Ignite Creation Date:
2025-12-24 @ 5:19 PM
Ignite Modification Date:
2026-01-24 @ 5:39 PM
Study NCT ID:
NCT02289950
Status:
COMPLETED
Last Update Posted:
2021-09-02
First Post:
2014-11-10
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Assess the Efficacy and Safety of Farletuzumab (MORAb 003) in Combination With Carboplatin Plus Paclitaxel or Carboplatin Plus Pegylated Liposomal Doxorubicin (PLD) in Participants With Low CA125 Platinum-sensitive Ovarian Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C527484', 'term': 'farletuzumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'esi_oncmedinfo@eisai.com', 'phone': '888-274-2378', 'title': 'Eisai Medical Information', 'phoneExt': '+1', 'organization': 'Eisai Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)', 'description': 'Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.', 'eventGroups': [{'id': 'EG000', 'title': 'Farletuzumab 5 mg/kg + Carboplatin/Paclitaxel or Carboplatin/PLD', 'description': "Participants received either carboplatin (area under the concentration-time curve \\[AUC\\] 5) plus paclitaxel 175 milligrams per square meter (mg/m\\^2) intravenously (IV) every 3 weeks or carboplatin (AUC 5) plus pegylated liposomal doxorubicin (PLD) 30 mg/m\\^2 IV every 4 weeks in combination with farletuzumab loading dose of 10 milligram per kilogram (mg/kg) for the first 2 weeks, followed by 5 mg/kg every week thereafter administered up to maximum of 8 cycles at the investigator's discretion. Participants who completed combination treatment phase and participants who experienced intolerable toxicity to chemotherapy in combination treatment phase continued to receive maintenance treatment with farletuzumab 5 mg/kg every week alone up to maximum of 64 cycles or until disease progression was confirmed by radiographic assessment, or participant discontinued treatment for any other reason.", 'otherNumAtRisk': 141, 'deathsNumAtRisk': 141, 'otherNumAffected': 140, 'seriousNumAtRisk': 141, 'deathsNumAffected': 1, 'seriousNumAffected': 42}, {'id': 'EG001', 'title': 'Placebo + Carboplatin/Paclitaxel or Carboplatin/PLD', 'description': "Participants received either carboplatin (AUC 5) plus paclitaxel 175 mg/ m\\^2 IV every 3 weeks or carboplatin (AUC 5) plus PLD 30 mg/ m\\^2 IV every 4 weeks in combination with placebo loading dose of 10 mg/kg for the first 2 weeks, followed by 5 mg/kg every week thereafter administered up to maximum of 8 cycles at the investigator's discretion. Participants who completed combination treatment phase and participants who experienced intolerable toxicity to chemotherapy in combination treatment phase continued to receive maintenance treatment with placebo 5 mg/kg every week alone up to maximum of 64 cycles or until disease progression was confirmed by radiographic assessment, or subject discontinued treatment for any other reason.", 'otherNumAtRisk': 70, 'deathsNumAtRisk': 70, 'otherNumAffected': 70, 'seriousNumAtRisk': 70, 'deathsNumAffected': 2, 'seriousNumAffected': 18}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 208, 'numAffected': 76}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 121, 'numAffected': 36}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 225, 'numAffected': 55}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 82, 'numAffected': 24}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 74, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 20, 'numAffected': 7}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 109, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 86, 'numAffected': 19}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 14, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 11, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 12, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 65, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 34, 'numAffected': 22}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 19, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 17, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 93, 'numAffected': 58}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 53, 'numAffected': 31}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 83, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 63, 'numAffected': 27}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 15, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 14, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 18, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 187, 'numAffected': 95}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 110, 'numAffected': 45}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 66, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 51, 'numAffected': 24}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 74, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 56, 'numAffected': 27}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 9, 'numAffected': 6}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 90, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 42, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 9, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 112, 'numAffected': 69}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 55, 'numAffected': 35}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 14, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 11, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 21, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 19, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Peripheral swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 37, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 16, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Drug hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 9, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 12, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 9, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 34, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 26, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 11, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 29, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 24, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 32, 'numAffected': 16}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 10, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 16, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 165, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 