Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2026-01-24 @ 11:00 PM
Study NCT ID:
NCT02004093
Status:
COMPLETED
Last Update Posted:
2014-12-04
First Post:
2013-12-03
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate the Effect of the Combination of Pertuzumab With Carboplatin-Based Standard Chemotherapy in Patients With Recurrent Ovarian Cancer
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': 'C485206', 'term': 'pertuzumab'}, {'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'D016190', 'term': 'Carboplatin'}], 'ancestors': [{'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D056831', 'term': 'Coordination Complexes'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'genentech@druginfo.com', 'phone': '800-821-8590', 'title': 'Medical Communications', 'organization': 'Hoffmann- LaRoche'}, 'certainAgreement': {'otherDetails': "The study being conducted under this agreement is part of the overall study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the study, but after the first publication or presentation that involves the overall study. Sponsor may request that confidential information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected from the date of randomization until 28 days after the last dose of the pertuzumab and/ or standard chemotherapy and continuously until end of study.', 'eventGroups': [{'id': 'EG000', 'title': 'Chemotherapy + Pertuzumab', 'description': 'Participants received loading dose of 840mg IV Pertuzumab, followed by 420 mg IV every 3 weeks (for a total of 17 cycles), along with chemotherapy with either Paclitaxel or Gemcitabine. Paclitaxel dosage was 175 mg/m2 IV every 3 weeks for 6 cycles, followed by Carboplatin AUC of 5; Gemcitabine dosage was 1000 mg/m2 IV on day 1 and 8 of each cycle for 6 cycles followed by Carboplatin AUC of 4, IV every 3 weeks for 6 cycles.', 'otherNumAtRisk': 75, 'otherNumAffected': 72, 'seriousNumAtRisk': 75, 'seriousNumAffected': 20}, {'id': 'EG001', 'title': 'Chemotherapy', 'description': 'Participants received chemotherapy with either Paclitaxel or Gemcitabine. Paclitaxel dosage was 175 mg/m2 IV every 3 weeks for 6 cycles followed by Carboplatin AUC of 5; Gemcitabine dosage was 1000 mg/ m2 IV on day 1 and 8 of each cycle for 6 cycles followed by Carboplatin AUC of 4, IV every 3 weeks for 6 cycles.', 'otherNumAtRisk': 74, 'otherNumAffected': 68, 'seriousNumAtRisk': 74, 'seriousNumAffected': 12}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 33}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 22}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 22}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Hemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA13.1'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 43}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 21}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 18}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 12}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 27}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 25}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 7}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 9}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Nail disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Lethargy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Drug hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 13}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Phlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Vaginal discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}], 'seriousEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Ileus paralytic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Large intesting perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Local swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Drug hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Diaphragmatic hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Left ventricular dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Hepatic lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Disease Progression or Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Chemotherapy + Pertuzumab', 'description': 'Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles.\n\nPertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER:1) paclitaxel 175 mg/m\\^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m\\^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.'}, {'id': 'OG001', 'title': 'Chemotherapy', 'description': 'Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m\\^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m\\^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.'}], 'classes': [{'categories': [{'measurements': [{'value': '87.8', 'groupId': 'OG000'}, {'value': '80.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression up to 104 weeks', 'description': 'Disease progression was assessed according to RECIST (Response Evaluation Criteria In Solid Tumors), for participants with measurable disease, or by changes in CA 125 (Cancer Antigen 125) according to GCIG (Gynecologic Cancer Inter Group) for all participants. Participants who did not progress or died while being followed were censored at the time of the last valid tumor assessment or valid CA 125 assessment.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants who received Randomized Treatment (All Treated Population, for Efficacy Analyses) were included in analysis.'