Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2026-02-13 @ 2:44 PM
Study NCT ID:
NCT00849667
Status:
TERMINATED
Last Update Posted:
2022-12-30
First Post:
2009-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of Farletuzumab (MORAb-003) in Combination With Carboplatin and Taxane in Participants With Platinum-sensitive Ovarian Cancer in First Relapse
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian Neoplasms'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'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': 'C527484', 'term': 'farletuzumab'}, {'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'C080625', 'term': 'taxane'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'esi_oncmedinfo@eisai.com', 'phone': '1-888-274-2378', 'title': 'Eisai Medical Information', 'organization': 'Eisai Inc.'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Study termination was based on the primary analysis results for progression-free survival (PFS). Data collection and analyses of health care resource utilization were not performed due to the study being terminated early. Pharmacokinetic data was collected and analyzed for a maximum of only 7 participants in this study.'}}, 'adverseEventsModule': {'timeFrame': 'Up to 48 months', 'eventGroups': [{'id': 'EG000', 'title': '1.25 mg/kg Farletuzumab Plus Taxane and Carboplatin', 'description': "Participants received farletuzumab 1.25 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel \\[175 mg/m\\^2\\] or docetaxel \\[75 mg/m\\^2\\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \\[mg\\] = Target AUC \\[mg\\*min/mL\\]\\*GFR \\[mL/min\\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 1.25 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days).", 'otherNumAtRisk': 376, 'deathsNumAtRisk': 376, 'otherNumAffected': 373, 'seriousNumAtRisk': 376, 'deathsNumAffected': 143, 'seriousNumAffected': 140}, {'id': 'EG001', 'title': '2.5 mg/kg Farletuzumab Plus Taxane and Carboplatin', 'description': "Participants received farletuzumab 2.5 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel \\[175 mg/m\\^2\\] or docetaxel \\[75 mg/m\\^2\\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \\[mg\\] = Target AUC \\[mg\\*min/mL\\]\\*GFR \\[mL/min\\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 2.5 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days).", 'otherNumAtRisk': 363, 'deathsNumAtRisk': 363, 'otherNumAffected': 358, 'seriousNumAtRisk': 363, 'deathsNumAffected': 119, 'seriousNumAffected': 130}, {'id': 'EG002', 'title': 'Placebo Plus Taxane and Carboplatin', 'description': "Participants received farletuzumab-matched placebo (0.9% saline) as an IV infusion, weekly followed by taxane (paclitaxel \\[175 mg/m\\^2\\] or docetaxel \\[75 mg/m\\^2\\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \\[mg\\] = Target AUC \\[mg\\*min/mL\\]\\*GFR \\[mL/min\\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab-matched placebo as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days).", 'otherNumAtRisk': 352, 'deathsNumAtRisk': 352, 'otherNumAffected': 347, 'seriousNumAtRisk': 352, 'deathsNumAffected': 121, 'seriousNumAffected': 112}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 486, 'numAffected': 215}, {'groupId': 'EG001', 'numAtRisk': 363, 'numEvents': 395, 'numAffected': 185}, {'groupId': 'EG002', 'numAtRisk': 352, 'numEvents': 459, 'numAffected': 188}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 251, 'numAffected': 134}, {'groupId': 'EG001', 'numAtRisk': 363, 'numEvents': 207, 'numAffected': 125}, {'groupId': 'EG002', 'numAtRisk': 352, 'numEvents': 262, 'numAffected': 126}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 224, 'numAffected': 129}, {'groupId': 'EG001', 'numAtRisk': 363, 'numEvents': 167, 'numAffected': 110}, {'groupId': 'EG002', 'numAtRisk': 352, 'numEvents': 211, 'numAffected': 103}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 167, 'numAffected': 119}, {'groupId': 'EG001', 'numAtRisk': 363, 'numEvents': 164, 'numAffected': 106}, {'groupId': 'EG002', 'numAtRisk': 352, 'numEvents': 155, 'numAffected': 101}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 155, 'numAffected': 106}, {'groupId': 'EG001', 'numAtRisk': 363, 'numEvents': 122, 'numAffected': 84}, {'groupId': 'EG002', 'numAtRisk': 352, 'numEvents': 149, 'numAffected': 91}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 55, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 363, 'numEvents': 54, 'numAffected': 47}, {'groupId': 'EG002', 'numAtRisk': 352, 'numEvents': 51, 'numAffected': 41}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 57, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 363, 'numEvents': 46, 'numAffected': 35}, {'groupId': 'EG002', 'numAtRisk': 352, 'numEvents': 47, 'numAffected': 34}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 52, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 363, 'numEvents': 28, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 352, 'numEvents': 58, 'numAffected': 33}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 28, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 363, 'numEvents': 29, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 352, 'numEvents': 30, 'numAffected': 24}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 622, 'numAffected': 205}, {'groupId': 'EG001', 'numAtRisk': 363, 'numEvents': 584, 'numAffected': 185}, {'groupId': 'EG002', 'numAtRisk': 352, 'numEvents': 639, 'numAffected': 169}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 214, 'numAffected': 139}, {'groupId': 'EG001', 'numAtRisk': 363, 'numEvents': 265, 'numAffected': 154}, {'groupId': 'EG002', 'numAtRisk': 352, 'numEvents': 193, 'numAffected': 120}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 351, 'numAffected': 126}, {'groupId': 'EG001', 'numAtRisk': 363, 'numEvents': 296, 'numAffected': 121}, {'groupId': 'EG002', 'numAtRisk': 352, 'numEvents': 237, 'numAffected': 99}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 283, 'numAffected': 74}, {'groupId': 'EG001', 'numAtRisk': 363, 'numEvents': 194, 'numAffected': 72}, {'groupId': 'EG002', 'numAtRisk': 352, 'numEvents': 282, 'numAffected': 74}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 63, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 363, 'numEvents': 39, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 352, 'numEvents': 85, 'numAffected': 21}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 319, 'numAffected': 171}, {'groupId': 'EG001', 'numAtRisk': 363, 'numEvents': 206, 'numAffected': 135}, {'groupId': 'EG002', 'numAtRisk': 352, 'numEvents': 319, 'numAffected': 149}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 162, 'numAffected': 76}, {'groupId': 'EG001', 'numAtRisk': 363, 'numEvents': 174, 'numAffected': 84}, {'groupId': 'EG002', 'numAtRisk': 352, 'numEvents': 134, 'numAffected': 64}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 92, 'numAffected': 58}, {'groupId': 'EG001', 'numAtRisk': 363, 'numEvents': 67, 'numAffected': 47}, {'groupId': 'EG002', 'numAtRisk': 352, 'numEvents': 73, 'numAffected': 48}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 98, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 363, 'numEvents': 43, 'numAffected': 37}, {'groupId': 'EG002', 'numAtRisk': 352, 'numEvents': 49, 'numAffected': 40}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 43, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 363, 'numEvents': 31, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 352, 'numEvents': 24, 'numAffected': 19}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 37, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 363, 'numEvents': 28, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 352, 'numEvents': 51, 'numAffected': 30}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 225, 'numAffected': 221}, {'groupId': 'EG001', 'numAtRisk': 363, 'numEvents': 186, 'numAffected': 184}, {'groupId': 'EG002', 'numAtRisk': 352, 'numEvents': 207, 'numAffected': 202}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 60, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 363, 'numEvents': 52, 'numAffected': 40}, {'groupId': 'EG002', 'numAtRisk': 352, 'numEvents': 77, 'numAffected': 39}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 93, 'numAffected': 52}, {'groupId': 'EG001', 'numAtRisk': 363, 'numEvents': 56, 'numAffected': 36}, {'groupId': 'EG002', 'numAtRisk': 352, 'numEvents': 66, 'numAffected': 37}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 138, 'numAffected': 89}, {'groupId': 'EG001', 'numAtRisk': 363, 'numEvents': 117, 'numAffected': 71}, {'groupId': 'EG002', 'numAtRisk': 352, 'numEvents': 121, 'numAffected': 90}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 125, 'numAffected': 79}, {'groupId': 'EG001', 'numAtRisk': 363, 'numEvents': 131, 'numAffected': 79}, {'groupId': 'EG002', 'numAtRisk': 352, 'numEvents': 137, 'numAffected': 71}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 80, 'numAffected': 65}, {'groupId': 'EG001', 'numAtRisk': 363, 'numEvents': 69, 'numAffected': 52}, {'groupId': 'EG002', 'numAtRisk': 352, 'numEvents': 53, 'numAffected': 37}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 69, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 363, 'numEvents': 65, 'numAffected': 51}, {'groupId': 'EG002', 'numAtRisk': 352, 'numEvents': 87, 'numAffected': 52}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 47, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 363, 'numEvents': 53, 'numAffected': 44}, {'groupId': 'EG002', 'numAtRisk': 352, 'numEvents': 49, 'numAffected': 40}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 55, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 363, 'numEvents': 48, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 352, 'numEvents': 54, 'numAffected': 28}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 34, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 363, 'numEvents': 30, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 352, 'numEvents': 22, 'numAffected': 12}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 193, 'numAffected': 93}, {'groupId': 'EG001', 'numAtRisk': 363, 'numEvents': 123, 'numAffected': 66}, {'groupId': 'EG002', 'numAtRisk': 352, 'numEvents': 170, 'numAffected': 86}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Myaligia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 116, 'numAffected': 68}, {'groupId': 'EG001', 'numAtRisk': 363, 'numEvents': 95, 'numAffected': 63}, {'groupId': 'EG002', 'numAtRisk': 352, 'numEvents': 108, 'numAffected': 54}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 69, 'numAffected': 52}, {'groupId': 'EG001', 'numAtRisk': 363, 'numEvents': 72, 'numAffected': 48}, {'groupId': 'EG002', 'numAtRisk': 352, 'numEvents': 63, 'numAffected': 47}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 80, 'numAffected': 58}, {'groupId': 'EG001', 'numAtRisk': 363, 'numEvents': 34, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 352, 'numEvents': 70, 'numAffected': 50}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 26, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 363, 'numEvents': 34, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 352, 'numEvents': 55, 'numAffected': 32}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 21, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 363, 'numEvents': 23, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 352, 'numEvents': 29, 'numAffected': 25}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 195, 'numAffected': 95}, {'groupId': 'EG001', 'numAtRisk': 363, 'numEvents': 137, 'numAffected': 74}, {'groupId': 'EG002', 'numAtRisk': 352, 'numEvents': 167, 'numAffected': 70}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 55, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 363, 'numEvents': 42, 'numAffected': 33}, {'groupId': 'EG002', 'numAtRisk': 352, 'numEvents': 32, 'numAffected': 26}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 54, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 363, 'numEvents': 54, 'numAffected': 34}, {'groupId': 'EG002', 'numAtRisk': 352, 'numEvents': 31, 'numAffected': 20}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 29, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 363, 'numEvents': 26, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 352, 'numEvents': 15, 'numAffected': 13}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 25, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 363, 'numEvents': 21, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 352, 'numEvents': 22, 'numAffected': 19}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 101, 'numAffected': 77}, {'groupId': 'EG001', 'numAtRisk': 363, 'numEvents': 84, 'numAffected': 