90, 'numAffected': 18}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 83, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 46, 'numAffected': 11}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 127, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 68, 'numAffected': 14}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 43, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 32, 'numAffected': 18}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 21, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 18, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Hypertriglyceridaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 12, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 49, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 9, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 33, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 11, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 52, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 27, 'numAffected': 15}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 24, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 24, 'numAffected': 18}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 10, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 7, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Flank pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 17, 'numAffected': 11}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 15, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 19, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 13, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 22, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 18, 'numAffected': 12}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 40, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 19, 'numAffected': 13}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 22, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 17, 'numAffected': 12}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 77, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 61, 'numAffected': 27}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 14, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 13, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 31, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 21, 'numAffected': 14}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 18, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 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1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Metastases to meninges', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Depressed level of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Hemiparesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Restrictive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Petechiae', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Pulmonary sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Farletuzumab 5 mg/kg + Carboplatin/Paclitaxel or Carboplatin/PLD', 'description': "Participants received either carboplatin (area under the concentration-time curve \\[AUC\\] 5) plus paclitaxel 175 milligrams per square meter (mg/m\\^2) intravenously (IV) every 3 weeks or carboplatin (AUC 5) plus pegylated liposomal doxorubicin (PLD) 30 mg/m\\^2 IV every 4 weeks in combination with farletuzumab loading dose of 10 milligram per kilogram (mg/kg) for the first 2 weeks, followed by 5 mg/kg every week thereafter administered up to maximum of 8 cycles at the investigator's discretion. Participants who completed combination treatment phase and participants who experienced intolerable toxicity to chemotherapy in combination treatment phase continued to receive maintenance treatment with farletuzumab 5 mg/kg every week alone up to maximum of 64 cycles or until disease progression was confirmed by radiographic assessment, or participant discontinued treatment for any other reason."}, {'id': 'OG001', 'title': 'Placebo + Carboplatin/Paclitaxel or Carboplatin/PLD', 'description': "Participants received either carboplatin (AUC 5) plus paclitaxel 175 mg/ m\\^2 IV every 3 weeks or carboplatin (AUC 5) plus PLD 30 mg/ m\\^2 IV every 4 weeks in combination with placebo loading dose of 10 mg/kg for the first 2 weeks, followed by 5 mg/kg every week thereafter administered up to maximum of 8 cycles at the investigator's discretion. Participants who completed combination treatment phase and participants who experienced intolerable toxicity to chemotherapy in combination treatment phase continued to receive maintenance treatment with placebo 5 mg/kg every week alone up to maximum of 64 cycles or until disease progression was confirmed by radiographic assessment, or subject discontinued treatment for any other reason."}], 'classes': [{'categories': [{'measurements': [{'value': '11.73', 'groupId': 'OG000', 'lowerLimit': '10.22', 'upperLimit': '13.60'}, {'value': '10.78', 'groupId': 'OG001', 'lowerLimit': '9.49', 'upperLimit': '13.17'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the date of randomization to the date of first documentation of PD, or date of death, whichever occurs first up to approximately 5 years 5 months', 'description': "PFS was defined as the time (in months) from the date of randomization of a participant to the date of first observation of progression or date of death, whatever the cause. PFS was assessed based on the investigators' assessments utilizing Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. Disease progression (PD) was defined as at least a 20 percent (%) increase or 5 millimeter (mm) increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) recorded since the treatment started or the appearance of 1 or more new lesions. PFS was estimated and analyzed using Kaplan-Meier method.", 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT Population (Full Analysis Set) included all randomized participants according to the assigned treatment by IRT system.