Ignite Creation Date:
2025-12-24 @ 10:17 PM
Ignite Modification Date:
2025-12-31 @ 12:05 AM
Study NCT ID:
NCT00913835
Status:
COMPLETED
Last Update Posted:
2019-09-26
First Post:
2009-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Liposomal Doxorubicin With or Without Olaratumab (IMC-3G3) in Platinum-Refractory or Resistant Advanced Ovarian Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000589393', 'term': 'olaratumab'}, {'id': 'C506643', 'term': 'liposomal doxorubicin'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'otherDetails': 'Investigators agreed to delay independently publishing or disclosing data, findings or conclusions from the study except as part of a multi-center publication. Upon study publication or if the draft publication is not produced within approximately 6 months of the final report of the study results, investigators may independently publish, subject to confidential information review/redaction by sponsor. The sponsor may request publication delay up to 90 days to seek patent protection.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Olaratumab and Liposomal Doxorubicin', 'description': "20 mg/kg of Olaratumab was administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.\n\n40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity.", 'otherNumAtRisk': 62, 'otherNumAffected': 62, 'seriousNumAtRisk': 62, 'seriousNumAffected': 27}, {'id': 'EG001', 'title': 'Liposomal Doxorubicin', 'description': "40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.\n\nUpon disease progression the participant had the option to receive Olaratumab monotherapy.", 'otherNumAtRisk': 61, 'otherNumAffected': 60, 'seriousNumAtRisk': 61, 'seriousNumAffected': 23}, {'id': 'EG002', 'title': 'Liposomal Doxorubicin: Optional Olaratumab Monotherapy', 'description': "40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity followed by 20 mg/kg of Olaratumab administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.", 'otherNumAtRisk': 28, 'otherNumAffected': 27, 'seriousNumAtRisk': 28, 'seriousNumAffected': 14}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 21, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 23, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 10, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 67, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 23, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 18, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 22, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 35, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 17, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 9, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 40, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 33, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 28, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 16, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 14, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 61, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 61, 'numAffected': 39}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 16, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Odynophagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 40, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 34, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 41, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 33, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 12, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 11, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 21, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Early satiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 64, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 50, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 19, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 38, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 13, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 16, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 15, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Oral candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 23, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 27, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 31, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 19, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 15, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 18, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 12, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 14, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 61, 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'Febrile infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Urinary tract infection fungal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Incorrect drug administration duration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Medication error', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Flank pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Haemorrhage intracranial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Bradyphrenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hydronephrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Venous thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression-Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Olaratumab and Liposomal Doxorubicin', 'description': "20 mg/kg of Olaratumab was administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.\n\n40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity."}, {'id': 'OG001', 'title': 'Liposomal Doxorubicin: Optional Olaratumab Monotherapy', 'description': "40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.\n\nUpon disease progression the participant had the option to receive Olaratumab monotherapy."