61}, {'groupId': 'EG002', 'numAtRisk': 352, 'numEvents': 66, 'numAffected': 56}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 60, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 363, 'numEvents': 67, 'numAffected': 53}, {'groupId': 'EG002', 'numAtRisk': 352, 'numEvents': 47, 'numAffected': 35}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 29, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 363, 'numEvents': 27, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 352, 'numEvents': 30, 'numAffected': 24}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 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thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Interstitial Lung Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 352, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pleural Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 363, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 352, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 363, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 352, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pulmonary Artery Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 363, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 352, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Chronic Obstructive Pulmonary Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 352, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 363, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 352, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 352, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 352, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Lung Infiltration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 363, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 352, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Obliterative Bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 363, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 352, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pleuritic Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 363, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 352, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 352, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pulmonary Fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 352, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dyspnoea Exertional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 352, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Laryngospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 352, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 352, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 363, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 352, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Malignant Tumour Excision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 363, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 352, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Mass Excision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 352, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Ureteral Stent Insertion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 352, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Cytoreductive Surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 352, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Deep Vein Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 363, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 352, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 363, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 352, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 352, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hot Flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 363, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 352, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 363, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 352, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Vena Cava Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 363, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 352, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Venous Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 352, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Peripheral Ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 352, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Thrombophlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 352, 'numEvents': 1, 'numAffected': 1}], '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': '370', 'groupId': 'OG000'}, {'value': '366', 'groupId': 'OG001'}, {'value': '364', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1.25 mg/kg Farletuzumab Plus Taxane and Carboplatin', 'description': "Participants received farletuzumab 1.25 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel \\[175 mg/m\\^2\\] or docetaxel \\[75 mg/m\\^2\\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \\[mg\\] = Target AUC \\[mg\\*min/mL\\]\\*GFR \\[mL/min\\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 1.25 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days)."}, {'id': 'OG001', 'title': '2.5 mg/kg Farletuzumab Plus Taxane and Carboplatin', 'description': "Participants received farletuzumab 2.5 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel \\[175 mg/m\\^2\\] or docetaxel \\[75 mg/m\\^2\\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \\[mg\\] = Target AUC \\[mg\\*min/mL\\]\\*GFR \\[mL/min\\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 2.5 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days)."}, {'id': 'OG002', 'title': 'Placebo Plus Taxane and Carboplatin', 'description': "Participants received farletuzumab-matched placebo (0.9% saline) as an IV infusion, weekly followed by taxane (paclitaxel \\[175 mg/m\\^2\\] or docetaxel \\[75 mg/m\\^2\\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \\[mg\\] = Target AUC \\[mg\\*min/mL\\]\\*GFR \\[mL/min\\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab-matched placebo as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days)."}], 'classes': [{'categories': [{'measurements': [{'value': '9.5', 'groupId': 'OG000', 'lowerLimit': '8.6', 'upperLimit': '10.2'}, {'value': '9.7', 'groupId': 'OG001', 'lowerLimit': '8.8', 'upperLimit': '10.4'}, {'value': '9.0', 'groupId': 'OG002', 'lowerLimit': '8.4', 'upperLimit': '9.8'}]}]}], 'analyses': [{'pValue': '0.4513', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.99', 'ciLowerLimit': '0.81', 'ciUpperLimit': '1.21', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'One-sided log rank test'}, {'pValue': '0.0761', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.86', 'ciLowerLimit': '0.70', 'ciUpperLimit': '1.06', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'One-sided log rank test'}], 'paramType': 'MEDIAN', 'timeFrame': 'From the date of randomization to the date of first documentation of disease progression, or date of death, whichever occurred first (up to 44 months)', 'description': 'PFS was defined as the time (in months) from the date of randomization to the date of the first observation of progression based on the independent radiologic assessment (modified response evaluation criteria in solid tumors \\[RECIST\\]), or date of death, whatever the cause. As per RECIST, disease progression was defined as at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the baseline sum of diameters of target lesions. If progression or death was not observed for a participant, the PFS time was censored at the date of the last tumor assessment without evidence of progression before the date of initiation of further antitumor treatment, or the cutoff date (whichever was earlier).', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants randomly assigned to treatment, according to the treatment assigned by the IWRS/IVRS.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '370', 'groupId': 'OG000'}, {'value': '366', 'groupId': 'OG001'}, {'value': '364', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1.25 mg/kg Farletuzumab Plus Taxane and Carboplatin', 'description': "Participants received farletuzumab 1.25 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel \\[175 mg/m\\^2\\] or docetaxel \\[75 mg/m\\^2\\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \\[mg\\] = Target AUC \\[mg\\*min/mL\\]\\*GFR \\[mL/min\\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 1.25 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days)."}, {'id': 'OG001', 'title': '2.5 mg/kg Farletuzumab Plus Taxane and Carboplatin', 'description': "Participants received farletuzumab 2.5 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel \\[175 mg/m\\^2\\] or docetaxel \\[75 mg/m\\^2\\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \\[mg\\] = Target AUC \\[mg\\*min/mL\\]\\*GFR \\[mL/min\\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 2.5 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days)."}, {'id': 'OG002', 'title': 'Placebo Plus Taxane and Carboplatin', 'description': "Participants received farletuzumab-matched placebo (0.9% saline) as an IV infusion, weekly followed by taxane (paclitaxel \\[175 mg/m\\^2\\] or docetaxel \\[75 mg/m\\^2\\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \\[mg\\] = Target AUC \\[mg\\*min/mL\\]\\*GFR \\[mL/min\\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab-matched placebo as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days)."}], 'classes': [{'categories': [{'measurements': [{'value': '28.7', 'groupId': 'OG000', 'lowerLimit': '26.6', 'upperLimit': '33.5'}, {'value': '32.1', 'groupId': 'OG001', 'lowerLimit': '26.7', 'upperLimit': '35.0'}, {'value': '29.1', 'groupId': 'OG002', 'lowerLimit': '25.6', 'upperLimit': '30.7'}]}]}], 'analyses': [{'pValue': '0.4823', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.99', 'ciLowerLimit': '0.78', 'ciUpperLimit': '1.27', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'One-sided log rank test'}, {'pValue': '0.1616', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.88', 'ciLowerLimit': '0.68', 'ciUpperLimit': '1.13', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'One-sided log rank test'}], 'paramType': 'MEDIAN', 'timeFrame': 'From the date of randomization until date of death from any cause, or study termination by sponsor, whichever came first (up to 48 months)', 'description': 'OS was defined as the time (in months) from the date of randomization to the date of death, due to any cause. If death was not observed for a participant, the survival time was censored on the last date the participant was known to be alive or the cutoff date, whichever was earlier.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants randomly assigned to treatment, according to the treatment assigned by the IWRS/IVRS.'}, {'type': 'SECONDARY', 'title': 'Cancer Antigen-125 (CA-125) Progression-Free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '370', 'groupId': 'OG000'}, {'value': '366', 'groupId': 'OG001'}, {'value': '364', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1.25 mg/kg Farletuzumab Plus Taxane and Carboplatin', 'description': "Participants received farletuzumab 1.25 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel \\[175 mg/m\\^2\\] or docetaxel \\[75 mg/m\\^2\\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \\[mg\\] = Target AUC \\[mg\\*min/mL\\]\\*GFR \\[mL/min\\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 1.25 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days)."}, {'id': 'OG001', 'title': '2.5 mg/kg Farletuzumab Plus Taxane and Carboplatin', 'description': "Participants received farletuzumab 2.5 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel \\[175 mg/m\\^2\\] or docetaxel \\[75 mg/m\\^2\\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \\[mg\\] = Target AUC \\[mg\\*min/mL\\]\\*GFR \\[mL/min\\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 2.5 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days)."}, {'id': 'OG002', 'title': 'Placebo Plus Taxane and Carboplatin', 'description': "Participants received farletuzumab-matched placebo (0.9% saline) as an IV infusion, weekly followed by taxane (paclitaxel \\[175 mg/m\\^2\\] or docetaxel \\[75 mg/m\\^2\\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \\[mg\\] = Target AUC \\[mg\\*min/mL\\]\\*GFR \\[mL/min\\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab-matched placebo as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days)."