Ignite Creation Date:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2025-12-26 @ 11:13 PM
Study NCT ID:
NCT01653912
Status:
COMPLETED
Last Update Posted:
2018-04-02
First Post:
2012-07-27
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Dose-finding Study in Platinum-Resistant Ovarian Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000595148', 'term': 'GSK2110183'}, {'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D017239', 'term': 'Paclitaxel'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '+41 613241111', 'title': 'Study Director', 'organization': 'Novartis Pharma AG'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Up to Day 51', 'description': 'Included Serious Adverse Events (SAEs) and Adverse Events (AEs) for ATS population', 'eventGroups': [{'id': 'EG000', 'title': 'Phase 1 (Dose Escalation): GSK2110183', 'description': 'GSK2110183, either at 50 mg, 75 mg, 100 mg, 125 mg or 150 mg capsule by mouth daily in combination with carboplatin AUC 5 and paclitaxel 175 mg/m2 given intravenously every 3 weeks for a maximum 6 cycles.', 'otherNumAtRisk': 29, 'otherNumAffected': 29, 'seriousNumAtRisk': 29, 'seriousNumAffected': 14}, {'id': 'EG001', 'title': 'Phase 2 (Treatment Group): GSK2110183', 'description': 'The dosing regimen identified in Phase 1 will then be evaluated in Phase 2, a single arm study focused on clinical efficacy. GSK2110183 125 mg (MTD) capsule by mouth daily in combination with carboplatin AUC 5 and paclitaxel 175 mg/m2 given intravenously every 3 weeks for a maximum 6 x 21 day cycles followed by continuous GSK2110183 150 mg capsule by mouth daily until progression, death or unacceptable toxicity.', 'otherNumAtRisk': 30, 'otherNumAffected': 30, 'seriousNumAtRisk': 30, 'seriousNumAffected': 16}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 45, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 38, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 53, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 20, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 44, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 22, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 20, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 14, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Gastroesophageal Reflux Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 25, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 11, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 18, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 14, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 10, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Mouth ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 17, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 17, 'numAffected': 16}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 18, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 8, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 12, 'numAffected': 11}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 37, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 27, 'numAffected': 18}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 27, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 22, 'numAffected': 14}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 11, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 11, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 9, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Neurotoxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 6, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 21, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 13, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 19, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 7, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 11, 'numAffected': 8}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Oral candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 16, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Drug hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 7, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 7, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'CARDIAC DISORDERS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'RENAL AND URINARY DISORDERS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 9, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'EYE DISORDERS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'REPRODUCTIVE SYSTEM AND BREAST DISORDERS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}], 'seriousEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 9, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Small Intestinal Obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Colonic Obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Lip Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Oesophageal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Neutropenic Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Lower Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Escherichia Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Gastroenteritis Viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Lobar Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Oral Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Peritonitis Bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Respiratory Tract Infection Bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Febrile Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Influenza Like Illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Mucosal Inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Drug Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Pleural Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Rash Maculo-Papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Upper Limb Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Transaminases Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Lethargy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Renal Failure Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Phase 1: Number of Subjects With Treatment-Emergent Adverse Events (TEAE) of Grade Greater Than or Equal to (≥) 3 in Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1 (Dose Escalation): GSK2110183', 'description': 'GSK2110183, either at 50 mg, 75 mg, 100 mg, 125 mg or 150 mg capsule by mouth daily in combination with carboplatin AUC 5 and paclitaxel 175 mg/m2 given intravenously every 3 weeks for a maximum 6 cycles.'