Ignite Creation Date:
2025-12-24 @ 7:04 PM
Ignite Modification Date:
2026-02-20 @ 8:27 PM
Study NCT ID:
NCT02810457
Status:
COMPLETED
Last Update Posted:
2022-03-10
First Post:
2016-06-03
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of FKB238 and Avastin in Patients With Advanced/Recurrent Non-squamous Non-small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Canada']}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068258', 'term': 'Bevacizumab'}, {'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D016190', 'term': 'Carboplatin'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D056831', 'term': 'Coordination Complexes'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Clinical-Trial@centusbio.com', 'phone': '+353 1 609 7100', 'title': 'Clinical Trial Information', 'organization': 'Centus Biotherapeutics Limited'}, 'certainAgreement': {'otherDetails': "Any publications/presentations made within 2 years of study completion require the Sponsor or CRO's prior written consent. The Sponsor shall be provided with copies of any materials relating to the study that they intend to publish/present at least 30 days in advance of publication, submission or presentation and the Institution shall withhold publication, submission or presentation for 90 days from the date on which the Sponsor receives the material (total time-frame of 120 days).", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.', 'description': 'All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.', 'eventGroups': [{'id': 'EG000', 'title': 'FKB238 / Paclitaxel / Carboplatin', 'description': 'Drug: FKB238:\n\n15 mg/kg IV infusion on Day 1 of each 21-day cycle.\n\nDrug: Paclitaxel:\n\n200 mg/m2 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.\n\nDrug: Carboplatin:\n\nAUC = 6.0 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.\n\nFKB238 (bevacizumab)\n\nPaclitaxel\n\nCarboplatin', 'otherNumAtRisk': 362, 'deathsNumAtRisk': 362, 'otherNumAffected': 341, 'seriousNumAtRisk': 362, 'deathsNumAffected': 195, 'seriousNumAffected': 91}, {'id': 'EG001', 'title': 'Avastin / Paclitaxel / Carboplatin', 'description': 'Drug: Avastin:\n\n15 mg/kg IV infusion on Day 1 of each 21-day cycle.\n\nDrug: Paclitaxel:\n\n200 mg/m2 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.\n\nDrug: Carboplatin:\n\nAUC = 6.0 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.\n\nAvastin (bevacizumab)\n\nPaclitaxel\n\nCarboplatin', 'otherNumAtRisk': 366, 'deathsNumAtRisk': 366, 'otherNumAffected': 348, 'seriousNumAtRisk': 366, 'deathsNumAffected': 177, 'seriousNumAffected': 95}], 'otherEvents': [{'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numEvents': 47, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 366, 'numEvents': 54, 'numAffected': 44}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numEvents': 53, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 366, 'numEvents': 45, 'numAffected': 35}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Aspartate aminotransferase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numEvents': 43, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 366, 'numEvents': 45, 'numAffected': 35}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numEvents': 24, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 366, 'numEvents': 39, 'numAffected': 27}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Gamma-glutamyltransferase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numEvents': 48, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 366, 'numEvents': 46, 'numAffected': 31}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numEvents': 32, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 366, 'numEvents': 30, 'numAffected': 25}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numEvents': 48, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 366, 'numEvents': 38, 'numAffected': 25}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numEvents': 48, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 366, 'numEvents': 62, 'numAffected': 56}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numEvents': 36, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 366, 'numEvents': 36, 'numAffected': 26}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numEvents': 20, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 366, 'numEvents': 26, 'numAffected': 25}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 366, 'numEvents': 29, 'numAffected': 29}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numEvents': 20, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 366, 'numEvents': 36, 'numAffected': 23}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numEvents': 135, 'numAffected': 105}, {'groupId': 'EG001', 'numAtRisk': 366, 'numEvents': 146, 'numAffected': 119}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numEvents': 58, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 366, 'numEvents': 89, 'numAffected': 50}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numEvents': 163, 'numAffected': 109}, {'groupId': 'EG001', 'numAtRisk': 366, 'numEvents': 212, 'numAffected': 145}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numEvents': 78, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 366, 'numEvents': 102, 'numAffected': 66}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numEvents': 21, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 366, 'numEvents': 24, 'numAffected': 23}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numEvents': 63, 'numAffected': 58}, {'groupId': 'EG001', 'numAtRisk': 366, 'numEvents': 60, 'numAffected': 52}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numEvents': 26, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 366, 'numEvents': 22, 'numAffected': 22}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numEvents': 28, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 366, 'numEvents': 25, 'numAffected': 25}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Polyneuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numEvents': 18, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 366, 'numEvents': 31, 'numAffected': 23}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numEvents': 45, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 366, 'numEvents': 71, 'numAffected': 59}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numEvents': 55, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 366, 'numEvents': 48, 'numAffected': 45}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numEvents': 18, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 366, 'numEvents': 15, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numEvents': 17, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 366, 