}], 'classes': [{'categories': [{'measurements': [{'value': '13.2', 'groupId': 'OG000', 'lowerLimit': '11.8', 'upperLimit': '14.4'}, {'value': '18.1', 'comment': 'Here NA signifies that the upper limit of confidence interval (CI) was not estimable due to insufficient number of events.', 'groupId': 'OG001', 'lowerLimit': '12.7', 'upperLimit': 'NA'}, {'value': '12.0', 'groupId': 'OG002', 'lowerLimit': '11.1', 'upperLimit': '14.6'}]}]}], 'analyses': [{'pValue': '0.2938', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.93', 'ciLowerLimit': '0.72', 'ciUpperLimit': '1.21', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'One-sided log-rank test'}, {'pValue': '0.0318', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.77', 'ciLowerLimit': '0.58', 'ciUpperLimit': '1.02', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'One-sided log-rank test'}], 'paramType': 'MEDIAN', 'timeFrame': 'From the date of randomization to the date of first documentation of disease progression, or date of death, whichever occurred first (up to 44 months)', 'description': 'CA-125 PFS was defined as the time (in months) from the date of randomization until the date of the first observation of progression based on the Rustin criteria, or date of death, whatever the cause. If progression or death was not observed for a participant, the CA-125 PFS time was censored at the date of the last CA-125 assessment without evidence of progression before the date of initiation of further antitumor treatment or the "primary analysis cut off" date, whichever was earlier. Based on Rustin criteria, progressive disease (PD) was a rise in CA125 since beginning of consolidation or previously normal CA125 that rises to greater than or equal to (\\>=) 2 multiple (\\*) ULN with either event documented on two occasions or CA-125 \\>=2\\*nadir value with either event documented on two occasions.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants randomly assigned to treatment, according to the treatment assigned by the IWRS/IVRS.'}, {'type': 'SECONDARY', 'title': 'Progression-Free Survival Based on Gynecologic Cancer InterGroup (GCIG) Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '370', 'groupId': 'OG000'}, {'value': '366', 'groupId': 'OG001'}, {'value': '364', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1.25 mg/kg Farletuzumab Plus Taxane and Carboplatin', 'description': "Participants received farletuzumab 1.25 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel \\[175 mg/m\\^2\\] or docetaxel \\[75 mg/m\\^2\\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \\[mg\\] = Target AUC \\[mg\\*min/mL\\]\\*GFR \\[mL/min\\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 1.25 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days)."}, {'id': 'OG001', 'title': '2.5 mg/kg Farletuzumab Plus Taxane and Carboplatin', 'description': "Participants received farletuzumab 2.5 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel \\[175 mg/m\\^2\\] or docetaxel \\[75 mg/m\\^2\\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \\[mg\\] = Target AUC \\[mg\\*min/mL\\]\\*GFR \\[mL/min\\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 2.5 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days)."}, {'id': 'OG002', 'title': 'Placebo Plus Taxane and Carboplatin', 'description': "Participants received farletuzumab-matched placebo (0.9% saline) as an IV infusion, weekly followed by taxane (paclitaxel \\[175 mg/m\\^2\\] or docetaxel \\[75 mg/m\\^2\\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \\[mg\\] = Target AUC \\[mg\\*min/mL\\]\\*GFR \\[mL/min\\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab-matched placebo as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days)."}], 'classes': [{'categories': [{'measurements': [{'value': '8.8', 'groupId': 'OG000', 'lowerLimit': '8.4', 'upperLimit': '9.7'}, {'value': '8.6', 'groupId': 'OG001', 'lowerLimit': '8.3', 'upperLimit': '9.5'}, {'value': '8.4', 'groupId': 'OG002', 'lowerLimit': '8.2', 'upperLimit': '9.0'}]}]}], 'analyses': [{'pValue': '0.5636', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.01', 'ciLowerLimit': '0.85', 'ciUpperLimit': '1.21', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'One-sided log-rank test'}, {'pValue': '0.1560', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.91', 'ciLowerLimit': '0.76', 'ciUpperLimit': '1.09', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'One-sided log-rank test'}], 'paramType': 'MEDIAN', 'timeFrame': 'From the date of randomization to the date of first documentation of disease progression, or date of death, whichever occurred first (up to 44 months)', 'description': 'PFS using GCIG criteria was defined as time (in months) from date of randomization until date of first observation of progression based on GCIG criteria, or date of death, whatever the cause. If progression or death was not observed for a participant, GCIG PFS time was censored at later date of last tumor assessment or CA-125 assessment without evidence of progression before date of initiation of further antitumor treatment or the "primary analysis cut off" date, whichever was earlier. Disease progression per GCIG: Participants with elevated CA-125 pretreatment and normalisation of CA-125 must show evidence of CA-125 \\>=two times ULN on two occasions at least one week apart or participants with elevated CA-125 pretreatment, which never normalises must show evidence of CA-125 \\>=two times nadir value on two occasions at least one week apart or participants with CA-125 in normal range pretreatment must show evidence of CA-125 \\>=two times ULN on two occasions at least one week apart.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants randomly assigned to treatment, according to the treatment assigned by the IWRS/IVRS.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Length of Second Remission Greater Than First Remission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '200', 'groupId': 'OG001'}, {'value': '201', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1.25 mg/kg Farletuzumab Plus Taxane and Carboplatin', 'description': "Participants received farletuzumab 1.25 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel \\[175 mg/m\\^2\\] or docetaxel \\[75 mg/m\\^2\\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \\[mg\\] = Target AUC \\[mg\\*min/mL\\]\\*GFR \\[mL/min\\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 1.25 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days)."}, {'id': 'OG001', 'title': '2.5 mg/kg Farletuzumab Plus Taxane and Carboplatin', 'description': "Participants received farletuzumab 2.5 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel \\[175 mg/m\\^2\\] or docetaxel \\[75 mg/m\\^2\\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \\[mg\\] = Target AUC \\[mg\\*min/mL\\]\\*GFR \\[mL/min\\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 2.5 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days)."}, {'id': 'OG002', 'title': 'Placebo Plus Taxane and Carboplatin', 'description': "Participants received farletuzumab-matched placebo (0.9% saline) as an IV infusion, weekly followed by taxane (paclitaxel \\[175 mg/m\\^2\\] or docetaxel \\[75 mg/m\\^2\\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \\[mg\\] = Target AUC \\[mg\\*min/mL\\]\\*GFR \\[mL/min\\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab-matched placebo as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days)."}], 'classes': [{'categories': [{'measurements': [{'value': '4.0', 'groupId': 'OG000', 'lowerLimit': '1.8', 'upperLimit': '7.8'}, {'value': '6.5', 'groupId': 'OG001', 'lowerLimit': '3.5', 'upperLimit': '10.9'}, {'value': '4.5', 'groupId': 'OG002', 'lowerLimit': '2.1', 'upperLimit': '8.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the date of last dose of platinum-based chemotherapy to date of relapse and date of last dose of platinum-based chemotherapy to first observation of progression (up to 48 months)', 'description': 'Length of first remission was defined as a.) the period of time (in months) from the date of completion of previous platinum-based chemotherapy until date of first relapse (that is, first observation of progression). It was assumed that the date of first relapse was the earlier of progression by CA-125 or progression by radiologic assessment, as judged by the investigator using GCIG criteria. b.) the period of time (in months) from the date of completion of previous platinum-based chemotherapy (used prior to study entry) until date of randomization. The length of the second remission was defined as the period of time (in months) from the date of completion of platinum-based chemotherapy until the first observation of progression based on GCIG criteria. Based on GCIG criteria, disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the baseline sum of diameters of target lesions.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants randomly assigned to treatment, according to the treatment assigned by the IWRS/IVRS. Here "N" overall number of participants analyzed included all participants with potential for second remission greater than first remission.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Objective Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '370', 'groupId': 'OG000'}, {'value': '366', 'groupId': 'OG001'}, {'value': '364', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1.25 mg/kg Farletuzumab Plus Taxane and Carboplatin', 'description': "Participants received farletuzumab 1.25 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel \\[175 mg/m\\^2\\] or docetaxel \\[75 mg/m\\^2\\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \\[mg\\] = Target AUC \\[mg\\*min/mL\\]\\*GFR \\[mL/min\\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 1.25 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days)."}, {'id': 'OG001', 'title': '2.5 mg/kg Farletuzumab Plus Taxane and Carboplatin', 'description': "Participants received farletuzumab 2.5 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel \\[175 mg/m\\^2\\] or docetaxel \\[75 mg/m\\^2\\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \\[mg\\] = Target AUC \\[mg\\*min/mL\\]\\*GFR \\[mL/min\\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 2.5 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days)."}, {'id': 'OG002', 'title': 'Placebo Plus Taxane and Carboplatin', 'description': "Participants received farletuzumab-matched placebo (0.9% saline) as an IV infusion, weekly followed by taxane (paclitaxel \\[175 mg/m\\^2\\] or docetaxel \\[75 mg/m\\^2\\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \\[mg\\] = Target AUC \\[mg\\*min/mL\\]\\*GFR \\[mL/min\\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab-matched placebo as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days)."}], 'classes': [{'categories': [{'measurements': [{'value': '57.6', 'groupId': 'OG000', 'lowerLimit': '52.4', 'upperLimit': '62.7'}, {'value': '58.2', 'groupId': 'OG001', 'lowerLimit': '53.0', 'upperLimit': '63.3'}, {'value': '55.8', 'groupId': 'OG002', 'lowerLimit': '50.5', 'upperLimit': '60.9'}]}]}], 'analyses': [{'pValue': '0.6864', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.8', 'ciLowerLimit': '-5.4', 'ciUpperLimit': '9.0', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4923', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.4', 'ciLowerLimit': '-4.8', 'ciUpperLimit': '9.6', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'From the date of randomization to the date of first documentation of disease progression, or date of death, whichever occurred first (up to 48 months)', 'description': 'Objective response was defined as either a confirmed complete response (CR) or confirmed partial response (PR) as assessed by investigator based on response evaluation criteria in solid tumors version 1.1 (RECIST version 1.1). CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis less than (\\<) 10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants randomly assigned to treatment, according to the treatment assigned by the IWRS/IVRS.'}, {'type': 'SECONDARY', 'title': 'Duration of Tumor Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}, {'value': '200', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1.25 mg/kg Farletuzumab Plus Taxane and Carboplatin', 'description': "Participants received farletuzumab 1.25 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel \\[175 mg/m\\^2\\] or docetaxel \\[75 mg/m\\^2\\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \\[mg\\] = Target AUC \\[mg\\*min/mL\\]\\*GFR \\[mL/min\\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 1.25 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days)."}, {'id': 'OG001', 'title': '2.5 mg/kg Farletuzumab Plus Taxane and Carboplatin', 'description': "Participants received farletuzumab 2.5 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel \\[175 mg/m\\^2\\] or docetaxel \\[75 mg/m\\^2\\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \\[mg\\] = Target AUC \\[mg\\*min/mL\\]\\*GFR \\[mL/min\\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 2.5 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days)."