}], 'classes': [{'title': 'Subjects with at Least 1 TEAE of Grade ≥3', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}]}]}, {'title': 'Neutropenia', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Hypomagnesaemia', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Diarrhoea', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Rash Maculo-Papular', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Vomiting', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Anaemia', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Rash', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Fatigue', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Nausea', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Neutropenic sepsis', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Hyperglycemia', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Week 3', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All Treated Subjects (ATS) in Phase 1.'}, {'type': 'PRIMARY', 'title': 'Phase 1 Safety: Number of Subjects Reporting Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1 (Dose Escalation): GSK2110183', 'description': 'GSK2110183, either at 50 mg, 75 mg, 100 mg, 125 mg or 150 mg capsule by mouth daily in combination with carboplatin AUC 5 and paclitaxel 175 mg/m2 given intravenously every 3 weeks for a maximum 6 cycles.'}], 'classes': [{'title': 'Treatment Emergent Adverse Events (TEAEs)', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}]}]}, {'title': 'Serious TEAEs', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'GSK2110183 Related Serious TEAEs', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'GSK2110183 Related TEAEs', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}]}]}, {'title': 'Study Treatment Related TEAEs', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}]}]}, {'title': 'TEAEs Leading to Discontinuation of GSK2110183', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'TEAEs Leading to Discontinuation of Study Treatmnt', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'TEAEs Leading to Dose Modification of GSK2110183', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}, {'title': 'TEAEs Leading to Dose Modification of Study Trtmnt', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}]}]}, {'title': 'TEAEs Leading to Death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Dose Limiting Toxicity', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Week 3', 'description': 'Study Treatment refers to GSK2110183 with or without Carboplatin and/or Paclitaxel.\n\nDose limiting toxicity (DLT): An event is considered a DLT if it had a reasonable causal relationship to study drug \\& occurs within first 3 weeks of therapy \\& met at least one of the following criteria:\n\n* Grade 3 or 4 non-hematologic toxicity as described in the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.0, 2009 \\[NCI, 2009\\] with the exceptions of Grade 3 electrolyte disturbances that respond to correction within 24 hours; or Grade 3 rash, diarrhea, nausea, vomiting and mucositis that responded to standard medical supportive care within 48 hours).\n* Grade 4 neutropenia lasting ≥5 days\n* Febrile neutropenia\n* Grade 3 thrombocytopenia with bleeding\n* Grade 4 thrombocytopenia\n* Grade 4 anemia\n* Treatment delay of \\>14 days due to unresolved toxicity\n* Alanine aminotransferase (ALT) \\>3 times upper limit of normal (ULN) with bilirubin \\>2 times ULN', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ATS population (Phase 1)'}, {'type': 'PRIMARY', 'title': 'Phase 1: Maximum Tolerated Dose (MTD) of GSK2110183', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1 (Dose Escalation): GSK2110183', 'description': 'GSK2110183, either at 50 mg, 75 mg, 100 mg, 125 mg or 150 mg capsule by mouth daily in combination with carboplatin AUC 5 and paclitaxel 175 mg/m2 given intravenously every 3 weeks for a maximum 6 cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '125', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Week 3', 'description': 'MTD is defined as the highest dose at which 1 or fewer of up to 6 subjects experience a dose limiting toxicity (DLT) during the first 3 weeks of combination therapy. MTD was considered exceeded if 2 or more subjects in a cohort of up to 6 subjects experienced a DLT.', 'unitOfMeasure': 'mg', 'reportingStatus': 'POSTED', 'populationDescription': 'ATS population (Phase 1).'}, {'type': 'PRIMARY', 'title': 'Overall Response Rate (ORR) in Phase 2 Subjects With Recurrent Platinum-resistant Ovarian Cancer (Cohort A)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2 (Treatment Group): GSK2110183', 'description': 'The dosing regimen identified in Phase 1 will then be evaluated in Phase 2, a single arm study focused on clinical efficacy. GSK2110183 125 mg (MTD) capsule by mouth daily in combination with carboplatin AUC 5 and paclitaxel 175 mg/m2 given intravenously every 3 weeks for a maximum 6 x 21 day cycles followed by continuous GSK2110183 150 mg capsule by mouth daily until progression, death or unacceptable toxicity.'