Ignite Creation Date:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2026-02-27 @ 11:19 AM
Study NCT ID:
NCT02825420
Status:
COMPLETED
Last Update Posted:
2021-10-29
First Post:
2016-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Non-interventional European Study of Trabectedin + PLD in the Treatment of Relapsed Ovarian Cancer (ROC) Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian Neoplasms'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077606', 'term': 'Trabectedin'}], 'ancestors': [{'id': 'D004149', 'term': 'Dioxoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D044005', 'term': 'Tetrahydroisoquinolines'}, {'id': 'D007546', 'term': 'Isoquinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@pharmamar.com', 'phone': '0034 91846 60 00', 'title': 'Clinical Developtment, Department of PharmaMar´s Oncology., Business Unit.', 'organization': 'Pharma Mar S.A.'}, 'certainAgreement': {'otherDetails': 'The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days from the time submitted to the sponsor for review.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)', 'description': 'Two patients were excluded from the safety set because of missing PLD treatment data', 'eventGroups': [{'id': 'EG000', 'title': 'Prior Use of Antiangiogenics', 'description': 'Patients who used a prior Antiangiogenics defined as type of therapy reported in the CRF categorized as "antiangiogenic" by the investigator or prior treatment reported by the investigator being bevacizumab (or Avastin®), pazopanib, or trabananib', 'otherNumAtRisk': 129, 'deathsNumAtRisk': 129, 'otherNumAffected': 106, 'seriousNumAtRisk': 129, 'deathsNumAffected': 30, 'seriousNumAffected': 23}, {'id': 'EG001', 'title': 'No Prior Use of Antiangiogenics', 'description': 'Antiangiogenics-naïve Patients. Antiangiogenics defined as type of therapy reported in the CRF categorized as "antiangiogenic" by the investigator or prior treatment reported by the investigator being bevacizumab (or Avastin®), pazopanib, or trabananib', 'otherNumAtRisk': 89, 'deathsNumAtRisk': 89, 'otherNumAffected': 78, 'seriousNumAtRisk': 89, 'deathsNumAffected': 12, 'seriousNumAffected': 14}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 99, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 48, 'numAffected': 25}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 36, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 22, 'numAffected': 7}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 162, 'numAffected': 57}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 152, 'numAffected': 46}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 34, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 14, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 22, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 15, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 10, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 63, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 36, 'numAffected': 26}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 42, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 19, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 64, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 61, 'numAffected': 37}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 16, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 22, 'numAffected': 15}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 30, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 13, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 21, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Palmar-plantar erythrodysaesthesia syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 17, 'numAffected': 12}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Skin hyperpigmentation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Gastrointestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Retching', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Enteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Disease progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Drug hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Device related infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Escherichia infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Infusion site infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Pneumocystis jirovecii pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Clostridium difficile infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Blood electrolytes decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Transaminases increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Hepatic cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Azotaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Dysphonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Pyoderma gangrenosum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Mood altered', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Off label use', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression-Free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '218', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Full Analysis Set', 'description': 'The full analysis set consisted of all the patients enrolled into the study and who had at least one administration of T + PLD.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.46', 'groupId': 'OG000', 'lowerLimit': '7.9', 'upperLimit': '10.9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From Day 1 to the earliest date of disease progression as reported by the investigator or death, up to 4.5 years (Jan 2015 to Sept 2019)', 'description': 'PFS was defined as time (in months) from Day 1 to the earliest date of disease progression as reported by the investigator or death, regardless of cause, (whichever is first). Patients with no reported disease progression and alive were censored at last contact date/last date known alive. PFS was calculated as the date of progressive disease or death minus date of Day 1, and the result in days was converted to months. All tumor assessment dates were based on the actual imaging dates reported by the investigator. Progressive disease (PD) defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Progression Free Survival by Prior Antiangiogenic Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prior Use of Antiangiogenics', 'description': 'Patients who used a prior Antiangiogenics defined as