}, {'id': 'OG002', 'title': 'Placebo Plus Taxane and Carboplatin', 'description': "Participants received farletuzumab-matched placebo (0.9% saline) as an IV infusion, weekly followed by taxane (paclitaxel \\[175 mg/m\\^2\\] or docetaxel \\[75 mg/m\\^2\\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \\[mg\\] = Target AUC \\[mg\\*min/mL\\]\\*GFR \\[mL/min\\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab-matched placebo as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days)."}], 'classes': [{'categories': [{'measurements': [{'value': '8.0', 'groupId': 'OG000', 'lowerLimit': '7.6', 'upperLimit': '9.2'}, {'value': '8.9', 'groupId': 'OG001', 'lowerLimit': '7.7', 'upperLimit': '9.7'}, {'value': '7.6', 'groupId': 'OG002', 'lowerLimit': '7.1', 'upperLimit': '8.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the first date of confirmed objective response (CR or PR) to first date of progression or death due to any cause (up to 48 months)', 'description': 'Duration of response was defined as the time (in months) from first documentation of objective response (confirmed CR or PR) to the first documentation of objective tumor progression or death due to any cause. Duration of response was derived only for those participants with objective evidence of confirmed CR or PR.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis performed on a subset of participants who had objective response.'}, {'type': 'SECONDARY', 'title': 'Time to Tumor Response (TTR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}, {'value': '200', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1.25 mg/kg Farletuzumab Plus Taxane and Carboplatin', 'description': "Participants received farletuzumab 1.25 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel \\[175 mg/m\\^2\\] or docetaxel \\[75 mg/m\\^2\\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \\[mg\\] = Target AUC \\[mg\\*min/mL\\]\\*GFR \\[mL/min\\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 1.25 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days)."}, {'id': 'OG001', 'title': '2.5 mg/kg Farletuzumab Plus Taxane and Carboplatin', 'description': "Participants received farletuzumab 2.5 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel \\[175 mg/m\\^2\\] or docetaxel \\[75 mg/m\\^2\\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \\[mg\\] = Target AUC \\[mg\\*min/mL\\]\\*GFR \\[mL/min\\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 2.5 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days)."}, {'id': 'OG002', 'title': 'Placebo Plus Taxane and Carboplatin', 'description': "Participants received farletuzumab-matched placebo (0.9% saline) as an IV infusion, weekly followed by taxane (paclitaxel \\[175 mg/m\\^2\\] or docetaxel \\[75 mg/m\\^2\\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \\[mg\\] = Target AUC \\[mg\\*min/mL\\]\\*GFR \\[mL/min\\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab-matched placebo as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days)."}], 'classes': [{'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000', 'lowerLimit': '1.4', 'upperLimit': '1.7'}, {'value': '1.5', 'groupId': 'OG001', 'lowerLimit': '1.4', 'upperLimit': '1.7'}, {'value': '1.5', 'groupId': 'OG002', 'lowerLimit': '1.4', 'upperLimit': '1.9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the date of randomization to first documentation of objective response (up to 48 months)', 'description': 'Time to tumor response was defined as the time (in months) from the date of randomization to first documentation of objective tumor response. Time to tumor response was derived for those participants with objective evidence of CR or PR.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis performed on a subset of participants who had objective response.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Serologic Response (SR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '273', 'groupId': 'OG000'}, {'value': '273', 'groupId': 'OG001'}, {'value': '272', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1.25 mg/kg Farletuzumab Plus Taxane and Carboplatin', 'description': "Participants received farletuzumab 1.25 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel \\[175 mg/m\\^2\\] or docetaxel \\[75 mg/m\\^2\\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \\[mg\\] = Target AUC \\[mg\\*min/mL\\]\\*GFR \\[mL/min\\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 1.25 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days)."}, {'id': 'OG001', 'title': '2.5 mg/kg Farletuzumab Plus Taxane and Carboplatin', 'description': "Participants received farletuzumab 2.5 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel \\[175 mg/m\\^2\\] or docetaxel \\[75 mg/m\\^2\\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \\[mg\\] = Target AUC \\[mg\\*min/mL\\]\\*GFR \\[mL/min\\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 2.5 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days)."}, {'id': 'OG002', 'title': 'Placebo Plus Taxane and Carboplatin', 'description': "Participants received farletuzumab-matched placebo (0.9% saline) as an IV infusion, weekly followed by taxane (paclitaxel \\[175 mg/m\\^2\\] or docetaxel \\[75 mg/m\\^2\\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \\[mg\\] = Target AUC \\[mg\\*min/mL\\]\\*GFR \\[mL/min\\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab-matched placebo as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days)."}], 'classes': [{'title': '50% SR (Responder)', 'categories': [{'measurements': [{'value': '91.9', 'groupId': 'OG000', 'lowerLimit': '88.1', 'upperLimit': '94.9'}, {'value': '97.4', 'groupId': 'OG001', 'lowerLimit': '94.8', 'upperLimit': '99.0'}, {'value': '92.3', 'groupId': 'OG002', 'lowerLimit': '88.4', 'upperLimit': '95.2'}]}]}, {'title': '75% SR (Responder)', 'categories': [{'measurements': [{'value': '86.1', 'groupId': 'OG000', 'lowerLimit': '81.4', 'upperLimit': '90.0'}, {'value': '85.7', 'groupId': 'OG001', 'lowerLimit': '81.0', 'upperLimit': '89.6'}, {'value': '82.0', 'groupId': 'OG002', 'lowerLimit': '76.9', 'upperLimit': '86.4'}]}]}, {'title': 'SR leading to normalization (Responder)', 'categories': [{'measurements': [{'value': '65.2', 'groupId': 'OG000', 'lowerLimit': '59.2', 'upperLimit': '70.8'}, {'value': '64.8', 'groupId': 'OG001', 'lowerLimit': '58.9', 'upperLimit': '70.5'}, {'value': '59.9', 'groupId': 'OG002', 'lowerLimit': '53.8', 'upperLimit': '65.8'}]}]}], 'analyses': [{'pValue': '0.8106', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-4.9', 'ciUpperLimit': '4.1', 'groupDescription': '50% serological response', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0064', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.1', 'ciLowerLimit': '1.4', 'ciUpperLimit': '8.8', 'groupDescription': '50% serological response', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3005', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.1', 'ciLowerLimit': '-2.0', 'ciUpperLimit': '10.2', 'groupDescription': '75% serological response', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2445', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.7', 'ciLowerLimit': '-2.5', 'ciUpperLimit': '9.9', 'groupDescription': '75% serological response', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2797', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.3', 'ciLowerLimit': '-2.8', 'ciUpperLimit': '13.4', 'groupDescription': 'Serologic response leading to normalization', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2136', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.9', 'ciLowerLimit': '-3.2', 'ciUpperLimit': '13.0', 'groupDescription': 'Serologic response leading to normalization', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 48 months', 'description': 'SR was defined as either normalization, 75% response, or 50% response using the Rustin criteria. Percentage of participants with 50% SR, 75% SR and SR leading to normalization were reported. A 50% response according to CA-125 was defined as a 50% decrease in serum CA-125 levels, as determined through a series of four CA-125 samples (one baseline sample with an elevated level, the sample that showed a 50% decrease, and a confirmatory sample at the decreased level). A 75% response was established if there had a serial decrease in serum CA-125 levels of 75% over three samples. In both the 50% and 75% response definitions, the final sample was analyzed at least 28 days after the previous sample.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'SR Evaluable Populations included all randomized participants who received at least one dose of study drug and who had a baseline and at least one assessment during treatment, sufficient to assess the endpoint of interest.'}, {'type': 'SECONDARY', 'title': 'Duration of 50% Serologic Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '251', 'groupId': 'OG000'}, {'value': '266', 'groupId': 'OG001'}, {'value': '251', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1.25 mg/kg Farletuzumab Plus Taxane and Carboplatin', 'description': "Participants received farletuzumab 1.25 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel \\[175 mg/m\\^2\\] or docetaxel \\[75 mg/m\\^2\\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \\[mg\\] = Target AUC \\[mg\\*min/mL\\]\\*GFR \\[mL/min\\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 1.25 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days)."}, {'id': 'OG001', 'title': '2.5 mg/kg Farletuzumab Plus Taxane and Carboplatin', 'description': "Participants received farletuzumab 2.5 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel \\[175 mg/m\\^2\\] or docetaxel \\[75 mg/m\\^2\\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \\[mg\\] = Target AUC \\[mg\\*min/mL\\]\\*GFR \\[mL/min\\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 2.5 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days)."}, {'id': 'OG002', 'title': 'Placebo Plus Taxane and Carboplatin', 'description': "Participants received farletuzumab-matched placebo (0.9% saline) as an IV infusion, weekly followed by taxane (paclitaxel \\[175 mg/m\\^2\\] or docetaxel \\[75 mg/m\\^2\\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \\[mg\\] = Target AUC \\[mg\\*min/mL\\]\\*GFR \\[mL/min\\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab-matched placebo as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days)."}], 'classes': [{'categories': [{'measurements': [{'value': '10.7', 'groupId': 'OG000', 'lowerLimit': '9.7', 'upperLimit': '12.0'}, {'value': '12.0', 'groupId': 'OG001', 'lowerLimit': '10.4', 'upperLimit': '16.7'}, {'value': '9.9', 'groupId': 'OG002', 'lowerLimit': '9.0', 'upperLimit': '11.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the first date of documentation of response to first documentation of serologic progression or death due to any cause (up to 48 months)', 'description': 'Duration of SR was defined as the time (in months) from first documentation of response to the first documentation of 50% serologic progression or death due to any cause. For responding participants who did not have serologic progression or did not die and who 1) were either still on study at the time of an analysis, 2) were given antitumor treatment other than study treatment, or 3) were withdrawn from study follow-up before documentation of serologic progression, the duration of SR was censored at the last date the participant was known to be without serologic progression. A 50% response according to CA-125 was defined as a 50% decrease in serum CA-125 levels, as determined through a series of three CA-125 samples (one baseline sample with an elevated level, the sample that showed a 50% decrease, and a confirmatory sample at the decreased level).', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on a subset of participants who had serologic response.'}, {'type': 'SECONDARY', 'title': 'Time to 50% Serologic Response (TSR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '251', 'groupId': 'OG000'}, {'value': '266', 'groupId': 'OG001'}, {'value': '251', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1.25 mg/kg Farletuzumab Plus Taxane and Carboplatin', 'description': "Participants received farletuzumab 1.25 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel \\[175 mg/m\\^2\\] or docetaxel \\[75 mg/m\\^2\\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \\[mg\\] = Target AUC \\[mg\\*min/mL\\]\\*GFR \\[mL/min\\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 1.25 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days)."