}], 'classes': [{'title': 'Complete Response', 'categories': [{'measurements': [{'value': '7.1', 'groupId': 'OG000'}]}]}, {'title': 'Partial Response', 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000'}]}]}, {'title': 'Stable Disease', 'categories': [{'measurements': [{'value': '39.3', 'groupId': 'OG000'}]}]}, {'title': 'Progressive Disease', 'categories': [{'measurements': [{'value': '14.3', 'groupId': 'OG000'}]}]}, {'title': 'Not Evaluable', 'categories': [{'measurements': [{'value': '14.3', 'groupId': 'OG000'}]}]}, {'title': 'Overall Response Rate', 'categories': [{'measurements': [{'value': '32.1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Every 3 weeks up to 6 months', 'description': 'Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST) 1.1 criteria for target lesions and assessed by MRI: Complete Response (CR) is Disappearance of all target lesions and Partial Response (PR) is greater than or equal to (≥) 30% decrease in the sum of the longest diameter of target lesions.\n\nOverall Response (OR) = CR + PR.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ATS population (Phase 2-Cohort A)'}, {'type': 'PRIMARY', 'title': 'ORR in Phase 2 Subjects With Recurrent Platinum-refractory Ovarian Cancer (Cohort B)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2 (Treatment Group): GSK2110183', 'description': 'The dosing regimen identified in Phase 1 will then be evaluated in Phase 2, a single arm study focused on clinical efficacy. GSK2110183 125 mg (MTD) capsule by mouth daily in combination with carboplatin AUC 5 and paclitaxel 175 mg/m2 given intravenously every 3 weeks for a maximum 6 x 21 day cycles followed by continuous GSK2110183 150 mg capsule by mouth daily until progression, death or unacceptable toxicity.'}], 'timeFrame': 'Every 3 weeks up to 6 months', 'description': 'Per RECIST version 1.1 criteria for target lesions and assessed by MRI: Complete Response (CR) is Disappearance of all target lesions and Partial Response (PR) is ≥30% decrease in the sum of the longest diameter of target lesions.\n\nOverall Response (OR) = CR + PR.', 'reportingStatus': 'POSTED', 'populationDescription': 'As described in SAP (dated 14-Jul-2015), data was not analyzed separately for Cohort B (n=2) as there were \\<10 subjects in this group due to difficulty in enrolling Platinum-refractory ovarian cancer subjects.'}, {'type': 'SECONDARY', 'title': 'ORR in Phase 1 Subjects With Recurrent Platinum-resistant Ovarian Cancer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1 (Dose Escalation): GSK2110183', 'description': 'GSK2110183, either at 50 mg, 75 mg, 100 mg, 125 mg or 150 mg capsule by mouth daily in combination with carboplatin AUC 5 and paclitaxel 175 mg/m2 given intravenously every 3 weeks for a maximum 6 cycles.'}], 'classes': [{'title': 'Complete Response', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Partial Response', 'categories': [{'measurements': [{'value': '24.1', 'groupId': 'OG000'}]}]}, {'title': 'Stable Disease', 'categories': [{'measurements': [{'value': '44.8', 'groupId': 'OG000'}]}]}, {'title': 'Progressive Disease', 'categories': [{'measurements': [{'value': '20.7', 'groupId': 'OG000'}]}]}, {'title': 'Not Evaluable', 'categories': [{'measurements': [{'value': '10.3', 'groupId': 'OG000'}]}]}, {'title': 'Overall Response Rate', 'categories': [{'measurements': [{'value': '24.1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Week 3', 'description': 'Per RECIST version 1.1 criteria for target lesions and assessed by MRI: Complete Response (CR) is disappearance of all target lesions and Partial Response (PR) is ≥30% decrease in the sum of the longest diameter of target lesions.\n\nOverall Response (OR) = CR + PR.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ATS population (Phase 1)'}, {'type': 'SECONDARY', 'title': 'Phase 2: Number of Subjects With Treatment-Emergent Adverse Events (TEAE) of Grade ≥3 in Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2 (Treatment Group): GSK2110183', 'description': 'The dosing regimen identified in Phase 1 will then be evaluated in Phase 2, a single arm study focused on clinical efficacy. GSK2110183 125 mg (MTD) capsule by mouth daily in combination with carboplatin AUC 5 and paclitaxel 175 mg/m2 given intravenously every 3 weeks for a maximum 6 x 21 day cycles followed by continuous GSK2110183 150 mg capsule by mouth daily until progression, death or unacceptable toxicity.'}], 'classes': [{'title': 'Subjects with at Least 1 TEAE of Grade ≥3', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}]}]}, {'title': 'Neutropenia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Hypomagnesaemia', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Diarrhoea', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Rash Maculo-Papular', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Vomiting', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Anaemia', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Rash', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Fatigue', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Nausea', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Neutropenic sepsis', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Hyperglycemia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 21 (Phase 2)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ATS population (Phase 2)'}, {'type': 'SECONDARY', 'title': 'Phase 2 Safety: Number of Subjects Reporting Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2 (Treatment Group): GSK2110183', 'description': 'The dosing regimen identified in Phase 1 will then be evaluated in Phase 2, a single arm study focused on clinical efficacy. GSK2110183 125 mg (MTD) capsule by mouth daily in combination with carboplatin AUC 5 and paclitaxel 175 mg/m2 given intravenously every 3 weeks for a maximum 6 x 21 day cycles followed by continuous GSK2110183 150 mg capsule by mouth daily until progression, death or unacceptable toxicity.'