type of therapy reported in the CRF categorized as "antiangiogenic" by the investigator or prior treatment reported by the investigator being bevacizumab (or Avastin®), pazopanib, or trabananib'}, {'id': 'OG001', 'title': 'No Prior Use of Antiangiogenics', 'description': 'Antiangiogenics-naïve Patients. Antiangiogenics defined as type of therapy reported in the CRF categorized as "antiangiogenic" by the investigator or prior treatment reported by the investigator being bevacizumab (or Avastin®), pazopanib, or trabananib'}], 'classes': [{'categories': [{'measurements': [{'value': '7.59', 'groupId': 'OG000', 'lowerLimit': '6.4', 'upperLimit': '10.0'}, {'value': '12.45', 'groupId': 'OG001', 'lowerLimit': '9.4', 'upperLimit': '14.3'}]}]}], 'analyses': [{'pValue': '0.007', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From Day 1 to the earliest date of disease progression as reported by the investigator or death, up to 4.5 years (Jan 2015 to Sept 2019)', 'description': 'PFS was defined as time (in months) from Day 1 to the earliest date of disease progression as reported by the investigator or death, regardless of cause, (whichever is first). Patients with no reported disease progression and alive were censored at last contact date/last date known alive. PFS was calculated as the date of progressive disease or death minus date of Day 1, and the result in days was converted to months. All tumor assessment dates were based on the actual imaging dates reported by the investigator. Progressive disease (PD) defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Progression Free Survival by BRCA1/2 Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Positive BRCA', 'description': 'Patients with Positive BRCA'}, {'id': 'OG001', 'title': 'Negative', 'description': 'Patients with Negative BRCA'}], 'classes': [{'categories': [{'measurements': [{'value': '9.23', 'groupId': 'OG000', 'lowerLimit': '6.0', 'upperLimit': '17.1'}, {'value': '8.97', 'groupId': 'OG001', 'lowerLimit': '7.1', 'upperLimit': '10.3'}]}]}], 'analyses': [{'pValue': '0.58', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From Day 1 to the earliest date of disease progression as reported by the investigator or death, up to 4.5 years (Jan 2015 to Sept 2019)', 'description': 'PFS was defined as time (in months) from Day 1 to the earliest date of disease progression as reported by the investigator or death, regardless of cause, (whichever is first). Patients with no reported disease progression and alive were censored at last contact date/last date known alive. PFS was calculated as the date of progressive disease or death minus date of Day 1, and the result in days was converted to months. All tumor assessment dates were based on the actual imaging dates reported by the investigator. Progressive disease (PD) defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Progression Free Survival by Platinum Sensitivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fully Platinum Sensitivity', 'description': 'Cancer that responds Fully to treatment with anticancer drugs that contain the metal platinum, such as cisplatin and carboplatin.'}, {'id': 'OG001', 'title': 'Partially Platinum Sensitivity', 'description': 'Cancer that responds Partially to treatment with anticancer drugs that contain the metal platinum, such as cisplatin and carboplatin.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.26', 'groupId': 'OG000', 'lowerLimit': '7.1', 'upperLimit': '12.5'}, {'value': '9.46', 'groupId': 'OG001', 'lowerLimit': '7.4', 'upperLimit': '11.4'}]}]}], 'analyses': [{'pValue': '0.62', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From Day 1 to the earliest date of disease progression as reported by the investigator or death, up to 4.5 years (Jan 2015 to Sept 2019)', 'description': 'PFS was defined as time (in months) from Day 1 to the earliest date of disease progression as reported by the investigator or death, regardless of cause, (whichever is first). Patients with no reported disease progression and alive were censored at last contact date/last date known alive. PFS was calculated as the date of progressive disease or death minus date of Day 1, and the result in days was converted to months. All tumor assessment dates were based on the actual imaging dates reported by the investigator. Progressive disease (PD) defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Best Tumor Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '218', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Full Analysis Set', 'description': 'The full analysis set consisted of all the patients enrolled into the study and who had at least one administration of T + PLD.'}], 'classes': [{'categories': [{'title': 'Complete response', 'measurements': [{'value': '24', 'groupId': 'OG000'}]}, {'title': 'Partial response', 'measurements': [{'value': '57', 'groupId': 'OG000'}]}, {'title': 'Stable disease', 'measurements': [{'value': '59', 'groupId': 'OG000'}]}, {'title': 'Progressive disease', 'measurements': [{'value': '62', 'groupId': 'OG000'}]}, {'title': 'Not evaluable/Not done', 'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 1 of study treatment to end of study, up to 4.5 years (Jan 2015 to Sept 2019)', 'description': 'Complete response (CR): Disappearance of all target lesions; Partial response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started; Progressive disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Best Response by Prior Antiangiogenic Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prior Use of Antiangiogenics', 'description': 'Patients who used a prior Antiangiogenics defined as type of therapy reported in the CRF categorized as "antiangiogenic" by the investigator or prior treatment reported by the investigator being bevacizumab (or Avastin®), pazopanib, or trabananib'}, {'id': 'OG001', 'title': 'No Prior Use of Antiangiogenics', 'description': 'Antiangiogenics-naïve Patients. Antiangiogenics defined as type of therapy reported in the CRF categorized as "antiangiogenic" by the investigator or prior treatment reported by the investigator being bevacizumab (or Avastin®), pazopanib, or trabananib'}], 'classes': [{'categories': [{'title': 'Progressive disease', 'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}, {'title': 'Stable disease', 'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}, {'title': 'Partial response', 'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}, {'title': 'Complete response', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}, {'title': 'Not evaluable/Not done', 'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.010', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 1 of study treatment to end of study, up to 4.5 years (Jan 2015 to Sept 2019)', 'description': 'Complete response (CR): Disappearance of all target lesions; Partial response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started; Progressive disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '218', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Full Analysis Set', 'description': 'The full analysis set consisted of all the patients enrolled into the study and who had at least one administration of T + PLD.'