Ignite Creation Date:
2025-12-25 @ 4:35 AM
Ignite Modification Date:
2025-12-26 @ 3:37 AM
Study NCT ID:
NCT01015118
Status:
COMPLETED
Last Update Posted:
2017-12-07
First Post:
2009-11-09
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
LUME-Ovar 1: Nintedanib (BIBF 1120) or Placebo in Combination With Paclitaxel and Carboplatin in First Line Treatment of Ovarian Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['New Zealand']}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D010534', 'term': 'Peritoneal 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'}, {'id': 'D000008', 'term': 'Abdominal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010532', 'term': 'Peritoneal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'C530716', 'term': 'nintedanib'}, {'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': 'D056831', 'term': 'Coordination Complexes'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127', 'title': 'Boehringer Ingelheim, Call Center', 'organization': 'Boehringer Ingelheim'}, 'certainAgreement': {'otherDetails': "Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'First drug administration until data cut-off 26September16, up to 62 months', 'description': 'Adverse Events were reported for the treated patients.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Patients to receive matching placebo soft gelatine capsule identical to those containing Nintedanib, taken orally twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.', 'otherNumAtRisk': 450, 'otherNumAffected': 442, 'seriousNumAtRisk': 450, 'seriousNumAffected': 157}, {'id': 'EG001', 'title': 'Nintedanib', 'description': 'Patients to receive Nintedanib 200 milligram (mg) soft gelatine capsule, taken orally twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.', 'otherNumAtRisk': 902, 'otherNumAffected': 891, 'seriousNumAtRisk': 902, 'seriousNumAffected': 379}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 129}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 317}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 78}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 165}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 203}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 419}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 87}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 301}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 55}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 111}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 281}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 58}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 125}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 151}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 254}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 114}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 692}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 77}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 53}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 231}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 583}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 51}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 119}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 391}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 65}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 163}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 201}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 388}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 62}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 48}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 35}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 64}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Drug hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 58}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 53}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 66}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 73}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 131}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 259}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 219}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 74}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 56}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 74}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 63}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 63}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 168}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 85}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 92}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 137}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 242}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 54}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 83}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 62}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 56}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 107}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 201}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 56}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 95}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 77}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 126}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 140}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 85}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 172}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 64}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 100}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 114}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 214}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Polyneuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 