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Farletuzumab 5 mg/kg + Carboplatin/Paclitaxel or Carboplatin/PLD', 'description': "Participants received either carboplatin (area under the concentration-time curve \\[AUC\\] 5) plus paclitaxel 175 milligrams per square meter (mg/m\\^2) intravenously (IV) every 3 weeks or carboplatin (AUC 5) plus pegylated liposomal doxorubicin (PLD) 30 mg/m\\^2 IV every 4 weeks in combination with farletuzumab loading dose of 10 milligram per kilogram (mg/kg) for the first 2 weeks, followed by 5 mg/kg every week thereafter administered up to maximum of 8 cycles at the investigator's discretion. Participants who completed combination treatment phase and participants who experienced intolerable toxicity to chemotherapy in combination treatment phase continued to receive maintenance treatment with farletuzumab 5 mg/kg every week alone up to maximum of 64 cycles or until disease progression was confirmed by radiographic assessment, or participant discontinued treatment for any other reason."}, {'id': 'OG001', 'title': 'Placebo + Carboplatin/Paclitaxel or Carboplatin/PLD', 'description': "Participants received either carboplatin (AUC 5) plus paclitaxel 175 mg/ m\\^2 IV every 3 weeks or carboplatin (AUC 5) plus PLD 30 mg/ m\\^2 IV every 4 weeks in combination with placebo loading dose of 10 mg/kg for the first 2 weeks, followed by 5 mg/kg every week thereafter administered up to maximum of 8 cycles at the investigator's discretion. Participants who completed combination treatment phase and participants who experienced intolerable toxicity to chemotherapy in combination treatment phase continued to receive maintenance treatment with placebo 5 mg/kg every week alone up to maximum of 64 cycles or until disease progression was confirmed by radiographic assessment, or subject discontinued treatment for any other reason."}], 'classes': [{'categories': [{'measurements': [{'value': '43.07', 'comment': 'Here, NA means that the upper limit of 95% confidence interval (CI) was not estimable due to insufficient number of events.', 'groupId': 'OG000', 'lowerLimit': '37.13', 'upperLimit': 'NA'}, {'value': '42.45', 'comment': 'Here, NA means that the upper limit of 95% confidence interval (CI) was not estimable due to insufficient number of events.', 'groupId': 'OG001', 'lowerLimit': '37.85', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the date of randomization until the date of death (up to approximately 5 years 5 months)', 'description': 'OS was defined as the time from the date of randomization until the date of death. Participants were censored at the date of last known to be alive. OS was analyzed using Kaplan-Meier method.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT Population (Full Analysis Set) included all randomized participants according to the assigned treatment by IRT system.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Best Overall Response (BOR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Farletuzumab 5 mg/kg + Carboplatin/Paclitaxel or Carboplatin/PLD', 'description': "Participants received either carboplatin (area under the concentration-time curve \\[AUC\\] 5) plus paclitaxel 175 milligrams per square meter (mg/m\\^2) intravenously (IV) every 3 weeks or carboplatin (AUC 5) plus pegylated liposomal doxorubicin (PLD) 30 mg/m\\^2 IV every 4 weeks in combination with farletuzumab loading dose of 10 milligram per kilogram (mg/kg) for the first 2 weeks, followed by 5 mg/kg every week thereafter administered up to maximum of 8 cycles at the investigator's discretion. Participants who completed combination treatment phase and participants who experienced intolerable toxicity to chemotherapy in combination treatment phase continued to receive maintenance treatment with farletuzumab 5 mg/kg every week alone up to maximum of 64 cycles or until disease progression was confirmed by radiographic assessment, or participant discontinued treatment for any other reason."}, {'id': 'OG001', 'title': 'Placebo + Carboplatin/Paclitaxel or Carboplatin/PLD', 'description': "Participants received either carboplatin (AUC 5) plus paclitaxel 175 mg/ m\\^2 IV every 3 weeks or carboplatin (AUC 5) plus PLD 30 mg/ m\\^2 IV every 4 weeks in combination with placebo loading dose of 10 mg/kg for the first 2 weeks, followed by 5 mg/kg every week thereafter administered up to maximum of 8 cycles at the investigator's discretion. Participants who completed combination treatment phase and participants who experienced intolerable toxicity to chemotherapy in combination treatment phase continued to receive maintenance treatment with placebo 5 mg/kg every week alone up to maximum of 64 cycles or until disease progression was confirmed by radiographic assessment, or subject discontinued treatment for any other reason."}], 'classes': [{'title': 'Complete Response', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Partial Response', 'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}, {'title': 'Stable Disease', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of study drug (Baseline) up to approximately 5 years 5 months', 'description': 'BOR was defined as the best response of complete response (CR) or partial response (PR) or stable disease (SD) for greater than or equal to(\\>=)6 months recorded from the start of the treatment until PD or death, whichever occurred first based on investigator assessment per RECIST v1.1. CR:disappearance of all target and non-target lesions. All pathological (whether target or non-target) must have a reduction in their short axis less than(\\<)10 mm. PR:at least a 30% decrease in the sum of diameter (SOD) of target lesions, taking as reference the baseline sum diameters. SD:neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SOD. PD was defined as at least 20% increase (including an absolute increase of at least 5mm) in the SOD of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Tumor Response Evaluable Analysis Set included all randomized participants who received at least 1 dose of study drug and who had a baseline and at least 1 on treatment tumor assessment performed.'}, {'type': 'SECONDARY', 'title': 'Time to Tumor Response (TTR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Farletuzumab 5 mg/kg + Carboplatin/Paclitaxel or Carboplatin/PLD', 'description': "Participants received either carboplatin (area under the concentration-time curve \\[AUC\\] 5) plus paclitaxel 175 milligrams per square meter (mg/m\\^2) intravenously (IV) every 3 weeks or carboplatin (AUC 5) plus pegylated liposomal doxorubicin (PLD) 30 mg/m\\^2 IV every 4 weeks in combination with farletuzumab loading dose of 10 milligram per kilogram (mg/kg) for the first 2 weeks, followed by 5 mg/kg every week thereafter administered up to maximum of 8 cycles at the investigator's discretion. Participants who completed combination treatment phase and participants who experienced intolerable toxicity to chemotherapy in combination treatment phase continued to receive maintenance treatment with farletuzumab 5 mg/kg every week alone up to maximum of 64 cycles or until disease progression was confirmed by radiographic assessment, or participant discontinued treatment for any other reason."