}], 'classes': [{'categories': [{'measurements': [{'value': '18.1', 'groupId': 'OG000', 'lowerLimit': '8.7', 'upperLimit': '27.0'}, {'value': '17.3', 'groupId': 'OG001', 'lowerLimit': '14.1', 'upperLimit': '31.9'}]}]}], 'analyses': [{'pValue': '0.8049', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.054', 'ciLowerLimit': '0.751', 'ciUpperLimit': '1.478', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Stratified by prior platinum treatment, platinum-refractory versus platinum-resistance reaction.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Randomization to Progressive Disease (PD) or Date of Death (Up to 35 Months)', 'description': 'PFS is defined as the time from the day of randomization to the first evidence of progression as defined by Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST v1.0) criteria or death from any cause. Progressive Disease (PD) is a 20% increase over the smallest sum of target lesions or new lesions. Participants who died without a reported prior disease 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 last tumor assessment.', 'unitOfMeasure': 'weeks', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent to Treat (mITT) Population: All randomized participants who received any amount of study drug. Participants censored: Olaratumab=13, Liposomal Doxorubicin=14.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Olaratumab and Liposomal Doxorubicin', 'description': "20 mg/kg of Olaratumab was administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.\n\n40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity."}, {'id': 'OG001', 'title': 'Liposomal Doxorubicin: Optional Olaratumab Monotherapy', 'description': "40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.\n\nUpon disease progression the participant had the option to receive Olaratumab monotherapy."}], 'classes': [{'categories': [{'measurements': [{'value': '72.3', 'groupId': 'OG000', 'lowerLimit': '52.4', 'upperLimit': '86.7'}, {'value': '70.6', 'groupId': 'OG001', 'lowerLimit': '51.4', 'upperLimit': '106.4'}]}]}], 'analyses': [{'pValue': '0.6346', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.115', 'ciLowerLimit': '0.768', 'ciUpperLimit': '1.618', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Stratified by prior platinum treatment, platinum-refractory versus platinum-resistance reaction.'}], 'paramType': 'MEDIAN', 'timeFrame': 'First Day of Therapy to Date of Death (Up to 35 Months)', 'description': 'OS is defined as the time from first day of therapy to the date of death from any cause. Participants who were alive at the end of the follow-up period or were lost to follow-up, OS was censored on the last date the participant was known to be alive.', 'unitOfMeasure': 'weeks', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population: All randomized participants who received any amount of study drug. Participants censored: Olaratumab=21, Liposomal Doxorubicin=23.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Olaratumab and Liposomal Doxorubicin', 'description': "20 mg/kg of Olaratumab was administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.\n\n40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity."}, {'id': 'OG001', 'title': 'Liposomal Doxorubicin: Optional Olaratumab Monotherapy', 'description': "40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.\n\nUpon disease progression the participant had the option to receive Olaratumab monotherapy."}], 'classes': [{'categories': [{'measurements': [{'value': '12.9', 'groupId': 'OG000', 'lowerLimit': '6.6', 'upperLimit': '22.1'}, {'value': '16.4', 'groupId': 'OG001', 'lowerLimit': '9.2', 'upperLimit': '26.2'}]}]}], 'analyses': [{'pValue': '0.6190', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Randomization to PD (Up to 35 Months)', 'description': 'The percentage of participants with a best overall response of confirmed CR or PR defined using RECIST v1.0 criteria. CR is the disappearance of all target and non-target lesions and normalization of cancer antigen-125 (CA-125) levels. PR is defined as having a ≥30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. The percentage of participants with objective response was calculated as: (number of participants whose best overall response of CR or PR/number of participants treated) \\* 100.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population: All randomized participants who received any amount of study drug.'}, {'type': 'SECONDARY', 'title': 'Median Duration of Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Olaratumab and Liposomal Doxorubicin', 'description': "20 mg/kg of Olaratumab was administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.\n\n40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity."}, {'id': 'OG001', 'title': 'Liposomal Doxorubicin: Optional Olaratumab Monotherapy', 'description': "40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.\n\nUpon disease progression the participant had the option to receive Olaratumab monotherapy."}], 'classes': [{'categories': [{'measurements': [{'value': '39.1', 'groupId': 'OG000', 'lowerLimit': '26.1', 'upperLimit': '56.1'}, {'value': '16.9', 'comment': 'Upper limit of confidence interval (CI) not estimable, did not reach the upper limit of CI.', 'groupId': 'OG001', 'lowerLimit': '15.3', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Date of Initial CR or PR to PD (Up to 35 Months)', 'description': 'Duration of response is the interval from the date of initial CR or PR until the first date criteria for PD is met using RECIST v1.0 criteria, or initiation of other (or additional) antitumor therapy is first reported, or death due to any cause. CR is the disappearance of all target and non-target lesions and the normalization of tumor marker levels. PR is a ≥30% decrease in the sum of the LD of target lesions without new lesions and progression of non-target lesions. PD is a ≥20% increase in the sum of the LD of target lesions and/or unequivocal progression of existing non-target lesions and/or detection of 1 or more new lesions. Participants who did not relapse were censored on the day of their last tumor assessment.', 'unitOfMeasure': 'weeks', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who achieved CR or PR. Participants censored: Olaratumab=2, Liposomal Doxorubicin=4.