}], 'classes': [{'categories': [{'measurements': [{'value': '23.56', 'groupId': 'OG000', 'lowerLimit': '18.1', 'upperLimit': '34.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From Day 1 to death, up to 4.5 years (Jan 2015 to Sept 2019)', 'description': 'Overall Survival time was calculated as the number of days from Day 1 to death. Time to death was summarized in months. Patients who did not die (no record of death) or were lost to follow up were censored at the date of last contact/last date known alive.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Overall Survival by Prior Antiangiogenic Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prior Use of Antiangiogenics', 'description': 'Patients who used a prior Antiangiogenics defined as type of therapy reported in the CRF categorized as "antiangiogenic" by the investigator or prior treatment reported by the investigator being bevacizumab (or Avastin®), pazopanib, or trabananib'}, {'id': 'OG001', 'title': 'No Prior Use of Antiangiogenics', 'description': 'Antiangiogenics-naïve Patients. Antiangiogenics defined as type of therapy reported in the CRF categorized as "antiangiogenic" by the investigator or prior treatment reported by the investigator being bevacizumab (or Avastin®), pazopanib, or trabananib'}], 'classes': [{'categories': [{'measurements': [{'value': '21.85', 'groupId': 'OG000', 'lowerLimit': '16.7', 'upperLimit': '39.6'}, {'value': '26.28', 'groupId': 'OG001', 'lowerLimit': '18.1', 'upperLimit': '40.1'}]}]}], 'analyses': [{'pValue': '0.048', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From Day 1 to death, up to 4.5 years (Jan 2015 to Sept 2019)', 'description': 'Overall Survival time was calculated as the number of days from Day 1 to death. Time to death was summarized in months. Patients who did not die (no record of death) or were lost to follow up were censored at the date of last contact/last date known alive.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Overall Survival by BRCA1/2 Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Positive BRCA', 'description': 'Patients with Positive BRCA'}, {'id': 'OG001', 'title': 'Negative', 'description': 'Patients with Negative BRCA'}], 'classes': [{'categories': [{'measurements': [{'value': '23.56', 'groupId': 'OG000', 'lowerLimit': '16.1', 'upperLimit': '40.1'}, {'value': '21.85', 'comment': 'Not reached: the last observation is censored', 'groupId': 'OG001', 'lowerLimit': '16.7', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.51', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From Day 1 to death, up to 4.5 years (Jan 2015 to Sept 2019)', 'description': 'Overall Survival time was calculated as the number of days from Day 1 to death. Time to death was summarized in months. Patients who did not die (no record of death) or were lost to follow up were censored at the date of last contact/last date known alive.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Overall Survival by Platinum Sensitivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fully Platinum Sensitivity', 'description': 'Cancer that responds Fully to treatment with anticancer drugs that contain the metal platinum, such as cisplatin and carboplatin.'}, {'id': 'OG001', 'title': 'Partially Platinum Sensitivity', 'description': 'Cancer that responds Partially to treatment with anticancer drugs that contain the metal platinum, such as cisplatin and carboplatin.'}], 'classes': [{'categories': [{'measurements': [{'value': '23.56', 'groupId': 'OG000', 'lowerLimit': '16.7', 'upperLimit': '34.1'}, {'value': '26.05', 'groupId': 'OG001', 'lowerLimit': '17.7', 'upperLimit': '39.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From Day 1 to death, up to 4.5 years (Jan 2015 to Sept 2019)', 'description': 'Overall Survival time was calculated as the number of days from Day 1 to death. Time to death was summarized in months. Patients who did not die (no record of death) or were lost to follow up were censored at the date of last contact/last date known alive.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Best Post-baseline ECOG Performance Status Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '218', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Full Analysis Set', 'description': 'The full analysis set consisted of all the patients enrolled into the study and who had at least one administration of T + PLD.'}], 'classes': [{'categories': [{'title': 'Less than 0 (improvement)', 'measurements': [{'value': '24', 'groupId': 'OG000'}]}, {'title': '0 (no change)', 'measurements': [{'value': '125', 'groupId': 'OG000'}]}, {'title': 'More than 0 to 2 (deterioration)', 'measurements': [{'value': '14', 'groupId': 'OG000'}]}, {'title': 'Missing', 'measurements': [{'value': '55', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through study completion, up to 4.5 years (Jan 2015 to Sept 2019)', 'description': 'Eastern Cooperative Oncology Group performance status (ECOG):\n\n0 Fully active, able to carry on all pre-disease performance without restriction; 1 Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature; 2 Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours; 3 Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours; 4 Completely disabled; cannot carry on any selfcare; totally confined to bed or chair; 5 Dead', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Best Post-baseline ECOG Performance Status Score by Prior Antiangiogenic Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prior Use of Antiangiogenics', 'description': 'Patients who used a prior Antiangiogenics defined as type of therapy reported in the CRF categorized as "antiangiogenic" by the investigator or prior