'numEvents': 24, 'numAffected': 21}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numEvents': 23, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 366, 'numEvents': 23, 'numAffected': 21}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numEvents': 44, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 366, 'numEvents': 41, 'numAffected': 35}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numEvents': 72, 'numAffected': 52}, {'groupId': 'EG001', 'numAtRisk': 366, 'numEvents': 57, 'numAffected': 45}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numEvents': 29, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 366, 'numEvents': 24, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numEvents': 31, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 366, 'numEvents': 52, 'numAffected': 41}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numEvents': 157, 'numAffected': 154}, {'groupId': 'EG001', 'numAtRisk': 366, 'numEvents': 162, 'numAffected': 159}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numEvents': 49, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 366, 'numEvents': 48, 'numAffected': 36}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numEvents': 25, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 366, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numEvents': 61, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 366, 'numEvents': 73, 'numAffected': 32}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numEvents': 56, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 366, 'numEvents': 48, 'numAffected': 42}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numEvents': 18, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 366, 'numEvents': 29, 'numAffected': 22}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numEvents': 20, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 366, 'numEvents': 24, 'numAffected': 20}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 366, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 366, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 366, 'numEvents': 19, 'numAffected': 18}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 366, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 366, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 366, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 366, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 366, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Cardiac disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 366, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 366, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Cor pulmonale', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 366, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 366, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 366, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Tachyarrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 366, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Adrenal insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 366, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 366, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Diverticulum intestinal haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 366, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 366, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Enterocolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 366, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal 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'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Oesophagobronchial fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 366, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 366, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 366, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 366, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 366, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pulmonary fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 366, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pulmonary haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 366, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pulmonary mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 366, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 366, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 366, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 366, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 366, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 366, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Response Rate (ORR) Assessed as the Proportion of Patients With a Best Overall Response (BOR) of Either Complete Response (CR) or Partial Response (PR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '364', 'groupId': 'OG000'}, {'value': '367', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FKB238 / Paclitaxel / Carboplatin', 'description': 'Drug: FKB238:\n\n15 mg/kg IV infusion on Day 1 of each 21-day cycle.\n\nDrug: Paclitaxel:\n\n200 mg/m2 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.\n\nDrug: Carboplatin:\n\nAUC = 6.0 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.\n\nFKB238 (bevacizumab)\n\nPaclitaxel\n\nCarboplatin'}, {'id': 'OG001', 'title': 'Avastin / Paclitaxel / Carboplatin', 'description': 'Drug: Avastin:\n\n15 mg/kg IV infusion on Day 1 of each 21-day cycle.\n\nDrug: Paclitaxel:\n\n200 mg/m2 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.\n\nDrug: Carboplatin:\n\nAUC = 6.0 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.\n\nAvastin (bevacizumab)\n\nPaclitaxel\n\nCarboplatin'}], 'classes': [{'categories': [{'measurements': [{'value': '51.6', 'groupId': 'OG000', 'lowerLimit': '46.38', 'upperLimit': '56.89'}, {'value': '53.7', 'groupId': 'OG001', 'lowerLimit': '48.43', 'upperLimit': '58.87'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio in ORR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.96', 'ciLowerLimit': '0.86', 'ciUpperLimit': '1.08', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'A 90% CI for the ORR ratio between FKB238 and Avastin was estimated and compared to the margin (0.73 to 1.38), which was deemed to represent a clinically acceptable difference with respect to ORR. If the 90% CI was within the equivalence margin (0.73 to 1.38), an equivalence between FKB238 and Avastin, with respect to the ORR, was confirmed.'