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events (AEs) and Who Died', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Olaratumab and Liposomal Doxorubicin', 'description': "20 mg/kg of Olaratumab was administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.\n\n40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity."}, {'id': 'OG001', 'title': 'Liposomal Doxorubicin', 'description': "40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.\n\nUpon disease progression the participant had the option to receive Olaratumab monotherapy.."}, {'id': 'OG002', 'title': 'Liposomal Doxorubicin: Optional Olaratumab Monotherapy', 'description': "40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity followed by 20 mg/kg of Olaratumab administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks."}], 'classes': [{'title': 'SAEs', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}]}, {'title': 'Other Non-SAEs', 'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}]}, {'title': 'Deaths on treatment or within 30 days of last dose', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline Up to End of Treatment and 30-day Post-dose Follow-up (Up to 35 Months)', 'description': 'Reported are the number of participants with clinically significant events, defined as serious AEs (SAEs) and other non-serious AEs regardless of causality and those who died during treatment and during the 30-day post-dose follow-up. A summary of SAEs and other non-serious AEs regardless of causality is located in the Reported Adverse Events module of this report.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received any amount of study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Anti-Olaratumab Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Olaratumab and Liposomal Doxorubicin', 'description': "20 mg/kg of Olaratumab was administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.\n\n40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity."}, {'id': 'OG001', 'title': 'Liposomal Doxorubicin: Optional Olaratumab Monotherapy', 'description': "40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity followed by 20 mg/kg of Olaratumab administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks."}], 'classes': [{'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline Up to 30-Day Postdose Follow-Up (Up To 35 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 received at least one dose of study drug and had evaluable baseline and evaluable post-baseline antibody data.'}, {'type': 'SECONDARY', 'title': 'PFS of Participants Who Received Olaratumab After Liposomal Doxorubicin Monotherapy (Descriptive Statistics for Safety and Efficacy for Participants Who Continue on Olaratumab Monotherapy Following Disease Progression on Liposomal Doxorubicin Monotherapy)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Liposomal Doxorubicin: Optional Olaratumab Monotherapy', 'description': "40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity followed by 20 mg/kg of Olaratumab administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks."}], 'classes': [{'categories': [{'measurements': [{'value': '7.7', 'groupId': 'OG000', 'lowerLimit': '7.1', 'upperLimit': '10.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From Start of Olaratumab Monotherapy to PD or Date of Death (Up to 20 Weeks)', 'description': 'PFS is defined as the time from start of Olaratumab monotherapy to the first evidence of progression as defined by RECIST v1.0 criteria or death from any cause. PD is a 20% increase over the smallest sum of target lesions or new lesions. Participants who died without a reported prior disease 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 last tumor assessment.', 'unitOfMeasure': 'weeks', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received Olaratumab treatment after PD on liposomal doxorubicin monotherapy. Participants censored=4'}, {'type': 'SECONDARY', 'title': 'Area Under the Curve (AUC) of Olaratumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Olaratumab and Liposomal Doxorubicin', 'description': "20 mg/kg of Olaratumab was administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.\n\n40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity."}, {'id': 'OG001', 'title': 'Liposomal Doxorubicin', 'description': "40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.\n\nUpon disease progression the participant had the option to receive Olaratumab monotherapy."}, {'id': 'OG002', 'title': 'Liposomal Doxorubicin: Optional Olaratumab Monotherapy', 'description': "40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity followed by 20 mg/kg of Olaratumab administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks."}], 'timeFrame': 'Prior to and 1 Hour (h) After Olaratumab Infusion in Cycles 1, 2, and 4 and 48 h or 72 h, 144 h, 240 h or 264 h and 336 h Post-dose in Cycles 1 and 4 (28-day Cycles)', 'reportingStatus': 'POSTED', 'populationDescription': 'Zero participants were analyzed. An insufficient amount of samples were collected to derive this measure.'}, {'type': 'SECONDARY', 'title': 'Maximum Concentration (Cmax) of Olaratumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Olaratumab and Liposomal Doxorubicin', 'description': "20 mg/kg of Olaratumab was administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.