT-G) Subscales in Randomized Portion: Overall Between-Treatment Comparison Based on the Repeated Measures Mixed Effects Model', 'timeFrame': 'Cycle 1 Day 1 pre-dose and before any other clinical assessments, every 4 weeks thereafter while on study, at end of study treatment/withdrawal, and follow-up and at Day 28 after last dose date', 'description': 'FACT-G is core questionnaire of Functional Assessment of Chronic Illness Therapy (FACIT) measurement system to evaluate QoL in cancer population. FACT-G consisted of 27 questions grouped in 4 domains of general HRQoL: PWB, SWB, EWB and FWB. Each of the individual subscale, except EWB has 7 items and each integer scored 0 to 4 making a maximum possible score of 28 (range 0 to 28). EWB has 6 items and each integer scored 0 to 4 making a maximum possible score of 24 (range 0 to 24). For all the 4 scales, higher values correspond to better health. The below table included the model estimated average based on all the observed values/time points. The mixed effect model was used.'}, {'measure': 'Functional Assessment of Cancer Therapy - Hepatobiliary Cancer Subscale (FACT Hep-CS18) Questionnaire in Randomized Portion: Overall Between-Treatment Comparison Based on the Repeated Measures Mixed Effects Model', 'timeFrame': 'Cycle 1 Day 1 pre-dose and before any other clinical assessments, every 4 weeks thereafter while on study, at end of study treatment/withdrawal, and follow-up and at Day 28 after last dose date', 'description': "This subscale consists of 18 items rated on a scale from '0' - not at all to '4' - very much regarding how much each item was present in the last 7 days. FACT-Hep-CS18 total score ranges from 0 to 72. The higher score reflects better QoL or fewer symptoms. The 18 items of this scale are associated with hepatocellular carcinoma. The below table included the model estimated average based on all the observed values/time points. The mixed effect model was used."}, {'measure': 'Functional Assessment of Cancer Therapy - Hepatobiliary Cancer Trial Outcome Index (FACT Hep-TOI) Questionnaire in Randomized Portion: Overall Between-Treatment Comparison Based on the Repeated Measures Mixed Effects Model', 'timeFrame': 'Cycle 1 Day 1 pre-dose and before any other clinical assessments, every 4 weeks thereafter while on study, at end of study treatment/withdrawal, and follow-up and at Day 28 after last dose date', 'description': "The trial outcome index is defined to be the sum (PWB+FWB+HepCS), making it 32 items altogether. Each ranges from '0' - not at all to '4' - very much regarding how much each item was present in the last 7 days. FACT Hep -TOI total score ranges from 0 to 128, where the highest score represents a maximum achievable quality of life. The below table included the model estimated average based on all the observed values/time points. The mixed effect model was used."}, {'measure': 'Time to Deterioration (TTD) Based on the Composite Endpoint in Randomized Portion: Overall Between-Treatment Comparison Based on the Repeated Measures Mixed Effects Model', 'timeFrame': 'From randomization to death or tumor progression or FHSI-8 mean score decrease >=3 points, whichever comes first', 'description': 'TTD analysis was performed for FHSI-8. Time to deterioration was defined as the time between date of randomization and date of the event.'}, {'measure': 'EuroQoL (EQ-5D)- Health State Profile Utility Score in Randomized Portion: Overall Between-Treatment Comparison Based on the Repeated Measures Mixed Effects Model', 'timeFrame': 'Cycle 1 Day 1 pre-dose and before any other clinical assessments, every 4 weeks thereafter while on study, at end of study treatment/withdrawal, and follow-up and at Day 28 after last dose date', 'description': 'EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. The below table included the model estimated average based on all the observed values/time points. The mixed effect model was used.'}, {'measure': 'EuroQoL Visual Analogue Scale (EQ-VAS) in Randomized Portion: Overall Between-Treatment Comparison Based on the Repeated Measures Mixed Effects Model', 'timeFrame': 'Cycle 1 Day 1 pre-dose and before any other clinical assessments, every 4 weeks thereafter while on study, at end of study treatment/withdrawal, and follow-up and at Day 28 after last dose date', 'description': "EQ-5D VAS in rates the participant's overall health status using values from 0 (worst imaginable) to 100 (best imaginable). The below table included the model estimated average based on all the observed values/time points. The mixed effect model was used."}, {'measure': 'Number of Participants With Dose-Limiting Toxicities (DLTs) in Non-Randomized Portion', 'timeFrame': 'Cycle 1 (4 weeks)', 'description': 'Number of Child-Pugh Class B (score 7) participants with DLT was evaluated during Cycle 1 of treatment in the non-randomized portion of the study.'