}, {'id': 'OG001', 'title': '2.5 mg/kg Farletuzumab Plus Taxane and Carboplatin', 'description': "Participants received farletuzumab 2.5 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel \\[175 mg/m\\^2\\] or docetaxel \\[75 mg/m\\^2\\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \\[mg\\] = Target AUC \\[mg\\*min/mL\\]\\*GFR \\[mL/min\\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 2.5 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days)."}, {'id': 'OG002', 'title': 'Placebo Plus Taxane and Carboplatin', 'description': "Participants received farletuzumab-matched placebo (0.9% saline) as an IV infusion, weekly followed by taxane (paclitaxel \\[175 mg/m\\^2\\] or docetaxel \\[75 mg/m\\^2\\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \\[mg\\] = Target AUC \\[mg\\*min/mL\\]\\*GFR \\[mL/min\\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab-matched placebo as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days)."}], 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '0.9', 'upperLimit': '1.0'}, {'value': '0.9', 'groupId': 'OG001', 'lowerLimit': '0.9', 'upperLimit': '1.0'}, {'value': '1.2', 'groupId': 'OG002', 'lowerLimit': '1.0', 'upperLimit': '1.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the date of randomization to first documentation of 50% SR (up to 48 months)', 'description': 'TSR was defined as the time (in months) from the date of randomization to first documentation of 50% SR. A 50% response according to CA-125 was defined as a 50% decrease in serum CA-125 levels, as determined through a series of three CA-125 samples (one baseline sample with an elevated level, the sample that showed a 50% decrease, and a confirmatory sample at the decreased level).', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on a subset of participants who had serologic response.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Clinical Benefit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '370', 'groupId': 'OG000'}, {'value': '366', 'groupId': 'OG001'}, {'value': '364', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1.25 mg/kg Farletuzumab Plus Taxane and Carboplatin', 'description': "Participants received farletuzumab 1.25 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel \\[175 mg/m\\^2\\] or docetaxel \\[75 mg/m\\^2\\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \\[mg\\] = Target AUC \\[mg\\*min/mL\\]\\*GFR \\[mL/min\\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 1.25 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days)."}, {'id': 'OG001', 'title': '2.5 mg/kg Farletuzumab Plus Taxane and Carboplatin', 'description': "Participants received farletuzumab 2.5 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel \\[175 mg/m\\^2\\] or docetaxel \\[75 mg/m\\^2\\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \\[mg\\] = Target AUC \\[mg\\*min/mL\\]\\*GFR \\[mL/min\\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 2.5 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days)."}, {'id': 'OG002', 'title': 'Placebo Plus Taxane and Carboplatin', 'description': "Participants received farletuzumab-matched placebo (0.9% saline) as an IV infusion, weekly followed by taxane (paclitaxel \\[175 mg/m\\^2\\] or docetaxel \\[75 mg/m\\^2\\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \\[mg\\] = Target AUC \\[mg\\*min/mL\\]\\*GFR \\[mL/min\\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab-matched placebo as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days)."}], 'classes': [{'categories': [{'measurements': [{'value': '68.9', 'groupId': 'OG000'}, {'value': '66.4', 'groupId': 'OG001'}, {'value': '64.6', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 48 months', 'description': 'Clinical benefit was defined as a confirmed CR or a confirmed PR, or stable disease (SD) using RECIST 1.0 criteria. CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis \\<10 mm. PR was defined as at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease taking as reference smallest sum of longest dimensions since treatment started associated to non-progressive disease response for non target lesions.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants randomly assigned to treatment, according to the treatment assigned by the IWRS/IVRS.'}, {'type': 'SECONDARY', 'title': 'Cmax: Maximum Observed Plasma Concentration of Total Carboplatin and Total Paclitaxel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1.25 mg/kg Farletuzumab Plus Taxane and Carboplatin', 'description': "Participants received farletuzumab 1.25 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel \\[175 mg/m\\^2\\] or docetaxel \\[75 mg/m\\^2\\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \\[mg\\] = Target AUC \\[mg\\*min/mL\\]\\*GFR \\[mL/min\\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 1.25 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days)."}, {'id': 'OG001', 'title': '2.5 mg/kg Farletuzumab Plus Taxane and Carboplatin', 'description': "Participants received farletuzumab 2.5 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel \\[175 mg/m\\^2\\] or docetaxel \\[75 mg/m\\^2\\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \\[mg\\] = Target AUC \\[mg\\*min/mL\\]\\*GFR \\[mL/min\\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 2.5 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days)."}, {'id': 'OG002', 'title': 'Placebo Plus Taxane and Carboplatin', 'description': "Participants received farletuzumab-matched placebo (0.9% saline) as an IV infusion, weekly followed by taxane (paclitaxel \\[175 mg/m\\^2\\] or docetaxel \\[75 mg/m\\^2\\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \\[mg\\] = Target AUC \\[mg\\*min/mL\\]\\*GFR \\[mL/min\\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab-matched placebo as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days)."}], 'classes': [{'title': 'Total Carboplatin', 'categories': [{'measurements': [{'value': '19.30', 'spread': 'NA', 'comment': 'Here NA signifies that standard deviation could not be determined because only one participant was analyzed.', 'groupId': 'OG000'}, {'value': '43.55', 'spread': '22.84', 'groupId': 'OG001'}, {'value': '21.72', 'spread': '12.08', 'groupId': 'OG002'}]}]}, {'title': 'Total Paclitaxel', 'categories': [{'measurements': [{'value': '3.29', 'spread': 'NA', 'comment': 'Here NA signifies that standard deviation could not be determined because only one participant was analyzed.', 'groupId': 'OG000'}, {'value': '3.86', 'spread': '0.20', 'groupId': 'OG001'}, {'value': '4.95', 'spread': '2.73', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 2 Week 1 Day 1: 0-45 hours post-dose (cycle length=21 days)', 'unitOfMeasure': 'microgram per milliliter (mcg/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Analysis Set included all participants who have sufficient pharmacokinetic data to derive at least one pharmacokinetic parameter. Here "overall number of participants analyzed" signifies participants who were analyzed for this outcome measure. Pharmacokinetic data was collected and analyzed only for a maximum of 7 participants in this study.'}, {'type': 'SECONDARY', 'title': 'Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) of Total Carboplatin and Total Paclitaxel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1.25 mg/kg Farletuzumab Plus Taxane and Carboplatin', 'description': "Participants received farletuzumab 1.25 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel \\[175 mg/m\\^2\\] or docetaxel \\[75 mg/m\\^2\\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \\[mg\\] = Target AUC \\[mg\\*min/mL\\]\\*GFR \\[mL/min\\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 1.25 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days)."}, {'id': 'OG001', 'title': '2.5 mg/kg Farletuzumab Plus Taxane and Carboplatin', 'description': "Participants received farletuzumab 2.5 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel \\[175 mg/m\\^2\\] or docetaxel \\[75 mg/m\\^2\\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \\[mg\\] = Target AUC \\[mg\\*min/mL\\]\\*GFR \\[mL/min\\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 2.5 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days)."}, {'id': 'OG002', 'title': 'Placebo Plus Taxane and Carboplatin', 'description': "Participants received farletuzumab-matched placebo (0.9% saline) as an IV infusion, weekly followed by taxane (paclitaxel \\[175 mg/m\\^2\\] or docetaxel \\[75 mg/m\\^2\\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \\[mg\\] = Target AUC \\[mg\\*min/mL\\]\\*GFR \\[mL/min\\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab-matched placebo as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days)."}], 'classes': [{'title': 'Total Carboplatin', 'categories': [{'measurements': [{'value': '0.75', 'groupId': 'OG000', 'lowerLimit': '0.75', 'upperLimit': '0.75'}, {'value': '0.79', 'groupId': 'OG001', 'lowerLimit': '0.50', 'upperLimit': '1.08'}, {'value': '1.96', 'groupId': 'OG002', 'lowerLimit': '0.75', 'upperLimit': '3.83'}]}]}, {'title': 'Total Paclitaxel', 'categories': [{'measurements': [{'value': '3.00', 'groupId': 'OG000', 'lowerLimit': '3.00', 'upperLimit': '3.00'}, {'value': '3.21', 'groupId': 'OG001', 'lowerLimit': '3.00', 'upperLimit': '3.42'}, {'value': '3.00', 'groupId': 'OG002', 'lowerLimit': '2.00', 'upperLimit': '3.17'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cycle 2 Week 1 Day 1: 0-45 hours post-dose (cycle length=21 days)', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Analysis Set included all participants who have sufficient pharmacokinetic data to derive at least one pharmacokinetic parameter. Here "overall number of participants analyzed" signifies participants who were analyzed for this outcome measure. Pharmacokinetic data was collected and analyzed only for a maximum of 7 participants in this study.'}, {'type': 'SECONDARY', 'title': 'AUC (0-inf): Area Under the Concentration-time Curve From Zero (Pre-dose) Extrapolated to Infinite Time of Total Carboplatin and Total Paclitaxel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1.25 mg/kg Farletuzumab Plus Taxane and Carboplatin', 'description': "Participants received farletuzumab 1.25 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel \\[175 mg/m\\^2\\] or docetaxel \\[75 mg/m\\^2\\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \\[mg\\] = Target AUC \\[mg\\*min/mL\\]\\*GFR \\[mL/min\\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 1.25 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days)."}, {'id': 'OG001', 'title': '2.5 mg/kg Farletuzumab Plus Taxane and Carboplatin', 'description': "Participants received farletuzumab 2.5 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel \\[175 mg/m\\^2\\] or docetaxel \\[75 mg/m\\^2\\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \\[mg\\] = Target AUC \\[mg\\*min/mL\\]\\*GFR \\[mL/min\\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 2.5 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days)."}, {'id': 'OG002', 'title': 'Placebo Plus Taxane and Carboplatin', 'description': "Participants received farletuzumab-matched placebo (0.9% saline) as an IV infusion, weekly followed by taxane (paclitaxel \\[175 mg/m\\^2\\] or docetaxel \\[75 mg/m\\^2\\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \\[mg\\] = Target AUC \\[mg\\*min/mL\\]\\*GFR \\[mL/min\\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab-matched placebo as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days)."}], 'classes': [{'title': 'Total Carboplatin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '58.70', 'spread': 'NA', 'comment': 'Here NA signifies that standard deviation could not be determined because only one participant was analyzed.', 'groupId': 'OG000'}, {'value': '77.05', 'spread': '8.41', 'groupId': 'OG001'}, {'value': '70.37', 'spread': '10.40', 'groupId': 'OG002'}]}]}, {'title': 'Total Paclitaxel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '12.30', 'spread': '1.27', 'groupId': 'OG001'}, {'value': '16.19', 'spread': '6.41', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 2 Week 1 Day 1: 0-45 hours post-dose (cycle length=21 days)', 'unitOfMeasure': 'microgram hour per liter (mcg*h/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Analysis Set included all participants who have sufficient pharmacokinetic data to derive at least one pharmacokinetic parameter. Pharmacokinetic data was collected and analyzed only for a maximum of 7 participants in this study. Here "overall number of participants analyzed" signifies participants who were analyzed for this outcome measure. Here "number of participants analyzed" signifies participants who were analyzed for this outcome measure for given categories.'