}], 'paramType': 'NUMBER', 'timeFrame': 'Until data cut-off, which occurred 12 months after randomization of the last patient enrolled, for a total estimated period of time of up to approximately 30 months.', 'description': 'The primary variable in this study was ORR, defined as the proportion of patients with a BOR of CR or PR (by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)). A BOR was defined as the best response (in the order of CR, PR, stable disease (SD), no evidence of disease (NED), progressive disease (PD), and not evaluable (NE)) among all post-baseline disease assessments that occurred until progression, or last evaluable assessment in the absence of progression prior to the initiation of subsequent anti-cancer therapy, irrespective of whether or not patients discontinued the study treatment. The 95% Pearson-Clopper confidence interval (CI) of ORR for each treatment arm was provided. Per RECIST v1.1 for target lesions and assessed by computed tomography (CT) or, if contraindicated, magnetic resonance imaging (MRI): CR=disappearance of all target lesions; PR=at least 30% decrease from baseline in the sum of diameters of target lesions. Overall Response=CR+PR.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'In order to meet the Food and Drug Administration (FDA) requirement, the primary efficacy analysis of ORR was performed using the Intent-to-Treat (ITT) population (patients included in each treatment arm as randomized), and the blinded independent central review (BICR) radiological assessments.'}, {'type': 'SECONDARY', 'title': 'ORR at Week 19', 'denoms': [{'units': 'Participants', 'counts': [{'value': '364', 'groupId': 'OG000'}, {'value': '367', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FKB238 / Paclitaxel / Carboplatin', 'description': 'Drug: FKB238:\n\n15 mg/kg IV infusion on Day 1 of each 21-day cycle.\n\nDrug: Paclitaxel:\n\n200 mg/m2 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.\n\nDrug: Carboplatin:\n\nAUC = 6.0 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.\n\nFKB238 (bevacizumab)\n\nPaclitaxel\n\nCarboplatin'}, {'id': 'OG001', 'title': 'Avastin / Paclitaxel / Carboplatin', 'description': 'Drug: Avastin:\n\n15 mg/kg IV infusion on Day 1 of each 21-day cycle.\n\nDrug: Paclitaxel:\n\n200 mg/m2 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.\n\nDrug: Carboplatin:\n\nAUC = 6.0 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.\n\nAvastin (bevacizumab)\n\nPaclitaxel\n\nCarboplatin'}], 'classes': [{'categories': [{'measurements': [{'value': '47.8', 'groupId': 'OG000', 'lowerLimit': '42.57', 'upperLimit': '53.07'}, {'value': '51.0', 'groupId': 'OG001', 'lowerLimit': '45.71', 'upperLimit': '56.18'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio in ORR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.94', 'ciLowerLimit': '0.83', 'ciUpperLimit': '1.06', 'groupDescription': 'Comparison between groups: Risk ratio in ORR at Week 19 by BICR.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Ratio in ORR analysis of FKB238 versus Avastin.'}], 'paramType': 'NUMBER', 'timeFrame': 'From the date of randomization up to Week 19.', 'description': 'ORR (by RECIST v1.1) at Week 19 was defined as the proportion of patients with a BOR of CR or PR assessed at Week 19. Only tumor assessments performed up until 19 weeks (i.e. Week 18 assessment + 7 day assessment window) from randomization were considered in this analysis. Per RECIST v1.1 for target lesions and assessed by CT or, if contraindicated, MRI: CR=disappearance of all target lesions; PR=at least 30% decrease from baseline in the sum of diameters of target lesions. Overall Response=CR+PR.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'In order to meet the FDA requirement, the secondary efficacy analysis of ORR was performed using the ITT population (patients included in each treatment arm as randomized), and the BICR radiological assessments.'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '364', 'groupId': 'OG000'}, {'value': '367', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FKB238 / Paclitaxel / Carboplatin', 'description': 'Drug: FKB238:\n\n15 mg/kg IV infusion on Day 1 of each 21-day cycle.\n\nDrug: Paclitaxel:\n\n200 mg/m2 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.\n\nDrug: Carboplatin:\n\nAUC = 6.0 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.\n\nFKB238 (bevacizumab)\n\nPaclitaxel\n\nCarboplatin'}, {'id': 'OG001', 'title': 'Avastin / Paclitaxel / Carboplatin', 'description': 'Drug: Avastin:\n\n15 mg/kg IV infusion on Day 1 of each 21-day cycle.\n\nDrug: Paclitaxel:\n\n200 mg/m2 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.\n\nDrug: Carboplatin:\n\nAUC = 6.0 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.\n\nAvastin (bevacizumab)\n\nPaclitaxel\n\nCarboplatin'}], 'classes': [{'categories': [{'measurements': [{'value': '7.72', 'groupId': 'OG000', 'lowerLimit': '7.46', 'upperLimit': '7.98'}, {'value': '7.62', 'groupId': 'OG001', 'lowerLimit': '6.90', 'upperLimit': '7.82'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.97', 'ciLowerLimit': '0.82', 'ciUpperLimit': '1.16', 'estimateComment': 'Treatment hazard ratio \\<1 favors FKB238.', 'groupDescription': 'Hazard ratio and its 95% CI were calculated using the Cox regression model adjusting for baseline characteristics (randomization stratification factors, Eastern Cooperative Oncology Group (ECOG) performance status at baseline, gender, smoking history and age) with ties handled by the Efron method.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Hazard ratio analysis of FKB238 versus Avastin.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Until data cut-off, which occurred 12 months after randomization of the last patient enrolled, for a total estimated period of time of up to approximately 30 months.', 'description': 'The event of interest for PFS was defined as the interval from the date of randomization until first documented disease progression or death from any cause, whichever occurs first. Disease progression was based on tumor assessments according to RECIST v1.1 criteria. The items of the overall response CR, PR, SD and NED were taken as progression-free whereas PD denoted disease progression. PFS was summarized using Kaplan-Meier estimates of the quartiles for each treatment arm, and 95% CIs for the medians were calculated. Per RECIST v1.1 for target lesions and assessed by CT or, if contraindicated, MRI: PD=at least a 20% increase in the sum of the longest diameter of target lesions, unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'This assessment was performed using the ITT population (patients included in each treatment arm as randomized) and the BICR radiological assessments.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '364', 'groupId': 'OG000'}, {'value': '367', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FKB238 / Paclitaxel / Carboplatin', 'description': 'Drug: FKB238:\n\n15 mg/kg IV infusion on Day 1 of each 21-day cycle.\n\nDrug: Paclitaxel:\n\n200 mg/m2 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.