\n\n40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity."}, {'id': 'OG001', 'title': 'Liposomal Doxorubicin', 'description': "40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.\n\nUpon disease progression the participant had the option to receive Olaratumab monotherapy."}, {'id': 'OG002', 'title': 'Liposomal Doxorubicin: Optional Olaratumab Monotherapy', 'description': "40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity followed by 20 mg/kg of Olaratumab administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks."}], 'timeFrame': 'Prior to and 1 h after Olaratumab Infusion in Cycles 1, 2, and 4 and 48 h or 72 h, 144 h, 240 h or 264 h and 336 h Post-dose in Cycles 1 and 4 (28-day Cycles)', 'reportingStatus': 'POSTED', 'populationDescription': 'Zero participants were analyzed. An insufficient amount of samples were collected to derive this measure.'}, {'type': 'SECONDARY', 'title': 'Half-life (t1/2) of Olaratumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Olaratumab and Liposomal Doxorubicin', 'description': "20 mg/kg of Olaratumab was administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.\n\n40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity."}, {'id': 'OG001', 'title': 'Liposomal Doxorubicin', 'description': "40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.\n\nUpon disease progression the participant had the option to receive Olaratumab monotherapy."}, {'id': 'OG002', 'title': 'Liposomal Doxorubicin: Optional Olaratumab Monotherapy', 'description': "40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity followed by 20 mg/kg of Olaratumab administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks."}], 'timeFrame': 'Prior to and 1 h after Olaratumab Infusion in Cycles 1, 2, and 4 and 48 h or 72 h, 144 h, 240 h or 264 h and 336 h Post-dose in Cycles 1 and 4 (28-day Cycles)', 'description': 'The time it takes to reduce the concentration of Olaratumab in the plasma by 50%.', 'reportingStatus': 'POSTED', 'populationDescription': 'Zero participants were analyzed. An insufficient amount of samples were collected to derive this measure.'}, {'type': 'SECONDARY', 'title': 'Clearance (CL) of Olaratumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Olaratumab and Liposomal Doxorubicin', 'description': "20 mg/kg of Olaratumab was administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.\n\n40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity."}, {'id': 'OG001', 'title': 'Liposomal Doxorubicin', 'description': "40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.\n\nUpon disease progression the participant had the option to receive Olaratumab monotherapy."}, {'id': 'OG002', 'title': 'Liposomal Doxorubicin: Optional Olaratumab Monotherapy', 'description': "40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity followed by 20 mg/kg of Olaratumab administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks."}], 'timeFrame': 'Prior to and 1 h after Olaratumab Infusion in Cycles 1, 2, and 4 and 48 h or 72 h, 144 h, 240 h or 264 h and 336 h Post-dose in Cycles 1 and 4 (28-day Cycles)', 'description': 'CL is the volume of serum cleared of Olaratumab per unit of time after a single dose of Olaratumab', 'reportingStatus': 'POSTED', 'populationDescription': 'Zero participants were analyzed. An insufficient amount of samples were collected to derive this measure.'}, {'type': 'SECONDARY', 'title': 'Apparent Volume of Distribution (Vss) of Olaratumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Olaratumab and Liposomal Doxorubicin', 'description': "20 mg/kg of Olaratumab was administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.\n\n40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity."}, {'id': 'OG001', 'title': 'Liposomal Doxorubicin', 'description': "40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.\n\nUpon disease progression the participant had the option to receive Olaratumab monotherapy."}, {'id': 'OG002', 'title': 'Liposomal Doxorubicin: Optional Olaratumab Treatment', 'description': "40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development Olaratumab administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks."}], 'timeFrame': 'Prior to and 1 h after Olaratumab Infusion in Cycles 1, 2, and 4 and 48 h or 72 h, 144 h, 240 h or 264 h and 336 h Post-dose in Cycles 1 and 4 (28-day Cycles)', 'description': 'Vss is an estimate of drug distribution independent of the elimination process and is proportional to the amount of drug in the body versus the drug plasma concentration at steady-state.', 'reportingStatus': 'POSTED', 'populationDescription': 'Zero participants were analyzed. An insufficient amount of samples were collected to derive this measure.'}, {'type': 'SECONDARY', 'title': 'PFS for Participants Who Had Tissue Samples for Platelet Derived Growth Factor Receptor Alpha (PDGFRα) Expression Determined by Immunohistochemistry (IHC) (Association Between PDGFRα Tumor Expression and PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Olaratumab and Liposomal Doxorubicin', 'description': "20 mg/kg of Olaratumab was administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.\n\n40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity."}, {'id': 'OG001', 'title': 'Liposomal Doxorubicin', 'description': "40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.\n\nUpon disease progression the participant had the option to receive Olaratumab monotherapy."