}, {'type': 'SECONDARY', 'title': 'T1/2: Terminal Half-life of Total Carboplatin and Total Paclitaxel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1.25 mg/kg Farletuzumab Plus Taxane and Carboplatin', 'description': "Participants received farletuzumab 1.25 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel \\[175 mg/m\\^2\\] or docetaxel \\[75 mg/m\\^2\\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \\[mg\\] = Target AUC \\[mg\\*min/mL\\]\\*GFR \\[mL/min\\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 1.25 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days)."}, {'id': 'OG001', 'title': '2.5 mg/kg Farletuzumab Plus Taxane and Carboplatin', 'description': "Participants received farletuzumab 2.5 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel \\[175 mg/m\\^2\\] or docetaxel \\[75 mg/m\\^2\\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \\[mg\\] = Target AUC \\[mg\\*min/mL\\]\\*GFR \\[mL/min\\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 2.5 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days)."}, {'id': 'OG002', 'title': 'Placebo Plus Taxane and Carboplatin', 'description': "Participants received farletuzumab-matched placebo (0.9% saline) as an IV infusion, weekly followed by taxane (paclitaxel \\[175 mg/m\\^2\\] or docetaxel \\[75 mg/m\\^2\\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \\[mg\\] = Target AUC \\[mg\\*min/mL\\]\\*GFR \\[mL/min\\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab-matched placebo as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days)."}], 'classes': [{'title': 'Total Carboplatin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.94', 'spread': 'NA', 'comment': 'Here NA signifies that standard deviation could not be determined because only one participant was analyzed.', 'groupId': 'OG000'}, {'value': '1.64', 'spread': '0.31', 'groupId': 'OG001'}, {'value': '1.72', 'spread': '0.65', 'groupId': 'OG002'}]}]}, {'title': 'Total Paclitaxel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.55', 'spread': 'NA', 'comment': 'Here NA signifies that standard deviation could not be determined because only one participant was analyzed.', 'groupId': 'OG000'}, {'value': '4.82', 'spread': '2.88', 'groupId': 'OG001'}, {'value': '4.78', 'spread': '3.24', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 2 Week 1 Day 1: 0-45 hours post-dose (cycle length=21 days)', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Analysis Set included all participants who have sufficient pharmacokinetic data to derive at least one pharmacokinetic parameter. Pharmacokinetic data was collected and analyzed only for a maximum of 7 participants in this study. Here "overall number of participants analyzed" signifies participants who were analyzed for this outcome measure. Here "number of participants analyzed" signifies participants who were analyzed for this outcome measure for given categories.'}, {'type': 'SECONDARY', 'title': 'CL: Clearance of Total Carboplatin and Total Paclitaxel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1.25 mg/kg Farletuzumab Plus Taxane and Carboplatin', 'description': "Participants received farletuzumab 1.25 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel \\[175 mg/m\\^2\\] or docetaxel \\[75 mg/m\\^2\\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \\[mg\\] = Target AUC \\[mg\\*min/mL\\]\\*GFR \\[mL/min\\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 1.25 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days)."}, {'id': 'OG001', 'title': '2.5 mg/kg Farletuzumab Plus Taxane and Carboplatin', 'description': "Participants received farletuzumab 2.5 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel \\[175 mg/m\\^2\\] or docetaxel \\[75 mg/m\\^2\\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \\[mg\\] = Target AUC \\[mg\\*min/mL\\]\\*GFR \\[mL/min\\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 2.5 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days)."}, {'id': 'OG002', 'title': 'Placebo Plus Taxane and Carboplatin', 'description': "Participants received farletuzumab-matched placebo (0.9% saline) as an IV infusion, weekly followed by taxane (paclitaxel \\[175 mg/m\\^2\\] or docetaxel \\[75 mg/m\\^2\\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \\[mg\\] = Target AUC \\[mg\\*min/mL\\]\\*GFR \\[mL/min\\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab-matched placebo as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days)."}], 'classes': [{'title': 'Total Carboplatin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6.65', 'spread': 'NA', 'comment': 'Here NA signifies that standard deviation could not be determined because only one participant was analyzed.', 'groupId': 'OG000'}, {'value': '8.77', 'spread': '2.02', 'groupId': 'OG001'}, {'value': '7.21', 'spread': '2.40', 'groupId': 'OG002'}]}]}, {'title': 'Total Paclitaxel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '24.80', 'spread': '1.27', 'groupId': 'OG001'}, {'value': '21.00', 'spread': '11.08', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 2 Week 1 Day 1: 0-45 hours post-dose (cycle length=21 days)', 'unitOfMeasure': 'liter per hour (L/h)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Analysis Set included all participants who have sufficient pharmacokinetic data to derive at least one pharmacokinetic parameter. Pharmacokinetic data was collected and analyzed only for a maximum of 7 participants in this study. Here "overall number of participants analyzed" signifies participants who were analyzed for this outcome measure. Here "number of participants analyzed" signifies participants who were analyzed for this outcome measure for given categories.'}, {'type': 'SECONDARY', 'title': 'Vd: Volume of Distribution of Total Carboplatin and Total Paclitaxel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1.25 mg/kg Farletuzumab Plus Taxane and Carboplatin', 'description': "Participants received farletuzumab 1.25 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel \\[175 mg/m\\^2\\] or docetaxel \\[75 mg/m\\^2\\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \\[mg\\] = Target AUC \\[mg\\*min/mL\\]\\*GFR \\[mL/min\\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 1.25 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days)."}, {'id': 'OG001', 'title': '2.5 mg/kg Farletuzumab Plus Taxane and Carboplatin', 'description': "Participants received farletuzumab 2.5 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel \\[175 mg/m\\^2\\] or docetaxel \\[75 mg/m\\^2\\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \\[mg\\] = Target AUC \\[mg\\*min/mL\\]\\*GFR \\[mL/min\\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 2.5 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days)."}, {'id': 'OG002', 'title': 'Placebo Plus Taxane and Carboplatin', 'description': "Participants received farletuzumab-matched placebo (0.9% saline) as an IV infusion, weekly followed by taxane (paclitaxel \\[175 mg/m\\^2\\] or docetaxel \\[75 mg/m\\^2\\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \\[mg\\] = Target AUC \\[mg\\*min/mL\\]\\*GFR \\[mL/min\\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab-matched placebo as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days)."}], 'classes': [{'title': 'Total Carboplatin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '28.20', 'spread': 'NA', 'comment': 'Here NA signifies that standard deviation could not be determined because only one participant was analyzed.', 'groupId': 'OG000'}, {'value': '20.30', 'spread': '0.85', 'groupId': 'OG001'}, {'value': '14.86', 'spread': '5.51', 'groupId': 'OG002'}]}]}, {'title': 'Total Paclitaxel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '169.50', 'spread': '94.05', 'groupId': 'OG001'}, {'value': '110.23', 'spread': '52.34', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 2 Week 1 Day 1: 0-45 hours post-dose (cycle length=21 days)', 'unitOfMeasure': 'liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Analysis Set included all participants who have sufficient pharmacokinetic data to derive at least one pharmacokinetic parameter. Pharmacokinetic data was collected and analyzed only for a maximum of 7 participants in this study. Here "overall number of participants analyzed" signifies participants who were analyzed for this outcome measure. Here "number of participants analyzed" signifies participants who were analyzed for this outcome measure for given categories.'}, {'type': 'SECONDARY', 'title': 'Mean Functional Assessment of Cancer Therapy-Ovarian Treatment Outcome Index (FACT-O TOI) Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '644', 'groupId': 'OG000'}, {'value': '300', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants: Farletuzumab', 'description': "Participants received farletuzumab 1.25 or 2.5 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel \\[175 mg/m\\^2\\] or docetaxel \\[75 mg/m\\^2\\]) as IV infusion and carboplatin dose to achieve at AUC 5 or 6 mg/min/mL (carboplatin dose \\[mg\\] = Target AUC (mg\\*min/mL)\\*(GFR \\[mL/min\\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 1.25 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days)."}, {'id': 'OG001', 'title': 'Placebo Plus Taxane and Carboplatin', 'description': "Participants received farletuzumab-matched placebo (0.9% saline) as an IV infusion, weekly followed by taxane (paclitaxel \\[175 mg/m\\^2\\] or docetaxel \\[75 mg/m\\^2\\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \\[mg\\] = Target AUC \\[mg\\*min/mL\\]\\*GFR \\[mL/min\\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab-matched placebo as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days)."}], 'classes': [{'title': 'Cycle 3', 'categories': [{'measurements': [{'value': '69.6', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '70.7', 'spread': '1.1', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 6', 'categories': [{'measurements': [{'value': '70.1', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '70.7', 'spread': '1.1', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 12', 'categories': [{'measurements': [{'value': '76.2', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '72.9', 'spread': '2.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 3, Cycle 6, Cycle 12 (each cycle length=21 days)', 'description': 'Participant-reported Quality of Life (QoL) was measured using the Functional Assessment of Cancer Therapy-Ovarian (FACT-O), version 4 and reported in the Treatment Outcome Index (TOI) format. TOI is a 26-item subset of the FACT-O questionnaire composed of the raw sum of the physical well-being subscale (7 items), the functional well-being subscale (7 items), and the ovarian cancer subscale (12 items). Each item was scored on a scale of 0 (not at all) to 4 (very much). Some items were reversed scored. Scores from each subsection were summed into one composite score, termed the FACT-O TOI score which ranged from 0 to 104 and a higher score reflected better QoL. As per planned analysis, farletuzumab treatment groups 1.25 mg/kg and 2.5 mg/kg were pooled for the QoL assessment.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The population comprised of all evaluable participants who received at least one dose of farletuzumab or placebo, with study treatment assignment designated according to the IWRS/IVRS, and who completed a baseline FACT-O assessment and at least one follow-up FACT-O assessment during the study. Here "overall number of participants analyzed" signifies participants who were analyzed for this outcome measure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '1.25 mg/kg Farletuzumab Plus Taxane and Carboplatin', 'description': "Participants received farletuzumab 1.25 milligram per kilogram (mg/kg) as an intravenous (IV) infusion, weekly followed by taxane (paclitaxel \\[175 milligram per meter square {mg/m\\^2}\\] or docetaxel \\[75 mg/m\\^2\\]) as IV infusion and carboplatin dose to achieve area under curve (AUC) 5 or 6 milligram per minute per milliliter (mg/min/mL) (carboplatin dose \\[milligram {mg}\\] = Target AUC \\[mg\\*min/mL\\]\\*glomerular filtration rate \\[GFR\\] milliliter per minute \\[mL/min\\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 1.25 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days)."}, {'id': 'FG001', 'title': '2.5 mg/kg Farletuzumab Plus Taxane and Carboplatin', 'description': "Participants received farletuzumab 2.5 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel \\[175 mg/m\\^2\\] or docetaxel \\[75 mg/m\\^2\\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \\[mg\\] = Target AUC \\[mg\\*min/mL\\]\\*GFR \\[mL/min\\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 2.5 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days)."