50}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 36}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 51}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 57}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 105}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 57}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 55}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 109}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 72}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 278}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 519}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 44}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 95}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 73}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 119}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 36}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Febrile bone marrow aplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 20}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Haemolytic uraemic syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Haemorrhagic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 8}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Microangiopathic haemolytic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 24}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 8}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Splenic infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Splenic vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 1}, {'groupId': 'EG001', 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19.0'}, {'term': 'Cardiogenic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cardiovascular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Mitral valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 3}], 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connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Rhabdomyolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 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'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Renal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Thyroid cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Tumour associated fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 0}], 'organSystem': 'Neoplasms 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'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Guillain-Barre syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hemianopia homonymous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Intracranial aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 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{'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 11}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pulmonary haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Dermatomyositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 1}], 'organSystem': 'Skin and 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[{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Urticarial vasculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Catheter placement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Central venous catheter removal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Chemotherapy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cholecystectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cytoreductive surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Ileostomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Intestinal resection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Laparotomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Large intestine anastomosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Vaginal operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Accelerated hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Aortic aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Axillary vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Circulatory collapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Lymphocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 6}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Lymphoedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Malignant hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pelvic venous thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Thrombophlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 6}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Varicose vein', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Vasculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Vena cava thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Venous occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Venous thrombosis limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 450, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'PFS Based on Investigator Assessment According to Modified Response Evaluation Criteria in Solid Tumors, Version 1.1 (mRECIST), and Additional Clinical Criteria.