Ignite Creation Date:
2025-12-26 @ 5:19 PM
Ignite Modification Date:
2025-12-29 @ 10:35 AM
Study NCT ID:
NCT01121406
Status:
COMPLETED
Last Update Posted:
2015-08-13
First Post:
2010-04-13
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
BI 6727 (Volasertib) Randomised Trial in Ovarian Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian Neoplasms'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'D019772', 'term': 'Topotecan'}, {'id': 'C506643', 'term': 'liposomal doxorubicin'}, {'id': 'C541363', 'term': 'BI 6727'}], 'ancestors': [{'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}]}}, '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': 'From first treatment administration to 21 days after the last drug administration (Up to 1403 days)', 'eventGroups': [{'id': 'EG000', 'title': 'Volasertib (BI 6727)', 'description': "Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.\n\nTreatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator's choice. The patients were to be followed for survival status.", 'otherNumAtRisk': 54, 'otherNumAffected': 53, 'seriousNumAtRisk': 54, 'seriousNumAffected': 24}, {'id': 'EG001', 'title': 'Cytotoxic', 'description': 'Patients received a non-platinum cytotoxic single agent. The investigator chose the most appropriate drug according to patient status (previous chemotherapy effects, cumulative toxic effects, performance status, and nutritional status), the product Summary of Product Characteristics (SPC), and the local standard of care. The following non-platinum regimens were recommended because they are regarded efficacious and safe in patients with resistant ovarian cancer:\n\n* Pegylated liposomal doxorubicin (PLD): 40 mg/m² at Day 1 (1 course = 28 days)\n* Topotecan: 1.25 mg/m² from Days 1 to 5 (1 course = 21 days), or 4 mg/m² at Days 1, 8, and 15 (1 course = 28 days)\n* Paclitaxel: 80 mg/m² at Days 1, 8, 15, and 21 (1 course = 28 days)\n* Gemcitabine: 1000 mg/m² at Days 1 and 8 (1 course = 21 days)', 'otherNumAtRisk': 55, 'otherNumAffected': 53, 'seriousNumAtRisk': 55, 'seriousNumAffected': 19}, {'id': 'EG002', 'title': 'Cytotoxic to Volasertib Switch', 'description': 'Patients of the cytotoxic arm who switched to treatment with Volasertib (BI 6727).', 'otherNumAtRisk': 24, 'otherNumAffected': 21, 'seriousNumAtRisk': 24, 'seriousNumAffected': 12}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 7}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Blood uric acid increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Hyperuricaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Hypoalbuminaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 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malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Tumour invasion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Panic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Pyelocaliectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Atelectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Poor venous access', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Disease Control Rate (DCR) at Week 24 According to Response Evaluation Criteria In Solid Tumours (RECIST) Version 1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Volasertib (BI 6727)', 'description': "Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.\n\nTreatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator's choice. The patients were to be followed for survival status."}, {'id': 'OG001', 'title': 'Cytotoxic', 'description': 'Patients received a non-platinum cytotoxic single agent. The investigator chose the most appropriate drug according to patient status (previous chemotherapy effects, cumulative toxic effects, performance status, and nutritional status), the product Summary of Product Characteristics (SPC), and the local standard of care. The following non-platinum regimens were recommended because they are regarded efficacious and safe in patients with resistant ovarian cancer:\n\n* Pegylated liposomal doxorubicin (PLD): 40 mg/m² at Day 1 (1 course = 28 days)\n* Topotecan: 1.25 mg/m² from Days 1 to 5 (1 course = 21 days), or 4 mg/m² at Days 1, 8, and 15 (1 course = 28 days)\n* Paclitaxel: 80 mg/m² at Days 1, 8, 15, and 21 (1 course = 28 days)\n* Gemcitabine: 1000 mg/m² at Days 1 and 8 (1 course = 21 days)'}], 'classes': [{'categories': [{'measurements': [{'value': '30.6', 'groupId': 'OG000', 'lowerLimit': '18.0', 'upperLimit': '43.2'}, {'value': '43.1', 'groupId': 'OG001', 'lowerLimit': '29.5', 'upperLimit': '56.7'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Kaplan-Meier DC rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12.5', 'ciLowerLimit': '-31.1', 'ciUpperLimit': '6.0', 'estimateComment': '95% CI using Greenwood´s variance estimate.