treatment reported by the investigator being bevacizumab (or Avastin®), pazopanib, or trabananib'}, {'id': 'OG001', 'title': 'No Prior Use of Antiangiogenics', 'description': 'Antiangiogenics-naïve Patients. Antiangiogenics defined as type of therapy reported in the CRF categorized as "antiangiogenic" by the investigator or prior treatment reported by the investigator being bevacizumab (or Avastin®), pazopanib, or trabananib'}], 'classes': [{'categories': [{'title': 'Less than 0 (improvement)', 'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}, {'title': '0 (no change)', 'measurements': [{'value': '83', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}, {'title': 'More than 0 to 2 (deterioration)', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}, {'title': 'Missing', 'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through study completion, up to 4.5 years (Jan 2015 to Sept 2019)', 'description': 'Eastern Cooperative Oncology Group performance status (ECOG):\n\n0 Fully active, able to carry on all pre-disease performance without restriction; 1 Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature; 2 Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours; 3 Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours; 4 Completely disabled; cannot carry on any selfcare; totally confined to bed or chair; 5 Dead', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Prior Use of Antiangiogenics', 'description': 'Patients who used a prior Antiangiogenics defined as type of therapy reported in the CRF categorized as "antiangiogenic" by the investigator or prior treatment reported by the investigator being bevacizumab (or Avastin®), pazopanib, or trabananib'}, {'id': 'FG001', 'title': 'No Prior Use of Antiangiogenics', 'description': 'Antiangiogenics-naïve Patients. Antiangiogenics defined as type of therapy reported in the CRF categorized as "antiangiogenic" by the investigator or prior treatment reported by the investigator being bevacizumab (or Avastin®), pazopanib, or trabananib'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '131'}, {'groupId': 'FG001', 'numSubjects': '89'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '88'}, {'groupId': 'FG001', 'numSubjects': '72'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '17'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'Progressive disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol amendment not signed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Did not receive PLD', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'A total of 220 patients treated according to standard local clinical practice in 57 sites across Italy, Spain, Germany, France, and Belgium have been enrolled in the study. The first patient was included in the study on 28 July 2015. Data were collected between 26 January 2015, date of first patient trabectedin administration (prior treatment before inclusion in the study) and 18 September 2019, date of last patient last visit.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '218', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Prior Use of Antiangiogenics', 'description': 'Patients who used a prior Antiangiogenics defined as type of therapy reported in the CRF categorized as "antiangiogenic" by the investigator or prior treatment reported by the investigator being bevacizumab (or Avastin®), pazopanib, or trabananib'}, {'id': 'BG001', 'title': 'No Prior Use of Antiangiogenics', 'description': 'Antiangiogenics-naïve Patients. Antiangiogenics defined as type of therapy reported in the CRF categorized as "antiangiogenic" by the investigator or prior treatment reported by the investigator being bevacizumab (or Avastin®), pazopanib, or trabananib'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '218', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '129', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '218', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '61.0', 'groupId': 'BG000', 'lowerLimit': '39', 'upperLimit': '82'}, {'value': '61.0', 'groupId': 'BG001', 'lowerLimit': '40', 'upperLimit': '86'}, {'value': '61.0', 'groupId': 'BG002', 'lowerLimit': '39', 'upperLimit': '86'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '218', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '129', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '218', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Belgium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '218', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'Italy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '218', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}]}]}, {'title': 'France', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '218', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}, {'title': 'Germany', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '218', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}, {'title': 'Spain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '218', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '199', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '64.0', 'groupId': 'BG000', 'lowerLimit': '40.0', 'upperLimit': '130.0'}, {'value': '68.0', 'groupId': 'BG001', 'lowerLimit': '43.0', 'upperLimit': '109.0'}, {'value': '65.0', 'groupId': 'BG002', 'lowerLimit': '40.0', 'upperLimit': '130.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Kg', 'dispersionType': 'FULL_RANGE', 'populationDescription': '19 patients not evaluated'}, {'title': 'Height', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '199', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '160', 'groupId': 'BG000', 'lowerLimit': '146', 'upperLimit': '178'}, {'value': '158', 'groupId': 'BG001', 'lowerLimit': '144', 'upperLimit': '173'}, {'value': '160', 'groupId': 'BG002', 'lowerLimit': '144', 'upperLimit': '178'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'cm', 'dispersionType': 'FULL_RANGE', 'populationDescription': '19 patients not evaluated'}, {'title': 'Calculated body surface area', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '194', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'BG000', 'lowerLimit': '1.3', 'upperLimit': '2.4'}, {'value': '1.7', 'groupId': 'BG001', 'lowerLimit': '1.4', 'upperLimit': '2.2'}, {'value': '1.7', 'groupId': 'BG002', 'lowerLimit': '1.3', 'upperLimit': '2.4'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'm^2', 'dispersionType': 'FULL_RANGE', 'populationDescription': '24 