\n\nDrug: Carboplatin:\n\nAUC = 6.0 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.\n\nFKB238 (bevacizumab)\n\nPaclitaxel\n\nCarboplatin'}, {'id': 'OG001', 'title': 'Avastin / Paclitaxel / Carboplatin', 'description': 'Drug: Avastin:\n\n15 mg/kg IV infusion on Day 1 of each 21-day cycle.\n\nDrug: Paclitaxel:\n\n200 mg/m2 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.\n\nDrug: Carboplatin:\n\nAUC = 6.0 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.\n\nAvastin (bevacizumab)\n\nPaclitaxel\n\nCarboplatin'}], 'classes': [{'categories': [{'measurements': [{'value': '14.13', 'groupId': 'OG000', 'lowerLimit': '12.52', 'upperLimit': '16.56'}, {'value': '16.95', 'groupId': 'OG001', 'lowerLimit': '14.65', 'upperLimit': '19.02'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.18', 'ciLowerLimit': '0.96', 'ciUpperLimit': '1.45', 'estimateComment': 'Treatment hazard ratio \\<1 favors FKB238.', 'groupDescription': 'Hazard ratio and its 95% CI were calculated using the Cox regression model adjusting for baseline characteristics (randomization stratification factors, ECOG performance status at baseline, gender, smoking history and age) with ties handled by the Efron method.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Hazard ratio analysis of FKB238 versus Avastin.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Until data cut-off, which occurred 12 months after randomization of the last patient enrolled, for a total estimated period of time of up to approximately 30 months.', 'description': 'The event of interest was defined as death from any cause. OS was defined as the interval from date of randomization until the date of death due to any cause. OS was summarized using Kaplan-Meier estimates of the quartiles for each treatment arm, and 95% CIs for the medians were calculated.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'This assessment was performed using the ITT population (patients included in each treatment arm as randomized).'}, {'type': 'SECONDARY', 'title': 'Duration Of Response (DOR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FKB238 / Paclitaxel / Carboplatin', 'description': 'Drug: FKB238:\n\n15 mg/kg IV infusion on Day 1 of each 21-day cycle.\n\nDrug: Paclitaxel:\n\n200 mg/m2 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.\n\nDrug: Carboplatin:\n\nAUC = 6.0 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.\n\nFKB238 (bevacizumab)\n\nPaclitaxel\n\nCarboplatin'}, {'id': 'OG001', 'title': 'Avastin / Paclitaxel / Carboplatin', 'description': 'Drug: Avastin:\n\n15 mg/kg IV infusion on Day 1 of each 21-day cycle.\n\nDrug: Paclitaxel:\n\n200 mg/m2 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.\n\nDrug: Carboplatin:\n\nAUC = 6.0 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.\n\nAvastin (bevacizumab)\n\nPaclitaxel\n\nCarboplatin'}], 'classes': [{'categories': [{'measurements': [{'value': '6.47', 'groupId': 'OG000', 'lowerLimit': '5.39', 'upperLimit': '7.69'}, {'value': '6.31', 'groupId': 'OG001', 'lowerLimit': '4.93', 'upperLimit': '7.29'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.96', 'ciLowerLimit': '0.74', 'ciUpperLimit': '1.23', 'estimateComment': 'Treatment hazard ratio \\<1 favors FKB238.', 'groupDescription': 'Hazard ratio and its 95% CI were calculated using the Cox regression model adjusting for baseline characteristics (randomization stratification factors, ECOG performance status at baseline, gender, smoking history and age) with ties handled by the Efron method.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Hazard ratio analysis of FKB238 versus Avastin.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Until data cut-off, which occurred 12 months after randomization of the last patient enrolled, for a total estimated period of time of up to approximately 30 months.', 'description': 'DOR was evaluated in this study as a secondary efficacy endpoint. Only the patients defined as responders in the primary analysis of ORR were taken into account for the analysis of DOR. The event of interest was defined as first documented disease progression or death due to any reason, whichever occurred first. DOR was defined as the interval from the first documented response (as defined per RECIST v1.1) until the earlier date of the first documented disease progression or death due to any reason. The date of first documented response was taken as the date of the first tumor assessment with an overall visit response of CR or PR. Per RECIST v1.1 for target lesions and assessed by CT or, if contraindicated, MRI: CR=disappearance of all target lesions; PR=at least 30% decrease from baseline in the sum of diameters of target lesions. DOR was calculated in units of months.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'This assessment of DOR was based on patients with events in the ITT population (patients included in each treatment arm as randomized), and the BICR radiological assessments.'}, {'type': 'SECONDARY', 'title': 'Disease Control Rate (DCR) Assessed as the Proportion of Patients With a BOR of Either CR, PR, SD or NED', 'denoms': [{'units': 'Participants', 'counts': [{'value': '364', 'groupId': 'OG000'}, {'value': '367', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FKB238 / Paclitaxel / Carboplatin', 'description': 'Drug: FKB238:\n\n15 mg/kg IV infusion on Day 1 of each 21-day cycle.\n\nDrug: Paclitaxel:\n\n200 mg/m2 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.\n\nDrug: Carboplatin:\n\nAUC = 6.0 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.\n\nFKB238 (bevacizumab)\n\nPaclitaxel\n\nCarboplatin'}, {'id': 'OG001', 'title': 'Avastin / Paclitaxel / Carboplatin', 'description': 'Drug: Avastin:\n\n15 mg/kg IV infusion on Day 1 of each 21-day cycle.\n\nDrug: Paclitaxel:\n\n200 mg/m2 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.\n\nDrug: Carboplatin:\n\nAUC = 6.0 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.\n\nAvastin (bevacizumab)\n\nPaclitaxel\n\nCarboplatin'}], 'classes': [{'categories': [{'measurements': [{'value': '87.6', 'groupId': 'OG000', 'lowerLimit': '83.81', 'upperLimit': '90.84'}, {'value': '87.5', 'groupId': 'OG001', 'lowerLimit': '83.64', 'upperLimit': '90.68'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.01', 'ciLowerLimit': '0.64', 'ciUpperLimit': '1.58', 'estimateComment': 'Odds ratio \\>1 favors FKB238.', 'groupDescription': 'The DCR was compared between treatment arms using logistic regression adjusting for baseline characteristics (randomization stratification factors, ECOG performance status at baseline, gender, smoking history and age).', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Comparison between arms: Odds ratio.'