}], 'classes': [{'title': 'TEAEs', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}]}]}, {'title': 'Serious TEAEs', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'GSK2110183 Related Serious TEAEs', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'GSK2110183 Related TEAEs', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}, {'title': 'Study Treatment Related TEAEs', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}]}]}, {'title': 'TEAEs Leading to Discontinuation of GSK2110183', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'TEAEs Leading to Discontinuation of Study Treatmnt', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'TEAEs Leading to Dose Modification of GSK2110183', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'TEAEs Leading to Dose Modification of Study Trtmnt', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}, {'title': 'TEAEs Leading to Death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Dose Limiting Toxicity', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 51', 'description': 'Dose limiting toxicity (DLT): An event is considered a DLT if it had a reasonable causal relationship to study drug \\& occurs within first 3 weeks of therapy \\& met at least one of the following criteria:\n\n* Grade 3 or 4 non-hematologic toxicity as described in the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.0, 2009 \\[NCI, 2009\\] with the exceptions of Grade 3 electrolyte disturbances that respond to correction within 24 hours; or Grade 3 rash, diarrhea, nausea, vomiting and mucositis that responded to standard medical supportive care within 48 hours).\n* Grade 4 neutropenia lasting ≥5 days\n* Febrile neutropenia\n* Grade 3 thrombocytopenia with bleeding\n* Grade 4 thrombocytopenia\n* Grade 4 anemia\n* Treatment delay of \\>14 days due to unresolved toxicity\n* Alanine aminotransferase (ALT) \\>3 times upper limit of normal (ULN) with bilirubin \\>2 times ULN', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ATS population (Phase 2)'}, {'type': 'SECONDARY', 'title': 'Phase 2: Response Rate (RR) Defined by Gynecologic Cancer Intergroup (GCIG) CA 125', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2 (Treatment Group): GSK2110183', 'description': 'The dosing regimen identified in Phase 1 will then be evaluated in Phase 2, a single arm study focused on clinical efficacy. GSK2110183 125 mg (MTD) capsule by mouth daily in combination with carboplatin AUC 5 and paclitaxel 175 mg/m2 given intravenously every 3 weeks for a maximum 6 x 21 day cycles followed by continuous GSK2110183 150 mg capsule by mouth daily until progression, death or unacceptable toxicity.'}], 'classes': [{'title': 'Complete CA 125 Response', 'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000'}]}]}, {'title': 'Partial CA 125 Response', 'categories': [{'measurements': [{'value': '30.0', 'groupId': 'OG000'}]}]}, {'title': 'Stable Response', 'categories': [{'measurements': [{'value': '30.0', 'groupId': 'OG000'}]}]}, {'title': 'CA 125 Progression', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Not Evaluable', 'categories': [{'measurements': [{'value': '23.3', 'groupId': 'OG000'}]}]}, {'title': 'Response rate', 'categories': [{'measurements': [{'value': '46.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Month 1 to 6', 'description': 'RR is defined by the percentage of subjects with investigator-assessed Partial Cancer Antigen (CA) 125 Response (PR) or Complete CA 125 Response (CR) at any time during the study by GCIG CA 125. PR is greater than (\\>) 50% decrease in CA-125 values from baseline and no clinical or radiological evidence of new lesions. CR is decrease in the CA-125 to within the normal limits and less than (\\<) 40 IU/mL and no clinical or radiological evidence of disease.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ATS population (Phase 2)'}, {'type': 'SECONDARY', 'title': 'Progression Free Survival (PFS) by RECIST or Clinical Symptomatic Progression of Subjects With Recurrent Platinum-resistant Ovarian Cancer (Phase 2-Cohort A)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2 (Treatment Group): GSK2110183', 'description': 'The dosing regimen identified in Phase 1 will then be evaluated in Phase 2, a single arm study focused on clinical efficacy. GSK2110183 125 mg (MTD) capsule by mouth daily in combination with carboplatin AUC 5 and paclitaxel 175 mg/m2 given intravenously every 3 weeks for a maximum 6 x 21 day cycles followed by continuous GSK2110183 150 mg capsule by mouth daily until progression, death or unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.5', 'groupId': 'OG000', 'lowerLimit': '4.4', 'upperLimit': '8.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From first dose until disease progression or death (approximately 36 months)', 'description': 'PFS was defined as the number of months between date of first GSK2110183 treatment and the earliest date of disease progression by RECIST or clinical symptomatic progression or death due to any cause whichever is earlier. Progression is defined using RECIST version 1.1 as at least a 20% increase in the sum of the longest diameter of target lesion in reference to the smallest sum of the longest diameter recorded since the treatment started.