Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2025-12-29 @ 12:15 AM
Study NCT ID:
NCT00918203
Status:
COMPLETED
Last Update Posted:
2019-01-10
First Post:
2009-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Paclitaxel/Carboplatin With or Without Olaratumab (IMC-3G3) in Previously Untreated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000589393', 'term': 'olaratumab'}, {'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D016190', 'term': 'Carboplatin'}], 'ancestors': [{'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': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D056831', 'term': 'Coordination Complexes'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'All randomized participants who received at least one dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Olaratumab + Paclitaxel + Carboplatin', 'description': 'Olaratumab 15 mg/kg over 30 mins (Days 1 and 8) plus Paclitaxel 200 mg/m2 over 3 hrs (Day 1) Carboplatin AUC=6 (Day 1) of each 21-day cycle\n\nParticipants can remain on study after completing chemotherapy and receive olaratumab monotherapy on Days 1 and 8, provided there is ongoing evidence of clinical benefit.\n\nOlaratumab: 15 mg/kg of IMC-3G3 on Days 1 and 8 of each 21-day cycle, administered IV at 25mg/min, with a minimum infusion time of 30 minutes.\n\nPaclitaxel: 200 mg/m2 is then administered IV over 3 hours\n\nCarboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months.', 'otherNumAtRisk': 67, 'otherNumAffected': 67, 'seriousNumAtRisk': 67, 'seriousNumAffected': 30}, {'id': 'EG001', 'title': 'Paclitaxel + Carboplatin', 'description': 'Paclitaxel: 200 mg/m2 is then administered IV over 3 hours\n\nCarboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months.', 'otherNumAtRisk': 64, 'otherNumAffected': 64, 'seriousNumAtRisk': 64, 'seriousNumAffected': 21}, {'id': 'EG002', 'title': 'Crossover to Olaratumab', 'description': 'Olaratumab monotherapy administered on Days 1 and 8 of each 21-day cycle.', 'otherNumAtRisk': 18, 'otherNumAffected': 11, 'seriousNumAtRisk': 18, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 45, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 41, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 32, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 19, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 19, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 67, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 39, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 64, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 32, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 8, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 7, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 29, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 29, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 47, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 26, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 14, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Lip swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 57, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 47, 'numAffected': 35}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Oral discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 36, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 30, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 75, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 49, 'numAffected': 33}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 15, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Soft tissue infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Radiation pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Blood lactate dehydrogenase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Blood phosphorus decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'International normalised ratio increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 17, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 35, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 16, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 15, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 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'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Abscess intestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Device related infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Eye infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pneumonia viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Incorrect drug administration duration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Radiation pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Subdural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hypercalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hypophagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hypovolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Metastatic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Neoplasm progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Peroneal nerve palsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Bronchopleural fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression-Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Olaratumab + Paclitaxel + Carboplatin', 'description': 'Olaratumab: 15 mg/kg of Olaratumab on Days 1 and 8 of each 21-day cycle, administered IV at 25mg/min, with a minimum infusion time of 30 minutes.\n\nPaclitaxel: 200 mg/m2 is then administered IV over 3 hours\n\nCarboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months.'