}, {'id': 'OG001', 'title': 'Placebo + Carboplatin/Paclitaxel or Carboplatin/PLD', 'description': "Participants received either carboplatin (AUC 5) plus paclitaxel 175 mg/ m\\^2 IV every 3 weeks or carboplatin (AUC 5) plus PLD 30 mg/ m\\^2 IV every 4 weeks in combination with placebo loading dose of 10 mg/kg for the first 2 weeks, followed by 5 mg/kg every week thereafter administered up to maximum of 8 cycles at the investigator's discretion. Participants who completed combination treatment phase and participants who experienced intolerable toxicity to chemotherapy in combination treatment phase continued to receive maintenance treatment with placebo 5 mg/kg every week alone up to maximum of 64 cycles or until disease progression was confirmed by radiographic assessment, or subject discontinued treatment for any other reason."}], 'classes': [{'categories': [{'measurements': [{'value': '2.69', 'groupId': 'OG000', 'lowerLimit': '1.74', 'upperLimit': '2.83'}, {'value': '2.53', 'groupId': 'OG001', 'lowerLimit': '1.48', 'upperLimit': '2.69'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the date of randomization until date of first observation of response (CR or PR) up to approximately 5 years 5 months', 'description': 'TTR was defined as the time (in months) from the date of randomization to the date of first observation of response (PR or CR) (whichever status was recorded first). TTR was assessed based on investigator assessment utilizing RECIST 1.1. CR: disappearance of all target and non-target lesions. All pathological (whether target or non-target) must have a reduction in their short axis \\<10 mm. PR: at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Tumor Response Evaluable Analysis Set included all randomized participants who received at least 1 dose of study drug and who had a baseline and at least 1 on treatment tumor assessment performed. Here "overall number of participants analyzed" signifies participants who had CR or PR.'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DOR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Farletuzumab 5 mg/kg + Carboplatin/Paclitaxel or Carboplatin/PLD', 'description': "Participants received either carboplatin (area under the concentration-time curve \\[AUC\\] 5) plus paclitaxel 175 milligrams per square meter (mg/m\\^2) intravenously (IV) every 3 weeks or carboplatin (AUC 5) plus pegylated liposomal doxorubicin (PLD) 30 mg/m\\^2 IV every 4 weeks in combination with farletuzumab loading dose of 10 milligram per kilogram (mg/kg) for the first 2 weeks, followed by 5 mg/kg every week thereafter administered up to maximum of 8 cycles at the investigator's discretion. Participants who completed combination treatment phase and participants who experienced intolerable toxicity to chemotherapy in combination treatment phase continued to receive maintenance treatment with farletuzumab 5 mg/kg every week alone up to maximum of 64 cycles or until disease progression was confirmed by radiographic assessment, or participant discontinued treatment for any other reason."}, {'id': 'OG001', 'title': 'Placebo + Carboplatin/Paclitaxel or Carboplatin/PLD', 'description': "Participants received either carboplatin (AUC 5) plus paclitaxel 175 mg/ m\\^2 IV every 3 weeks or carboplatin (AUC 5) plus PLD 30 mg/ m\\^2 IV every 4 weeks in combination with placebo loading dose of 10 mg/kg for the first 2 weeks, followed by 5 mg/kg every week thereafter administered up to maximum of 8 cycles at the investigator's discretion. Participants who completed combination treatment phase and participants who experienced intolerable toxicity to chemotherapy in combination treatment phase continued to receive maintenance treatment with placebo 5 mg/kg every week alone up to maximum of 64 cycles or until disease progression was confirmed by radiographic assessment, or subject discontinued treatment for any other reason."}], 'classes': [{'categories': [{'measurements': [{'value': '10.12', 'groupId': 'OG000', 'lowerLimit': '8.54', 'upperLimit': '11.47'}, {'value': '8.51', 'groupId': 'OG001', 'lowerLimit': '6.31', 'upperLimit': '10.97'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From date of the first observation of CR or PR until the date of first observation of progression or date of death up to approximately 5 years 5 months', 'description': "DOR was defined as the time (in months) from the date of first observation of response (PR or CR) to the date of the first observation of progression based on the investigator's assessment utilizing RECIST 1.1, or date of death, whatever the cause. CR: disappearance of all target and non-target lesions. All pathological (whether target or non-target) must have a reduction in their short axis \\<10 mm. PR: at least a 30 % decrease in the SOD of target lesions, taking as reference the baseline sum diameters. PD was defined as at least 20% increase (including an absolute increase of at least 5 mm) in the SOD of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.", 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Tumor Response Evaluable Analysis Set included all randomized participants who received at least 1 dose of study drug and who had a baseline and at least 1 on treatment tumor assessment performed. Here "overall number of participants analyzed" signifies participants who had CR or PR.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Each Second Platinum-Free Interval Stratified by First Platinum-Free Interval', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Farletuzumab 5 mg/kg + Carboplatin/Paclitaxel or Carboplatin/PLD', 'description': "Participants received either carboplatin (area under the concentration-time curve \\[AUC\\] 5) plus paclitaxel 175 milligrams per square meter (mg/m\\^2) intravenously (IV) every 3 weeks or carboplatin (AUC 5) plus pegylated liposomal doxorubicin (PLD) 30 mg/m\\^2 IV every 4 weeks in combination with farletuzumab loading dose of 10 milligram per kilogram (mg/kg) for the first 2 weeks, followed by 5 mg/kg every week thereafter administered up to maximum of 8 cycles at the investigator's discretion. Participants who completed combination treatment phase and participants who experienced intolerable toxicity to chemotherapy in combination treatment phase continued to receive maintenance treatment with farletuzumab 5 mg/kg every week alone up to maximum of 64 cycles or until disease progression was confirmed by radiographic assessment, or participant discontinued treatment for any other reason."