}, {'measure': 'Number of Participants With Treatment-Emergent Adverse Events (AEs) in Non-Randomized Portion', 'timeFrame': 'Up to 28 days after last dose of study drug (up to 6 years)', 'description': 'An AE was an untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes: death, initial or prolonged inpatient hospitalization, life-threatening experience, persistent or significant disability/incapacity, congenital anomaly. Treatment-emergent AEs were those with initial onset or that worsen in severity after the first dose of study medication. The grade of an AE was determined according to Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0.'}, {'measure': 'Number of Participants With Treatment-Related Adverse Events (AEs) in Non-Randomized Portion', 'timeFrame': 'Up to 28 days after last dose of study drug (up to 6 years)', 'description': 'Treatment-related AE was any untoward medical occurrence in a participant with causal relationship to the study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The grade of an AE was determined according to CTCAE Version 3.0.'}, {'measure': 'Number of Participants With Treatment-Emergent Adverse Events (AEs) in Randomized Portion', 'timeFrame': 'Up to 28 days after last dose of study drug (up to 6 years)', 'description': 'An AE was an untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes: death, initial or prolonged inpatient hospitalization, life-threatening experience, persistent or significant disability/incapacity, congenital anomaly. Treatment-emergent AEs were those with initial onset or that worsen in severity after the first dose of study medication. The grade of an AE was determined according to CTCAE Version 3.0.'}, {'measure': 'Number of Participants With Treatment-Related Adverse Events (AEs) in Randomized Portion', 'timeFrame': 'Up to 28 days after last dose of study drug (up to 6 years)', 'description': 'Treatment-related AE was any untoward medical occurrence in a participant with causal relationship to the study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The grade of an AE was determined according to CTCAE Version 3.0.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Hepatocellular Carcinoma'], 'conditions': ['Hepatocellular Carcinoma']}, 'referencesModule': {'references': [{'pmid': '26386123', 'type': 'DERIVED', 'citation': 'Kang YK, Yau T, Park JW, Lim HY, Lee TY, Obi S, Chan SL, Qin S, Kim RD, Casey M, Chen C, Bhattacharyya H, Williams JA, Valota O, Chakrabarti D, Kudo M. Randomized phase II study of axitinib versus placebo plus best supportive care in second-line treatment of advanced hepatocellular carcinoma. Ann Oncol. 2015 Dec;26(12):2457-63. doi: 10.1093/annonc/mdv388. Epub 2015 Sep 18.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A4061058&StudyName=Axitinib%20For%20The%20Treatment%20Of%20Advanced%20Hepatocellular%20Carcinoma', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The study is designed to demonstrate that axitinib plus best supportive care is superior to placebo plus best supportive care in prolonging survival in patients with advanced hepatocellular carcinoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Locally advanced or metastatic HCC\n* Failure of one prior antiangiogenic therapy including sorafenib, bevacizumab and brivanib.\n* Child-Pugh Class A or B (score 7 only) disease.\n\nExclusion Criteria:\n\n* Prior treatment of advanced HCC with more than one prior first-line systemic therapy.\n* Any prior local therapy within 2 weeks of starting the study treatment.\n* Presence of hepatic encephalopathy and/or clinically relevant ascites.\n* Presence of main portal vein invasion by HCC.'}, 'identificationModule': {'nctId': 'NCT01210495', 'briefTitle': 'Axitinib For The Treatment Of Advanced Hepatocellular Carcinoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A MULTICENTER, GLOBAL, RANDOMIZED, DOUBLE-BLIND STUDY OF AXITINIB PLUS BEST SUPPORTIVE CARE VERSUS PLACEBO PLUS BEST SUPPORTIVE CARE IN PATIENTS WITH ADVANCED HEPATOCELLULAR CARCINOMA FOLLOWING FAILURE OF ONE PRIOR ANTIANGIOGENIC THERAPY', 'orgStudyIdInfo': {'id': 'A4061058'}, 'secondaryIdInfos': [{'id': '2010-021590-37', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non-randomized portion. Study treatment was administered in cycles of 4 weeks in duration', 'interventionNames': ['Drug: Axitinib (AG-013736)', 'Other: Best Supportive Care']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'B', 'description': 'Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration. The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child-Pugh Class B, score 7, were not permitted to enter the randomized portion of the study', 'interventionNames': ['Drug: Placebo', 'Other: Best Supportive Care']}], 'interventions': [{'name': 'Axitinib (AG-013736)', 'type': 'DRUG', 'description': 'Axitinib \\[tablet, 1 mg, 5 mg\\] will be given twice daily \\[BID\\] with continuous dosing; duration is approximately 3-6 months; starting dose is 5 mg BID', 'armGroupLabels': ['A']}, {'name': 'Best Supportive Care', 'type': 'OTHER', 'description': 'BSC may include medications and supportive measures deemed necessary to palliate disease related symptoms and improve quality of life.', 'armGroupLabels': ['A']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo \\[tablet, 1 mg, 5 mg\\] will be given twice daily \\[BID\\] with continuous 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