}, {'id': 'OG001', 'title': 'Paclitaxel + Carboplatin', 'description': 'Paclitaxel: 200 mg/m2 is then administered IV over 3 hours\n\nCarboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months.'}, {'id': 'OG002', 'title': 'Crossover to Olaratumab', 'description': 'Olaratumab monotherapy administered on Days 1 and 8 of each 21-day cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '19.1', 'groupId': 'OG000', 'lowerLimit': '16.4', 'upperLimit': '23.6'}, {'value': '19.0', 'groupId': 'OG001', 'lowerLimit': '15.3', 'upperLimit': '25'}, {'value': '8.3', 'groupId': 'OG002', 'lowerLimit': '5.0', 'upperLimit': '13.4'}]}]}], 'analyses': [{'pValue': '0.2133', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.29', 'ciLowerLimit': '0.86', 'ciUpperLimit': '1.93', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to Measured PD or Death From Any Cause (Up to 31 Months)', 'description': 'PFS is defined as the time from the day of randomization to the first evidence of progression by RECIST version 1.1, or death from any cause. Participants who died without a reported prior progression were considered to have progressed on the day of their death. Participants who did not progress and were subsequently lost to follow-up had their data censored at the day of their last tumor assessment. If there was no radiologic assessment at baseline or post baseline, participants were censored at the date of randomization. If death or progressive disease (PD) occurred after 2 or more consecutive missing radiographic visits, censoring occurred at the date of the last radiographic visit prior to the missed visits.', 'unitOfMeasure': 'weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received any dose of study drug. Participants censored: paclitaxel + carboplatin = 13, olaratumab + paclitaxel + carboplatin = 20, and crossover to olaratumab = 4. 1 participant did not cross over to Olaratumab until after efficacy data completion, no efficacy data collected on this participant.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Olaratumab + Pacilitaxel + Carboplatin', 'description': 'Olaratumab: 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, administered IV at 25mg/min, with a minimum infusion time of 30 minutes.\n\nPaclitaxel: 200 mg/m2 is then administered IV over 3 hours\n\nCarboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months.'}, {'id': 'OG001', 'title': 'Paclitaxel + Carboplatin', 'description': 'Paclitaxel: 200 mg/m2 is then administered IV over 3 hours\n\nCarboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months.'}, {'id': 'OG002', 'title': 'Crossover to Olaratumab', 'description': 'Olaratumab monotherapy administered on Days 1 and 8 of each 21-day cycle.'}], 'classes': [{'title': 'AE', 'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}, {'title': "SAE's", 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Study Completion (Up to 43 Months)', 'description': "A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received any dose of study drug. 1 participant did not cross over to Olaratumab until after efficacy data completion, no efficacy data collected on this participant.'}, {'type': 'SECONDARY', 'title': 'Safety and Tolerability of Olaratumab Administered at a More Rapid Rate (25mg/Min With Minimum Infusion Time of 30 Minutes), Determined by Number of Participants With Treatment Related Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Olaratumab + Paclitaxel + Carboplatin', 'description': 'Olaratumab: 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, administered IV at 25mg/min, with a minimum infusion time of 30 minutes.\n\nPaclitaxel: 200 mg/m2 is then administered IV over 3 hours\n\nCarboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months.'}, {'id': 'OG001', 'title': 'Paclitaxel + Carboplatin', 'description': 'Paclitaxel: 200 mg/m2 is then administered IV over 3 hours\n\nCarboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months.'}, {'id': 'OG002', 'title': 'Crossover to Olaratumab', 'description': 'Olaratumab monotherapy administered on Days 1 and 8 of each 21-day cycle.'}], 'classes': [{'title': 'AE', 'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}, {'title': "SAE's", 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 43 Months', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received any dose of study drug. 1 participant did not cross over to Olaratumab until after efficacy data completion, no efficacy data collected on this participant.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Olaratumab + Paclitaxel + Carboplatin', 'description': 'Olaratumab: 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, administered IV at 25mg/min, with a minimum infusion time of 30 minutes.\n\nPaclitaxel: 200 mg/m2 is then administered IV over 3 hours\n\nCarboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months.'}, {'id': 'OG001', 'title': 'Paclitaxel + Carboplatin', 'description': 'Paclitaxel: 200 mg/m2 is then administered IV over 3 hours\n\nCarboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '51.3', 'groupId': 'OG000', 'lowerLimit': '39.7', 'upperLimit': '68.7'}, {'value': '50.1', 'groupId': 'OG001', 'lowerLimit': '41.4', 'upperLimit': '75.9'}]}]}], 'analyses': [{'pValue': '0.8731', 'groupIds': ['OG000'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.04', 'ciLowerLimit': '0.68', 'ciUpperLimit': '1.57', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to Death From Any Cause (Up to 31 Months)', 'description': 'Overall survival is defined as the time from date of randomization to the date of death from any cause. If the participant is alive at the end of the follow-up period or is lost to follow-up, OS was censored on the last date the participants is known to be alive.', 'unitOfMeasure': 'weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received any dose of study drug. OS data was not analyzed in the crossover olaratumab arm. Participants censored: olaratumab + paclitaxel + carboplatin = 19 and paclitaxel + carboplatin = 20.