}, {'type': 'PRIMARY', 'title': 'Progression-Free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Chemotherapy + Pertuzumab', 'description': 'Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles.\n\nPertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER:1) paclitaxel 175 mg/m\\^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m\\^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.'}, {'id': 'OG001', 'title': 'Chemotherapy', 'description': 'Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m\\^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m\\^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.'}], 'classes': [{'categories': [{'measurements': [{'value': '34.1', 'groupId': 'OG000', 'lowerLimit': '31', 'upperLimit': '38'}, {'value': '40.0', 'groupId': 'OG001', 'lowerLimit': '33', 'upperLimit': '43'}]}]}], 'analyses': [{'pValue': '0.3967', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.4552', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.3972', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '1.17', 'ciLowerLimit': '0.92', 'ciUpperLimit': '1.49', 'pValueComment': 'p-value resulting from Wald test of null hypothesis that the hazard ratio equals (=) 1', 'statisticalMethod': 'Wald test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression up to 104 weeks', 'description': 'Progression-free survival was defined as the time from first administration of study drug (Study Day 1) to documented disease progression or death, whichever occurred earlier. Disease progression was assessed according to RECIST, for participants with measurable disease, or by changes in CA 125 according to GCIG for all participants. Participants who did not progress or died while being followed were censored at the time of the last valid tumor assessment or valid CA 125 assessment.', 'unitOfMeasure': 'weeks', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated patients who received Randomized Treatment (All Treated Population, for Efficacy Analyses) were included in analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Best Overall Confirmed Response Based on Combined CA 125 and RECIST Measurements', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Chemotherapy + Pertuzumab', 'description': 'Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles.\n\nPertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER:1) paclitaxel 175 mg/m\\^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m\\^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.'}, {'id': 'OG001', 'title': 'Chemotherapy', 'description': 'Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m\\^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m\\^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.'}], 'classes': [{'categories': [{'measurements': [{'value': '74.3', 'groupId': 'OG000'}, {'value': '68.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.3943', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Response Rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '6.32', 'ciLowerLimit': '-3.9', 'ciUpperLimit': '16.6', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '1.36', 'ciLowerLimit': '0.86', 'ciUpperLimit': '2.17', 'estimateComment': 'approximate 80% confidence interval (CI) for difference of two rates using Hauck-Anderson method', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression up to 104 weeks', 'description': 'Response by tumor measurement occurred if there was documented and confirmed complete response (CR) or partial response (PR). For all participants, response was assessed by both the RECIST and by CA 125 levels, according to whether the participant had measurable or non-measurable disease at baseline. Response according to CA 125 levels was defined as at least a 50% reduction from baseline. The decrease had to be confirmed and maintained for at least 28 days. The confirmatory sample must have been less than or equal to the previous sample (within an assay variability of 10%). For overall response, the response categories were "response", "stable disease" and "progressive disease". Stable disease included 1) stable disease as defined by RECIST for solid tumors and 2) CA 125 levels that had not met the definition of "response" or "progressive disease".', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated patients who received Randomized Treatment (All Treated Population, for Efficacy Analyses) were included in analysis.'}, {'type': 'SECONDARY', 'title': 'Duration of Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Chemotherapy + Pertuzumab', 'description': 'Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles.Pertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER:1) paclitaxel 175 mg/m\\^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m\\^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off'}, {'id': 'OG001', 'title': 'Chemotherapy', 'description': 'Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m\\^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m\\^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.'