}, {'id': 'OG001', 'title': 'Placebo + Carboplatin/Paclitaxel or Carboplatin/PLD', 'description': "Participants received either carboplatin (AUC 5) plus paclitaxel 175 mg/ m\\^2 IV every 3 weeks or carboplatin (AUC 5) plus PLD 30 mg/ m\\^2 IV every 4 weeks in combination with placebo loading dose of 10 mg/kg for the first 2 weeks, followed by 5 mg/kg every week thereafter administered up to maximum of 8 cycles at the investigator's discretion. Participants who completed combination treatment phase and participants who experienced intolerable toxicity to chemotherapy in combination treatment phase continued to receive maintenance treatment with placebo 5 mg/kg every week alone up to maximum of 64 cycles or until disease progression was confirmed by radiographic assessment, or subject discontinued treatment for any other reason."}], 'classes': [{'title': 'Second platinum free interval (<6 months): First platinum free interval (6 to 12 months)', 'categories': [{'measurements': [{'value': '71.2', 'groupId': 'OG000', 'lowerLimit': '57.92', 'upperLimit': '82.24'}, {'value': '63.3', 'groupId': 'OG001', 'lowerLimit': '43.86', 'upperLimit': '80.07'}]}]}, {'title': 'Second platinum free interval (6-12 months): First platinum free interval (6 to 12 months)', 'categories': [{'measurements': [{'value': '6.8', 'groupId': 'OG000', 'lowerLimit': '1.88', 'upperLimit': '16.46'}, {'value': '23.3', 'groupId': 'OG001', 'lowerLimit': '9.93', 'upperLimit': '42.28'}]}]}, {'title': 'Second platinum free interval (>12-36 months): First platinum free interval (6 to 12 months)', 'categories': [{'measurements': [{'value': '16.9', 'groupId': 'OG000', 'lowerLimit': '8.44', 'upperLimit': '28.97'}, {'value': '10.0', 'groupId': 'OG001', 'lowerLimit': '2.11', 'upperLimit': '26.53'}]}]}, {'title': 'Second platinum free interval (>36 months): First platinum free interval (6 to 12 months)', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '6.06'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '11.57'}]}]}, {'title': 'Second platinum free interval (<6 months): First platinum free interval (>12 to 36 months)', 'categories': [{'measurements': [{'value': '42.2', 'groupId': 'OG000', 'lowerLimit': '31.40', 'upperLimit': '53.51'}, {'value': '52.4', 'groupId': 'OG001', 'lowerLimit': '36.42', 'upperLimit': '68.00'}]}]}, {'title': 'Second platinum free interval (6-12 months): First platinum free interval (>12 to 36 months)', 'categories': [{'measurements': [{'value': '33.7', 'groupId': 'OG000', 'lowerLimit': '23.72', 'upperLimit': '44.95'}, {'value': '28.6', 'groupId': 'OG001', 'lowerLimit': '15.72', 'upperLimit': '44.58'}]}]}, {'title': 'Second platinum free interval (>12-36 months): First platinum free interval (>12 to 36 months)', 'categories': [{'measurements': [{'value': '20.5', 'groupId': 'OG000', 'lowerLimit': '12.41', 'upperLimit': '30.76'}, {'value': '16.7', 'groupId': 'OG001', 'lowerLimit': '6.97', 'upperLimit': '31.36'}]}]}, {'title': 'Second platinum free interval (>36 months): First platinum free interval (>12 to 36 months)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '4.35'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '8.41'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the date of randomization to the date of first relapse (or first observation of progression/death) up to approximately 5 year 5 months', 'description': 'Percentage of participants achieving each second platinum-free interval (\\<6 months, 6-12 months, greater than \\[\\>\\] 12-36 months, and \\>36 months) stratified by first platinum-free interval (6 to 12 months and \\>12 to 36 months) was reported. First platinum-free interval was defined as the date of completion of previous platinum-based chemotherapy until the date of first relapse (that is, first observation of progression). The date of first relapse was the progression date. Second platinum-free interval was defined as the date of completion of platinum-based chemotherapy (last dosing date) during the study until the date of progression or death (or censoring, if applicable).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT Population (Full Analysis Set) included all randomized participants according to the assigned treatment by IRT system.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Farletuzumab 5 mg/kg + Carboplatin/Paclitaxel or Carboplatin/PLD', 'description': "Participants received either carboplatin (area under the concentration-time curve \\[AUC\\] 5) plus paclitaxel 175 milligrams per square meter (mg/m\\^2) intravenously (IV) every 3 weeks or carboplatin (AUC 5) plus pegylated liposomal doxorubicin (PLD) 30 mg/m\\^2 IV every 4 weeks in combination with farletuzumab loading dose of 10 milligram per kilogram (mg/kg) for the first 2 weeks, followed by 5 mg/kg every week thereafter administered up to maximum of 8 cycles at the investigator's discretion. Participants who completed combination treatment phase and participants who experienced intolerable toxicity to chemotherapy in combination treatment phase continued to receive maintenance treatment with farletuzumab 5 mg/kg every week alone up to maximum of 64 cycles or until disease progression was confirmed by radiographic assessment, or participant discontinued treatment for any other reason."}, {'id': 'FG001', 'title': 'Placebo + Carboplatin/Paclitaxel or Carboplatin/PLD', 'description': "Participants received either carboplatin (AUC 5) plus paclitaxel 175 mg/ m\\^2 IV every 3 weeks or carboplatin (AUC 5) plus PLD 30 mg/ m\\^2 IV every 4 weeks in combination with placebo loading dose of 10 mg/kg for the first 2 weeks, followed by 5 mg/kg every week thereafter administered up to maximum of 8 cycles at the investigator's discretion. Participants who completed combination treatment phase and participants who experienced intolerable toxicity to chemotherapy in combination treatment phase continued to receive maintenance treatment with placebo 5 mg/kg every week alone up to maximum of 64 cycles or until disease progression was confirmed by radiographic assessment, or subject discontinued treatment for any other reason."