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieve Best Overall Tumor Response of Complete Response (CR) or Partial Response (PR) Objective Tumor Response Rate (ORR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Olaratumab + Paclitaxel + Carboplatin', 'description': 'Olaratumab: 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, administered IV at 25mg/min, with a minimum infusion time of 30 minutes.\n\nPaclitaxel: 200 mg/m2 is then administered IV over 3 hours\n\nCarboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months.'}, {'id': 'OG001', 'title': 'Paclitaxel + Carboplatin', 'description': 'Paclitaxel: 200 mg/m2 is then administered IV over 3 hours\n\nCarboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months.'}, {'id': 'OG002', 'title': 'Crossover to Olaratumab', 'description': 'Olaratumab monotherapy administered on Days 1 and 8 of each 21-day cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '41.8', 'groupId': 'OG000', 'lowerLimit': '29.8', 'upperLimit': '54.5'}, {'value': '34.4', 'groupId': 'OG001', 'lowerLimit': '22.9', 'upperLimit': '47.3'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '19.5'}]}]}], 'analyses': [{'pValue': '0.4721', 'groupIds': ['OG000'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Measured PD or Study Discontinuation (Up to 31 Months)', 'description': 'The ORR is equal to the percentage of participants achieving a best overall response of partial response or complete response (PR + CR), according to RECIST version 1.1 criteria. CR was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes must have reduction in short axis to \\<10 millimeter (mm) and normalization of tumor marker level of non-target lesions; PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions; PD was defined as having at least 20% increase in sum of longest diameter of target lesions and minimum 5 mm increase above nadir; Stable Disease (SD) was defined as small changes that did not meet above criteria. Participants who had no post baseline tumor assessments were considered non-responders and included in the denominator when calculating response rate. Percentage of participants=(number of participants with CR+PR/total number of participants)\\*100.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received any dose of study drug. 1 participant did not cross over to Olaratumab until after efficacy data completion, no efficacy data collected on this participant.'}, {'type': 'SECONDARY', 'title': 'Median Duration of Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Olaratumab + Paclitaxel + Carboplatin', 'description': 'Olaratumab: 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, administered IV at 25mg/min, with a minimum infusion time of 30 minutes.\n\nPaclitaxel: 200 mg/m2 is then administered IV over 3 hours\n\nCarboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months.'}, {'id': 'OG001', 'title': 'Paclitaxel + Carboplatin', 'description': 'Paclitaxel: 200 mg/m2 is then administered IV over 3 hours\n\nCarboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.4', 'groupId': 'OG000', 'lowerLimit': '12.7', 'upperLimit': '18.1'}, {'value': '12.9', 'groupId': 'OG001', 'lowerLimit': '11.4', 'upperLimit': '35.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'First Criteria Met for CR or PR to Measured PD Start of Other Antitumor Therapy or Death From Any Cause (Up to 31 Months)', 'description': 'The duration of overall response is measured from the time measurement criteria are first met for Complete Response (CR)/Partial Response (PR) (whichever is first recorded) until the first date that the criteria for PD are met (taking as a reference for PD the smallest measurement recorded since the treatment started), initiation of other/additional antitumor therapy is first reported, or death, is objectively documented.', 'unitOfMeasure': 'weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received any dose of study drug and had achieved tumor response of CR or PR. Median Duration of Response data was not analyzed in the crossover olaratumab arm.'}, {'type': 'SECONDARY', 'title': 'Pharmacodynamics of Olaratumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Olaratumab + Paclitaxel + Carboplatin', 'description': 'Olaratumab: 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, administered IV at 25mg/min, with a minimum infusion time of 30 minutes.\n\nPaclitaxel: 200 mg/m2 is then administered IV over 3 hours\n\nCarboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months.'}], 'timeFrame': 'Cycle 1: Days 1, 8, and 15 pre- and post-infusion of Olaratumab; Cycles 2-6: day 1 only, pre- and post-infusion of Olaratumab', 'description': 'Pharmacodynamics of Olaratumab was determined by analysis of pharmacodynamic markers vascular endothelial growth factor (VEGF) and platelet derived growth factor (PDGF).', 'reportingStatus': 'POSTED', 'populationDescription': 'No data was available due to the collection of plasma samples was not fit for the assessment of PDGFs, as the collection procedure did not prevent platelet activation resulting in elevated levels of PDGFs in the circulation. Pharmacodynamics data was not analyzed in the paclitaxel + carboplatin arm or the crossover to olaratumab arm.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Anti-Olaratumab Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Olaratumab + Paclitaxel + Carboplatin', 'description': 'Olaratumab: 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, administered IV at 25mg/min, with a minimum infusion time of 30 minutes.