}], 'classes': [{'categories': [{'measurements': [{'value': '28.7', 'groupId': 'OG000', 'lowerLimit': '22', 'upperLimit': '48'}, {'value': '37.0', 'groupId': 'OG001', 'lowerLimit': '25', 'upperLimit': '43'}]}]}], 'analyses': [{'pValue': '0.3655', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.1319', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.3679', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '1.22', 'ciLowerLimit': '0.92', 'ciUpperLimit': '1.61', 'statisticalMethod': 'Wald test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value resulting from Wald test of null hypothesis that the hazard ratio=1', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 15 of Cycles 2, 4, 6, and Day 15 of all Cycles from Cycle 7 to 17 until disease progression up to 104 weeks', 'description': 'For participants who achieved a response, the duration of response was defined as the interval between initial documentation of response to the first documentation of disease progression or death. Participants who responded and did not progress or die while on study or while being followed were censored at the last valid tumor or CA 125 measurement.', 'unitOfMeasure': 'weeks', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants with a response were included in the analysis; 8 participants and 13 participants were censored in the chemotherapy + pertuzumab and chemotherapy only treatment groups, respectively.'}, {'type': 'SECONDARY', 'title': 'Kaplan-Meier Probability of Maintaining a Response to at Least 1 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Chemotherapy + Pertuzumab', 'description': 'Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles.\n\nPertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER: 1) paclitaxel 175 mg/m\\^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m\\^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.'}, {'id': 'OG001', 'title': 'Chemotherapy', 'description': 'Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m\\^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m\\^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 year', 'unitOfMeasure': 'percent', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated patients who received Randomized Treatment (All Treated Population, for Efficacy Analyses) were included in analysis. 7 and 5 participants in the chemotherapy + pertuzumab and chemotherapy treatment groups, respectively, remained at risk.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Disease Progression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Chemotherapy + Pertuzumab', 'description': 'Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles.\n\nPertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER:1) paclitaxel 175 mg/m\\^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m\\^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.'}, {'id': 'OG001', 'title': 'Chemotherapy', 'description': 'Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m\\^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m\\^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.'}], 'classes': [{'categories': [{'measurements': [{'value': '83.8', 'groupId': 'OG000'}, {'value': '76.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression', 'description': 'Disease progression was assessed according to RECIST, for participants with measurable disease, or by changes in CA 125 according to GCIG for all participants. Participants who did not progress while being followed were censored at the time of the last valid tumor assessment or valid CA 125 assessment.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants were included in analysis'}, {'type': 'SECONDARY', 'title': 'Time to Progressive Disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Chemotherapy + Pertuzumab', 'description': 'Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles.\n\nPertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER:1) paclitaxel 175 mg/m\\^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m\\^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.'}, {'id': 'OG001', 'title': 'Chemotherapy', 'description': 'Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m\\^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m\\^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.'}], 'classes': [{'categories': [{'measurements': [{'value': '34.3', 'groupId': 'OG000', 'lowerLimit': '27', 'upperLimit': '48'}, {'value': '37.3', 'groupId': 'OG001', 'lowerLimit': '29', 'upperLimit': '47'}]}]}], 'analyses': [{'pValue': '0.8129', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.6920', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.8137', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '1.04', 'ciLowerLimit': '0.82', 'ciUpperLimit': '1.32', 'statisticalMethod': 'Wald test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value resulting from Wald test of null hypothesis that the hazard ratio=1', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression', 'description': 'The time to progressive disease is the interval of time from date of first dose of study medication to date of first documentation of progressive disease by either RECIST or CA 125 criteria. Participants who never progressed while being followed were censored at the last valid tumor measurement or CA 125 measurement.', 'unitOfMeasure': 'weeks', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated patients with an event (disease progression) were included in analysis'}, {'type': 'SECONDARY', 'title': 'Kaplan-Meier Probability of Being Progression Free at 1 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Chemotherapy + Pertuzumab', 'description': 'Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles.\n\nPertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER:1) paclitaxel 175 mg/m\\^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m\\^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.'}, {'id': 'OG001', 'title': 'Chemotherapy', 'description': 'Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m\\^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m\\^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 year', 'unitOfMeasure': 'percent', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated patients who received Randomized Treatment (All Treated Population, for Efficacy Analyses) were included in analysis. 16 and 10 participants in the chemotherapy + pertuzumab and chemotherapy treatment groups, respectively, remained at risk.'}, {'type': 'PRIMARY', 'title': 'Kaplan-Meier Probability of No Disease or Progression at 1 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Chemotherapy + Pertuzumab', 'description': 'Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles.\n\nPertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER:1) paclitaxel 175 mg/m\\^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m\\^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.'}, {'id': 'OG001', 'title': 'Chemotherapy', 'description': 'Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m\\^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m\\^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 year', 'description': 'The probability of being event free (no disease progression or death events) at 1 year in participants remaining at risk.', 'unitOfMeasure': 'percent', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated patients who received Randomized Treatment (All Treated Population, for Efficacy Analyses) were included in analysis. 17 and 12 participants in the chemotherapy + pertuzumab and chemotherapy treatment groups, respectively, remained at risk.'}, {'type': 'SECONDARY', 'title': 'Time To Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Chemotherapy + Pertuzumab', 'description': 'Participants received pertuzumab for a total of seventeen17 3-week cycles and chemotherapy for a total of six 3-week cycles.\n\nPertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER:1) paclitaxel 175 mg/m\\^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m\\^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.'}, {'id': 'OG001', 'title': 'Chemotherapy', 'description': 'Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m\\^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m\\^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.0', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '17'}, {'value': '6.3', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '15'}]}]}], 'analyses': [{'pValue': '0.5726', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.3903', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.5870', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '1.11', 'ciLowerLimit': '0.87', 'ciUpperLimit': '1.43', 'statisticalMethod': 'Wald test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value resulting from Wald test of null hypothesis that the hazard ratio=1', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until 2 years after last dose of treatment', 'description': 'Time to response was the date of first dose of study medication to the date of the first documentation of response, according to CA 125 criteria for all participants or response according to RECIST criteria for participants with measurable disease. If response was evaluable by both criteria, then the date of response was for the earlier of the two events.', 'unitOfMeasure': 'weeks', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants with a response were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Died', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Chemotherapy + Pertuzumab', 'description': 'Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles.\n\nPertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER:1) paclitaxel 175 mg/m\\^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m\\^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.'}, {'id': 'OG001', 'title': 'Chemotherapy', 'description': 'Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m\\^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m\\^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.'}], 'classes': [{'categories': [{'measurements': [{'value': '45.9', 'groupId': 'OG000'}, {'value': '41.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until 2 years after last dose of treatment', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants were included in analysis'}, {'type': 'SECONDARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Chemotherapy + Pertuzumab', 'description': 'Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles.\n\nPertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER:1) paclitaxel 175 mg/m\\^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m\\^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.'}, {'id': 'OG001', 'title': 'Chemotherapy', 'description': 'Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m\\^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m\\^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.'