patients not evaluated'}, {'title': 'Investigator reported body surface area', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '194', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'BG000', 'lowerLimit': '1.3', 'upperLimit': '2.2'}, {'value': '1.7', 'groupId': 'BG001', 'lowerLimit': '1.4', 'upperLimit': '2.1'}, {'value': '1.7', 'groupId': 'BG002', 'lowerLimit': '1.3', 'upperLimit': '2.2'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'm^2', 'dispersionType': 'FULL_RANGE', 'populationDescription': '24 patients not evaluated'}, {'title': 'Tumor grade at diagnosis', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '218', 'groupId': 'BG002'}]}], 'categories': [{'title': 'High grade', 'measurements': [{'value': '95', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '156', 'groupId': 'BG002'}]}, {'title': 'Intermediate grade', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Low grade', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Not done/not reported/unknown', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Histopathology at initial ovarian cancer diagnosis', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '218', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Papillary/serous', 'measurements': [{'value': '97', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '157', 'groupId': 'BG002'}]}, {'title': 'Endometroid', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Clear cell carcinoma', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Peritoneal carcinoma', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Mixed epithelial tumour', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Mucinous', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Undifferentiated carcinoma', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Fallopian tube carcinoma', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Transitional carcinoma (brenner)', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Transitional carcinoma (no brenner)', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Platinum sensitivity', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '218', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Partially Platinum Sensitive', 'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '127', 'groupId': 'BG002'}]}, {'title': 'Fully Platinum Sensitive', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'BRCA 1/2 status tested', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '218', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Positive', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}, {'title': 'Negative', 'measurements': [{'value': '68', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}, {'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Not tested', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'ECOG performance status', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '218', 'groupId': 'BG002'}]}], 'categories': [{'title': 'PS 0', 'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}]}, {'title': 'PS 1', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}, {'title': 'PS 2', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Eastern Cooperative Oncology Group performance status:\n\n0 Fully active, able to carry on all pre-disease performance without restriction; 1 Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature; 2 Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours; 3 Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours; 4 Completely disabled; cannot carry on any selfcare; totally confined to bed or chair; 5 Dead', 'unitOfMeasure': 'Participants'}, {'title': 'Prior surgery', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '218', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '118', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '199', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Surgery residual disease', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '218', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Prior radiotherapy', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '218', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Prior chemotherapy', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '218', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '129', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '217', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of prior chemotherapy lines', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '218', 'groupId': 'BG002'}]}], 'categories': [{'title': 'None', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': '1 prior line', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}, {'title': '2 prior lines', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}]}, {'title': '3 prior lines', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}, {'title': '4-8 prior lines', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Best response to prior therapy regimen', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '218', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Complete Response', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}, {'title': 'Partial Response', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}, {'title': 'Stable Disease', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}, {'title': 'Disease recurrence/Progression disease', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}, {'title': 'Not Evaluable/Not done/Unknown', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Complete response (CR): Disappearance of all target lesions; Partial response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started; Progressive disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions', 'unitOfMeasure': 'Participants'}], 'populationDescription': '2 patients enrolled did not receive PLD'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-09-18', 'size': 491328, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-06-04T07:07', 'hasProtocol': True}, {'date': '2019-10-02', 'size': 683428, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-06-04T07:08', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 220}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2019-09-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-30', 'studyFirstSubmitDate': '2016-06-27', 'resultsFirstSubmitDate': '2021-07-28', 'studyFirstSubmitQcDate': '2016-07-01', 'lastUpdatePostDateStruct': {'date': '2021-10-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-09-30', 