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': '214', 'achievements': [{'groupId': 'FG000', 'numSubjects': '142'}, {'groupId': 'FG001', 'numSubjects': '72'}]}, {'type': 'Treated', 'achievements': [{'comment': '1 participant randomized to placebo group but was treated with farletuzumab, and was analyzed in the farletuzumab group in safety analysis set.', 'groupId': 'FG000', 'numSubjects': '140'}, {'groupId': 'FG001', 'numSubjects': '71'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '142'}, {'groupId': 'FG001', 'numSubjects': '72'}]}], 'dropWithdraws': [{'type': 'Progressive disease by RECIST 1.1', 'reasons': [{'groupId': 'FG000', 'numSubjects': '99'}, {'groupId': 'FG001', 'numSubjects': '52'}]}, {'type': 'Progressive disease by Clinical Assessment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Subject chose to discontinue therapy but will continue to survival follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Test article held for greater than 28 days', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Not Treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants took part in the study at 60 investigative sites in the United states, Belgium, Germany, Italy, Spain, United Kingdom and Japan from 19 March 2015 to 13 August 2020.', 'preAssignmentDetails': 'A total of 332 participants were screened, of which 118 were screen failures and 214 were randomized out of which 211 were treated. .'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '214', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Farletuzumab 5 mg/kg + Carboplatin/Paclitaxel or Carboplatin/PLD', 'description': "Participants received either carboplatin (area under the concentration-time curve \\[AUC\\] 5) plus paclitaxel 175 milligrams per square meter (mg/m\\^2) intravenously (IV) every 3 weeks or carboplatin (AUC 5) plus pegylated liposomal doxorubicin (PLD) 30 mg/m\\^2 IV every 4 weeks in combination with farletuzumab loading dose of 10 milligram per kilogram (mg/kg) for the first 2 weeks, followed by 5 mg/kg every week thereafter administered up to maximum of 8 cycles at the investigator's discretion. Participants who completed combination treatment phase and participants who experienced intolerable toxicity to chemotherapy in combination treatment phase continued to receive maintenance treatment with farletuzumab 5 mg/kg every week alone up to maximum of 64 cycles or until disease progression was confirmed by radiographic assessment, or participant discontinued treatment for any other reason."}, {'id': 'BG001', 'title': 'Placebo + Carboplatin/Paclitaxel or Carboplatin/PLD', 'description': "Participants received either carboplatin (AUC 5) plus paclitaxel 175 mg/ m\\^2 IV every 3 weeks or carboplatin (AUC 5) plus PLD 30 mg/ m\\^2 IV every 4 weeks in combination with placebo loading dose of 10 mg/kg for the first 2 weeks, followed by 5 mg/kg every week thereafter administered up to maximum of 8 cycles at the investigator's discretion. Participants who completed combination treatment phase and participants who experienced intolerable toxicity to chemotherapy in combination treatment phase continued to receive maintenance treatment with placebo 5 mg/kg every week alone up to maximum of 64 cycles or until disease progression was confirmed by radiographic assessment, or subject discontinued treatment for any other reason."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.0', 'spread': '10.74', 'groupId': 'BG000'}, {'value': '62.9', 'spread': '10.50', 'groupId': 'BG001'}, {'value': '62.3', 'spread': '10.64', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'categories': [{'title': 'Females', 'measurements': [{'value': '141', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '213', 'groupId': 'BG002'}]}, {'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '126', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '194', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', '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': '14', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '117', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '179', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The intent-to-treat (ITT) Population (the Full Analysis Set) included all randomized participants according to the assigned treatment by interactive response technology (IRT) system.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-11-06', 'size': 1585562, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-07-28T12:18', 'hasProtocol': True}, {'date': '2019-10-31', 'size': 1690454, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-07-28T12:19', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 332}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'dispFirstSubmitDate': '2020-05-27', 'completionDateStruct': {'date': '2020-08-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-09', 'studyFirstSubmitDate': '2014-11-10', 'dispFirstSubmitQcDate': '2020-05-27', 'resultsFirstSubmitDate': '2021-08-09', 'studyFirstSubmitQcDate': '2014-11-10', 'dispFirstPostDateStruct': {'date': '2020-05-29', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2021-09-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-08-09', 'studyFirstPostDateStruct': {'date': '2014-11-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-09-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression Free Survival (PFS)', 'timeFrame': 'From the date of randomization to the date of first documentation of PD, or date of death, whichever occurs first up to approximately 5 years 5 months', 'description': "PFS was defined as the time (in months) from the date of randomization of a participant to the date of first observation of progression or date of death, whatever the cause. PFS was assessed based on the investigators' assessments utilizing Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. Disease progression (PD) was defined as at least a 20 percent (%) increase or 5 millimeter (mm) increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) recorded since the treatment started or the appearance of 1 or more new lesions. PFS was estimated and analyzed using Kaplan-Meier method."}], 'secondaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': 'From the date of randomization until the date of death (up to approximately 5 years 5 months)', 'description': 'OS was defined as the time from the date of randomization until the date of death. Participants were censored at the date of last known to be alive. OS was analyzed using Kaplan-Meier method.'