\n\nPaclitaxel: 200 mg/m2 is then administered IV over 3 hours\n\nCarboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months.'}, {'id': 'OG001', 'title': 'Crossover to Olaratumab', 'description': 'Olaratumab monotherapy administered on Days 1 and 8 of each 21-day cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.4', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Study Completion (Up to 8 Months)', 'description': 'Participants with Treatment Emergent (TE) anti-olaratumab antibodies were participants with a 4-fold increase (2 dilutions) increase over a positive baseline antibody titer or for a negative baseline titer, a participant with an increase from the baseline to a level of 1:20.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had baseline and post baseline Anti-Olaratumab antibodies. Those participants who did not meet eligibility criteria were not included in this assessment.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics (PK) - Area Under the Curve (AUC) 0-168 of Olaratumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Olaratumab + Paclitaxel + Carboplatin', 'description': 'Olaratumab: 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, administered IV at 25mg/min, with a minimum infusion time of 30 minutes.\n\nPaclitaxel: 200 mg/m2 is then administered IV over 3 hours\n\nCarboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '47600', 'spread': '29.2', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 3, Day 1: Predose, 30 minutes (min), 1.5 hours (hrs), 24,48,96,168 Hrs Post Dose', 'description': 'AUC(0-168) = area under the concentration versus time curve from time zero to 168 hours post dose.', 'unitOfMeasure': 'microgram*hour/milliliter (ug*hr/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received any dose of study drug and had evaluable PK data in Cycle 3. PK data was not analyzed in the paclitaxel + carboplatin arm or the crossover to olaratumab arm.'}, {'type': 'SECONDARY', 'title': 'PK - Maximum Concentration (Cmax) of Olaratumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Olaratumab + Paclitaxel + Carboplatin', 'description': 'Olaratumab: 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, administered IV at 25mg/min, with a minimum infusion time of 30 minutes.\n\nPaclitaxel: 200 mg/m2 is then administered IV over 3 hours\n\nCarboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '489', 'spread': '13', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 3, Day 1: Predose, 30 min, 1.5 hrs, 24,48,96,168 Hrs Post Dose', 'unitOfMeasure': 'micrograms/milliliter (ug/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received any dose of study drug and had evaluable PK data in Cycle 3 first dose. PK data was not analyzed in the paclitaxel + carboplatin arm or the crossover to olaratumab arm.'}, {'type': 'SECONDARY', 'title': 'PK - Half-Life (t1/2) of Olaratumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Olaratumab + Paclitaxel + Carboplatin', 'description': 'Olaratumab: 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, administered IV at 25 mg/min, with a minimum infusion time of 30 minutes.\n\nPaclitaxel: 200 mg/m2 is then administered IV over 3 hours\n\nCarboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.79', 'groupId': 'OG000', 'lowerLimit': '4.29', 'upperLimit': '8.78'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 3, Day 1: Predose, 30 min, 1.5 hrs, 24,48,96,168 Hrs Post Dose', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received any dose of study drug and had evaluable PK data in Cycle 3 first dose. PK data was not analyzed in the paclitaxel + carboplatin arm or the crossover to olaratumab arm.'}, {'type': 'SECONDARY', 'title': 'PK - Clearance (Cl) of Olaratumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Olaratumab + Paclitaxel + Carboplatin', 'description': 'Olaratumab: 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, administered IV at 25mg/min, with a minimum infusion time of 30 minutes.\n\nPaclitaxel: 200 mg/m2 is then administered IV over 3 hours\n\nCarboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0218', 'spread': '24.8', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 3, Day 1: Predose, 30 min, 1.5 hr, 24,48,96,168 Hrs Post Dose', 'unitOfMeasure': 'Liter/hour (L/h)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received any dose of study drug and had evaluable PK data in Cycle 3 first dose.'}, {'type': 'SECONDARY', 'title': 'PK - Steady State Volume of Distribution (Vss) of Olaratumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Olaratumab + Paclitaxel + Carboplatin', 'description': 'Olaratumab: 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, administered IV at 25mg/min, with a minimum infusion time of 30 minutes.\n\nPaclitaxel: 200 mg/m2 is then administered IV over 3 hours\n\nCarboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.22', 'spread': '9.51', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 3, Day 1: Predose, 30 min, 1.5 hrs, 24,48,96,168 Hrs Post Dose', 'unitOfMeasure': 'Liter (L)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received any dose of study drug and had evaluable PK data in Cycle 3 first dose.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Olaratumab + Paclitaxel + Carboplatin', 'description': 'Olaratumab: 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, administered IV at 25mg/min, with a minimum infusion time of 30 minutes.\n\nPaclitaxel 200 milligram/square meter (mg/m2) over 3 hrs (Day 1) Carboplatin Area Under Concentration (AUC)=6 (Day 1) of each 21-day cycle\n\nPaclitaxel 200 mg/m2 over 3 hrs (Day 1) Carboplatin AUC=6 (Day 1) of each 21-day cycle\n\nParticipants who experience progressive disease may cross over to olaratumab monotherapy.