}], 'classes': [{'title': 'High Expression (n=41, 36)', 'categories': [{'measurements': [{'value': '21.0', 'groupId': 'OG000', 'lowerLimit': '8.7', 'upperLimit': '34.1'}, {'value': '17.3', 'groupId': 'OG001', 'lowerLimit': '12.3', 'upperLimit': '33.9'}]}]}, {'title': 'Low Expression (n=13,11)', 'categories': [{'measurements': [{'value': '32.7', 'groupId': 'OG000', 'lowerLimit': '7.6', 'upperLimit': '41.3'}, {'value': '24.0', 'groupId': 'OG001', 'lowerLimit': '8.1', 'upperLimit': '36.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Randomization to PD or Date of Death (Up to 130 Weeks)', 'description': 'PFS is defined as the time from the day of randomization to the first evidence of progression as defined by RECIST v1.0 criteria or death from any cause. PD is a 20% increase over the smallest sum of target lesions or new lesions. Participants who died without a prior disease 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 last tumor assessment. PDGFRα protein expression at baseline in tumor cells is determined by IHC using H-Scores and a cut point of 0. Participants were considered to have a high relative expression when H-Score is \\>0 and a low relative expression when H-Score=0. H-Score was calculated by summing the percentage of cell staining at each intensity multiplied by the weighted intensity of staining. Staining intensity: 0 (no staining), 1+ (weak staining), 2+ (medium staining), 3+ (strongest staining). H-Scores could range from 0-300.', 'unitOfMeasure': 'weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who had evaluable PDGFRα results.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Olaratumab + Liposomal Doxorubicin', 'description': "20 milligrams per kilogram (mg/kg) of Olaratumab was administered as an intravenous (IV) infusion every 2 weeks (14 days) until there was evidence of progressive disease (PD) or development of unacceptable toxicity.\n\n40 milligrams per square meter (mg/m²) of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity."}, {'id': 'FG001', 'title': 'Liposomal Doxorubicin: Optional Olaratumab Monotherapy', 'description': "40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days). Treatment continued until there is evidence of PD or development of unacceptable toxicity up to 130 weeks.\n\nUpon disease progression the participant had the option to receive Olaratumab monotherapy."}], 'periods': [{'title': 'Olara+Lip Dox and Lip Dox Monotherapy', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '63'}, {'groupId': 'FG001', 'numSubjects': '62'}]}, {'type': 'Received Any Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '62'}, {'groupId': 'FG001', 'numSubjects': '61'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}, {'groupId': 'FG001', 'numSubjects': '55'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Off Study Treatment/Alive', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Lip Dox: Olaratumab Monotherapy', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'Received at Least 1 Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'preAssignmentDetails': 'Participants from liposomal doxorubicin (Lip Dox) treatment group who had progressive disease (PD) had the option to receive to Olaratumab (Olara) monotherapy. Participants who had evidence of PD, died in either period, or received optional Olaratumab monotherapy from liposomal doxorubicin monotherapy were considered to have completed the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '123', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Olaratumab and Liposomal Doxorubicin', 'description': "20 mg/kg of Olaratumab was administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.\n\n40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity."}, {'id': 'BG001', 'title': 'Liposomal Doxorubicin: Optional Olaratumab Monotherapy', 'description': "40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.\n\nUpon disease progression the participant had the option to receive Olaratumab monotherapy."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.7', 'spread': '10.07', 'groupId': 'BG000'}, {'value': '59.8', 'spread': '9.70', 'groupId': 'BG001'}, {'value': '59.3', 'spread': '9.86', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '123', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'Native Hawaiian of Other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)', 'classes': [{'title': '0-Fully Active', 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}]}, {'title': '1-ambulatory, able to do light/sedentary nature', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'ECOG PS classified participants according to their functional impairment.', 'unitOfMeasure': 'Participants'}, {'title': 'Stratification Factor', 'classes': [{'title': 'Platinum Refractory', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}, {'title': 'Platinum Resistant', 'categories': [{'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Participants reaction to prior platinum treatment.', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Modified Intent to Treat (mITT) Population: All participants who were randomized and received any quantity of study drug.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 125}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'dispFirstSubmitDate': '2011-09-19', 'completionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-10', 'studyFirstSubmitDate': '2009-06-02', 'dispFirstSubmitQcDate': '2011-09-19', 'resultsFirstSubmitDate': '2016-11-18', 'studyFirstSubmitQcDate': '2009-06-03', 'dispFirstPostDateStruct': {'date': '2011-09-26', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2019-09-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-03-03', 'studyFirstPostDateStruct': {'date': '2009-06-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-04-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-Free Survival (PFS)', 'timeFrame': 'Randomization to Progressive Disease (PD) or Date of Death (Up to 35 Months)', 'description': 'PFS is defined as the time from the day of randomization to the first evidence of progression as defined by Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST v1.0) criteria or death from any cause. Progressive Disease (PD) is a 20% increase over the smallest sum of target lesions or new lesions. Participants who died without a reported prior disease 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 last tumor assessment.'