}, {'measure': 'Number of Participants With Best Overall Response (BOR)', 'timeFrame': 'From first dose of study drug (Baseline) up to approximately 5 years 5 months', 'description': 'BOR was defined as the best response of complete response (CR) or partial response (PR) or stable disease (SD) for greater than or equal to(\\>=)6 months recorded from the start of the treatment until PD or death, whichever occurred first based on investigator assessment per RECIST v1.1. CR:disappearance of all target and non-target lesions. All pathological (whether target or non-target) must have a reduction in their short axis less than(\\<)10 mm. PR:at least a 30% decrease in the sum of diameter (SOD) of target lesions, taking as reference the baseline sum diameters. SD:neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SOD. PD was defined as at least 20% increase (including an absolute increase of at least 5mm) in the SOD of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.'}, {'measure': 'Time to Tumor Response (TTR)', 'timeFrame': 'From the date of randomization until date of first observation of response (CR or PR) up to approximately 5 years 5 months', 'description': 'TTR was defined as the time (in months) from the date of randomization to the date of first observation of response (PR or CR) (whichever status was recorded first). TTR was assessed based on investigator assessment utilizing RECIST 1.1. CR: disappearance of all target and non-target lesions. All pathological (whether target or non-target) must have a reduction in their short axis \\<10 mm. PR: at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD.'}, {'measure': 'Duration of Response (DOR)', 'timeFrame': 'From date of the first observation of CR or PR until the date of first observation of progression or date of death up to approximately 5 years 5 months', 'description': "DOR was defined as the time (in months) from the date of first observation of response (PR or CR) to the date of the first observation of progression based on the investigator's assessment utilizing RECIST 1.1, or date of death, whatever the cause. CR: disappearance of all target and non-target lesions. All pathological (whether target or non-target) must have a reduction in their short axis \\<10 mm. PR: at least a 30 % decrease in the SOD of target lesions, taking as reference the baseline sum diameters. PD was defined as at least 20% increase (including an absolute increase of at least 5 mm) in the SOD of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions."}, {'measure': 'Percentage of Participants Achieving Each Second Platinum-Free Interval Stratified by First Platinum-Free Interval', 'timeFrame': 'From the date of randomization to the date of first relapse (or first observation of progression/death) up to approximately 5 year 5 months', 'description': 'Percentage of participants achieving each second platinum-free interval (\\<6 months, 6-12 months, greater than \\[\\>\\] 12-36 months, and \\>36 months) stratified by first platinum-free interval (6 to 12 months and \\>12 to 36 months) was reported. First platinum-free interval was defined as the date of completion of previous platinum-based chemotherapy until the date of first relapse (that is, first observation of progression). The date of first relapse was the progression date. Second platinum-free interval was defined as the date of completion of platinum-based chemotherapy (last dosing date) during the study until the date of progression or death (or censoring, if applicable).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ovarian Cancer in in first relapse', 'Platinum-Sensitive'], 'conditions': ['Platinum-Sensitive Ovarian Cancer in First Relapse']}, 'referencesModule': {'references': [{'pmid': '36758420', 'type': 'DERIVED', 'citation': 'Herzog TJ, Pignata S, Ghamande SA, Rubio MJ, Fujiwara K, Vulsteke C, Armstrong DK, Sehouli J, Coleman RL, Gabra H, Scambia G, Monk BJ, Arranz JA, Ushijima K, Hanna R, Zamagni C, Wenham RM, Gonzalez-Martin A, Slomovitz B, Jia Y, Ramsay L, Tewari KS, Weil SC, Vergote IB. Randomized phase II trial of farletuzumab plus chemotherapy versus placebo plus chemotherapy in low CA-125 platinum-sensitive ovarian cancer. Gynecol Oncol. 2023 Mar;170:300-308. doi: 10.1016/j.ygyno.2023.01.003. Epub 2023 Feb 7.'}]}, 'descriptionModule': {'briefSummary': 'MORAb-003-011 is a global, multicenter, double-blind, randomized placebo-controlled study to assess the safety and efficacy of farletuzumab in combination with standard chemotherapy in subjects with low cancer antigen 125 (CA125) platinum-sensitive ovarian cancer in first relapse.', 'detailedDescription': "Participants will be enrolled into 1 of 2 chemotherapy treatment arms at the investigator's discretion: carboplatin plus paclitaxel or carboplatin plus Pegylated Liposomal Doxorubicin (PLD), and then randomized in a 2:1 ratio to receive weekly farletuzumab 5 mg/kg or placebo (ie, Test Article). All participants will receive a loading dose for the first 2 weeks of 10 mg/kg Test Article (farletuzumab or placebo). Participants will be stratified at randomization by individual chemotherapy treatment regimen (targeted 1:1 ratio) and platinum-free interval following first-line therapy (6 to 12 months vs greater than 12 to 36 months)."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Female subjects who are at least 18 years of age at the time of informed consent\n2. CA125 less than or equal to 3 x upper limit of normal (ULN) \\[105 units per millilitre (U/mL)\\] confirmed within 2 weeks of randomization using a centralized laboratory assay\n3. A histologically confirmed diagnosis of high-grade serous epithelial ovarian cancer including primary peritoneal and fallopian tube malignancies; all other histologies, including mixed histology, are excluded\n4. Have been treated with debulking surgery and a first-line platinum-based chemotherapy regimen\n5. Maintenance therapy during the first platinum-free interval is allowed; however, the last dose must have been at least 21 days prior to Randomization.\n6. Must be in a first relapse and have evaluable disease by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) scan, according to RECIST 1.1 (subjects with measurable disease per RECIST 1.1 or radiographically visible and evaluable disease). Subjects with only ascites or pleural effusion are excluded.