\n\nVolasertib (BI 6727) minus Cytotoxic.', 'groupDescription': "Kaplan Meier estimates and confidence intervals (CI) were calculated using Greenwood's variance estimate within each treatment arm and the asymptotic CI for the difference in the rates found. The time was censored in those cases where there was no death or progression until the last trial visit", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': 'DCR was defined as the proportion of patients who had an overall response of complete response (CR), partial response (PR), or stable disease (SD).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'TS'}, {'type': 'SECONDARY', 'title': 'Progression Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Volasertib (BI 6727)', 'description': "Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.\n\nTreatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator's choice. The patients were to be followed for survival status."}, {'id': 'OG001', 'title': 'Cytotoxic', 'description': 'Patients received a non-platinum cytotoxic single agent. The investigator chose the most appropriate drug according to patient status (previous chemotherapy effects, cumulative toxic effects, performance status, and nutritional status), the product Summary of Product Characteristics (SPC), and the local standard of care. The following non-platinum regimens were recommended because they are regarded efficacious and safe in patients with resistant ovarian cancer:\n\n* Pegylated liposomal doxorubicin (PLD): 40 mg/m² at Day 1 (1 course = 28 days)\n* Topotecan: 1.25 mg/m² from Days 1 to 5 (1 course = 21 days), or 4 mg/m² at Days 1, 8, and 15 (1 course = 28 days)\n* Paclitaxel: 80 mg/m² at Days 1, 8, 15, and 21 (1 course = 28 days)\n* Gemcitabine: 1000 mg/m² at Days 1 and 8 (1 course = 21 days)'}], 'classes': [{'categories': [{'measurements': [{'value': '13.1', 'groupId': 'OG000', 'lowerLimit': '6.6', 'upperLimit': '30.1'}, {'value': '20.6', 'groupId': 'OG001', 'lowerLimit': '11.6', 'upperLimit': '30.7'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.01', 'ciLowerLimit': '0.66', 'ciUpperLimit': '1.53', 'estimateComment': 'Cox proportional-hazards regression model, stratified by disease status at baseline (measurable vs. non measurable disease) and platinum resistant vs platinum refractory disease at baseline.\n\nHR calculated as Volasertib (BI 6727) /Cytotoxic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization until disease progression, death or study discontinuation; Up to 213 weeks', 'description': "Progression-free survival of a patient was based on the investigator's assessment; it was defined as the number of days from the date of randomisation until the date of either disease progression or death from any cause, whichever occurred first.\n\nDefinition of disease progression according to RECIST version 1.1; Patients with measurable tumour lesions at baseline, Target-lesions: at least a 20% increase in the sum of diameters of target lesions, the sum of diameters must also demonstrate an absolute increase of at least 5 mm,taking as reference the smallest sum on study, or appearance of 1 or more new lesions.\n\nNon-target lesions: unequivocal progression of existing non-target lesions or appearance of 1 or more new lesions Patients with non-measurable tumour lesions at baseline, Non-target lesions: requires unequivocal progression of existing non-target lesions or appearance of 1 or more new lesions", 'unitOfMeasure': 'weeks', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'TS'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Volasertib (BI 6727)', 'description': "Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.\n\nTreatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator's choice. The patients were to be followed for survival status."