}, {'id': 'FG002', 'title': 'Placebo Plus Taxane and Carboplatin', 'description': "Participants received farletuzumab-matched placebo (0.9 percent \\[%\\] saline) as an IV infusion, weekly followed by taxane (paclitaxel \\[175 mg/m\\^2\\] or docetaxel \\[75 mg/m\\^2\\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \\[mg\\] = Target AUC \\[mg\\*min/mL\\]\\*GFR \\[mL/min\\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab-matched placebo as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days)."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '370'}, {'groupId': 'FG001', 'numSubjects': '366'}, {'groupId': 'FG002', 'numSubjects': '364'}]}, {'type': 'Safety Analysis Set', 'achievements': [{'groupId': 'FG000', 'numSubjects': '376'}, {'groupId': 'FG001', 'numSubjects': '363'}, {'groupId': 'FG002', 'numSubjects': '352'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '370'}, {'groupId': 'FG001', 'numSubjects': '366'}, {'groupId': 'FG002', 'numSubjects': '364'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '33'}, {'groupId': 'FG002', 'numSubjects': '35'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '18'}]}, {'type': 'Progressive disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '119'}, {'groupId': 'FG001', 'numSubjects': '100'}, {'groupId': 'FG002', 'numSubjects': '112'}]}, {'type': 'Sponsor decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '208'}, {'groupId': 'FG001', 'numSubjects': '204'}, {'groupId': 'FG002', 'numSubjects': '190'}]}, {'type': 'Investigator discretion', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants took part in the study at 274 investigative sites in North America, Europe, Asia Pacific, Latin America, and Japan from 16 April 2009 to 12 April 2013.', 'preAssignmentDetails': 'A total of 1100 participants were randomized and enrolled, out of which 1091 participants received study treatment. Study was terminated early due to lack of efficacy based on the results for progression-free survival (PFS).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '370', 'groupId': 'BG000'}, {'value': '366', 'groupId': 'BG001'}, {'value': '364', 'groupId': 'BG002'}, {'value': '1100', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': '1.25 mg/kg Farletuzumab Plus Taxane and Carboplatin', 'description': "Participants received farletuzumab 1.25 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel \\[175 mg/m\\^2\\] or docetaxel \\[75 mg/m\\^2\\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \\[mg\\] = Target AUC \\[mg\\*min/mL\\]\\*GFR \\[mL/min\\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 1.25 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days)."}, {'id': 'BG001', 'title': '2.5 mg/kg Farletuzumab Plus Taxane and Carboplatin', 'description': "Participants received farletuzumab 2.5 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel \\[175 mg/m\\^2\\] or docetaxel \\[75 mg/m\\^2\\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \\[mg\\] = Target AUC \\[mg\\*min/mL\\]\\*GFR \\[mL/min\\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 2.5 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days)."}, {'id': 'BG002', 'title': 'Placebo Plus Taxane and Carboplatin', 'description': "Participants received farletuzumab-matched placebo (0.9% saline) as an IV infusion, weekly followed by taxane (paclitaxel \\[175 mg/m\\^2\\] or docetaxel \\[75 mg/m\\^2\\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \\[mg\\] = Target AUC \\[mg\\*min/mL\\]\\*GFR \\[mL/min\\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab-matched placebo as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days)."}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.3', 'spread': '10.35', 'groupId': 'BG000'}, {'value': '58.3', 'spread': '10.26', 'groupId': 'BG001'}, {'value': '59.0', 'spread': '10.22', 'groupId': 'BG002'}, {'value': '58.6', 'spread': '10.27', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '370', 'groupId': 'BG000'}, {'value': '366', 'groupId': 'BG001'}, {'value': '364', 'groupId': 'BG002'}, {'value': '1100', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '97', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '331', 'groupId': 'BG000'}, {'value': '321', 'groupId': 'BG001'}, {'value': '331', 'groupId': 'BG002'}, {'value': '983', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}, {'value': '247', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '272', 'groupId': 'BG000'}, {'value': '271', 'groupId': 'BG001'}, {'value': '268', 'groupId': 'BG002'}, {'value': '811', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Intent-to-Treat (ITT) population included all participants randomly assigned to treatment, according to the treatment assigned by the interactive web or voice response randomization system (IWRS/IVRS).'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1100}}, 'statusModule': {'whyStopped': 'Lack of efficacy', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-04-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'dispFirstSubmitDate': '2015-06-25', 'completionDateStruct': {'date': '2013-04-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-05', 'studyFirstSubmitDate': '2009-02-13', 'dispFirstSubmitQcDate': '2015-06-25', 'resultsFirstSubmitDate': '2022-12-05', 'studyFirstSubmitQcDate': '2009-02-20', 'dispFirstPostDateStruct': {'date': '2015-07-20', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2022-12-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-12-05', 'studyFirstPostDateStruct': {'date': '2009-02-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-12-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free Survival (PFS)', 'timeFrame': 'From the date of randomization to the date of first documentation of disease progression, or date of death, whichever occurred first (up to 44 months)', 'description': 'PFS was defined as the time (in months) from the date of randomization to the date of the first observation of progression based on the independent radiologic assessment (modified response evaluation criteria in solid tumors \\[RECIST\\]), or date of death, whatever the cause. As per RECIST, disease progression was defined as at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the baseline sum of diameters of target lesions. If progression or death was not observed for a participant, the PFS time was censored at the date of the last tumor assessment without evidence of progression before the date of initiation of further antitumor treatment, or the cutoff date (whichever was earlier).'}], 'secondaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': 'From the date of randomization until date of death from any cause, or study termination by sponsor, whichever came first (up to 48 months)', 'description': 'OS was defined as the time (in months) from the date of randomization to the date of death, due to any cause. If death was not observed for a participant, the survival time was censored on the last date the participant was known to be alive or the cutoff date, whichever was earlier.'}, {'measure': 'Cancer Antigen-125 (CA-125) Progression-Free Survival', 'timeFrame': 'From the date of randomization to the date of first documentation of disease progression, or date of death, whichever occurred first (up to 44 months)', 'description': 'CA-125 PFS was defined as the time (in months) from the date of randomization until the date of the first observation of progression based on the Rustin criteria, or date of death, whatever the cause. If progression or death was not observed for a participant, the CA-125 PFS time was censored at the date of the last CA-125 assessment without evidence of progression before the date of initiation of further antitumor treatment or the "primary analysis cut off" date, whichever was earlier. Based on Rustin criteria, progressive disease (PD) was a rise in CA125 since beginning of consolidation or previously normal CA125 that rises to greater than or equal to (\\>=) 2 multiple (\\*) ULN with either event documented on two occasions or CA-125 \\>=2\\*nadir value with either event documented on two occasions.'}, {'measure': 'Progression-Free Survival Based on Gynecologic Cancer InterGroup (GCIG) Criteria', 'timeFrame': 'From the date of randomization to the date of first documentation of disease progression, or date of death, whichever occurred first (up to 44 months)', 'description': 'PFS using GCIG criteria was defined as time (in months) from date of randomization until date of first observation of progression based on GCIG criteria, or date of death, whatever the cause. If progression or death was not observed for a participant, GCIG PFS time was censored at later date of last tumor assessment or CA-125 assessment without evidence of progression before date of initiation of further antitumor treatment or the "primary analysis cut off" date, whichever was earlier. Disease progression per GCIG: Participants with elevated CA-125 pretreatment and normalisation of CA-125 must show evidence of CA-125 \\>=two times ULN on two occasions at least one week apart or participants with elevated CA-125 pretreatment, which never normalises must show evidence of CA-125 \\>=two times nadir value on two occasions at least one week apart or participants with CA-125 in normal range pretreatment must show evidence of CA-125 \\>=two times ULN on two occasions at least one week apart.'}, {'measure': 'Percentage of Participants With Length of Second Remission Greater Than First Remission', 'timeFrame': 'From the date of last dose of platinum-based chemotherapy to date of relapse and date of last dose of platinum-based chemotherapy to first observation of progression (up to 48 months)', 'description': 'Length of first remission was defined as a.) the period of time (in months) from the date of completion of previous platinum-based chemotherapy until date of first relapse (that is, first observation of progression). It was assumed that the date of first relapse was the earlier of progression by CA-125 or progression by radiologic assessment, as judged by the investigator using GCIG criteria. b.) the period of time (in months) from the date of completion of previous platinum-based chemotherapy (used prior to study entry) until date of randomization. The length of the second remission was defined as the period of time (in months) from the date of completion of platinum-based chemotherapy until the first observation of progression based on GCIG criteria. Based on GCIG criteria, disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the baseline sum of diameters of target lesions.'}, {'measure': 'Percentage of Participants With Objective Response', 'timeFrame': 'From the date of randomization to the date of first documentation of disease progression, or date of death, whichever occurred first (up to 48 months)', 'description': 'Objective response was defined as either a confirmed complete response (CR) or confirmed partial response (PR) as assessed by investigator based on response evaluation criteria in solid tumors version 1.1 (RECIST version 1.1). CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis less than (\\<) 10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters.'}, {'measure': 'Duration of Tumor Response', 'timeFrame': 'From the first date of confirmed objective response (CR or PR) to first date of progression or death due to any cause (up to 48 months)', 'description': 'Duration of response was defined as the time (in months) from first documentation of objective response (confirmed CR or PR) to the first documentation of objective tumor progression or death due to any cause. Duration of response was derived only for those participants with objective evidence of confirmed CR or PR.'}, {'measure': 'Time to Tumor Response (TTR)', 'timeFrame': 'From the date of randomization to first documentation of objective response (up to 48 months)', 'description': 'Time to tumor response was defined as the time (in months) from the date of randomization to first documentation of objective tumor response. Time to tumor response was derived for those participants with objective evidence of CR or PR.'}, {'measure': 'Percentage of Participants With Serologic Response (SR)', 'timeFrame': 'Up to 48 months', 'description': 'SR was defined as either normalization, 75% response, or 50% response using the Rustin criteria. Percentage of participants with 50% SR, 75% SR and SR leading to normalization were reported. A 50% response according to CA-125 was defined as a 50% decrease in serum CA-125 levels, as determined through a series of four CA-125 samples (one baseline sample with an elevated level, the sample that showed a 50% decrease, and a confirmatory sample at the decreased level). A 75% response was established if there had a serial decrease in serum CA-125 levels of 75% over three samples. In both the 50% and 75% response definitions, the final sample was analyzed at least 28 days after the previous sample.'