}], 'paramType': 'NUMBER', 'timeFrame': 'Until data cut-off, which occurred 12 months after randomization of the last patient enrolled, for a total estimated period of time of up to approximately 30 months.', 'description': 'The DCR was defined as the proportion of patients defined as responders. The number and percentage of responders and non-responders and the 95% Pearson-Clopper CI of DCR for each treatment arm was provided. The odds ratio for treatment (FKB238 arm versus Avastin arm) and the corresponding 95% Wald CI were produced based on a logistic regression analysis of DCR. Per RECIST v1.1 for target lesions and assessed by CT or, if contraindicated, MRI: CR=disappearance of all target lesions; PR=at least 30% decrease from baseline in the sum of diameters of target lesions; SD=neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of diameters while on study. DCR=CR+PR+SD (≥ 6 weeks).', 'unitOfMeasure': 'percentage of participants with response', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'This assessment of DCR was based on patients in the ITT population (patients included in each treatment arm as randomized), and the BICR radiological assessments.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Serum Trough Concentration (Ctrough)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '345', 'groupId': 'OG000'}, {'value': '351', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FKB238 / Paclitaxel / Carboplatin', 'description': 'Drug: FKB238:\n\n15 mg/kg IV infusion on Day 1 of each 21-day cycle.\n\nDrug: Paclitaxel:\n\n200 mg/m2 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.\n\nDrug: Carboplatin:\n\nAUC = 6.0 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.\n\nFKB238 (bevacizumab)\n\nPaclitaxel\n\nCarboplatin'}, {'id': 'OG001', 'title': 'Avastin / Paclitaxel / Carboplatin', 'description': 'Drug: Avastin:\n\n15 mg/kg IV infusion on Day 1 of each 21-day cycle.\n\nDrug: Paclitaxel:\n\n200 mg/m2 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.\n\nDrug: Carboplatin:\n\nAUC = 6.0 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.\n\nAvastin (bevacizumab)\n\nPaclitaxel\n\nCarboplatin'}], 'classes': [{'title': 'Cycle 1, Day 1 end of infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '343', 'groupId': 'OG000'}, {'value': '347', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '255.15', 'spread': '184.3', 'groupId': 'OG000'}, {'value': '245.11', 'spread': '206.8', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 2, Day 1 pre-infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '325', 'groupId': 'OG000'}, {'value': '327', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '42.74', 'spread': '91.9', 'groupId': 'OG000'}, {'value': '48.48', 'spread': '77.3', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 4, Day 1 pre-infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '280', 'groupId': 'OG000'}, {'value': '284', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '77.16', 'spread': '69.4', 'groupId': 'OG000'}, {'value': '83.26', 'spread': '85.5', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 4, Day 1 end of infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '278', 'groupId': 'OG000'}, {'value': '283', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '339.91', 'spread': '91.3', 'groupId': 'OG000'}, {'value': '373.92', 'spread': '51.6', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 6, Day 1 pre-infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '247', 'groupId': 'OG000'}, {'value': '253', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '87.25', 'spread': '124.5', 'groupId': 'OG000'}, {'value': '108.22', 'spread': '69.8', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 1 (pre- and post-infusion), Cycle 2 Day 1 (pre), Cycle 4 Day 1 (pre and post), Cycle 6 Day 1 (pre), discontinuation visit, and every 12 weeks (up to 1 year [±14 days] after randomisation) until death, or the patient was lost to follow-up.', 'description': 'Ctrough (pre-infusion) and serum maximum concentration (Cmax; at completion of infusion) were compared between treatment arms and time points, and descriptive statistics provided. Ctrough and Cmax concentrations were summarized using the pharmacokinetics (PK) population for each visit at which samples were taken. The pre-dose serum concentrations at Cycles 2, 4, and 6 were considered as Ctrough values and the post-dose serum concentrations at Cycles 1 and 4 were considered as Cmax values. PK data at Cycle 1 Day 1 pre-infusion were not calculable and are therefore not presented in the outcome measure data table. Data are only provided for the time points at which the serum trough concentration was measured.', 'unitOfMeasure': 'ug/ml', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients randomized to treatment who received at least 1 dose of investigational product with no important protocol deviations, and at least 1 serum drug concentration data after investigational product administration (PK population).'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Proportion of Patients Developing Anti-drug Antibodies (ADAs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '305', 'groupId': 'OG000'}, {'value': '305', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FKB238 / Paclitaxel / Carboplatin', 'description': 'Drug: FKB238:\n\n15 mg/kg IV infusion on Day 1 of each 21-day cycle.\n\nDrug: Paclitaxel:\n\n200 mg/m2 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.\n\nDrug: Carboplatin:\n\nAUC = 6.0 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.\n\nFKB238 (bevacizumab)\n\nPaclitaxel\n\nCarboplatin'}, {'id': 'OG001', 'title': 'Avastin / Paclitaxel / Carboplatin', 'description': 'Drug: Avastin:\n\n15 mg/kg IV infusion on Day 1 of each 21-day cycle.\n\nDrug: Paclitaxel:\n\n200 mg/m2 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.\n\nDrug: Carboplatin:\n\nAUC = 6.0 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.\n\nAvastin (bevacizumab)\n\nPaclitaxel\n\nCarboplatin'}], 'classes': [{'title': 'ADA prevalence (ADA positive, baseline or post)', 'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000'}, {'value': '3.0', 'groupId': 'OG001'}]}]}, {'title': 'Treatment-emergent ADA positive (ADA incidence)', 'categories': [{'measurements': [{'value': '2.3', 'groupId': 'OG000'}, {'value': '2.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Pre-dose at Cycles 1, 2, 4 and 6, discontinuation visit, and every 12 weeks (up to 1 year [±14 days] after randomisation) until death, or the patient was lost to follow-up, whichever occurred first.', 'description': 'The ADA levels were summarized at baseline and post-baseline time points using descriptive statistics.