}], 'classes': [{'categories': [{'measurements': [{'value': '28.2', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '52'}, {'value': 'NA', 'comment': 'Given the duration of follow-up at time of data analysis the median had not been reached and could not be calculated (at least 50% of patients had not died).', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '34'}]}]}], 'analyses': [{'pValue': '0.9261', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.8591', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.9262', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '1.02', 'ciLowerLimit': '0.74', 'ciUpperLimit': '1.41', 'pValueComment': 'p-value resulting from Wald test of null hypothesis that the hazard ratio=1', 'statisticalMethod': 'Wald test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until 2 years after last dose of treatment', 'description': 'Survival was the interval of time from date of first dose of study medication to date of death at any time. Participants who had not died were censored at the date of last contact when they were known to be alive.', 'unitOfMeasure': 'months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants were included in analysis'}, {'type': 'SECONDARY', 'title': 'Kaplan-Meier Probability of Being Alive at 1 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Chemotherapy + Pertuzumab', 'description': 'Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles.\n\nPertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER:1) paclitaxel 175 mg/m\\^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m\\^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.'}, {'id': 'OG001', 'title': 'Chemotherapy', 'description': 'Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m\\^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m\\^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.'}], 'classes': [{'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 year', 'unitOfMeasure': 'percent', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated patients who received Randomized Treatment (All Treated Population, for Efficacy Analyses) were included in analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Chemotherapy + Pertuzumab', 'description': 'Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles.\n\nPertuzumab: Participants received pertuzumab 840 milligrams (mg) intravenously (IV) on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER:1) paclitaxel 175 mg/square meters (m\\^2) IV on Day 1 and carboplatin target area under the curve (AUC) 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m\\^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.'}, {'id': 'FG001', 'title': 'Chemotherapy', 'description': 'Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m\\^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m\\^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Includes 1 participant who was randomized to chemotherapy group but received pertuzumab+chemotherapy', 'groupId': 'FG000', 'numSubjects': '75'}, {'groupId': 'FG001', 'numSubjects': '74'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '74'}, {'groupId': 'FG001', 'numSubjects': '73'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '66'}, {'groupId': 'FG001', 'numSubjects': '62'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '149', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Chemotherapy + Pertuzumab', 'description': 'Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles.\n\nPertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER: 1) paclitaxel 175 mg/m\\^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m\\^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.'}, {'id': 'BG001', 'title': 'Chemotherapy', 'description': 'Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m\\^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m\\^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.1', 'spread': '10.16', 'groupId': 'BG000'}, {'value': '55.3', 'spread': '11.41', 'groupId': 'BG001'}, {'value': '56.7', 'spread': '10.86', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '149', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All participants who received randomized treatment (All Treated Population, for Efficacy Analyses); 1 participant was randomized to the chemotherapy arm but received pertuzumab+chemotherapy and is thus included in this arm for all analyses.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 149}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-25', 'studyFirstSubmitDate': '2013-12-03', 'resultsFirstSubmitDate': '2014-07-31', 'studyFirstSubmitQcDate': '2013-12-03', 'lastUpdatePostDateStruct': {'date': '2014-12-04', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-11-25', 'studyFirstPostDateStruct': {'date': '2013-12-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-12-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Disease Progression or Death', 'timeFrame': 'Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression up to 104 weeks', 'description': 'Disease progression was assessed according to RECIST (Response Evaluation Criteria In Solid Tumors), for participants with measurable disease, or by changes in CA 125 (Cancer Antigen 125) according to GCIG (Gynecologic Cancer Inter Group) for all participants. Participants who did not progress or died while being followed were censored at the time of the last valid tumor assessment or valid CA 125 assessment.'