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '911', 'groupId': 'OG000'}, {'value': '455', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nintedanib', 'description': 'Patients to receive Nintedanib 200 milligram (mg) soft gelatine capsule, taken orally twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients to receive matching placebo soft gelatine capsule identical to those containing Nintedanib, taken orally twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.2', 'groupId': 'OG000', 'lowerLimit': '11.1', 'upperLimit': '32.5'}, {'value': '16.6', 'groupId': 'OG001', 'lowerLimit': '10.8', 'upperLimit': '30.4'}]}]}], 'analyses': [{'pValue': '0.0239', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.84', 'ciLowerLimit': '0.72', 'ciUpperLimit': '0.98', 'estimateComment': 'If hazard ratio is below 1 then favours nintedanib.', 'groupDescription': 'Hazard ratio (HR), Confidence Interval (CI) and P-value obtained from a proportional-hazards model stratified by Macroscopic residual postoperative tumour (Yes vs. no), the International Federation of Gynecology and Obstetrics (FIGO) Stage (IIB-III vs. IV) and carboplatin level Area under curve 5 (AUC5) vs. Area under curve 6 (AUC6).', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Breslow method was used for handling ties.'}], 'paramType': 'MEDIAN', 'timeFrame': 'First drug administration to date of disease progression or death whichever occurs first , upto 29 months', 'description': 'Progression free survival (PFS) is calculated as the time from randomisation to the date of disease progression, or to the date of death, whichever occurs first according to the Investigator assessment.\n\nThe primary PFS analysis of this trial was performed when approximately 753 patients had experienced a PFS event\n\nMedian, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve for each treatment arm.', 'unitOfMeasure': 'Months', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomised Set (RS)'}, {'type': 'PRIMARY', 'title': 'PFS Based on Investigator Assessment According to Modified Response Evaluation Criteria in Solid Tumors, Version 1.1 (mRECIST), and Additional Clinical Criteria (Follow up Analysis).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '911', 'groupId': 'OG000'}, {'value': '455', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nintedanib', 'description': 'Patients to receive Nintedanib 200 milligram (mg) soft gelatine capsule, taken orally twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients to receive matching placebo soft gelatine capsule identical to those containing Nintedanib, taken orally twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.6', 'groupId': 'OG000', 'lowerLimit': '11.1', 'upperLimit': '38.0'}, {'value': '16.6', 'groupId': 'OG001', 'lowerLimit': '10.8', 'upperLimit': '37.3'}]}]}], 'analyses': [{'pValue': '0.0286', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.86', 'ciLowerLimit': '0.75', 'ciUpperLimit': '0.98', 'estimateComment': 'If hazard ratio is below 1 then favours nintedanib.', 'groupDescription': 'Hazard ratio (HR), Confidence Interval (CI) and P-value obtained from a proportional-hazards model stratified by Macroscopic residual postoperative tumour (Yes vs. no), the International Federation of Gynecology and Obstetrics (FIGO) Stage (IIB-III vs. IV) and carboplatin level (AUC5 vs. AUC6).', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Breslow method was used for handling ties.'}], 'paramType': 'MEDIAN', 'timeFrame': 'First drug administration to date of disease progression or death whichever occurs first until final Data Base Lock (DBL) 26September16, upto 62 months', 'description': 'Follow-up analysis was conducted at the time of overall survival analysis. Progression free survival (PFS) is calculated as the time from randomisation to the date of disease progression, or to the date of death, whichever occurs first according to the Investigator assessment.\n\nMedian, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve for each treatment arm.', 'unitOfMeasure': 'Months', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomised Set (RS)'}, {'type': 'SECONDARY', 'title': 'PFS Based on Investigator Assessment According to mRECIST Version 1.1 (Key Secondary Endpoint).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '911', 'groupId': 'OG000'}, {'value': '455', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nintedanib', 'description': 'Patients to receive Nintedanib 200 milligram (mg) soft gelatine capsule, taken orally twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients to receive matching placebo soft gelatine capsule identical to those containing Nintedanib, taken orally twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.'}], 'classes': [{'categories': [{'measurements': [{'value': '18.3', 'groupId': 'OG000', 'lowerLimit': '11.1', 'upperLimit': '32.5'}, {'value': '16.6', 'groupId': 'OG001', 'lowerLimit': '10.8', 'upperLimit': '30.4'}]}]}], 'analyses': [{'pValue': '0.0186', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.83', 'ciLowerLimit': '0.72', 'ciUpperLimit': '0.97', 'estimateComment': 'If hazard ratio is below 1 then favours nintedanib.', 'groupDescription': 'HR, CI and P-value obtained from a proportional-hazards model stratified by Macroscopic residual postoperative tumour (Yes vs. no), the International Federation of Gynecology and Obstetrics (FIGO) Stage (IIB-III vs. IV) and carboplatin level (AUC5 vs. AUC6).', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Breslow method was used for handling ties.'}], 'paramType': 'MEDIAN', 'timeFrame': 'First drug administration to date of disease progression or death whichever occurs first , upto 29 months', 'description': 'Progression free survival is calculated as the time from randomisation to the date of disease progression, or to the date of death, whichever occurs first based on the Investigator assessment according to Modified Response Evaluation Criteria (mRECIST), version 1.1.\n\nThe primary PFS analysis of this trial was performed when approximately 753 patients had experienced a PFS event.\n\nMedian, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve for each treatment arm.', 'unitOfMeasure': 'Months', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomised Set (RS)'}, {'type': 'SECONDARY', 'title': 'PFS Based on Investigator Assessment According to mRECIST Version 1.1 (Key Secondary Endpoint - Follow up Analysis).