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes all patients randomized to treatment who received at least 1 dose of investigational product with no important protocol deviations, and who had non-missing baseline ADA and at least 1 non-missing post-baseline ADA result (ADA evaluable population).'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Adverse Events (AEs)', 'timeFrame': 'From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Vital Signs', 'timeFrame': 'Up to approximately 30 days after last dose of study treatment.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Hematology', 'timeFrame': 'Up to approximately 30 days after last dose of study treatment.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Clinical Chemistry', 'timeFrame': 'Up to approximately 30 days after last dose of study treatment.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Urinalysis', 'timeFrame': 'Up to approximately 30 days after last dose of study treatment.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Electrocardiogram', 'timeFrame': 'Up to approximately 30 days after last dose of study treatment.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Eastern Collaborative Oncology Group Performance Status', 'timeFrame': 'Up to approximately 30 days after last dose of study treatment.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Physical Examination', 'timeFrame': 'Up to approximately 30 days after last dose of study treatment.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'FKB238 / Paclitaxel / Carboplatin', 'description': 'Drug: FKB238:\n\n15 mg/kg IV infusion on Day 1 of each 21-day cycle.\n\nDrug: Paclitaxel:\n\n200 mg/m2 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.\n\nDrug: Carboplatin:\n\nArea under the curve (AUC) = 6.0 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.\n\nFKB238 (bevacizumab)\n\nPaclitaxel\n\nCarboplatin'}, {'id': 'FG001', 'title': 'Avastin / Paclitaxel / Carboplatin', 'description': 'Drug: Avastin:\n\n15 mg/kg IV infusion on Day 1 of each 21-day cycle.\n\nDrug: Paclitaxel:\n\n200 mg/m2 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.\n\nDrug: Carboplatin:\n\nAUC = 6.0 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.\n\nAvastin (bevacizumab)\n\nPaclitaxel\n\nCarboplatin'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '362 patients received study treatment', 'groupId': 'FG000', 'numSubjects': '364'}, {'comment': '366 patients received study treatment', 'groupId': 'FG001', 'numSubjects': '367'}]}, {'type': 'COMPLETED', 'comment': 'Patients still in the study at DCO', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '38'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '327'}, {'groupId': 'FG001', 'numSubjects': '329'}]}], 'dropWithdraws': [{'type': 'Randomised but no treatment received', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Objective PD assessed by RECIST v1.1', 'reasons': [{'groupId': 'FG000', 'numSubjects': '191'}, {'groupId': 'FG001', 'numSubjects': '199'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '43'}]}, {'type': 'Patient decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '35'}]}, {'type': 'Patient lost to follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'Ongoing at data cutoff and discontinued', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Clinical progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'Investigator decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Patient ineligibility', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Miscalculated PD', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Screening occurred at 146 centers in 24 countries (randomized at 136 centers, 24 countries) in Belarus, Bosnia \\& Herzegovina, Bulgaria, Croatia, Georgia, Germany, Greece, Hungary, Italy, Japan, South Korea, Peru, Philippines, Poland, Romania, Russia, Serbia, Spain, Taiwan, Thailand, Turkey, Ukraine, US and Vietnam. No screening occurred in Canada.', 'preAssignmentDetails': 'Of a total of 1023 patients who signed informed consent and were screened, 292 patients were not randomized. Of the 731 randomized patients, 2 patients were randomized in error and never received any study treatment, and 1 patient was randomized but withdrew consent prior to receiving any study treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '364', 'groupId': 'BG000'}, {'value': '367', 'groupId': 'BG001'}, {'value': '731', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'FKB238 / Paclitaxel / Carboplatin', 'description': 'Drug: FKB238:\n\n15 mg/kg IV infusion on Day 1 of each 21-day cycle.\n\nDrug: Paclitaxel:\n\n200 mg/m2 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.\n\nDrug: Carboplatin:\n\nAUC = 6.0 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.\n\nFKB238 (bevacizumab)\n\nPaclitaxel\n\nCarboplatin'}, {'id': 'BG001', 'title': 'Avastin / Paclitaxel / Carboplatin', 'description': 'Drug: Avastin:\n\n15 mg/kg IV infusion on Day 1 of each 21-day cycle.\n\nDrug: Paclitaxel:\n\n200 mg/m2 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.\n\nDrug: Carboplatin:\n\nAUC = 6.0 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.\n\nAvastin (bevacizumab)\n\nPaclitaxel\n\nCarboplatin'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Adults (18-64 years)', 'categories': [{'measurements': [{'value': '238', 'groupId': 'BG000'}, {'value': '224', 'groupId': 'BG001'}, {'value': '462', 'groupId': 'BG002'}]}]}, {'title': 'From 65-84 years', 'categories': [{'measurements': [{'value': '126', 'groupId': 'BG000'}, {'value': '143', 'groupId': 'BG001'}, {'value': '269', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '119', 'groupId': 'BG000'}, {'value': '129', 'groupId': 'BG001'}, {'value': '248', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '245', 'groupId': 'BG000'}, {'value': '238', 'groupId': 'BG001'}, {'value': '483', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '316', 'groupId': 'BG000'}, {'value': '320', 'groupId': 'BG001'}, {'value': '636', 'groupId': 'BG002'}]}]}, {'title': 'Black and African American', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Asian, other than Japanese', 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}]}, {'title': 'Japanese', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-05-22', 'size': 1538740, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-01-22T03:46', 'hasProtocol': True}, {'date': '2019-05-07', 'size': 3101800, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-01-22T03:46', 'hasProtocol': False}]}}, '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': 731}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2022-01-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-25', 'studyFirstSubmitDate': '2016-06-03', 'resultsFirstSubmitDate': '2020-01-24', 'studyFirstSubmitQcDate': '2016-06-20', 