\n7. Must have relapsed radiographically between 6 months and 36 months of completion of first-line platinum chemotherapy\n8. Must be a candidate for treatment with either carboplatin plus paclitaxel or carboplatin plus PLD with no medical contraindications present as outlined in the product labels for the selected regimen to be used in this study\n9. Have a life expectancy of at least 6 months, as estimated by the investigator\n10. Other significant medical conditions must be well-controlled and stable in the opinion of the investigator for at least 30 days prior to Randomization\n11. Have an Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2\n12. Subjects being enrolled to receive paclitaxel plus carboplatin treatment must have neuropathic function (sensory and motor less than or equal to Grade 2 according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) v4.03 (2010)\n13. Laboratory results within the 2 weeks prior to Randomization must be as follows:\n\n * Absolute neutrophil count (ANC) greater than or equal to 1.5 x 10\\^9/L\n * Platelet count greater than or equal to 100 x 10\\^9/L\n * Hemoglobin greater than or equal to 9 g/dL\n * Creatinine less than 1.5 x ULN (CTCAE Grade 1)\n * Bilirubin less than 1.5 x ULN (CTCAE Grade 1)\n * Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) less than 3 x ULN\n * Alkaline Phosphatase less than 2.5 x ULN (CTCAE Grade 1)\n * Baseline albumin greater than or equal to Lower Limit of Normal\n14. Subjects of childbearing potential must be surgically sterile or consent to use a medically acceptable method of contraception throughout the study period. All females will be considered to be of childbearing potential unless they are postmenopausal (eg, amenorrheic for at least 12 consecutive months, in the appropriate age group, and without other known or suspected cause) or have been sterilized surgically (ie, bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing). If a patient of childbearing potential is neither surgically sterile nor postmenopausal, a highly-effective contraceptive method (ie, a method that can achieve a failure rate of less than 1 percent (%) per year when used consistently and correctly) must start either before or at Screening and continue throughout the entire study period and for 6 months after the last dose of Test Article is administered. Pregnant and/or lactating females are excluded\n\nExclusion Criteria:\n\n1. Known central nervous system (CNS) tumor involvement\n2. Evidence of other active invasive malignancy requiring treatment other than surgery in the past 3 years\n3. Clinically significant heart disease (eg, congestive heart failure of New York Heart Association Class 3 or 4 angina, not well controlled by medication, or myocardial infarction within 6 months)\n4. Electrocardiogram (ECG) demonstrating clinically significant arrhythmias that are not adequately medically managed (Note: subjects with chronic atrial arrhythmia, ie, atrial fibrillation or paroxysmal supraventricular tachycardia \\[SVT\\], are eligible)\n5. Active serious systemic disease, including active bacterial or fungal infection\n6. Active viral hepatitis or active human immunodeficiency virus (HIV) infection. Asymptomatic positive serology is not exclusionary.\n7. Other concurrent immunotherapy (eg, immunosuppressants or chronic use of systemic corticosteroids, with the exception that low-dose corticosteroids \\[50 mg/day prednisone or equivalent corticosteroid\\] are allowed; these should be discussed with the Medical Monitor)\n8. Known allergic reaction to a prior monoclonal antibody therapy or have any documented Anti-Drug Antibody (ADA) response; additionally known allergic reaction to the concomitant chemotherapies selected by the investigator for planned treatment in this study unless desensitization is planned\n9. Previous treatment with farletuzumab or other folate receptor targeting agents\n10. Previous treatment with cancer vaccine therapy\n11. For subjects being enrolled to receive PLD plus carboplatin, prior treatment with anthracyclines or anthracenodiones\n12. Breast-feeding, pregnant, or likely to become pregnant during the study\n13. Any medical or other condition that, in the opinion of the investigator, would preclude the subject's participation in a clinical study including medical contraindications as outlined in the product labels for the chemotherapies selected by the investigator for planned treatment in this study\n14. Patients who have had secondary debulking surgery or any second line therapy\n15. Currently enrolled in another clinical study or used any investigational drug or device within 30 days (or 5 x half-life for investigational drugs where the half-life is known) preceding informed consent"}, 'identificationModule': {'nctId': 'NCT02289950', 'briefTitle': 'A Study to Assess the Efficacy and Safety of Farletuzumab (MORAb 003) in Combination With Carboplatin Plus Paclitaxel or Carboplatin Plus Pegylated Liposomal Doxorubicin (PLD) in Participants With Low CA125 Platinum-sensitive Ovarian Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eisai Inc.'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Assess the Efficacy and Safety of Farletuzumab (MORAb 003) in Combination With Carboplatin Plus Paclitaxel or Carboplatin Plus Pegylated Liposomal Doxorubicin (PLD) in Subjects With Low CA125 Platinum-Sensitive Ovarian Cancer', 'orgStudyIdInfo': {'id': 'MORAb-003-011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Farletuzumab', 'description': 'All participants will receive a loading dose for the first 2 weeks of 10 milligram per kilogram (mg/kg) farletuzumab, followed by 5 mg/kg weekly farletuzumab administered intravenously (IV).', 'interventionNames': ['Drug: Farletuzumab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'All subjects will receive placebo weekly, administered intravenously (IV).', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Farletuzumab', 'type': 'DRUG', 'description': 'Farletuzumab will be administered intravenously (IV) weekly', 'armGroupLabels': ['Farletuzumab']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo will be administered intravenously (IV) weekly', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'Orange', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'city': 'Roseville', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 38.75212, 'lon': -121.28801}}, {'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'city': 'Miramar', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 25.98731, 'lon': -80.23227}}, {'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'geoPoint': 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