}], 'secondaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': 'First Day of Therapy to Date of Death (Up to 35 Months)', 'description': 'OS is defined as the time from first day of therapy to the date of death from any cause. Participants who were alive at the end of the follow-up period or were lost to follow-up, OS was censored on the last date the participant was known to be alive.'}, {'measure': 'Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]', 'timeFrame': 'Randomization to PD (Up to 35 Months)', 'description': 'The percentage of participants with a best overall response of confirmed CR or PR defined using RECIST v1.0 criteria. CR is the disappearance of all target and non-target lesions and normalization of cancer antigen-125 (CA-125) levels. PR is defined as having a ≥30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. The percentage of participants with objective response was calculated as: (number of participants whose best overall response of CR or PR/number of participants treated) \\* 100.'}, {'measure': 'Median Duration of Response', 'timeFrame': 'Date of Initial CR or PR to PD (Up to 35 Months)', 'description': 'Duration of response is the interval from the date of initial CR or PR until the first date criteria for PD is met using RECIST v1.0 criteria, or initiation of other (or additional) antitumor therapy is first reported, or death due to any cause. CR is the disappearance of all target and non-target lesions and the normalization of tumor marker levels. PR is a ≥30% decrease in the sum of the LD of target lesions without new lesions and progression of non-target lesions. PD is a ≥20% increase in the sum of the LD of target lesions and/or unequivocal progression of existing non-target lesions and/or detection of 1 or more new lesions. Participants who did not relapse were censored on the day of their last tumor assessment.'}, {'measure': 'Number of Participants With Adverse Events (AEs) and Who Died', 'timeFrame': 'Baseline Up to End of Treatment and 30-day Post-dose Follow-up (Up to 35 Months)', 'description': 'Reported are the number of participants with clinically significant events, defined as serious AEs (SAEs) and other non-serious AEs regardless of causality and those who died during treatment and during the 30-day post-dose follow-up. A summary of SAEs and other non-serious AEs regardless of causality is located in the Reported Adverse Events module of this report.'}, {'measure': 'Percentage of Participants With Anti-Olaratumab Antibodies', 'timeFrame': 'Baseline Up to 30-Day Postdose Follow-Up (Up To 35 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': 'PFS of Participants Who Received Olaratumab After Liposomal Doxorubicin Monotherapy (Descriptive Statistics for Safety and Efficacy for Participants Who Continue on Olaratumab Monotherapy Following Disease Progression on Liposomal Doxorubicin Monotherapy)', 'timeFrame': 'From Start of Olaratumab Monotherapy to PD or Date of Death (Up to 20 Weeks)', 'description': 'PFS is defined as the time from start of Olaratumab monotherapy to the first evidence of progression as defined by RECIST v1.0 criteria or death from any cause. PD is a 20% increase over the smallest sum of target lesions or new lesions. Participants who died without a reported prior disease 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 last tumor assessment.'}, {'measure': 'Area Under the Curve (AUC) of Olaratumab', 'timeFrame': 'Prior to and 1 Hour (h) After Olaratumab Infusion in Cycles 1, 2, and 4 and 48 h or 72 h, 144 h, 240 h or 264 h and 336 h Post-dose in Cycles 1 and 4 (28-day Cycles)'}, {'measure': 'Maximum Concentration (Cmax) of Olaratumab', 'timeFrame': 'Prior to and 1 h after Olaratumab Infusion in Cycles 1, 2, and 4 and 48 h or 72 h, 144 h, 240 h or 264 h and 336 h Post-dose in Cycles 1 and 4 (28-day Cycles)'}, {'measure': 'Half-life (t1/2) of Olaratumab', 'timeFrame': 'Prior to and 1 h after Olaratumab Infusion in Cycles 1, 2, and 4 and 48 h or 72 h, 144 h, 240 h or 264 h and 336 h Post-dose in Cycles 1 and 4 (28-day Cycles)', 'description': 'The time it takes to reduce the concentration of Olaratumab in the plasma by 50%.'}, {'measure': 'Clearance (CL) of Olaratumab', 'timeFrame': 'Prior to and 1 h after Olaratumab Infusion in Cycles 1, 2, and 4 and 48 h or 72 h, 144 h, 240 h or 264 h and 336 h Post-dose in Cycles 1 and 4 (28-day Cycles)', 'description': 'CL is the volume of serum cleared of Olaratumab per unit of time after a single dose of Olaratumab'}, {'measure': 'Apparent Volume of Distribution (Vss) of Olaratumab', 'timeFrame': 'Prior to and 1 h after Olaratumab Infusion in Cycles 1, 2, and 4 and 48 h or 72 h, 144 h, 240 h or 264 h and 336 h Post-dose in Cycles 1 and 4 (28-day Cycles)', 'description': 'Vss is an estimate of drug distribution independent of the elimination process and is proportional to the amount of drug in the body versus the drug plasma concentration at steady-state.'