\n\nPaclitaxel: 200 mg/m2 is then administered intravenously (IV) over 3 hours\n\ncarboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months.'}, {'id': 'FG001', 'title': 'Paclitaxel + Carboplatin', 'description': 'Paclitaxel: 200 mg/m2 is then administered IV over 3 hours\n\nCarboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months.'}, {'id': 'FG002', 'title': 'Crossover to Olaratumab Monotherapy', 'description': 'Olaratumab was administered IV at 15 mg/kg on Day 1 and Day 8 every 3 weeks.'}], 'periods': [{'title': 'Treatment With or Without Olaratumab', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '70'}, {'groupId': 'FG001', 'numSubjects': '67'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Received at Least 1 Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '67'}, {'groupId': 'FG001', 'numSubjects': '64'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Death Due to Any Cause', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}, {'groupId': 'FG001', 'numSubjects': '47'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Alive/On Study at End/Off Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '64'}, {'groupId': 'FG001', 'numSubjects': '57'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Other Therapy Started', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Never Treated/Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Crossover to Olaratumab Monotherapy', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'comment': '18 participants who had progressive disease crossed over to monotherapy.', 'groupId': 'FG002', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Participants who had evidence of progressive disease (PD), died or crossover to Olaratumab were considered to have completed the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '131', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Olaratumab + Paclitaxel + Carboplatin', 'description': 'Olaratumab 15 mg/kg over 30 mins (Days 1 and 8) plus Paclitaxel 200 mg/m2 over 3 hrs (Day 1) Carboplatin AUC=6 (Day 1) of each 21-day cycle\n\nParticipants can remain on study after completing chemotherapy and receive olaratumab monotherapy on Days 1 and 8, provided there is ongoing evidence of clinical benefit.\n\nOlaratumab: 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, administered IV at 25mg/min, with a minimum infusion time of 30 minutes.\n\nPaclitaxel: 200 mg/m2 is then administered IV over 3 hours\n\nCarboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months.'}, {'id': 'BG001', 'title': 'Paclitaxel + Carboplatin', 'description': 'Paclitaxel: 200 mg/m2 is then administered IV over 3 hours\n\nCarboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.6', 'spread': '10.77', 'groupId': 'BG000'}, {'value': '63.8', 'spread': '9.67', 'groupId': 'BG001'}, {'value': '63.7', 'spread': '10.21', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '126', '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': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '110', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', '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': 'Eastern Cooperative Oncology Group Performance Status (ECOG PS)', 'classes': [{'title': 'ECOG PS 0', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}]}, {'title': 'ECOG PS 1', 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'ECOG performance status classified participants according to their functional impairment. Scores ranged from 0 (fully active) to 5 (death).', 'unitOfMeasure': 'participants'}, {'title': 'Stratification Factor Case Report Form (CRF)', 'classes': [{'title': 'Non-Squamous Cell Carcinoma', 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}]}, {'title': 'Squamous Cell Carcinoma', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'All phase 2 participants who were randomized and received any dose of study drug.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 137}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'dispFirstSubmitDate': '2014-04-25', 'completionDateStruct': {'date': '2017-11-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-16', 'studyFirstSubmitDate': '2009-06-09', 'dispFirstSubmitQcDate': '2014-04-25', 'resultsFirstSubmitDate': '2016-11-18', 'studyFirstSubmitQcDate': '2009-06-10', 'dispFirstPostDateStruct': {'date': '2014-05-13', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2019-01-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-11-18', 'studyFirstPostDateStruct': {'date': '2009-06-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-01-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-Free Survival (PFS)', 'timeFrame': 'Baseline to Measured PD or Death From Any Cause (Up to 31 Months)', 'description': 'PFS is defined as the time from the day of randomization to the first evidence of progression by RECIST version 1.1, or death from any cause. Participants who died without a reported prior progression were considered to have progressed on the day of their death. Participants who did not progress and were subsequently lost to follow-up had their data censored at the day of their last tumor assessment. If there was no radiologic assessment at baseline or post baseline, participants were censored at the date of randomization. If death or progressive disease (PD) occurred after 2 or more consecutive missing radiographic visits, censoring occurred at the date of the last radiographic visit prior to the missed visits.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)', 'timeFrame': 'Baseline to Study Completion (Up to 43 Months)', 'description': "A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section."