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '911', 'groupId': 'OG000'}, {'value': '455', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nintedanib', 'description': 'Patients to receive Nintedanib 200 milligram (mg) soft gelatine capsule, taken orally twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients to receive matching placebo soft gelatine capsule identical to those containing Nintedanib, taken orally twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.'}], 'classes': [{'categories': [{'measurements': [{'value': '18.4', 'groupId': 'OG000', 'lowerLimit': '11.1', 'upperLimit': '38.5'}, {'value': '16.6', 'groupId': 'OG001', 'lowerLimit': '10.8', 'upperLimit': '37.3'}]}]}], 'analyses': [{'pValue': '0.0256', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.85', 'ciLowerLimit': '0.74', 'ciUpperLimit': '0.98', 'estimateComment': 'If hazard ratio is below 1 then favours nintedanib.', 'groupDescription': 'HR, CI and P-value obtained from a proportional-hazards model stratified by Macroscopic residual postoperative tumour (Yes vs. no), the International Federation of Gynecology and Obstetrics (FIGO) Stage (IIB-III vs. IV) and carboplatin level (AUC5 vs. AUC6).', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Breslow method was used for handling ties.'}], 'paramType': 'MEDIAN', 'timeFrame': 'First drug administration to date of disease progression or death whichever occurs first until final Data Base Lock (DBL) 26September16, upto 62 months', 'description': 'Follow-up analysis was conducted at the time of overall survival analysis. Progression free survival is calculated as the time from randomisation to the date of disease progression, or to the date of death, whichever occurs first based on the Investigator assessment according to Modified Response Evaluation Criteria (mRECIST), version 1.1. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve for each treatment arm.', 'unitOfMeasure': 'Months', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomised Set (RS)'}, {'type': 'SECONDARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '911', 'groupId': 'OG000'}, {'value': '455', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nintedanib', 'description': 'Patients to receive Nintedanib 200 milligram (mg) soft gelatine capsule, taken orally twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients to receive matching placebo soft gelatine capsule identical to those containing Nintedanib, taken orally twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.'}], 'classes': [{'categories': [{'measurements': [{'value': '62.0', 'comment': 'Not calculable because of insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': '30.0', 'upperLimit': 'NA'}, {'value': '62.8', 'comment': 'Not calculable because of insufficient number of participants with events', 'groupId': 'OG001', 'lowerLimit': '30.6', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.8653', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.99', 'ciLowerLimit': '0.83', 'ciUpperLimit': '1.17', 'estimateComment': 'If hazard ratio is below 1 then favours nintedanib.', 'groupDescription': 'HR, CI and P-value obtained from a proportional-hazards model stratified by Macroscopic residual postoperative tumour (Yes vs. no), the International Federation of Gynecology and Obstetrics (FIGO) Stage (IIB-III vs. IV) and carboplatin level (AUC5 vs. AUC6).', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Breslow method was used for handling ties.'}], 'paramType': 'MEDIAN', 'timeFrame': 'First drug administration to date of death until final DBL 26September16, upto 62 months', 'description': 'Overall survival is defined as time from randomization to date of death (irrespective of reason).\n\nMedian, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve for each treatment arm.', 'unitOfMeasure': 'Months', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomised Set (RS)'}, {'type': 'SECONDARY', 'title': 'Time to CA-125 Tumour Marker Progression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '911', 'groupId': 'OG000'}, {'value': '455', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nintedanib', 'description': 'Patients to receive Nintedanib 200 milligram (mg) soft gelatine capsule, taken orally twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients to receive matching placebo soft gelatine capsule identical to those containing Nintedanib, taken orally twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.6', 'groupId': 'OG000', 'lowerLimit': '10.6', 'upperLimit': '47.0'}, {'value': '14.1', 'groupId': 'OG001', 'lowerLimit': '8.6', 'upperLimit': '42.6'}]}]}], 'analyses': [{'pValue': '0.0749', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.88', 'ciLowerLimit': '0.77', 'ciUpperLimit': '1.01', 'estimateComment': 'If hazard ratio is below 1 then favours nintedanib.', 'groupDescription': 'HR, CI and P-value obtained from a proportional-hazards model stratified by Macroscopic residual postoperative tumour (Yes vs. no), the International Federation of Gynecology and Obstetrics (FIGO) Stage (IIB-III vs. IV) and carboplatin level (AUC5 vs. AUC6).', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Breslow method was used for handling ties.'