}, {'measure': 'PFS for Participants Who Had Tissue Samples for Platelet Derived Growth Factor Receptor Alpha (PDGFRα) Expression Determined by Immunohistochemistry (IHC) (Association Between PDGFRα Tumor Expression and PFS)', 'timeFrame': 'Randomization to PD or Date of Death (Up to 130 Weeks)', 'description': 'PFS is defined as the time from the day of randomization to the first evidence of progression as defined by RECIST v1.0 criteria or death from any cause. PD is a 20% increase over the smallest sum of target lesions or new lesions. Participants who died without a prior disease 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 last tumor assessment. PDGFRα protein expression at baseline in tumor cells is determined by IHC using H-Scores and a cut point of 0. Participants were considered to have a high relative expression when H-Score is \\>0 and a low relative expression when H-Score=0. H-Score was calculated by summing the percentage of cell staining at each intensity multiplied by the weighted intensity of staining. Staining intensity: 0 (no staining), 1+ (weak staining), 2+ (medium staining), 3+ (strongest staining). H-Scores could range from 0-300.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Liposomal Doxorubicin', 'IMC-3G3', '3G3', 'Platinum resistant', 'Platinum refractory', 'Ovary', 'Neoplasm', 'PDGFr'], 'conditions': ['Ovarian Neoplasms']}, 'referencesModule': {'references': [{'pmid': '37185961', 'type': 'DERIVED', 'citation': 'Gaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3.'}, {'pmid': '30591028', 'type': 'DERIVED', 'citation': 'McGuire WP, Penson RT, Gore M, Herraez AC, Peterson P, Shahir A, Ilaria R Jr. Randomized phase II study of the PDGFRalpha antibody olaratumab plus liposomal doxorubicin versus liposomal doxorubicin alone in patients with platinum-refractory or platinum-resistant advanced ovarian cancer. BMC Cancer. 2018 Dec 27;18(1):1292. doi: 10.1186/s12885-018-5198-4.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if participants with platinum-refractory or platinum-resistant advanced ovarian cancer have a better outcome when treated with Olaratumab (IMC-3G3) in combination with Liposomal Doxorubicin than when treated with Liposomal Doxorubicin alone.', 'detailedDescription': 'The primary objective of this study is to evaluate the progression-free survival (PFS) in participants with platinum-refractory or platinum-resistant advanced ovarian cancer when treated with the monoclonal antibody Olaratumab in combination with liposomal doxorubicin versus liposomal doxorubicin alone.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The participant has histologically or cytologically confirmed epithelial ovarian cancer, primary peritoneal carcinoma, fallopian tube cancer, or ovarian clear cell carcinoma\n* The participant must have at least one of the following: a platinum-free interval of ≤12 months after the final dose of primary or subsequent platinum-based therapy (platinum-resistant), progression during primary or subsequent platinum-based therapy (platinum-refractory), or persistent radiographic disease after primary or subsequent platinum-based therapy (platinum-refractory)\n* The participant has a pre-study echocardiogram or multigated acquisition (MUGA) scan with an actual left ventricular ejection fraction (LVEF) ≥50%, within 21 days prior to randomization\n* The participant has at least one unidimensionally measurable target lesion \\[≥20 millimeters (mm) with conventional techniques, or ≥10 mm by spiral computed tomography (CT) or magnetic resonance imaging (MRI)\\], as defined by Response Evaluation Criteria in Solid Tumors, Version 1.0 (RECIST v1.0) guidelines. 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\n* The participant has recovered to Grade ≤1 by the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 3.0 (NCI-CTCAE v3.0) from the effects of recent surgery, radiotherapy, chemotherapy, hormonal therapy, or other targeted therapies for ovarian cancer, with the exception of alopecia or peripheral neuropathy (which must have resolved to ≤Grade 2). The exceptions for such effects are allowed lab values of ≤Grade 2 specified elsewhere in these inclusion criteria\n* The participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status score of ≤1 at study entry\n* The participant has the ability to understand and the willingness to sign a written informed consent\n* The participant has adequate hematological functions \\[absolute neutrophil count (ANC) ≥1200 cells/microliter (cells/μL), hemoglobin ≥9 grams/deciliter (g/dL), and platelets ≥100,000 cells/μL\\]\n* The participant has adequate hepatic function as defined by total bilirubin ≤1.5 × the upper limit of normal (ULN), and aspartate transaminase (AST) and alanine transaminase (ALT) ≤3 × the ULN (or ≤5 × the ULN in the presence of known liver metastases)\n* The participant has adequate renal function as defined by serum creatinine ≤1.5 × the institutional ULN. If creatinine is above the ULN, the participant\'s creatinine clearance is ≥60 milliliters/minute (mL/min)\n* 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 \\<1000 milligrams (mg) of protein to allow participation\n* The participant must have adequate coagulation function as defined by International Normalized Ratio (INR) ≤1.5 and a partial thromboplastin time (PTT) ≤5seconds above ULN. Participants on anticoagulation must be on a stable dose of anticoagulant with a therapeutic INR and no active bleeding within 14 days prior to randomization, or on low molecular weight heparin AND have no pathological condition carrying a high risk of bleeding. Mild elevations of PTT of up to 1.5 × the ULN are acceptable, provided that, in the opinion of the investigator, they are related to ongoing use of coumarins \\[for example (e.g.), warfarin\\]\n* The participant has a pre-study echocardiogram or MUGA scan with an actual LVEF ≥50%, within 21 days prior to randomization\n* Women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to randomization and for the duration of study participation\n\nExclusion Criteria:\n\n* The participant has brain metastases or leptomeningeal disease\n* The