}, {'measure': 'Progression-Free Survival', 'timeFrame': 'Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression up to 104 weeks', 'description': 'Progression-free survival was defined as the time from first administration of study drug (Study Day 1) to documented disease progression or death, whichever occurred earlier. Disease progression was assessed according to RECIST, for participants with measurable disease, or by changes in CA 125 according to GCIG for all participants. Participants who did not progress or died while being followed were censored at the time of the last valid tumor assessment or valid CA 125 assessment.'}, {'measure': 'Kaplan-Meier Probability of No Disease or Progression at 1 Year', 'timeFrame': '1 year', 'description': 'The probability of being event free (no disease progression or death events) at 1 year in participants remaining at risk.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With a Best Overall Confirmed Response Based on Combined CA 125 and RECIST Measurements', 'timeFrame': 'Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression up to 104 weeks', 'description': 'Response by tumor measurement occurred if there was documented and confirmed complete response (CR) or partial response (PR). For all participants, response was assessed by both the RECIST and by CA 125 levels, according to whether the participant had measurable or non-measurable disease at baseline. Response according to CA 125 levels was defined as at least a 50% reduction from baseline. The decrease had to be confirmed and maintained for at least 28 days. The confirmatory sample must have been less than or equal to the previous sample (within an assay variability of 10%). For overall response, the response categories were "response", "stable disease" and "progressive disease". Stable disease included 1) stable disease as defined by RECIST for solid tumors and 2) CA 125 levels that had not met the definition of "response" or "progressive disease".'}, {'measure': 'Duration of Response', 'timeFrame': 'Day 15 of Cycles 2, 4, 6, and Day 15 of all Cycles from Cycle 7 to 17 until disease progression up to 104 weeks', 'description': 'For participants who achieved a response, the duration of response was defined as the interval between initial documentation of response to the first documentation of disease progression or death. Participants who responded and did not progress or die while on study or while being followed were censored at the last valid tumor or CA 125 measurement.'}, {'measure': 'Kaplan-Meier Probability of Maintaining a Response to at Least 1 Year', 'timeFrame': '1 year'}, {'measure': 'Percentage of Participants With Disease Progression', 'timeFrame': 'Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression', 'description': 'Disease progression was assessed according to RECIST, for participants with measurable disease, or by changes in CA 125 according to GCIG for all participants. Participants who did not progress while being followed were censored at the time of the last valid tumor assessment or valid CA 125 assessment.'}, {'measure': 'Time to Progressive Disease', 'timeFrame': 'Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression', 'description': 'The time to progressive disease is the interval of time from date of first dose of study medication to date of first documentation of progressive disease by either RECIST or CA 125 criteria. Participants who never progressed while being followed were censored at the last valid tumor measurement or CA 125 measurement.'}, {'measure': 'Kaplan-Meier Probability of Being Progression Free at 1 Year', 'timeFrame': '1 year'}, {'measure': 'Time To Response', 'timeFrame': 'Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until 2 years after last dose of treatment', 'description': 'Time to response was the date of first dose of study medication to the date of the first documentation of response, according to CA 125 criteria for all participants or response according to RECIST criteria for participants with measurable disease. If response was evaluable by both criteria, then the date of response was for the earlier of the two events.'}, {'measure': 'Percentage of Participants Who Died', 'timeFrame': 'Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until 2 years after last dose of treatment'}, {'measure': 'Overall Survival', 'timeFrame': 'Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until 2 years after last dose of treatment', 'description': 'Survival was the interval of time from date of first dose of study medication to date of death at any time. Participants who had not died were censored at the date of last contact when they were known to be alive.'}, {'measure': 'Kaplan-Meier Probability of Being Alive at 1 Year', 'timeFrame': '1 year'}]}, 'conditionsModule': {'conditions': ['Ovarian Cancer']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the efficacy and safety of pertuzumab in combination with carboplatin-based standard chemotherapy in patients with platinum-sensitive recurrent ovarian cancer. The anticipated time on study treatment is 3-12 months.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* histologically confirmed ovarian, primary peritoneal, or fallopian tube cancer;\n* only 1 previous regimen, which must be platinum-based;\n* platinum-sensitive disease which is defined by a progression-free interval of greater than 6 months after completion of platinum-based chemotherapy.