}], 'paramType': 'MEDIAN', 'timeFrame': 'First drug administration until final DBL 26September16, upto 62 months', 'description': 'Time to tumour-marker progression was defined as the time from randomisation until the date when Carbohydrate (cancer) antigen (CA-125) values increased to higher than twice the nadir value. CA-125 \\>=2 x nadir in case nadir value \\> Upper limit of normal (ULN) or CA-125 \\>=2 x ULN in case nadir value \\<= ULN.', 'unitOfMeasure': 'Months', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomised set (RS)'}, {'type': 'SECONDARY', 'title': 'Objective Response Based on Investigator Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '911', 'groupId': 'OG000'}, {'value': '455', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nintedanib', 'description': 'Patients to receive Nintedanib 200 milligram (mg) soft gelatine capsule, taken orally twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients to receive matching placebo soft gelatine capsule identical to those containing Nintedanib, taken orally twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.'}], 'classes': [{'categories': [{'measurements': [{'value': '74.3', 'groupId': 'OG000'}, {'value': '70.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.3490', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.22', 'ciLowerLimit': '0.81', 'ciUpperLimit': '1.82', 'estimateComment': 'An odds ratio \\>1 favours nintedanib.', 'groupDescription': 'Odds ratio and p-value are obtained from logistic regression model adjusting for, macroscopic residual postoperative tumour (yes vs. no), the International Federation of Gynecology and Obstetrics (FIGO) stage (IIB-III vs. IV) and carboplatin level (AUC5 vs. AUC6).', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'First drug administration until final DBL 26September16, upto 62 months', 'description': 'Objective tumour response defined as either complete response \\[CR\\] or partial response \\[PR\\] in patients with at least 1 target lesion reported at baseline', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomised Set (RS) for patients with at least 1 target lesion reported at baseline'}, {'type': 'SECONDARY', 'title': 'Change in Abdominal/Gastro-intestinal Symptoms Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '911', 'groupId': 'OG000'}, {'value': '455', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nintedanib', 'description': 'Patients to receive Nintedanib 200 milligram (mg) soft gelatine capsule, taken orally twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients to receive matching placebo soft gelatine capsule identical to those containing Nintedanib, taken orally twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.'}], 'classes': [{'categories': [{'measurements': [{'value': '24.63', 'spread': '0.49', 'groupId': 'OG000'}, {'value': '19.34', 'spread': '0.64', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.29', 'ciLowerLimit': '3.88', 'ciUpperLimit': '6.69', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.72', 'estimateComment': 'Mean difference presented is the Adjusted mean difference. Difference calculated as nintedanib minus placebo. High values represent a worse level of symptoms.', 'groupDescription': 'Adjusted for the stratification factors macroscopic residual postoperative tumour at baseline (yes vs. no), the International Federation of Gynecology and Obstetrics (FIGO) stage (IIB-III vs IV), and carboplatin level (AUC5 vs. AUC6).', 'statisticalMethod': 'Mixed effect growth curve model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Mixed-effects growth curve models (longitudinal models) with the average profile over time for each endpoint described by a piecewise linear model.'}], 'paramType': 'MEAN', 'timeFrame': 'First drug administration until final DBL 26September16, upto 62 months', 'description': 'Change in abdominal/gastro-intestinal over time was calculated on symptoms (scale composite of items 31 to 37 of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Module for Ovarian Cancer 28 (EORTC QLQ OV-28).\n\nAs specified in the EORTC scoring manual, for each scale or item, a linear transformation was applied to standardize the raw score to a range from 0 to 100 (high scores represent a high/severe level of symptomatology).\n\nMean presented is Adjusted mean. Adjusted for the stratification factors macroscopic residual postoperative tumour at baseline (yes vs. no), FIGO stage (IIB-III vs IV), and Carboplatin level (AUC5 vs. AUC6).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomised Set (RS) for patients with abdominal/gastro-intestinal symptoms'}, {'type': 'SECONDARY', 'title': 'Change in Global Health Status/ Quality of Life (QoL) Scale Over Time.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '911', 'groupId': 'OG000'}, {'value': '455', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nintedanib', 'description': 'Patients to receive Nintedanib 200 milligram (mg) soft gelatine capsule, taken orally twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients to receive matching placebo soft gelatine capsule identical to those containing Nintedanib, taken orally twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.'}], 'classes': [{'categories': [{'measurements': [{'value': '68.79', 'spread': '0.48', 'groupId': 'OG000'}, {'value': '70.67', 'spread': '0.65', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0124', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.88', 'ciLowerLimit': '-3.35', 'ciUpperLimit': '-0.41', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.75', 'estimateComment': 'Mean difference calculated is the Adjusted mean. High values represent a better level of functioning. Difference calculated as nintedanib minus placebo.', 'groupDescription': 'Adjusted for the stratification factors macroscopic residual postoperative tumour at baseline (yes vs. no), the International Federation of Gynecology and Obstetrics (FIGO) stage (IIB-III vs IV), and carboplatin level (AUC5 vs. AUC6).', 'statisticalMethod': 'Mixed effect growth curve model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Mixed-effects growth curve models (longitudinal models) with the average profile over time for each endpoint described by a piecewise linear model.'