participant received more than one biologic and/or more than one hormonal therapy, administered either concomitantly with platinum-based therapy or separately\n* The participant has a history of treatment with other agents targeting platelet derived growth factor (PDGF) or PDGF receptor (PDGFR)\n* The participant has an increased level of cancer antigen-125 (CA-125) in the absence of concomitant clinical or radiographic progression\n* The participant has received radiotherapy, chemotherapy, or biologic therapy directed at the malignant tumor within 3 weeks prior to randomization, or hormonal therapy directed at the malignant tumor within 1 week prior to randomization. Continuation of hormone replacement therapy is permitted\n* The participant has a suspected impending bowel obstruction (including partial obstruction), based on clinical or radiographic data\n* The participant has a history of allergic reactions attributed to compounds of chemical or biologic composition similar to that of IMC-3G3\n* The participant has an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring parenteral antibiotics, symptomatic congestive heart failure,uncontrolled hypertension, clinically significant cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements\n* 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; or c) other primary solid tumor treated with curative intent and no known active disease present and no treatment administered during the last 3 years prior to randomization\n* The participant is pregnant or lactating\n* The participant has ongoing side effects ≥Grade 2 due to agents administered more than 28 days prior to randomization. The exceptions for such effects are allowed lab values and toxicities of ≤Grade 2, specified in the inclusion criteria\n* The participant has unstable angina pectoris, angioplasty, cardiac stenting, or myocardial infarction 6 months prior to randomization\n* The participant has participated in clinical trials of experimental agents within 28 days prior to randomization\n* The participant has a history of uncontrolled hereditary or acquired bleeding or thrombotic disorders\n* The participant has a serious or nonhealing active wound, ulcer, or bone fracture\n* The participant has known human immunodeficiency virus positivity\n* The participant had a major surgical procedure, an open biopsy, or significant traumatic injury within 28 days prior to randomization\n* The participant has received an anthracycline for any indication in the past'}, 'identificationModule': {'nctId': 'NCT00913835', 'briefTitle': 'A Study of Liposomal Doxorubicin With or Without Olaratumab (IMC-3G3) in Platinum-Refractory or Resistant Advanced Ovarian Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'Randomized Phase 2 Trial Investigating Liposomal Doxorubicin With or Without Anti-Platelet Derived Growth Factor Receptor-Alpha (PDGFRα) Monoclonal Antibody IMC-3G3 in Patients With Platinum-Refractory or Platinum-Resistant Advanced Ovarian Cancer', 'orgStudyIdInfo': {'id': '13899'}, 'secondaryIdInfos': [{'id': '2009-009035-30', 'type': 'EUDRACT_NUMBER'}, {'id': 'CP15-0802', 'type': 'OTHER', 'domain': 'ImClone Systems'}, {'id': 'I5B-IE-JGDA', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Olaratumab and Liposomal Doxorubicin', 'description': 'Olaratumab and Liposomal Doxorubicin', 'interventionNames': ['Biological: Olaratumab', 'Drug: liposomal doxorubicin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Liposomal Doxorubicin: Optional Olaratumab Monotherapy', 'description': 'Liposomal Doxorubicin Monotherapy until disease progression. Upon disease progression the participant had the option to receive Olaratumab monotherapy.', 'interventionNames': ['Biological: Olaratumab', 'Drug: liposomal doxorubicin']}], 'interventions': [{'name': 'Olaratumab', 'type': 'BIOLOGICAL', 'otherNames': ['LY3012207', 'IMC-3G3'], 'description': '20 milligrams per kilogram (mg/kg) administered by intervenous (IV) infusion every 2 weeks (14 days). Treatment will continue until there is evidence of progressive disease (PD) or development of unacceptable toxicity', 'armGroupLabels': ['Liposomal Doxorubicin: Optional Olaratumab Monotherapy', 'Olaratumab and Liposomal Doxorubicin']}, {'name': 'liposomal doxorubicin', 'type': 'DRUG', 'description': "40 milligrams per square meter (mg/m²) administered according to the manufacture's instructions every 4 weeks (28 days). Treatment will continue until there is evidence of PD or development of unacceptable toxicity", 'armGroupLabels': ['Liposomal Doxorubicin: Optional Olaratumab Monotherapy', 'Olaratumab and Liposomal Doxorubicin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60435', 'city': 'Joliet', 'state': 'Illinois', 'country': 'United States', 'facility': 'ImClone Investigational Site', 'geoPoint': {'lat': 41.52519, 'lon': -88.0834}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'ImClone Investigational Site', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '21237', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'ImClone Investigational Site', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02114-2621', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'ImClone Investigational Site', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'ImClone Investigational Site', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '28204', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'ImClone Investigational Site', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}], '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'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.', 'ipdSharing': 'YES', 'description': 'Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.', 'accessCriteria': 'A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}