'studyFirstPostDateStruct': {'date': '2016-07-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-10-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-Free Survival', 'timeFrame': 'From Day 1 to the earliest date of disease progression as reported by the investigator or death, up to 4.5 years (Jan 2015 to Sept 2019)', 'description': 'PFS was defined as time (in months) from Day 1 to the earliest date of disease progression as reported by the investigator or death, regardless of cause, (whichever is first). Patients with no reported disease progression and alive were censored at last contact date/last date known alive. PFS was calculated as the date of progressive disease or death minus date of Day 1, and the result in days was converted to months. All tumor assessment dates were based on the actual imaging dates reported by the investigator. Progressive disease (PD) defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.'}, {'measure': 'Progression Free Survival by Prior Antiangiogenic Treatment', 'timeFrame': 'From Day 1 to the earliest date of disease progression as reported by the investigator or death, up to 4.5 years (Jan 2015 to Sept 2019)', 'description': 'PFS was defined as time (in months) from Day 1 to the earliest date of disease progression as reported by the investigator or death, regardless of cause, (whichever is first). Patients with no reported disease progression and alive were censored at last contact date/last date known alive. PFS was calculated as the date of progressive disease or death minus date of Day 1, and the result in days was converted to months. All tumor assessment dates were based on the actual imaging dates reported by the investigator. Progressive disease (PD) defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.'}, {'measure': 'Progression Free Survival by BRCA1/2 Status', 'timeFrame': 'From Day 1 to the earliest date of disease progression as reported by the investigator or death, up to 4.5 years (Jan 2015 to Sept 2019)', 'description': 'PFS was defined as time (in months) from Day 1 to the earliest date of disease progression as reported by the investigator or death, regardless of cause, (whichever is first). Patients with no reported disease progression and alive were censored at last contact date/last date known alive. PFS was calculated as the date of progressive disease or death minus date of Day 1, and the result in days was converted to months. All tumor assessment dates were based on the actual imaging dates reported by the investigator. Progressive disease (PD) defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.'}, {'measure': 'Progression Free Survival by Platinum Sensitivity', 'timeFrame': 'From Day 1 to the earliest date of disease progression as reported by the investigator or death, up to 4.5 years (Jan 2015 to Sept 2019)', 'description': 'PFS was defined as time (in months) from Day 1 to the earliest date of disease progression as reported by the investigator or death, regardless of cause, (whichever is first). Patients with no reported disease progression and alive were censored at last contact date/last date known alive. PFS was calculated as the date of progressive disease or death minus date of Day 1, and the result in days was converted to months. All tumor assessment dates were based on the actual imaging dates reported by the investigator. Progressive disease (PD) defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.'}], 'secondaryOutcomes': [{'measure': 'Best Tumor Response', 'timeFrame': 'From Day 1 of study treatment to end of study, up to 4.5 years (Jan 2015 to Sept 2019)', 'description': 'Complete response (CR): Disappearance of all target lesions; Partial response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started; Progressive disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions'}, {'measure': 'Best Response by Prior Antiangiogenic Treatment', 'timeFrame': 'From Day 1 of study treatment to end of study, up to 4.5 years (Jan 2015 to Sept 2019)', 'description': 'Complete response (CR): Disappearance of all target lesions; Partial response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started; Progressive disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions'}, {'measure': 'Overall Survival', 'timeFrame': 'From Day 1 to death, up to 4.5 years (Jan 2015 to Sept 2019)', 'description': 'Overall Survival time was calculated as the number of days from Day 1 to death. Time to death was summarized in months. Patients who did not die (no record of death) or were lost to follow up were censored at the date of last contact/last date known alive.'}, {'measure': 'Overall Survival by Prior Antiangiogenic Treatment', 'timeFrame': 'From Day 1 to death, up to 4.5 years (Jan 2015 to Sept 2019)', 'description': 'Overall Survival time was calculated as the number of days from Day 1 to death. Time to death was summarized in months. Patients who did not die (no record of death) or were lost to follow up were censored at the date of last contact/last date known alive.'}, {'measure': 'Overall Survival by BRCA1/2 Status', 'timeFrame': 'From Day 1 to death, up to 4.5 years (Jan 2015 to Sept 2019)', 'description': 'Overall Survival time was calculated as the number of days from Day 1 to death. Time to death was summarized in months. Patients who did not die (no record of death) or were lost to follow up were censored at the date of last contact/last date known alive.'}, {'measure': 'Overall Survival by Platinum Sensitivity', 'timeFrame': 'From Day 1 to death, up to 4.5 years (Jan 2015 to Sept 2019)', 'description': 'Overall Survival time was calculated as the number of days from Day 1 to death. Time to death was summarized in months. Patients who did not die (no record of death) or were lost to follow up were censored at the date of last contact/last date known alive.'