}], 'paramType': 'MEAN', 'timeFrame': 'First drug administration until final DBL 26September16, upto 62 months', 'description': 'Change in Global Health Status/ Quality of life (QoL) over time was calculated on Global Health Status/QoL scale (composite of items 29 and 30 of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-30 (EORTC QLQ-C30) as a general measure.\n\nAs specified in the EORTC scoring manual, for each scale or item, a linear transformation was applied to standardize the raw score to a range from 0 to 100 (high scores represent a high/healthy level of functioning).\n\nMean presented is Adjusted mean. Adjusted for the stratification factors macroscopic residual postoperative tumour at baseline (yes vs. no), FIGO stage (IIB-III vs IV), and Carboplatin level (AUC5 vs. AUC6).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomised Set (RS) for patients with global health status/QoL'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Nintedanib', 'description': 'Patients to receive Nintedanib 200 milligram (mg) soft gelatine capsule, taken orally twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Patients to receive matching placebo soft gelatine capsule identical to those containing Nintedanib, taken orally twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '911'}, {'groupId': 'FG001', 'numSubjects': '455'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Patients who completed max trial therapy duration.', 'groupId': 'FG000', 'numSubjects': '242'}, {'comment': 'Patients who completed max trial therapy duration.', 'groupId': 'FG001', 'numSubjects': '128'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '669'}, {'groupId': 'FG001', 'numSubjects': '327'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '103'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'Other Adverse Event (AE)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '141'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'Worsening or AE of underlying disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Progressive disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '364'}, {'groupId': 'FG001', 'numSubjects': '229'}]}, {'type': 'Not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Other than stated above', 'reasons': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '23'}]}]}], 'preAssignmentDetails': '1366 patients were randomised for this study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '911', 'groupId': 'BG000'}, {'value': '455', 'groupId': 'BG001'}, {'value': '1366', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Nintedanib', 'description': 'Patients to receive Nintedanib 200 milligram (mg) soft gelatine capsule, taken orally twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Patients to receive matching placebo soft gelatine capsule identical to those containing Nintedanib, taken orally twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.5', 'spread': '11.0', 'groupId': 'BG000'}, {'value': '56.9', 'spread': '11.1', 'groupId': 'BG001'}, {'value': '57.3', 'spread': '11.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '911', 'groupId': 'BG000'}, {'value': '455', 'groupId': 'BG001'}, {'value': '1366', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Randomised Set (RS): included all randomised patients, regardless of whether or not they had received treatment. Patients were assigned to nintedanib or placebo as randomised.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1366}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'dispFirstSubmitDate': '2014-03-27', 'completionDateStruct': {'date': '2016-09-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-03', 'studyFirstSubmitDate': '2009-11-09', 'dispFirstSubmitQcDate': '2014-03-27', 'resultsFirstSubmitDate': '2014-11-14', 'studyFirstSubmitQcDate': '2009-11-17', 'dispFirstPostDateStruct': {'date': '2014-04-24', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2017-12-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-01-13', 'studyFirstPostDateStruct': {'date': '2009-11-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-01-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PFS Based on Investigator Assessment According to Modified Response Evaluation Criteria in Solid Tumors, Version 1.1 (mRECIST), and Additional Clinical Criteria.', 'timeFrame': 'First drug administration to date of disease progression or death whichever occurs first , upto 29 months', 'description': 'Progression free survival (PFS) is calculated as the time from randomisation to the date of disease progression, or to the date of death, whichever occurs first according to the Investigator assessment.\n\nThe primary PFS analysis of this trial was performed when approximately 753 patients had experienced a PFS event\n\nMedian, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve for each treatment arm.'}, {'measure': 'PFS Based on Investigator Assessment According to Modified Response Evaluation Criteria in Solid Tumors, Version 1.1 (mRECIST), and Additional Clinical Criteria (Follow up Analysis).', 'timeFrame': 'First drug administration to date of disease progression or death whichever occurs first until final Data Base Lock (DBL) 26September16, upto 62 months', 'description': 'Follow-up analysis was conducted at the time of overall survival analysis. Progression free survival (PFS) is calculated as the time from randomisation to the date of disease progression, or to the date of death, whichever occurs first according to the Investigator assessment.\n\nMedian, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve for each treatment arm.'