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ATS population (Phase 2-Cohort A)'}, {'type': 'SECONDARY', 'title': 'PFS by RECIST of Subjects With Recurrent Platinum-resistant Ovarian Cancer (Phase 2-Cohort A)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2 (Treatment Group): GSK2110183', 'description': 'The dosing regimen identified in Phase 1 will then be evaluated in Phase 2, a single arm study focused on clinical efficacy. GSK2110183 125 mg (MTD) capsule by mouth daily in combination with carboplatin AUC 5 and paclitaxel 175 mg/m2 given intravenously every 3 weeks for a maximum 6 x 21 day cycles followed by continuous GSK2110183 150 mg capsule by mouth daily until progression, death or unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.1', 'groupId': 'OG000', 'lowerLimit': '6.3', 'upperLimit': '9.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From first dose until disease progression or death (approximately 36 months)', 'description': 'PFS was defined as the number of months between date of first GSK2110183 treatment and the earliest date of disease progression by RECIST or death due to any cause whichever is earlier. Progression is defined using RECIST version 1.1 as at least a 20% increase in the sum of the longest diameter of target lesion in reference to the smallest sum of the longest diameter recorded since the treatment started.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ATS population ((Phase 2-Cohort A)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Phase 1 (Dose Escalation)-Cohort 1: GSK2110183 50 mg', 'description': 'GSK2110183 50 mg capsule by mouth daily in combination with carboplatin Area Under the Curve (AUC) 5 and paclitaxel 175 mg/m2 given intravenously every 3 weeks for a maximum 6 cycles.'}, {'id': 'FG001', 'title': 'Phase 1 (Dose Escalation)-Cohort 1.5: GSK2110183 75 mg', 'description': 'GSK2110183 75 mg capsule by mouth daily in combination with carboplatin AUC 5 and paclitaxel 175 mg/m2 given intravenously every 3 weeks for a maximum 6 cycles.'}, {'id': 'FG002', 'title': 'Phase 1 (Dose Escalation)-Cohort 2: GSK2110183 100 mg', 'description': 'GSK2110183 100 mg capsule by mouth daily in combination with carboplatin AUC 5 and paclitaxel 175 mg/m2 given intravenously every 3 weeks for a maximum 6 cycles.'}, {'id': 'FG003', 'title': 'Phase 1 (Dose Escalation)-Cohort 3: GSK2110183 125 mg', 'description': 'GSK2110183 125 mg capsule by mouth daily in combination with carboplatin AUC 5 and paclitaxel 175 mg/m2 given intravenously every 3 weeks for a maximum 6 cycles.'}, {'id': 'FG004', 'title': 'Phase 1 (Dose Escalation)-Cohort 4: GSK2110183 150 mg', 'description': 'GSK2110183 150 mg capsule by mouth daily in combination with carboplatin AUC 5 and paclitaxel 175 mg/m2 given intravenously every 3 weeks for a maximum 6 cycles.'}, {'id': 'FG005', 'title': 'Phase 2 (Treatment Group): GSK2110183 125 mg (MTD)', 'description': 'The dosing regimen identified in Phase I will then be evaluated in Phase II, a single arm study focused on clinical efficacy. GSK2110183 125 mg (MTD) capsule by mouth daily in combination with carboplatin AUC 5 and paclitaxel 175 mg/m2 given intravenously every 3 weeks for a maximum 6 x 21 day cycles followed by continuous GSK2110183 150 mg capsule by mouth daily until progression, death or unacceptable toxicity.'}], 'periods': [{'title': 'Phase 1-Cohort 1: GSK2110183 50 mg', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Phase 1-Cohort 1.5: GSK2110183 75 mg', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Clinical Progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Phase 1-Cohort 2: GSK2110183 100 mg', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Phase 1-Cohort 3: GSK2110183 125 mg', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '12'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '10'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Clinical Progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Phase 1-Cohort 4: GSK2110183 150 mg', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Phase 2: GSK2110183 125 mg', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'comment': 'Per SAP, Cohort B (n=2) data was summarized in phase 2 total column as cohort B had \\<10 subjects.', 'groupId': 'FG005', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Clinical Progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '6'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Subjects were enrolled at 10 centers in 3 countries (United Kingdom, Australia, and Russia)', 'preAssignmentDetails': 'As described in Statistical Analysis Plan (SAP) dated 14-Jul-2015, as there were \\<10 subjects in Cohort B (n=2), data was summarized in phase 2 total column but not presented in a separate column for Cohort B.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Phase 1 (Dose Escalation): GSK2110183', 'description': 'GSK2110183, either at 50 mg, 75 mg, 100 mg, 125 mg or 150 mg capsule by mouth daily in combination with carboplatin AUC 5 and paclitaxel 175 mg/m2 given intravenously every 3 weeks for a maximum 6 cycles.'}, {'id': 'BG001', 'title': 'Phase 2 (Treatment Group): GSK2110183', 'description': 'The dosing regimen identified in Phase 1 will then be evaluated in Phase 2, a single arm study focused on clinical efficacy. GSK2110183 125 mg (MTD) capsule by mouth daily in combination with carboplatin AUC 5 and paclitaxel 175 mg/m2 given intravenously every 3 weeks for a maximum 6 x 21 day cycles followed by continuous GSK2110183 150 mg capsule by mouth daily until progression, death or unacceptable toxicity.