}, {'measure': 'Duration of 50% Serologic Response', 'timeFrame': 'From the first date of documentation of response to first documentation of serologic progression or death due to any cause (up to 48 months)', 'description': 'Duration of SR was defined as the time (in months) from first documentation of response to the first documentation of 50% serologic progression or death due to any cause. For responding participants who did not have serologic progression or did not die and who 1) were either still on study at the time of an analysis, 2) were given antitumor treatment other than study treatment, or 3) were withdrawn from study follow-up before documentation of serologic progression, the duration of SR was censored at the last date the participant was known to be without serologic progression. A 50% response according to CA-125 was defined as a 50% decrease in serum CA-125 levels, as determined through a series of three CA-125 samples (one baseline sample with an elevated level, the sample that showed a 50% decrease, and a confirmatory sample at the decreased level).'}, {'measure': 'Time to 50% Serologic Response (TSR)', 'timeFrame': 'From the date of randomization to first documentation of 50% SR (up to 48 months)', 'description': 'TSR was defined as the time (in months) from the date of randomization to first documentation of 50% SR. A 50% response according to CA-125 was defined as a 50% decrease in serum CA-125 levels, as determined through a series of three CA-125 samples (one baseline sample with an elevated level, the sample that showed a 50% decrease, and a confirmatory sample at the decreased level).'}, {'measure': 'Percentage of Participants With Clinical Benefit', 'timeFrame': 'Up to 48 months', 'description': 'Clinical benefit was defined as a confirmed CR or a confirmed PR, or stable disease (SD) using RECIST 1.0 criteria. CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis \\<10 mm. PR was defined as at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease taking as reference smallest sum of longest dimensions since treatment started associated to non-progressive disease response for non target lesions.'}, {'measure': 'Cmax: Maximum Observed Plasma Concentration of Total Carboplatin and Total Paclitaxel', 'timeFrame': 'Cycle 2 Week 1 Day 1: 0-45 hours post-dose (cycle length=21 days)'}, {'measure': 'Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) of Total Carboplatin and Total Paclitaxel', 'timeFrame': 'Cycle 2 Week 1 Day 1: 0-45 hours post-dose (cycle length=21 days)'}, {'measure': 'AUC (0-inf): Area Under the Concentration-time Curve From Zero (Pre-dose) Extrapolated to Infinite Time of Total Carboplatin and Total Paclitaxel', 'timeFrame': 'Cycle 2 Week 1 Day 1: 0-45 hours post-dose (cycle length=21 days)'}, {'measure': 'T1/2: Terminal Half-life of Total Carboplatin and Total Paclitaxel', 'timeFrame': 'Cycle 2 Week 1 Day 1: 0-45 hours post-dose (cycle length=21 days)'}, {'measure': 'CL: Clearance of Total Carboplatin and Total Paclitaxel', 'timeFrame': 'Cycle 2 Week 1 Day 1: 0-45 hours post-dose (cycle length=21 days)'}, {'measure': 'Vd: Volume of Distribution of Total Carboplatin and Total Paclitaxel', 'timeFrame': 'Cycle 2 Week 1 Day 1: 0-45 hours post-dose (cycle length=21 days)'}, {'measure': 'Mean Functional Assessment of Cancer Therapy-Ovarian Treatment Outcome Index (FACT-O TOI) Scores', 'timeFrame': 'Cycle 3, Cycle 6, Cycle 12 (each cycle length=21 days)', 'description': 'Participant-reported Quality of Life (QoL) was measured using the Functional Assessment of Cancer Therapy-Ovarian (FACT-O), version 4 and reported in the Treatment Outcome Index (TOI) format. TOI is a 26-item subset of the FACT-O questionnaire composed of the raw sum of the physical well-being subscale (7 items), the functional well-being subscale (7 items), and the ovarian cancer subscale (12 items). Each item was scored on a scale of 0 (not at all) to 4 (very much). Some items were reversed scored. Scores from each subsection were summed into one composite score, termed the FACT-O TOI score which ranged from 0 to 104 and a higher score reflected better QoL. As per planned analysis, farletuzumab treatment groups 1.25 mg/kg and 2.5 mg/kg were pooled for the QoL assessment.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ovarian cancer', 'relapsed ovarian cancer', 'Platinum-sensitive Ovarian Cancer'], 'conditions': ['Ovarian Cancer']}, 'descriptionModule': {'briefSummary': 'This research is being done to find out if Carboplatin and Taxane works better alone or when given with an experimental drug called MORAb-003(farletuzumab) in subjects with first platinum sensitive relapsed ovarian cancer.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A histologically or cytologically confirmed diagnosis of non-mucinous epithelial ovarian cancer including primary peritoneal or fallopian tube malignancies\n* Must have measurable disease by CT or MRI scan\n* Must have relapsed radiologically with a randomization date within ≥6 and \\< 24 months of completion of first-line platinum chemotherapy\n* Have been treated with debulking surgery and first-line platinum and taxane based chemotherapy.\n* Prior bevacizumbab maintenance is allowed. The last dose of bevacizumab must have been at least 30 days before study Day 1. No cytotoxic maintenance therapy (e.g. taxane) or cancer vaccine therapy is allowed.\n* Must be a candidate for carboplatin and taxane therapy\n* Neurologic function: neuropathy (sensory and motor) ≤CTCAE Grade 1\n\nExclusion Criteria:\n\n* Subjects who never responded to first-line platinum-based therapy or whose first relapse occurs \\<6 months or \\>24 months from the last platinum therapy\n* Subjects who have received other therapy to treat their ovarian cancer since relapse\n* Known central nervous system (CNS) tumor involvement\n* Evidence of other active invasive malignancy requiring treatment in the past 5 years\n* Known allergic reaction to a prior monoclonal antibody therapy or have any documented HAHA\n* Previous treatment with MORAb-003 (farletuzumab)\n* Clinical contraindications to use of a taxane'}, 'identificationModule': {'nctId': 'NCT00849667', 'briefTitle': 'Efficacy and Safety of Farletuzumab (MORAb-003) in Combination With Carboplatin and Taxane in Participants With Platinum-sensitive Ovarian Cancer in First Relapse', 'organization': {'class': 'INDUSTRY', 'fullName': 'Morphotek'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study to Assess the Efficacy and Safety of Weekly Farletuzumab (MORAb-003) in Combination With Carboplatin and Taxane in Subjects With Platinum-sensitive Ovarian Cancer in First Relapse', 'orgStudyIdInfo': {'id': 'MORAb003-004'}, 'secondaryIdInfos': [{'id': '2008-005872-29', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Farletuzumab (1.25 mg/kg)', 'description': 'Participants will receive farletuzumab 1.25 milligram per kilogram (mg/kg) administer as an intravenous (IV) infusion weekly, followed by taxane (paclitaxel \\[175 milligram per meter square {mg/m\\^2}\\] or docetaxel \\[75 mg/m\\^2\\]), administer as IV infusion and followed by carboplatin (to maintain area under curve \\[AUC\\] 5-6 milligram per milliliter per minute \\[mg/mL/minute\\]), administer as IV infusion, every three weeks, on Day 1 of each 21-day cycle for 6 cycles (combination therapy). Following completion of combination therapy, maintenance treatment with farletuzumab 1.25 mg/kg, administer as IV infusion, weekly is given until disease progression.', 'interventionNames': ['Drug: Farletuzumab', 'Drug: Carboplatin', 'Drug: Taxane']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Farletuzumab (2.5 mg/kg)', 'description': 'Participants will receive farletuzumab 2.5 mg/kg administer as an IV infusion weekly, followed by taxane (paclitaxel \\[175 mg/m\\^2\\] or docetaxel \\[75 mg/m\\^2\\]), administer as IV infusion and followed by carboplatin (to maintain AUC 5-6 mg/mL/minute), administer as IV infusion, every three weeks on Day 1 of each 21-day cycle for 6 cycles (combination therapy). Following completion of combination therapy, maintenance treatment with farletuzumab 2.5 mg/kg, administer as IV infusion, weekly is given until disease progression.', 'interventionNames': ['Drug: Farletuzumab', 'Drug: Carboplatin', 'Drug: Taxane']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will receive farletuzumab-matched placebo (0.9 percent \\[%\\] saline) administer as an IV infusion weekly, followed by taxane (paclitaxel \\[175 mg/m\\^2\\] or docetaxel \\[75 mg/m\\^2\\]), administer as IV infusion and followed by carboplatin (to maintain AUC 5-6 mg/mL/minute), administer as IV infusion, every three weeks on Day 1 of each 21-day cycle for 6 cycles (combination therapy). Following completion of combination therapy, maintenance treatment with farletuzumab-matched placebo (0.9% saline), administer as IV infusion, weekly is given until disease progression.', 'interventionNames': ['Drug: Carboplatin', 'Drug: Taxane', 'Drug: Farletuzumab-matched placebo']}], 'interventions': [{'name': 'Farletuzumab', 'type': 'DRUG', 'otherNames': ['MORAb-003'], 'description': 'Farletuzumab IV infusion.', 'armGroupLabels': ['Farletuzumab (1.25 mg/kg)', 'Farletuzumab (2.5 mg/kg)']}, {'name': 'Carboplatin', 'type': 'DRUG', 'description': 'Carboplatin IV infusion.', 'armGroupLabels': ['Farletuzumab (1.25 mg/kg)', 'Farletuzumab (2.5 mg/kg)', 'Placebo']}, {'name': 'Taxane', 'type': 'DRUG', 'description': 'Taxane (Paclitaxel or Docetaxel) IV infusion.', 'armGroupLabels': ['Farletuzumab (1.25 mg/kg)', 'Farletuzumab (2.5 mg/kg)', 'Placebo']}, {'name': 'Farletuzumab-matched placebo', 'type': 'DRUG', 'description': 'Farletuzumab-matched placebo IV infusion.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University Of Alabama At Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35801', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Oncology Specialties, PC', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '85012', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Hematology & Oncology Associates', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85013', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': "St. Joseph's Hospital, Barrow Neurology Clinics", 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85712', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Oncology Associates', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Cancer Center', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '91505', 'city': 'Burbank', 'state': 'California', 'country': 'United States', 'facility': 'Providence St. Joseph Medical Center', 'geoPoint': {'lat': 34.18084, 'lon': -118.30897}}, {'zip': '94904', 'city': 'Greenbrae', 'state': 'California', 'country': 'United States', 'facility': 'California Cancer Care, Inc.', 'geoPoint': {'lat': 37.94854, 'lon': -122.5247}}, {'zip': '92093-0698', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Diego', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of California Los Angeles Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92663', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'Gynecologic Oncology Associates', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'University of California Davis Cancer Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80907', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'Catholic Health Initiatives', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '80204', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Denver Health and Hospital Authority', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '06902', 'city': 'Stamford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Hematology Oncology P.C.', 'geoPoint': {'lat': 41.05343, 'lon': -73.53873}}, {'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Washington Hospital Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33435', 'city': 'Boynton Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Palm Beach Institute of Hematology and Oncology', 'geoPoint': {'lat': 26.52535, 'lon': -80.06643}}, {'zip': '33435', 'city': 'Boynton Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'University Cancer Institute', 'geoPoint': {'lat': 26.52535, 'lon': -80.06643}}, {'zip': '32605', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'Gainsville Hematology Oncology Associates', 'geoPoint': {'lat': 29.65163, 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