'lastUpdatePostDateStruct': {'date': '2022-03-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-03-02', 'studyFirstPostDateStruct': {'date': '2016-06-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Serum Trough Concentration (Ctrough)', 'timeFrame': 'Cycle 1 Day 1 (pre- and post-infusion), Cycle 2 Day 1 (pre), Cycle 4 Day 1 (pre and post), Cycle 6 Day 1 (pre), discontinuation visit, and every 12 weeks (up to 1 year [±14 days] after randomisation) until death, or the patient was lost to follow-up.', 'description': 'Ctrough (pre-infusion) and serum maximum concentration (Cmax; at completion of infusion) were compared between treatment arms and time points, and descriptive statistics provided. Ctrough and Cmax concentrations were summarized using the pharmacokinetics (PK) population for each visit at which samples were taken. The pre-dose serum concentrations at Cycles 2, 4, and 6 were considered as Ctrough values and the post-dose serum concentrations at Cycles 1 and 4 were considered as Cmax values. PK data at Cycle 1 Day 1 pre-infusion were not calculable and are therefore not presented in the outcome measure data table. Data are only provided for the time points at which the serum trough concentration was measured.'}, {'measure': 'Proportion of Patients Developing Anti-drug Antibodies (ADAs)', 'timeFrame': 'Pre-dose at Cycles 1, 2, 4 and 6, discontinuation visit, and every 12 weeks (up to 1 year [±14 days] after randomisation) until death, or the patient was lost to follow-up, whichever occurred first.', 'description': 'The ADA levels were summarized at baseline and post-baseline time points using descriptive statistics.'}, {'measure': 'Adverse Events (AEs)', 'timeFrame': 'From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months.'}, {'measure': 'Vital Signs', 'timeFrame': 'Up to approximately 30 days after last dose of study treatment.'}, {'measure': 'Hematology', 'timeFrame': 'Up to approximately 30 days after last dose of study treatment.'}, {'measure': 'Clinical Chemistry', 'timeFrame': 'Up to approximately 30 days after last dose of study treatment.'}, {'measure': 'Urinalysis', 'timeFrame': 'Up to approximately 30 days after last dose of study treatment.'}, {'measure': 'Electrocardiogram', 'timeFrame': 'Up to approximately 30 days after last dose of study treatment.'}, {'measure': 'Eastern Collaborative Oncology Group Performance Status', 'timeFrame': 'Up to approximately 30 days after last dose of study treatment.'}, {'measure': 'Physical Examination', 'timeFrame': 'Up to approximately 30 days after last dose of study treatment.'}], 'primaryOutcomes': [{'measure': 'Overall Response Rate (ORR) Assessed as the Proportion of Patients With a Best Overall Response (BOR) of Either Complete Response (CR) or Partial Response (PR)', 'timeFrame': 'Until data cut-off, which occurred 12 months after randomization of the last patient enrolled, for a total estimated period of time of up to approximately 30 months.', 'description': 'The primary variable in this study was ORR, defined as the proportion of patients with a BOR of CR or PR (by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)). A BOR was defined as the best response (in the order of CR, PR, stable disease (SD), no evidence of disease (NED), progressive disease (PD), and not evaluable (NE)) among all post-baseline disease assessments that occurred until progression, or last evaluable assessment in the absence of progression prior to the initiation of subsequent anti-cancer therapy, irrespective of whether or not patients discontinued the study treatment. The 95% Pearson-Clopper confidence interval (CI) of ORR for each treatment arm was provided. Per RECIST v1.1 for target lesions and assessed by computed tomography (CT) or, if contraindicated, magnetic resonance imaging (MRI): CR=disappearance of all target lesions; PR=at least 30% decrease from baseline in the sum of diameters of target lesions. Overall Response=CR+PR.'}], 'secondaryOutcomes': [{'measure': 'ORR at Week 19', 'timeFrame': 'From the date of randomization up to Week 19.', 'description': 'ORR (by RECIST v1.1) at Week 19 was defined as the proportion of patients with a BOR of CR or PR assessed at Week 19. Only tumor assessments performed up until 19 weeks (i.e. Week 18 assessment + 7 day assessment window) from randomization were considered in this analysis. Per RECIST v1.1 for target lesions and assessed by CT or, if contraindicated, MRI: CR=disappearance of all target lesions; PR=at least 30% decrease from baseline in the sum of diameters of target lesions. Overall Response=CR+PR.'}, {'measure': 'Progression-free Survival (PFS)', 'timeFrame': 'Until data cut-off, which occurred 12 months after randomization of the last patient enrolled, for a total estimated period of time of up to approximately 30 months.', 'description': 'The event of interest for PFS was defined as the interval from the date of randomization until first documented disease progression or death from any cause, whichever occurs first. Disease progression was based on tumor assessments according to RECIST v1.1 criteria. The items of the overall response CR, PR, SD and NED were taken as progression-free whereas PD denoted disease progression. PFS was summarized using Kaplan-Meier estimates of the quartiles for each treatment arm, and 95% CIs for the medians were calculated. Per RECIST v1.1 for target lesions and assessed by CT or, if contraindicated, MRI: PD=at least a 20% increase in the sum of the longest diameter of target lesions, unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Until data cut-off, which occurred 12 months after randomization of the last patient enrolled, for a total estimated period of time of up to approximately 30 months.', 'description': 'The event of interest was defined as death from any cause. OS was defined as the interval from date of randomization until the date of death due to any cause. OS was summarized using Kaplan-Meier estimates of the quartiles for each treatment arm, and 95% CIs for the medians were calculated.'}, {'measure': 'Duration Of Response (DOR)', 'timeFrame': 'Until data cut-off, which occurred 12 months after randomization of the last patient enrolled, for a total estimated period of time of up to approximately 30 months.', 'description': 'DOR was evaluated in this study as a secondary efficacy endpoint. Only the patients defined as responders in the primary analysis of ORR were taken into account for the analysis of DOR. The event of interest was defined as first documented disease progression or death due to any reason, whichever occurred first. DOR was defined as the interval from the first documented response (as defined per RECIST v1.1) until the earlier date of the first documented disease progression or death due to any reason. The date of first documented response was taken as the date of the first tumor assessment with an overall visit response of CR or PR. Per RECIST v1.1 for target lesions and assessed by CT or, if contraindicated, MRI: CR=disappearance of all target lesions; PR=at least 30% decrease from baseline in the sum of diameters of target lesions. DOR was calculated in units of months.'