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '18 - 64 years', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}, {'title': '65 - 84 years', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Australia', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}, {'title': 'Russian Federation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '160.81', 'spread': '6.609', 'groupId': 'BG000'}, {'value': '160.92', 'spread': '6.016', 'groupId': 'BG001'}, {'value': '160.86', 'spread': '6.264', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '68.01', 'spread': '15.847', 'groupId': 'BG000'}, {'value': '69.45', 'spread': '15.836', 'groupId': 'BG001'}, {'value': '68.74', 'spread': '15.721', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-30', 'studyFirstSubmitDate': '2012-07-27', 'resultsFirstSubmitDate': '2017-02-13', 'studyFirstSubmitQcDate': '2012-07-27', 'lastUpdatePostDateStruct': {'date': '2018-04-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-08-30', 'studyFirstPostDateStruct': {'date': '2012-07-31', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-04-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Phase 1: Number of Subjects With Treatment-Emergent Adverse Events (TEAE) of Grade Greater Than or Equal to (≥) 3 in Severity', 'timeFrame': 'Up to Week 3'}, {'measure': 'Phase 1 Safety: Number of Subjects Reporting Adverse Events', 'timeFrame': 'Up to Week 3', 'description': 'Study Treatment refers to GSK2110183 with or without Carboplatin and/or Paclitaxel.\n\nDose limiting toxicity (DLT): An event is considered a DLT if it had a reasonable causal relationship to study drug \\& occurs within first 3 weeks of therapy \\& met at least one of the following criteria:\n\n* Grade 3 or 4 non-hematologic toxicity as described in the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.0, 2009 \\[NCI, 2009\\] with the exceptions of Grade 3 electrolyte disturbances that respond to correction within 24 hours; or Grade 3 rash, diarrhea, nausea, vomiting and mucositis that responded to standard medical supportive care within 48 hours).\n* Grade 4 neutropenia lasting ≥5 days\n* Febrile neutropenia\n* Grade 3 thrombocytopenia with bleeding\n* Grade 4 thrombocytopenia\n* Grade 4 anemia\n* Treatment delay of \\>14 days due to unresolved toxicity\n* Alanine aminotransferase (ALT) \\>3 times upper limit of normal (ULN) with bilirubin \\>2 times ULN'}, {'measure': 'Phase 1: Maximum Tolerated Dose (MTD) of GSK2110183', 'timeFrame': 'Up to Week 3', 'description': 'MTD is defined as the highest dose at which 1 or fewer of up to 6 subjects experience a dose limiting toxicity (DLT) during the first 3 weeks of combination therapy. MTD was considered exceeded if 2 or more subjects in a cohort of up to 6 subjects experienced a DLT.'}, {'measure': 'Overall Response Rate (ORR) in Phase 2 Subjects With Recurrent Platinum-resistant Ovarian Cancer (Cohort A)', 'timeFrame': 'Every 3 weeks up to 6 months', 'description': 'Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST) 1.1 criteria for target lesions and assessed by MRI: Complete Response (CR) is Disappearance of all target lesions and Partial Response (PR) is greater than or equal to (≥) 30% decrease in the sum of the longest diameter of target lesions.\n\nOverall Response (OR) = CR + PR.'}, {'measure': 'ORR in Phase 2 Subjects With Recurrent Platinum-refractory Ovarian Cancer (Cohort B)', 'timeFrame': 'Every 3 weeks up to 6 months', 'description': 'Per RECIST version 1.1 criteria for target lesions and assessed by MRI: Complete Response (CR) is Disappearance of all target lesions and Partial Response (PR) is ≥30% decrease in the sum of the longest diameter of target lesions.\n\nOverall Response (OR) = CR + PR.'}], 'secondaryOutcomes': [{'measure': 'ORR in Phase 1 Subjects With Recurrent Platinum-resistant Ovarian Cancer', 'timeFrame': 'Up to Week 3', 'description': 'Per RECIST version 1.1 criteria for target lesions and assessed by MRI: Complete Response (CR) is disappearance of all target lesions and Partial Response (PR) is ≥30% decrease in the sum of the longest diameter of target lesions.\n\nOverall Response (OR) = CR + PR.'}, {'measure': 'Phase 2: Number of Subjects With Treatment-Emergent Adverse Events (TEAE) of Grade ≥3 in Severity', 'timeFrame': 'Up to Day 21 (Phase 2)'}, {'measure': 'Phase 2 Safety: Number of Subjects Reporting Adverse Events', 'timeFrame': 'Up to Day 51', 'description': 'Dose limiting toxicity (DLT): An event is considered a DLT if it had a reasonable causal relationship to study drug \\& occurs within first 3 weeks of therapy \\& met at least one of the following criteria:\n\n* Grade 3 or 4 non-hematologic toxicity as described in the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.0, 2009 \\[NCI, 2009\\] with the exceptions of Grade 3 electrolyte disturbances that respond to correction within 24 hours; or Grade 3 rash, diarrhea, nausea, vomiting and mucositis that responded to standard medical supportive care within 48 hours).\n* Grade 4 neutropenia lasting ≥5 days\n* Febrile neutropenia\n* Grade 3 thrombocytopenia with bleeding\n* Grade 4 thrombocytopenia\n* Grade 4 anemia\n* Treatment delay of \\>14 days due to unresolved toxicity\n* Alanine aminotransferase (ALT) \\>3 times upper limit of normal (ULN) with bilirubin \\>2 times ULN'}, {'measure': 'Phase 2: Response Rate (RR) Defined by Gynecologic Cancer Intergroup (GCIG) CA 125', 'timeFrame': 'From Month 1 to 6', 'description': 'RR is defined by the percentage of subjects with investigator-assessed Partial Cancer Antigen (CA) 125 Response (PR) or Complete CA 125 Response (CR) at any time during the study by GCIG CA 125. PR is greater than (\\>) 50% decrease in CA-125 values from baseline and no clinical or radiological evidence of new lesions. CR is decrease in the CA-125 to within the normal limits and less than (\\<) 40 IU/mL and no clinical or radiological evidence of disease.'