\n\nExclusion Criteria:\n\n* previous radiotherapy;\n* previous treatment with an anti-cancer vaccine or any targeted therapy;\n* major surgery or traumatic injury within 4 weeks of study;\n* history or evidence of central nervous system metastases.'}, 'identificationModule': {'nctId': 'NCT02004093', 'briefTitle': 'A Study to Evaluate the Effect of the Combination of Pertuzumab With Carboplatin-Based Standard Chemotherapy in Patients With Recurrent Ovarian Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Randomized, Open-label Study of the Effect of Omnitarg in Combination With Carboplatin-based Chemotherapy Versus Carboplatin-based Therapy Alone on Treatment Response in Patients With Platinum-sensitive Recurrent Ovarian Cancer', 'orgStudyIdInfo': {'id': 'BO17931'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Chemotherapy + Pertuzumab', 'interventionNames': ['Drug: pertuzumab', 'Drug: paclitaxel', 'Drug: gemcitabine', 'Drug: carboplatin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Chemotherapy', 'interventionNames': ['Drug: paclitaxel', 'Drug: gemcitabine', 'Drug: carboplatin']}], 'interventions': [{'name': 'pertuzumab', 'type': 'DRUG', 'description': 'Loading dose of 840 mg IV, followed by 420 mg IV every 3 weeks', 'armGroupLabels': ['Chemotherapy + Pertuzumab']}, {'name': 'paclitaxel', 'type': 'DRUG', 'description': '175 mg/m2 IV every 3 weeks for 6 cycles', 'armGroupLabels': ['Chemotherapy', 'Chemotherapy + Pertuzumab']}, {'name': 'gemcitabine', 'type': 'DRUG', 'description': '1000 mg/m2 IV Day 1 and 8 of each cycle for 6 cycles', 'armGroupLabels': ['Chemotherapy', 'Chemotherapy + Pertuzumab']}, {'name': 'carboplatin', 'type': 'DRUG', 'description': 'Target AUC of 5 following paclitaxel or AUC of 4 following gemcitabine IV every 3 weeks for 6 cycles', 'armGroupLabels': ['Chemotherapy', 'Chemotherapy + Pertuzumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Brussels', 'country': 'Belgium', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '2610', 'city': 'Wilrijk', 'country': 'Belgium', 'geoPoint': {'lat': 51.16734, 'lon': 4.39513}}, {'zip': 'T2N 4N2', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'V1Y 5L3', 'city': 'Kelowna', 'state': 'British Columbia', 'country': 'Canada', 'geoPoint': {'lat': 49.88307, 'lon': -119.48568}}, {'zip': 'V5Z 4E6', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': '1122', 'city': 'Budapest', 'country': 'Hungary', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '4032', 'city': 'Debrecen', 'country': 'Hungary', 'geoPoint': {'lat': 47.53167, 'lon': 21.62444}}, {'zip': '9024', 'city': 'Győr', 'country': 'Hungary', 'geoPoint': {'lat': 47.68333, 'lon': 17.63512}}, {'zip': '43100', 'city': 'Parma', 'state': 'Emilia-Romagna', 'country': 'Italy', 'geoPoint': {'lat': 44.79935, 'lon': 10.32618}}, {'zip': '20133', 'city': 'Milan', 'state': 'Lombardy', 'country': 'Italy', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '1066 CX', 'city': 'Amsterdam', 'country': 'Netherlands', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '1081 HV', 'city': 'Amsterdam', 'country': 'Netherlands', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '60-535', 'city': 'Poznan', 'country': 'Poland', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'zip': '02-781', 'city': 'Warsaw', 'country': 'Poland', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '420029', 'city': "Kazan'", 'country': 'Russia', 'geoPoint': {'lat': 55.78874, 'lon': 49.12214}}, {'zip': '105203', 'city': 'Moscow', 'country': 'Russia', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '115478', 'city': 'Moscow', 'country': 'Russia', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '117837', 'city': 'Moscow', 'country': 'Russia', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '125284', 'city': 'Moscow', 'country': 'Russia', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '143423', 'city': 'Moscow', 'country': 'Russia', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '197022', 'city': 'Saint Petersburg', 'country': 'Russia', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '197758', 'city': 'Saint Petersburg', 'country': 'Russia', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '634028', 'city': 'Tomsk', 'country': 'Russia', 'geoPoint': {'lat': 56.50049, 'lon': 84.98216}}, {'zip': '08035', 'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08036', 'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28041', 'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '46009', 'city': 'Valencia', 'state': 'Valencia', 'country': 'Spain', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': 'B18 7QH', 'city': 'Birmingham', 'country': 'United Kingdom', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'zip': 'W12 OHS', 'city': 'London', 'country': 'United Kingdom', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'M20 4BX', 'city': 'Manchester', 'country': 'United Kingdom', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'zip': 'PL6 8DH', 'city': 'Plymouth', 'country': 'United Kingdom', 'geoPoint': {'lat': 50.37153, 'lon': -4.14305}}, {'zip': 'SM2 5PT', 'city': 'Sutton', 'country': 'United Kingdom', 'geoPoint': {'lat': 51.35, 'lon': -0.2}}, {'zip': 'BA21 4AT', 'city': 'Yeovil', 'country': 'United Kingdom', 'geoPoint': {'lat': 50.94159, 'lon': -2.63211}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_CHAIR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}