}, {'measure': 'Change From Baseline to Best Post-baseline ECOG Performance Status Score', 'timeFrame': 'Through study completion, up to 4.5 years (Jan 2015 to Sept 2019)', 'description': 'Eastern Cooperative Oncology Group performance status (ECOG):\n\n0 Fully active, able to carry on all pre-disease performance without restriction; 1 Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature; 2 Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours; 3 Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours; 4 Completely disabled; cannot carry on any selfcare; totally confined to bed or chair; 5 Dead'}, {'measure': 'Change From Baseline to Best Post-baseline ECOG Performance Status Score by Prior Antiangiogenic Treatment', 'timeFrame': 'Through study completion, up to 4.5 years (Jan 2015 to Sept 2019)', 'description': 'Eastern Cooperative Oncology Group performance status (ECOG):\n\n0 Fully active, able to carry on all pre-disease performance without restriction; 1 Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature; 2 Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours; 3 Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours; 4 Completely disabled; cannot carry on any selfcare; totally confined to bed or chair; 5 Dead'}]}, 'conditionsModule': {'conditions': ['Relapsed Ovarian Cancer']}, 'descriptionModule': {'briefSummary': 'Non-interventional, multicenter, prospective, European study to describe the effectiveness of trabectedin + PLD in the treatment of relapsed ovarian cancer (ROC) patients according to SmPC regardless of previous use of an antiangiogenic drug'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with platinum-sensitive relapsed ovarian cancer who are receiving trabectedin + PLD according to SmPC.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women aged 18 years or older.\n* Presence of platinum-sensitive relapsed ovarian cancer.\n* Treatment and treated indication according to local label SmPC and reimbursement for trabectedin and PLD treatment.\n* Prior treatment with a minimum of 1 cycle of trabectedin + PLD according to SmPC before inclusion in the study, and no more than 3 previous treatment lines.\n* Written informed consent indicating that patients understand the purpose and procedures and are willing to participate in the study.\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT02825420', 'acronym': 'NIMES-ROC', 'briefTitle': 'Non-interventional European Study of Trabectedin + PLD in the Treatment of Relapsed Ovarian Cancer (ROC) Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'PharmaMar'}, 'officialTitle': 'NonInterventional, Multicenter, Prospective, European Study to Describe the Effectiveness of Trabectedin + PLD in the Treatment of Relapsed Ovarian Cancer (ROC) Patients According to SmPC Regardless of Previous Use of an Antiangiogenic Drug', 'orgStudyIdInfo': {'id': 'ET-D-031-14'}}, 'armsInterventionsModule': {'interventions': [{'name': 'trabectedin', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '164-9300', 'city': 'Aalst', 'state': 'Flanders', 'country': 'Belgium', 'facility': 'O.L.V. Aalst', 'geoPoint': {'lat': 50.93604, 'lon': 4.0355}}, {'zip': '1026-9000', 'city': 'Ghent', 'state': 'Flanders', 'country': 'Belgium', 'facility': 'AZ Maria Middelares', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '7100', 'city': 'La Louvière', 'state': 'Henao', 'country': 'Belgium', 'facility': 'Centre Hospitalier de Jolimont', 'geoPoint': {'lat': 50.48657, 'lon': 4.18785}}, {'zip': '02-7000', 'city': 'Mons', 'state': 'Henao', 'country': 'Belgium', 'facility': 'CHU Ambroise-Paré', 'geoPoint': {'lat': 50.45413, 'lon': 3.95229}}, {'zip': '807500', 'city': 'Tournai', 'state': 'Henao', 'country': 'Belgium', 'facility': 'Centre Hospitalier de Wallonie Picarde', 'geoPoint': {'lat': 50.60715, 'lon': 3.38932}}, {'zip': '32-1180', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'CHIREC - Cancer Institute', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '21000', 'city': 'Dijon', 'state': 'Borgoña', 'country': 'France', 'facility': "Centre d'Oncologie et de Radiothérapie du Parc", 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '83000', 'city': 'Toulon', 'state': "Provence-Alpes-Côte d'Azur Region", 'country': 'France', 'facility': 'Clinique Saint Jean', 'geoPoint': {'lat': 43.12442, 'lon': 5.92836}}, {'city': 'Neuilly-sur-Seine', 'state': 'Seine', 'country': 'France', 'facility': "Institut d'Oncologie Hauts-de-Seine Nord", 'geoPoint': {'lat': 48.8846, 'lon': 2.26965}}, {'zip': '72000', 'city': 'Le Mans', 'state': 'Sharte', 'country': 'France', 'facility': 'Clinique Victor Hugo - Centre Jean Bernard', 'geoPoint': {'lat': 48.0021, 'lon': 0.20251}}, {'zip': '80000', 'city': 'Amiens', 'country': 'France', 'facility': "Clinique de l'Europe", 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'zip': '73190', 'city': 'Challes-les-Eaux', 'country': 'France', 'facility': 'Medipole de Savoie', 'geoPoint': {'lat': 45.54685, 'lon': 5.98098}}, {'zip': '95520', 'city': 'Osny', 'country': 'France', 'facility': "Oncologie médicale du Val d'Oise", 'geoPoint': {'lat': 49.0701, 'lon': 2.06277}}, {'zip': '75010', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Saint Louis', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '67000', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Strasbourg Oncologie Libérale Centre de radiothérapie', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '26655', 'city': 'Westerstede', 'state': 'Ammerland', 'country': 'Germany', 'facility': 'Onkologie Westerstede', 'geoPoint': {'lat': 53.25682, 'lon': 7.92737}}, {'zip': '87439', 'city': 'Kempten (Allgäu)', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Klinikum Kempten', 'geoPoint': {'lat': 47.72674, 'lon': 10.31389}}, {'zip': '42653', 'city': 'Solingen', 'state': 'Düsseldorf', 'country': 'Germany', 'facility': 'Städtisches Klinikum', 'geoPoint': {'lat': 51.17343, 'lon': 7.0845}}, {'zip': '64283', 'city': 'Darmstadt', 'state': 'Hesse', 'country': 'Germany', 'facility': 'Klinikum Darmstadt Frauenklinik', 'geoPoint': {'lat': 49.87167, 'lon': 8.65027}}, {'zip': '35578', 'city': 'Wetzlar', 'state': 'Hesse', 'country': 'Germany', 'facility': 'Brustzentrum', 'geoPoint': {'lat': 50.56109, 'lon': 8.50495}}, {'zip': '66424', 'city': 'Homburg/Saar', 'state': 'Homburg', 'country': 'Germany', 'facility': 'Uniklinik Homburg - Klinik Für Frauenheilkunde, Geburtshilfe und Reproduktionsmedizin'}, {'zip': '1307', 'city': 'Dresden', 'state': 'Saxony', 'country': 'Germany', 'facility': 'Onkologische Schwerpunktpraxis', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '49124', 'city': 'Georgsmarienhutte', 'state': 'Saxony', 'country': 'Germany', 'facility': 'Franziskus-Hospital Harderberg Internistische Onkologie und Hämatologie'}, {'zip': '92224', 'city': 'Amberg', 'country': 'Germany', 'facility': 'Klinikum St. Marien Amberg', 'geoPoint': {'lat': 49.44287, 'lon': 11.86267}}, {'zip': '59759', 'city': 'Arnsberg', 'country': 'Germany', 'facility': 'Klinikum Arnsberg, Karolinen