}, {'measure': 'Safety and Tolerability of Olaratumab Administered at a More Rapid Rate (25mg/Min With Minimum Infusion Time of 30 Minutes), Determined by Number of Participants With Treatment Related Adverse Events', 'timeFrame': 'Up to 43 Months'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Baseline to Death From Any Cause (Up to 31 Months)', 'description': 'Overall survival is defined as the time from date of randomization to the date of death from any cause. If the participant is alive at the end of the follow-up period or is lost to follow-up, OS was censored on the last date the participants is known to be alive.'}, {'measure': 'Percentage of Participants Who Achieve Best Overall Tumor Response of Complete Response (CR) or Partial Response (PR) Objective Tumor Response Rate (ORR)', 'timeFrame': 'Baseline to Measured PD or Study Discontinuation (Up to 31 Months)', 'description': 'The ORR is equal to the percentage of participants achieving a best overall response of partial response or complete response (PR + CR), according to RECIST version 1.1 criteria. CR was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes must have reduction in short axis to \\<10 millimeter (mm) and normalization of tumor marker level of non-target lesions; PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions; PD was defined as having at least 20% increase in sum of longest diameter of target lesions and minimum 5 mm increase above nadir; Stable Disease (SD) was defined as small changes that did not meet above criteria. Participants who had no post baseline tumor assessments were considered non-responders and included in the denominator when calculating response rate. Percentage of participants=(number of participants with CR+PR/total number of participants)\\*100.'}, {'measure': 'Median Duration of Response', 'timeFrame': 'First Criteria Met for CR or PR to Measured PD Start of Other Antitumor Therapy or Death From Any Cause (Up to 31 Months)', 'description': 'The duration of overall response is measured from the time measurement criteria are first met for Complete Response (CR)/Partial Response (PR) (whichever is first recorded) until the first date that the criteria for PD are met (taking as a reference for PD the smallest measurement recorded since the treatment started), initiation of other/additional antitumor therapy is first reported, or death, is objectively documented.'}, {'measure': 'Pharmacodynamics of Olaratumab', 'timeFrame': 'Cycle 1: Days 1, 8, and 15 pre- and post-infusion of Olaratumab; Cycles 2-6: day 1 only, pre- and post-infusion of Olaratumab', 'description': 'Pharmacodynamics of Olaratumab was determined by analysis of pharmacodynamic markers vascular endothelial growth factor (VEGF) and platelet derived growth factor (PDGF).'}, {'measure': 'Percentage of Participants With Anti-Olaratumab Antibodies', 'timeFrame': 'Baseline to Study Completion (Up to 8 Months)', 'description': 'Participants with Treatment Emergent (TE) anti-olaratumab antibodies were participants with a 4-fold increase (2 dilutions) increase over a positive baseline antibody titer or for a negative baseline titer, a participant with an increase from the baseline to a level of 1:20.'}, {'measure': 'Pharmacokinetics (PK) - Area Under the Curve (AUC) 0-168 of Olaratumab', 'timeFrame': 'Cycle 3, Day 1: Predose, 30 minutes (min), 1.5 hours (hrs), 24,48,96,168 Hrs Post Dose', 'description': 'AUC(0-168) = area under the concentration versus time curve from time zero to 168 hours post dose.'}, {'measure': 'PK - Maximum Concentration (Cmax) of Olaratumab', 'timeFrame': 'Cycle 3, Day 1: Predose, 30 min, 1.5 hrs, 24,48,96,168 Hrs Post Dose'}, {'measure': 'PK - Half-Life (t1/2) of Olaratumab', 'timeFrame': 'Cycle 3, Day 1: Predose, 30 min, 1.5 hrs, 24,48,96,168 Hrs Post Dose'}, {'measure': 'PK - Clearance (Cl) of Olaratumab', 'timeFrame': 'Cycle 3, Day 1: Predose, 30 min, 1.5 hr, 24,48,96,168 Hrs Post Dose'}, {'measure': 'PK - Steady State Volume of Distribution (Vss) of Olaratumab', 'timeFrame': 'Cycle 3, Day 1: Predose, 30 min, 1.5 hrs, 24,48,96,168 Hrs Post Dose'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Lung neoplasms', 'IMC-3G3', 'carboplatin', 'paclitaxel', 'PDGFr'], 'conditions': ['Non-Small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if participants with untreated locally advanced or metastatic non-small cell lung cancer have a better outcome when treated with olaratumab in combination with paclitaxel/carboplatin then when treated with paclitaxel/carboplatin alone.', 'detailedDescription': 'The primary objective of this study is to evaluate the progression-free survival (PFS) in previously untreated participants with Stage IIIB/IV non-small cell lung cancer (NSCLC) treated with olaratumab plus paclitaxel and carboplatin versus paclitaxel and carboplatin in the first-line metastatic setting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The participants has histologically or cytologically confirmed Non-Small Cell Lung Cancer (NSCLC)Stage IIIB with effusion. Mixed Non-Small Cell Lung Cancer (NSCLC) tumors will be categorized by the predominant cell type. Primary or metastatic site may be used for histology\n2. For squamous cell histology or for centrally located mediastinal masses (\\< 3 cm from the carina) identified by computed tomography scan (CT) or chest x-ray, the participant must undergo a magnetic resonance imaging (MRI) of the chest or I.V. contrast CT scan within 3 weeks of randomization, to exclude major airway or blood vessel invasion (in the investigator\'s opinion) by cancer\n3. The participant has measurable disease (Tumors within a previously irradiated field will be designated as "nontarget" lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy\n4. The participant\'s Eastern Cooperative Oncology Group (ECOG) performance status is 0-1\n5. The participant\'s age at the time of study entry is ≥ 18 years\n6. The participant has adequate hematologic function as defined by an absolute neutrophil count (ANC) ≥ 1500/μL, hemoglobin ≥ 9.5 g/dL, and a platelet count ≥ 100,000/μL obtained within 2 weeks prior to randomization\n7. The participant has adequate hepatic function as defined by a total bilirubin ≤ 1.5 mg/dL, and aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3.0 × the upper limit of normal (ULN), or ≤ 5 × the ULN in the presence of known liver metastases)\n8. The participant has adequate renal function as defined by serum creatinine ≤ 1.5 × the institutional ULN. If creatinine is above the ULN, the patient\'s creatinine clearance (CrCl) is ≥ 60 mL/min\n9. The participant has urinary protein ≤ 1+ on dipstick or routine urinalysis; if urine dipstick or routine analysis is ≥ 2+, a 24-hour urine for protein must demonstrate \\< 1 g of protein in 24 hours to allow participation\n10. The participant has adequate coagulation function, as defined by international normalized ratio (INR) ≤ 1.5 and a partial thromboplastin time (PTT) ≤ 5 seconds above ULN if not receiving anticoagulation therapy. Participants on full-dose anticoagulation must be on a stable dose of oral anticoagulant or low molecular weight heparin, have therapeutic INR, no active bleeding (defined as within 14 days randomization) and no pathological condition that carries a high risk of bleeding (eg, tumor involving major vessels or known varices)\n11. Because the teratogenicity of Olaratumab is not known, women of childbearing potential (WOCBP) and sexually active males must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to randomization and for the duration of study participation\n12. The participant has resolution to Grade ≤ 1 by the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4 (NCI-CTCAE v 4.02) of all clinically significant toxic effects of prior locoregional therapy, surgery, chemoembolization, or other anticancer therapy. The exceptions for such effects are events that pertain to the lab values found elsewhere in these inclusion criteria. (For example, criterion # 6 states that a patient with hemoglobin ≥ 9.5 g/dL is considered eligible, even though NCI-CTCAE v 4.02 defines this value as Grade 2 anemia.)\n13. The participant has a life expectancy of ≥ 3 months\n14. The participant has provided signed informed consent\n\nExclusion Criteria:\n\n1. The participant has untreated central nervous system (CNS) metastases. Participants are eligible if they are clinically stable, off all steroids after cranial irradiation (whole brain radiation therapy, focal radiation therapy, stereotactic radiosurgery)ending at least 2 weeks prior to randomization, or after surgical resection performed at least 4 weeks prior to randomization\n2. The participant has radiologically documented evidence of major blood vessel invasion or encasement by cancer, or of intratumor cavitation\n3. The participant received prior systemic chemotherapy or biologic therapy (eg erlotinib) for Stage IIIB/IV NSCLC outside of the adjuvant setting. Participants who received prior cytotoxic chemotherapy or biologic therapy in the adjuvant setting will not be excluded based on such therapy\n4. The participant has a history of another primary cancer, with the exception of a) curatively resected nonmelanomatous skin cancer b) curatively treated cervical carcinoma in situ c)other primary solid tumor treated with curative intent, no known active disease present, and no treatment administered during the last 3 years prior to randomization\n5. The participant is receiving concurrent treatment with other anticancer therapy, including other chemotherapy, immunotherapy, hormonal therapy, radiotherapy, chemo-embolization, targeted therapy, or an investigational agent\n6. The participant has an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring parenteral antibiotics, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements\n7. The participant has an uncontrolled thrombotic or hemorrhagic disorder\n8. The participant has a history of gross hemoptysis (defined as bright red blood or ≥ 1/2 teaspoon) within 2 months of randomization\n9. The participant has a serious non-healing wound, ulcer, or bone fracture within 28 days prior to randomization\n10. The participant has undergone major surgery within 28 days prior to randomization\n11. The participant has received adjuvant chemotherapy 21 days prior to randomization or has participated in clinical trials of experimental agents within 28 days prior to randomization\n12. The participant has an elective or a planned major surgery to be performed during the course of the trial\n13. The participant has peripheral neuropathy ≥ Grade 2 NCI-CTCAE v 4.02\n14. The participant has known human immunodeficiency virus (HIV) positivity\n15. The participant, if female, is pregnant or lactating\n16. The participant has received previous therapy with any agent that targets platelet derived growth factor (PDGF) or platelet derived growth factor receptor (PDGFR)\n17. The participant has a known allergy to any of the treatment components\n18. The participant has a history of allergic reactions attributed to compounds of chemical or biologic composition similar to that of Olaratumab'}, 'identificationModule': {'nctId': 'NCT00918203', 'briefTitle': 'A Study of Paclitaxel/Carboplatin With or Without Olaratumab (IMC-3G3) in Previously