}], 'secondaryOutcomes': [{'measure': 'PFS Based on Investigator Assessment According to mRECIST Version 1.1 (Key Secondary Endpoint).', 'timeFrame': 'First drug administration to date of disease progression or death whichever occurs first , upto 29 months', 'description': 'Progression free survival is calculated as the time from randomisation to the date of disease progression, or to the date of death, whichever occurs first based on the Investigator assessment according to Modified Response Evaluation Criteria (mRECIST), version 1.1.\n\nThe primary PFS analysis of this trial was performed when approximately 753 patients had experienced a PFS event.\n\nMedian, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve for each treatment arm.'}, {'measure': 'PFS Based on Investigator Assessment According to mRECIST Version 1.1 (Key Secondary Endpoint - Follow up Analysis).', 'timeFrame': 'First drug administration to date of disease progression or death whichever occurs first until final Data Base Lock (DBL) 26September16, upto 62 months', 'description': 'Follow-up analysis was conducted at the time of overall survival analysis. Progression free survival is calculated as the time from randomisation to the date of disease progression, or to the date of death, whichever occurs first based on the Investigator assessment according to Modified Response Evaluation Criteria (mRECIST), version 1.1. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve for each treatment arm.'}, {'measure': 'Overall Survival', 'timeFrame': 'First drug administration to date of death until final DBL 26September16, upto 62 months', 'description': 'Overall survival is defined as time from randomization to date of death (irrespective of reason).\n\nMedian, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve for each treatment arm.'}, {'measure': 'Time to CA-125 Tumour Marker Progression', 'timeFrame': 'First drug administration until final DBL 26September16, upto 62 months', 'description': 'Time to tumour-marker progression was defined as the time from randomisation until the date when Carbohydrate (cancer) antigen (CA-125) values increased to higher than twice the nadir value. CA-125 \\>=2 x nadir in case nadir value \\> Upper limit of normal (ULN) or CA-125 \\>=2 x ULN in case nadir value \\<= ULN.'}, {'measure': 'Objective Response Based on Investigator Assessment', 'timeFrame': 'First drug administration until final DBL 26September16, upto 62 months', 'description': 'Objective tumour response defined as either complete response \\[CR\\] or partial response \\[PR\\] in patients with at least 1 target lesion reported at baseline'}, {'measure': 'Change in Abdominal/Gastro-intestinal Symptoms Over Time', 'timeFrame': 'First drug administration until final DBL 26September16, upto 62 months', 'description': 'Change in abdominal/gastro-intestinal over time was calculated on symptoms (scale composite of items 31 to 37 of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Module for Ovarian Cancer 28 (EORTC QLQ OV-28).\n\nAs specified in the EORTC scoring manual, for each scale or item, a linear transformation was applied to standardize the raw score to a range from 0 to 100 (high scores represent a high/severe level of symptomatology).\n\nMean presented is Adjusted mean. Adjusted for the stratification factors macroscopic residual postoperative tumour at baseline (yes vs. no), FIGO stage (IIB-III vs IV), and Carboplatin level (AUC5 vs. AUC6).'}, {'measure': 'Change in Global Health Status/ Quality of Life (QoL) Scale Over Time.', 'timeFrame': 'First drug administration until final DBL 26September16, upto 62 months', 'description': 'Change in Global Health Status/ Quality of life (QoL) over time was calculated on Global Health Status/QoL scale (composite of items 29 and 30 of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-30 (EORTC QLQ-C30) as a general measure.\n\nAs specified in the EORTC scoring manual, for each scale or item, a linear transformation was applied to standardize the raw score to a range from 0 to 100 (high scores represent a high/healthy level of functioning).\n\nMean presented is Adjusted mean. Adjusted for the stratification factors macroscopic residual postoperative tumour at baseline (yes vs. no), FIGO stage (IIB-III vs IV), and Carboplatin level (AUC5 vs. AUC6).'}]}, 'conditionsModule': {'conditions': ['Ovarian Neoplasms', 'Peritoneal Neoplasms']}, 'referencesModule': {'references': [{'pmid': '37185961', 'type': 'DERIVED', 'citation': 'Gaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3.'}, {'pmid': '26590673', 'type': 'DERIVED', 'citation': 'du Bois A, Kristensen G, Ray-Coquard I, Reuss A, Pignata S, Colombo N, Denison U, Vergote I, Del Campo JM, Ottevanger P, Heubner M, Minarik T, Sevin E, de Gregorio N, Bidzinski M, Pfisterer J, Malander S, Hilpert F, Mirza MR, Scambia G, Meier W, Nicoletto MO, Bjorge L, Lortholary A, Sailer MO, Merger M, Harter P; AGO Study Group led Gynecologic Cancer Intergroup/European Network of Gynaecologic Oncology Trials Groups Intergroup Consortium. Standard first-line chemotherapy with or without nintedanib for advanced ovarian cancer (AGO-OVAR 12): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet Oncol. 2016 Jan;17(1):78-89. doi: 10.1016/S1470-2045(15)00366-6. Epub 2015 Nov 16.'}]}, 'descriptionModule': {'briefSummary': 'The trial will be performed to evaluate if BIBF 1120 in combination with paclitaxel and carboplatin is more effective than placebo in combination with paclitaxel and carboplatin in first-line treatment of patients with advanced ovarian cancer. Safety information about BIBF1120/paclitaxel/carboplatin will be obtained.