Hospital, Frauenheilkunde', 'geoPoint': {'lat': 51.38333, 'lon': 8.08333}}, {'zip': '46236', 'city': 'Bottrop', 'country': 'Germany', 'facility': 'Onkologische Gemeinschaftspraxis', 'geoPoint': {'lat': 51.52392, 'lon': 6.9285}}, {'zip': '44137', 'city': 'Dortmund', 'country': 'Germany', 'facility': 'Städt. Klinik Dortmund, Frauenklinik', 'geoPoint': {'lat': 51.51494, 'lon': 7.466}}, {'zip': '80804', 'city': 'München', 'country': 'Germany', 'facility': 'Instirtut für klinische Forschung (IKF) Städtisches Klinikum München GmbH', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': '09481', 'city': 'Scheibenberg', 'country': 'Germany', 'facility': 'Praxis Dr. Rene Schubert', 'geoPoint': {'lat': 50.54023, 'lon': 12.91215}}, {'zip': '04860', 'city': 'Torgau', 'country': 'Germany', 'facility': 'Kreiskrankenhaus Torgau', 'geoPoint': {'lat': 51.56016, 'lon': 12.99617}}, {'zip': '71013', 'city': 'San Giovanni Rotondo', 'state': 'Foggia', 'country': 'Italy', 'facility': 'IRCCS Casa Sollievo Della Sofferenza', 'geoPoint': {'lat': 41.70643, 'lon': 15.7277}}, {'zip': '33081', 'city': 'Aviano', 'state': 'Pordenone', 'country': 'Italy', 'facility': 'Centro Riferimento Oncologico di Aviano', 'geoPoint': {'lat': 46.07056, 'lon': 12.59472}}, {'zip': '09042', 'city': 'Monserrato', 'state': 'Sardinia', 'country': 'Italy', 'facility': 'Policlinico Universitario Monserrato - Presidio Policlinico Duilio Casula', 'geoPoint': {'lat': 39.25642, 'lon': 9.1444}}, {'zip': '24047', 'city': 'Bergamo', 'state': 'Savona', 'country': 'Italy', 'facility': 'Ospedale S.Maria d. Misericordia', 'geoPoint': {'lat': 45.69601, 'lon': 9.66721}}, {'zip': '14100', 'city': 'Asti', 'country': 'Italy', 'facility': 'Ospedale Cardinal Massaia', 'geoPoint': {'lat': 44.90162, 'lon': 8.20751}}, {'zip': '70124', 'city': 'Bari', 'country': 'Italy', 'facility': 'Istituto Tumori Giovanni Paolo II IRCCS', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}, {'zip': '82100', 'city': 'Benevento', 'country': 'Italy', 'facility': 'Azienda Ospedaliera Gaetano Rummo', 'geoPoint': {'lat': 41.1307, 'lon': 14.77816}}, {'zip': '24127', 'city': 'Bergamo', 'country': 'Italy', 'facility': 'A. O. Papa Giovanni XXIII', 'geoPoint': {'lat': 45.69601, 'lon': 9.66721}}, {'zip': '22020', 'city': 'Como', 'country': 'Italy', 'facility': 'Ospedale S. Anna', 'geoPoint': {'lat': 45.80819, 'lon': 9.0832}}, {'zip': '50134', 'city': 'Florence', 'country': 'Italy', 'facility': 'Azienda Ospedaliera Universitaria Careggi', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'zip': '20157', 'city': 'Milan', 'country': 'Italy', 'facility': 'A.O. Sacco', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '80131', 'city': 'Napoli', 'country': 'Italy', 'facility': 'Istituto Nazionale Tumori IRCCS Pascale', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'zip': '43126', 'city': 'Parma', 'country': 'Italy', 'facility': 'A.O.U. di Parma', 'geoPoint': {'lat': 44.79935, 'lon': 10.32618}}, {'zip': '00168', 'city': 'Roma', 'country': 'Italy', 'facility': 'Policlinico Universitario Agostino Gemelli Università Cattolica di Roma', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '10153', 'city': 'Torino', 'country': 'Italy', 'facility': 'Ospedale Gradenigo', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}, {'zip': '31100', 'city': 'Treviso', 'country': 'Italy', 'facility': 'Ospedale Cà Foncello', 'geoPoint': {'lat': 45.66673, 'lon': 12.2416}}, {'zip': '23007', 'city': 'Jaén', 'state': 'Jaen', 'country': 'Spain', 'facility': 'Complejo Hospitalario de Jaén', 'geoPoint': {'lat': 37.76922, 'lon': -3.79028}}, {'zip': '35010', 'city': 'Las Palmas de Gran Canaria', 'state': 'Las Palmas', 'country': 'Spain', 'facility': 'Hospital Doctor Negrín', 'geoPoint': {'lat': 28.10178, 'lon': -15.41573}}, {'zip': '28040', 'city': 'León', 'state': 'León', 'country': 'Spain', 'facility': 'Hospital de León', 'geoPoint': {'lat': 42.60003, 'lon': -5.57032}}, {'zip': '06080', 'city': 'Parla', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Infanta Cristina', 'geoPoint': {'lat': 40.23604, 'lon': -3.76752}}, {'zip': '36204', 'city': 'Vigo', 'state': 'Pontevedra', 'country': 'Spain', 'facility': 'Hospital Xeral-Cíes de Vigo', 'geoPoint': {'lat': 42.23282, 'lon': -8.72264}}, {'zip': '38320', 'city': 'San Cristóbal de La Laguna', 'state': 'Santa Cruz De Tenerife', 'country': 'Spain', 'facility': 'Hospital Universitario de La Laguna', 'geoPoint': {'lat': 28.4853, 'lon': -16.32014}}, {'zip': '48013', 'city': 'Bilbao', 'state': 'Vizcaya', 'country': 'Spain', 'facility': 'Hospital de Basurto', 'geoPoint': {'lat': 43.26271, 'lon': -2.92528}}, {'zip': '48960', 'city': 'Galdakao', 'state': 'Vizcaya', 'country': 'Spain', 'facility': 'Hospital de Galdakao', 'geoPoint': {'lat': 43.23073, 'lon': -2.8429}}, {'zip': '15006', 'city': 'A Coruña', 'country': 'Spain', 'facility': 'Complejo Hospitalario de La Coruña', 'geoPoint': {'lat': 43.37135, 'lon': -8.396}}, {'zip': '08026', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '43204', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital de Reus', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28033', 'city': 'Madrid', 'country': 'Spain', 'facility': 'MD Anderson', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28034', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Ramón y Cajal', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28040', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Clínico San Carlos', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '30120', 'city': 'Murcia', 'country': 'Spain', 'facility': 'Hospital Virgen de la Arrixaca', 'geoPoint': {'lat': 37.98704, 'lon': -1.13004}}, {'zip': '07198', 'city': 'Palma de Mallorca', 'country': 'Spain', 'facility': 'Hospital Son Llatzer', 'geoPoint': {'lat': 39.56939, 'lon': 2.65024}}, {'zip': '41071', 'city': 'Seville', 'country': 'Spain', 'facility': 'Hospital Virgen Macarena', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '46009', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Instituto Valenciano de Oncología', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '50009', 'city': 'Zaragoza', 'country': 'Spain', 'facility': 'Hospital Clínico Universitario Lozano Blesa', 'geoPoint': {'lat': 41.65606, 'lon': -0.87734}}], 'overallOfficials': [{'name': 'María José Pontes', 'role': 'STUDY_CHAIR', 'affiliation': 'PharmaMar'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PharmaMar', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}