Untreated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Randomized Phase 2 Study of Human Anti-PDGFRα Monoclonal Antibody (IMC-3G3) With Paclitaxel/Carboplatin or Paclitaxel/Carboplatin Alone in Previously Untreated Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer', 'orgStudyIdInfo': {'id': '13900'}, 'secondaryIdInfos': [{'id': 'CP15-0804', 'type': 'OTHER', 'domain': 'ImClone Systems'}, {'id': 'I5B-IE-JGDB', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Paclitaxel + Carboplatin', 'description': '(Initial 4-6 cycles) Paclitaxel 200 milligram/square meter (mg/m2) over 3 hrs (Day 1) Carboplatin Area Under Concentration (AUC)=6 (Day 1) of each 21-day cycle (Initial 4-6 cycles) Paclitaxel 200 mg/m2 over 3 hrs (Day 1) Carboplatin AUC=6 (Day 1) of each 21-day cycle\n\nParticipants who experience progressive disease may cross over to olaratumab monotherapy.', 'interventionNames': ['Drug: Paclitaxel', 'Drug: Carboplatin']}, {'type': 'EXPERIMENTAL', 'label': 'Olaratumab + Paclitaxel + Carboplatin', 'description': '(Initial 4-6 cycles)\n\nOlaratumab 15 milligrams/kilogram (mg/kg) over 30 mins (Days 1 and 8) plus Paclitaxel 200 mg/m2 over 3 hrs (Day 1) Carboplatin AUC=6 (Day 1) of each 21-day cycle\n\nParticipants can remain on study after completing chemotherapy and receive olaratumab monotherapy on Days 1 and 8, provided there is ongoing evidence of clinical benefit.', 'interventionNames': ['Biological: Olaratumab', 'Drug: Paclitaxel', 'Drug: Carboplatin']}], 'interventions': [{'name': 'Olaratumab', 'type': 'BIOLOGICAL', 'otherNames': ['LY3012207', 'IMC-3G3'], 'description': '15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, administered intravenously (IV) at 25 milligram/minute (mg/min), with a minimum infusion time of 30 minutes.', 'armGroupLabels': ['Olaratumab + Paclitaxel + Carboplatin']}, {'name': 'Paclitaxel', 'type': 'DRUG', 'description': '200 mg/m2 is then administered IV over 3 hours', 'armGroupLabels': ['Olaratumab + Paclitaxel + Carboplatin', 'Paclitaxel + Carboplatin']}, {'name': 'Carboplatin', 'type': 'DRUG', 'description': 'AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months.', 'armGroupLabels': ['Olaratumab + Paclitaxel + Carboplatin', 'Paclitaxel + Carboplatin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'ImClone Investigational Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '93309', 'city': 'Bakersfield', 'state': 'California', 'country': 'United States', 'facility': 'ImClone Investigational Site', 'geoPoint': {'lat': 35.37329, 'lon': -119.01871}}, {'zip': '92346', 'city': 'Highland', 'state': 'California', 'country': 'United States', 'facility': 'ImClone Investigational Site', 'geoPoint': {'lat': 34.12834, 'lon': -117.20865}}, {'zip': '06902', 'city': 'Stamford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'ImClone Investigational Site', 'geoPoint': {'lat': 41.05343, 'lon': -73.53873}}, {'zip': '34952', 'city': 'Port Saint Lucie', 'state': 'Florida', 'country': 'United States', 'facility': 'ImClone Investigational Site', 'geoPoint': {'lat': 27.29393, 'lon': -80.35033}}, {'zip': '60435', 'city': 'Joliet', 'state': 'Illinois', 'country': 'United States', 'facility': 'ImClone Investigational Site', 'geoPoint': {'lat': 41.52519, 'lon': -88.0834}}, {'zip': '70809', 'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'facility': 'ImClone Investigational Site', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'ImClone Investigational Site', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '28203', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'ImClone Investigational Site', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '20854', 'city': 'Gastonia', 'state': 'North Carolina', 'country': 'United States', 'facility': 'ImClone Investigational Site', 'geoPoint': {'lat': 35.26208, 'lon': -81.1873}}, {'zip': '28078', 'city': 'Huntersville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'ImClone Investigational Site', 'geoPoint': {'lat': 35.41069, 'lon': -80.84285}}, {'zip': '44708', 'city': 'Canton', 'state': 'Ohio', 'country': 'United States', 'facility': 'ImClone Investigational Site', 'geoPoint': {'lat': 40.79895, 'lon': -81.37845}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'ImClone Investigational Site', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'ImClone Investigational Site', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '44646', 'city': 'Massillon', 'state': 'Ohio', 'country': 'United States', 'facility': 'ImClone Investigational Site', 'geoPoint': {'lat': 40.79672, 'lon': -81.52151}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'ImClone Investigational Site', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'ImClone Investigational Site', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '75390-8852', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'ImClone Investigational Site', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '78665', 'city': 'Round Rock', 'state': 'Texas', 'country': 'United States', 'facility': 'ImClone Investigational Site', 'geoPoint': {'lat': 30.50826, 'lon': -97.6789}}, {'zip': '76508', 'city': 'Temple', 'state': 'Texas', 'country': 'United States', 'facility': 'ImClone Investigational Site', 'geoPoint': {'lat': 31.09823, 'lon': -97.34278}}, {'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'ImClone Investigational Site', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}, {'zip': 'T2N 4N2', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'ImClone Investigational Site', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'T6G 1Z2', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'ImClone Investigational Site', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}