}, {'measure': 'Disease Control Rate (DCR) Assessed as the Proportion of Patients With a BOR of Either CR, PR, SD or NED', 'timeFrame': 'Until data cut-off, which occurred 12 months after randomization of the last patient enrolled, for a total estimated period of time of up to approximately 30 months.', 'description': 'The DCR was defined as the proportion of patients defined as responders. The number and percentage of responders and non-responders and the 95% Pearson-Clopper CI of DCR for each treatment arm was provided. The odds ratio for treatment (FKB238 arm versus Avastin arm) and the corresponding 95% Wald CI were produced based on a logistic regression analysis of DCR. Per RECIST v1.1 for target lesions and assessed by CT or, if contraindicated, MRI: CR=disappearance of all target lesions; PR=at least 30% decrease from baseline in the sum of diameters of target lesions; SD=neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of diameters while on study. DCR=CR+PR+SD (≥ 6 weeks).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cancer', 'Bevacizumab', 'Carboplatin', 'Paclitaxel'], 'conditions': ['Carcinoma, Non-Small-Cell Lung']}, 'referencesModule': {'references': [{'pmid': '34264503', 'type': 'DERIVED', 'citation': 'Syrigos K, Abert I, Andric Z, Bondarenko IN, Dvorkin M, Galic K, Galiulin R, Kuchava V, Sriuranpong V, Trukhin D, Zhavrid E, Fu D, Kassalow LM, Jones S, Bashir Z; AVANA Investigators. Efficacy and Safety of Bevacizumab Biosimilar FKB238 Versus Originator Bevacizumab: Results from AVANA, a Phase III Trial in Patients with Non-Squamous Non-Small-Cell Lung Cancer (non-sq-NSCLC). BioDrugs. 2021 Jul;35(4):417-428. doi: 10.1007/s40259-021-00489-4. Epub 2021 Jul 15.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to compare the effectiveness and safety of FKB238 against Avastin® in men and women with advanced/recurrent non squamous non-small cell lung cancer'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 18 years or older\n* Newly diagnosed advanced (stage IV) /recurrent non-squamous NSCLC for which they had not received any systemic anti-cancer therapy for metastatic disease\n* Histologically or cytologically confirmed diagnosis of predominantly non-squamous NSCLC\n* Existence of at least 1 measurable lesion by RECIST v1.1\n* Adequate hematological, renal and liver function\n* Eastern Collaborative Oncology Group Performance Status (ECOG PS) 0 or 1\n* Life expectancy longer than 6 months\n\nExclusion Criteria:\n\n* Small cell lung cancer (SCLC) or combination SCLC and NSCLC. Squamous-cell tumors and mixed adenosquamous carcinomas of predominantly squamous nature\n* Any unresolved toxicities from prior systemic therapy\n* Known sensitizing epidermal growth factor receptor (EGFR) mutations or echinoderm microtubule-associated protein-like 4-anaplastic lymphoma kinase (EML4-ALK) translocation positive mutations\n* Previous dosing with vascular endothelial growth factor (VEGF) inhibitor\n* Known hypersensitivity to any excipients of the Investigational Products (IPs) and combination chemotherapy\n* Use of prohibited concomitant medication\n* Known Hepatitis B, Hepatitis C, or human immunodeficiency virus (HIV) infection\n* Fertile men or women of childbearing potential not using adequate contraception.\n\nOther inclusion/exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT02810457', 'acronym': 'AVANA', 'briefTitle': 'Evaluation of FKB238 and Avastin in Patients With Advanced/Recurrent Non-squamous Non-small Cell Lung Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Centus Biotherapeutics Limited'}, 'officialTitle': 'A Randomised, Parallel, Double Blinded Study to Compare the Efficacy and Safety of FKB238 to Avastin® In 1st Line Treatment for Patients With Advanced/Recurrent Non Squamous NSCLC in Combination of Paclitaxel and Carboplatin', 'orgStudyIdInfo': {'id': 'FKB238-002'}, 'secondaryIdInfos': [{'id': '2015-004104-33', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FKB238 / paclitaxel / carboplatin', 'description': 'Drug: FKB238:\n\n15 mg/kg IV infusion on Day 1 of each 21-day cycle.\n\nDrug: Paclitaxel:\n\n200 mg/m2 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.\n\nDrug: Carboplatin:\n\nArea Under Curve (AUC) = 6.0 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.', 'interventionNames': ['Drug: FKB238 (bevacizumab)', 'Drug: Paclitaxel', 'Drug: Carboplatin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Avastin / paclitaxel / carboplatin', 'description': 'Drug: Avastin:\n\n15 mg/kg IV infusion on Day 1 of each 21-day cycle.\n\nDrug: Paclitaxel:\n\n200 mg/m2 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.\n\nDrug: Carboplatin:\n\nAUC = 6.0 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.', 'interventionNames': ['Drug: Avastin (bevacizumab)', 'Drug: Paclitaxel', 'Drug: Carboplatin']}], 'interventions': [{'name': 'FKB238 (bevacizumab)', 'type': 'DRUG', 'armGroupLabels': ['FKB238 / paclitaxel / carboplatin']}, {'name': 'Avastin (bevacizumab)', 'type': 'DRUG', 'armGroupLabels': ['Avastin / paclitaxel / carboplatin']}, {'name': 'Paclitaxel', 'type': 'DRUG', 'armGroupLabels': ['Avastin / paclitaxel / carboplatin', 'FKB238 / paclitaxel / carboplatin']}, {'name': 'Carboplatin', 'type': 'DRUG', 'armGroupLabels': ['Avastin / paclitaxel / carboplatin', 'FKB238 / paclitaxel / carboplatin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92708', 'city': 'Fountain Valley', 'state': 'California', 'country': 'United States', 'facility': 'Research Site 7814 - Compassionate Care Research Group', 'geoPoint': {'lat': 33.70918, 'lon': -117.95367}}, {'zip': '90603', 'city': 'Whittier', 'state': 'California', 'country': 'United States', 'facility': 'Research Site 7811 - Innovative Clinical Research Institute', 'geoPoint': {'lat': 33.97918, 'lon': -118.03284}}, {'zip': '32204', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site 7803 - 21st Century Oncology', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '60435', 'city': 'Joliet', 'state': 'Illinois', 'country': 'United States', 'facility': 'Research Site 7812 - Joliet Oncology-Hematology Associates, Ltd.', 'geoPoint': {'lat': 41.52519, 'lon': -88.0834}}, {'zip': '60076', 'city': 'Skokie', 'state': 'Illinois', 'country': 'United States', 'facility': 'Research Site 7810 - Edward H. 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