}, {'measure': 'Progression Free Survival (PFS) by RECIST or Clinical Symptomatic Progression of Subjects With Recurrent Platinum-resistant Ovarian Cancer (Phase 2-Cohort A)', 'timeFrame': 'From first dose until disease progression or death (approximately 36 months)', 'description': 'PFS was defined as the number of months between date of first GSK2110183 treatment and the earliest date of disease progression by RECIST or clinical symptomatic progression or death due to any cause whichever is earlier. Progression is defined using RECIST version 1.1 as at least a 20% increase in the sum of the longest diameter of target lesion in reference to the smallest sum of the longest diameter recorded since the treatment started.'}, {'measure': 'PFS by RECIST of Subjects With Recurrent Platinum-resistant Ovarian Cancer (Phase 2-Cohort A)', 'timeFrame': 'From first dose until disease progression or death (approximately 36 months)', 'description': 'PFS was defined as the number of months between date of first GSK2110183 treatment and the earliest date of disease progression by RECIST or death due to any cause whichever is earlier. Progression is defined using RECIST version 1.1 as at least a 20% increase in the sum of the longest diameter of target lesion in reference to the smallest sum of the longest diameter recorded since the treatment started.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cancer', 'ovarian', 'platinum-resistant'], 'conditions': ['Recurrent Platinum-resistant Ovarian Cancer']}, 'referencesModule': {'references': [{'pmid': '30563934', 'type': 'DERIVED', 'citation': 'Blagden SP, Hamilton AL, Mileshkin L, Wong S, Michael A, Hall M, Goh JC, Lisyanskaya AS, DeSilvio M, Frangou E, Stronach EA, Gopalakrishna P, Meniawy TM, Gabra H. Phase IB Dose Escalation and Expansion Study of AKT Inhibitor Afuresertib with Carboplatin and Paclitaxel in Recurrent Platinum-resistant Ovarian Cancer. Clin Cancer Res. 2019 Mar 1;25(5):1472-1478. doi: 10.1158/1078-0432.CCR-18-2277. Epub 2018 Dec 18.'}]}, 'descriptionModule': {'briefSummary': '* Dose-finding study of GSK2110183 administered in combination with carboplatin and paclitaxel to any subject with recurrent ovarian cancer.\n* Safety and efficacy study of GSK2110183 administered in combination with carboplatin and paclitaxel to subjects with platinum-resistant ovarian cancer.', 'detailedDescription': 'PKB116611 is an open-label Phase I/II study of the investigational drug GSK2110183 given in combination with carboplatin and paclitaxel to subjects with recurrent ovarian cancer. Phase I is a dose escalation evaluation of daily oral doses of GSK2110183 administered in combination with every 3 week carboplatin and paclitaxel to any subject with recurrent ovarian cancer. Phase II is a single arm evaluation of the clinical efficacy of the combination identified in Phase I to subjects with platinum-resistant ovarian cancer.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Phase I Inclusion Criteria:\n\n* Female, 18 years of age as of signing the informed consent form, capable of giving/complying with written informed consent\n* Histologically or cytologically confirmed serous ovarian cancer (includes primary peritoneal and Fallopian tube)\n* Negative serum pregnancy test in women of childbearing potential within 14 days of first dose of treatment, agree to use effective contraception during/after (6 months post dose of paclitaxel or 30 days post dose GSK2110183 whichever is longer)\n* Performance Status score of 0-2 according to the ECOG scale.\n* Able to swallow and retain oral medication\n* Subjects diagnosed previously with Type 2 diabetes must have been diagnosed ≥ 6 months prior to enrollment\n* Prior treatment-related toxicities (except for alopecia) must be ≤ Grade 1 according to NCI-CTCAE (Version 4.0 \\[NCI, 2009\\]) at the time of treatment allocation OR ≤ Grade 2 and stable for 4 weeks or longer at the time of screening evaluation. Exception: Subjects with peripheral neuropathy \\>/= Grade 2 will NOT be eligible\n* Adequate organ system function\n\nPhase II Inclusion Criteria:\n\nCohort A\n\n* Phase I criteria\n* Documented complete or partial response by RECIST to at least 1 prior platinum-based therapy\n* Progression defined by either (1) RECIST v1.1 criteria or (2) GCIG CA 125 criteria associated with symptoms necessitating treatment between 1 and 6 months of prior platinum-based therapy either in adjuvant or metastatic setting\n* Subjects allowed to have a maximum of one non-platinum-based therapy between the onset of platinum resistance\n* Must have radiologically measurable disease i.e. presenting with at least one measurable lesion per RECIST 1.1\n\nCohort B\n\n* Phase I criteria\n* Documented complete or partial response by RECIST to at least 1 prior platinum-based therapy\n* Progression defined by either (1) RECIST v1.1 criteria or (2) GCIG CA 125 criteria associated with symptoms necessitating treatment while being treated with a regimen containing carboplatin and paclitaxel (or within 4 weeks of completing treatment)\n* Subjects will be required to start on treatment within 8 weeks after the last infusion of chemotherapy and may not have had any other anti-cancer therapy in the intervening time\n* Must have radiologically measurable disease i.e. presenting with at least one measurable lesion per RECIST 1.1\n* Additional restrictions on number of prior therapies may be added to eligibility criteria based on emerging data\n\nExclusion Criteria:\n\n* History of another malignancy (some exceptions may apply)\n* Serious and/or unstable pre-existing medical or psychiatric disorder, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures\n* Current use of prohibited medication during treatment.