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* first diagnosis of histologically confirmed epithelial ovarian cancer, fallopian tube or primary peritoneal cancer\n* International Federation of Gynecology and Obstetrics (FIGO) Stages IIB - IV\n* females, age 18 years or older\n* life expectancy of at least 6 months\n* Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2\n* prior surgery, defined as either (a) debulking surgery with maximum surgical effort at cytoreduction with the goal of no residual disease or (b) biopsy or limited surgery in patients with stage IV disease for whom surgical debulking was not considered appropriate, if diagnosis is confirmed by histology and no surgery is planned prior to disease progression (including interval debulking surgery)\n* patient has given written informed consent which must be consistent with the International Conference on Harmonization - Good Clinical Practice (ICH-GCP) and local legislation\n* planned application of first dose of chemotherapy after wound healing, but no later than 10 weeks after surgery\n\nExclusion criteria:\n\n* histologic diagnosis of a benign or borderline tumour or of a malignant tumour of non-epithelial origin of the ovary, the fallopian tube or the peritoneum\n* planned surgery within 124 weeks after randomisation in this trial, including interval debulking surgery\n* clinically relevant non-healing wound, ulcer or bone fracture\n* clinical symptoms or signs of gastrointestinal obstruction that require parenteral nutrition or hydration\n* brain metastases\n* pre-existing sensory or motor neuropathy Common Terminology Criteria for Adverse Events (CTCAE) grade 2 or higher, except due to trauma\n* history of major thromboembolic event\n* known inherited or acquired bleeding disorder\n* significant cardiovascular diseases\n* clinically relevant pericardial effusion\n* history of a cerebral vascular accident, transient ischemic attack or subarachnoid haemorrhage within the past 6 months\n* inadequate safety laboratory values\n* serious infections in particular if requiring systemic antibiotic (antimicrobial, antifungal) or antiviral therapy, including Hepatitis B, Hepatitis C, Human Immunodeficiency Virus (HIV)\n* poorly controlled diabetes mellitus or other contraindication to high dose corticosteroid therapy\n* gastrointestinal disorders or abnormalities that would interfere with absorption of the study drug\n* other malignancy diagnosed within the past 5 years. In exception to this rule, the following malignancies may be included if adequately treated: non-melanomatous skin cancer, cervical carcinoma in situ, carcinoma in situ of the breast, low risk endometrial cancer\n* prior systemic therapy for ovarian cancer (e.g. chemotherapy, monoclonal antibody therapy, oral targeted therapy, hormonal therapy)\n* prior systemic cytotoxic chemotherapy\n* prior treatment with BIBF 1120 or any other angiogenesis inhibitor\n* prior radiotherapy\n* serious illness or concomitant non-oncological disease such as neurologic, psychiatric or infectious disease or a laboratory abnormality that may increase the risk associated with study participation or study drug administration\n* Women of childbearing potential who are sexually active and not using a highly effective method of birth control during the trial and for at least twelve months after the end of active therapy.\n* pregnancy or breast feeding\n* psychological, familial, sociological or geographical factors potentially hampering compliance with the study protocol and follow-up schedule\n* active alcohol or drug abuse\n* patients unable to comply with the protocol\n* any contraindications for therapy with paclitaxel or carboplatin\n* treatment with other investigational drugs or participation in another clinical trial testing a drug within the past four weeks before start of therapy or concomitantly with this trial'}, 'identificationModule': {'nctId': 'NCT01015118', 'briefTitle': 'LUME-Ovar 1: Nintedanib (BIBF 1120) or Placebo in Combination With Paclitaxel and Carboplatin in First Line Treatment of Ovarian Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Multicenter, Randomised, Double-blind Phase III Trial to Investigate the Efficacy and Safety of BIBF 1120 in Combination With Carboplatin and Paclitaxel Compared to Placebo Plus Carboplatin and Paclitaxel in Patients With Advanced Ovarian Cancer', 'orgStudyIdInfo': {'id': '1199.15'}, 'secondaryIdInfos': [{'id': 'AGO-OVAR12', 'type': 'OTHER', 'domain': 'OTHER'}, {'id': '2008-006831-10', 'type': 'EUDRACT_NUMBER', 'domain': 'EudraCT'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BIBF 1120', 'description': 'patients to receive BIBF 1120 standard dose twice daily PO in combination with combination with carboplatin and paclitaxel', 'interventionNames': ['Drug: BIBF 1120', 'Drug: Paclitaxel', 'Drug: Carboplatin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'patients to receive capsules identical to those containing BIBF 1120 in combination with combination with carboplatin and paclitaxel', 'interventionNames': ['Drug: Placebo', 'Drug: Paclitaxel', 'Drug: Carboplatin']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'comparator to BIBF 1120', 'armGroupLabels': ['Placebo']}, {'name': 'Paclitaxel', 'type': 'DRUG', 'description': 'Paclitaxel (standard chemo-therapy)', 'armGroupLabels': ['Placebo']}, {'name': 'BIBF 1120', 'type': 'DRUG', 'description': 'comparison of BIBF 1120 in combination with chemotherapy and placebo in combination with chemotherapy (paclitaxel/carboplatin)', 'armGroupLabels': ['BIBF 1120']}, {'name': 'Carboplatin', 'type': 'DRUG', 'description': 'Carboplatin (standard chemo-therapy)', 'armGroupLabels': ['Placebo']}, {'name': 'Paclitaxel', 'type': 'DRUG', 'description': 'Paclitaxel (standard chemo-therapy)', 'armGroupLabels': ['BIBF 1120']}, {'name': 'Carboplatin', 'type': 'DRUG', 'description': 'Carboplatin (standard chemo-therapy)', 'armGroupLabels': ['BIBF 1120']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': '1199.15.10113 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': '1199.15.10030 Boehringer Ingelheim 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