\n* Chemotherapy, immunotherapy, or other anti-cancer therapy within 14 days prior to the first dose study drug\n* Radiotherapy prior to initiation of therapy (some exceptions may apply)\n* Contraindications (identified by the investigator) to the doses of carboplatin and/or paclitaxel\n* History of reduction in standard of care paclitaxel dose for peripheral neuropathy\n* No known immediate or delayed hypersensitivity reaction or idiosyncratic reaction to drugs similar or related to GSK2110183\n* No known delayed hypersensitivity reaction or idiosyncratic reaction to drugs similar to carboplatin or paclitaxel (some exceptions may apply)\n* Prior use of a drug that targets AKT including perifosine\n* History of Type 1 diabetes\n* Gastrointestinal disease or other condition that could affect absorption or predispose subject to gastrointestinal ulceration\n* Mucosal or internal bleeding\n* Major surgery within the last four weeks\n* Infection requiring parenteral or oral anti-infective treatment\n* Severe or uncontrolled systemic diseases\n* Brain metastases and/or leptomeningeal disease\n* QTcF interval ≥ 470 msecs\n* Bundle branch block, pacemaker or clinically significant ECG abnormalities including 2nd degree (Type II) or 3rd degree atrioventricular (AV) block\n* History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty,stenting or bypass grafting within six months of Screening\n* Class II, III or IV heart failure as defined by the NYHA functional classification system\n* Pregnant or lactating female\n* Malignancies related to HIV or solid organ transplant; history of known HIV, history of know HBV surface antigen positivity (subjects with documented laboratory evidence of HBV clearance may be enrolled) or positive HCV antibody"}, 'identificationModule': {'nctId': 'NCT01653912', 'briefTitle': 'Dose-finding Study in Platinum-Resistant Ovarian Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Accenture'}, 'officialTitle': 'An Open-Label Phase I/II Study of GSK2110183 in Combination With Carboplatin and Paclitaxel in Subjects With Platinum-Resistant Ovarian Cancer', 'orgStudyIdInfo': {'id': 'PKB116611'}, 'secondaryIdInfos': [{'id': '2012-002483-27', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GSK2110183, carboplatin and paclitaxel', 'description': 'Subjects will be treated with a maximum of six doses of carboplatin + paclitaxel in combination with continuous daily GSK2110183 followed by single agent GSK2110183 at the single-agent MTD of 125 mg or above oral daily.', 'interventionNames': ['Drug: GSK2110183 in combination with carboplatin and paclitaxel']}], 'interventions': [{'name': 'GSK2110183 in combination with carboplatin and paclitaxel', 'type': 'DRUG', 'otherNames': ['Taxol (paclitaxel)', 'Paraplatin (carboplatin)', 'AKT Inhibitor'], 'description': 'Phase I is a dose escalation evaluation of increasing doses of GSK2110183 administered on a continuous daily schedule in combination with carboplatin AUC 5 and paclitaxel 175mg/m2 given every three weeks for a maximum 6 cycles. The dosing regimen identified in Phase I will then be evaluated in Phase II, a single arm study focused on clinical efficacy. Treatment with the three drug regimen will continue for a maximum of 6 x 21 day cycles followed by continuous GSK2110183 at the single agent MTD. Subjects may continue on study drug until progression, death or unacceptable toxicity.', 'armGroupLabels': ['GSK2110183, carboplatin and paclitaxel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4029', 'city': 'Herston', 'state': 'Queensland', 'country': 'Australia', 'facility': "Royal Brisbane and Women's Hospital", 'geoPoint': {'lat': -27.44453, 'lon': 153.01852}}, {'zip': '8006', 'city': 'East Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Peter MacCallum Cancer Centre', 'geoPoint': {'lat': -37.81667, 'lon': 144.9879}}, {'zip': '3011', 'city': 'Footscray', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Western Hospital', 'geoPoint': {'lat': -37.8, 'lon': 144.9}}, {'zip': '3052', 'city': 'Parkville', 'state': 'Victoria', 'country': 'Australia', 'facility': "Royal Women's Hospital", 'geoPoint': {'lat': -37.78333, 'lon': 144.95}}, {'zip': '6009', 'city': 'Nedlands', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'Sir Charles Gairdner Hospital', 'geoPoint': {'lat': -31.98184, 'lon': 115.8073}}, {'zip': '249036', 'city': 'Omskaya', 'country': 'Russia', 'facility': 'Medical Radiology Scientific Center of Ministry of Healthcare and Social Development of RF'}, {'zip': '198255', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'City Clinical Oncology Dispensary', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': 'HA6 2RN', 'city': 'Northwood, Middlesex', 'state': 'London', 'country': 'United Kingdom', 'facility': 'Mount Vernon Cancer Center'}, {'zip': 'GU2 7XP', 'city': 'Guildford', 'state': 'Surry', 'country': 'United Kingdom', 'facility': 'Royal Surrey County Hospital NHS Foundation Trust', 'geoPoint': {'lat': 51.23536, 'lon': -0.57427}}, {'zip': 'W 12 0HS', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Imperial College Healthcare NHS Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Richard A Brigandi, MD, PhD, FAAP', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}, {'name': 'Anne L Hamilton', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Royal Women's Hospital"}, {'name': 'Sarah P Blagden', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Imperial College Healthcare NHS Trust'}, {'name': 'Linda Mileshkin', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peter MacCallum Cancer Centre, Australia'}, {'name': 'Shirley S Wong', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Western Hospital'}, {'name': 'Andrew Dean', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sir Charles Gairdner Hospital'}, {'name': 'Marcia Hall', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mount Vernon Cancer Center'}, {'name': 'Bhawana Awasthy, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Syneos Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Accenture', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}