}, {'id': 'OG001', 'title': 'Cytotoxic', 'description': 'Patients received a non-platinum cytotoxic single agent. The investigator chose the most appropriate drug according to patient status (previous chemotherapy effects, cumulative toxic effects, performance status, and nutritional status), the product Summary of Product Characteristics (SPC), and the local standard of care. The following non-platinum regimens were recommended because they are regarded efficacious and safe in patients with resistant ovarian cancer:\n\n* Pegylated liposomal doxorubicin (PLD): 40 mg/m² at Day 1 (1 course = 28 days)\n* Topotecan: 1.25 mg/m² from Days 1 to 5 (1 course = 21 days), or 4 mg/m² at Days 1, 8, and 15 (1 course = 28 days)\n* Paclitaxel: 80 mg/m² at Days 1, 8, 15, and 21 (1 course = 28 days)\n* Gemcitabine: 1000 mg/m² at Days 1 and 8 (1 course = 21 days)'}], 'classes': [{'categories': [{'measurements': [{'value': '60.1', 'groupId': 'OG000', 'lowerLimit': '31.3', 'upperLimit': '95.4'}, {'value': '68.6', 'groupId': 'OG001', 'lowerLimit': '28.7', 'upperLimit': '119.4'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.94', 'ciLowerLimit': '0.63', 'ciUpperLimit': '1.42', 'estimateComment': 'Cox proportional-hazards regression model, stratified by disease status at baseline (measurable vs. non measurable disease) and platinum resistant vs platinum refractory disease at baseline.\n\nHR calculated as Volasertib (BI 6727) /Cytotoxic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization until death or study discontinuation; Up to 213 weeks', 'description': 'OS is defined as time from randomisation to death irrespective of the cause of the death.', 'unitOfMeasure': 'weeks', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'TS'}, {'type': 'SECONDARY', 'title': 'Best Overall Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Volasertib (BI 6727)', 'description': "Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.\n\nTreatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator's choice. The patients were to be followed for survival status."}, {'id': 'OG001', 'title': 'Cytotoxic', 'description': 'Patients received a non-platinum cytotoxic single agent. The investigator chose the most appropriate drug according to patient status (previous chemotherapy effects, cumulative toxic effects, performance status, and nutritional status), the product Summary of Product Characteristics (SPC), and the local standard of care. The following non-platinum regimens were recommended because they are regarded efficacious and safe in patients with resistant ovarian cancer:\n\n* Pegylated liposomal doxorubicin (PLD): 40 mg/m² at Day 1 (1 course = 28 days)\n* Topotecan: 1.25 mg/m² from Days 1 to 5 (1 course = 21 days), or 4 mg/m² at Days 1, 8, and 15 (1 course = 28 days)\n* Paclitaxel: 80 mg/m² at Days 1, 8, 15, and 21 (1 course = 28 days)\n* Gemcitabine: 1000 mg/m² at Days 1 and 8 (1 course = 21 days)'}], 'classes': [{'title': 'CR- Measurable disease', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'PR- Measurable disease', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'SD- Measurable disease', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}, {'title': 'PD- Measurable disease', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Missing- Measurable disease', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'CR- Non-measurable disease', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Non-CR/Non-PD- Non-measurable disease', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'PD- Non-measurable disease', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Missing- Non-measurable disease', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'time from the date of randomisation until study completion/discontinuation; Up to 213 weeks', 'description': 'Best overall response (BOR) is defined as the best response recorded at any time from the date of randomisation until the end of treatment.\n\nMissing categories signify that no tumour imaging has been performed post baseline, and therefore the response status could not be assessed.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'TS'}, {'type': 'SECONDARY', 'title': 'Biological Tumour Response Based on Serum Cancer Antigen 125 (CA-125) According to the Gynaecologic Cancer Intergroup (GCIG) Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Volasertib (BI 6727)', 'description': "Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.\n\nTreatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator's choice. The patients were to be followed for survival status."}, {'id': 'OG001', 'title': 'Cytotoxic', 'description': 'Patients received a non-platinum cytotoxic single agent. The investigator chose the most appropriate drug according to patient status (previous chemotherapy effects, cumulative toxic effects, performance status, and nutritional status), the product Summary of Product Characteristics (SPC), and the local standard of care. The following non-platinum regimens were recommended because they are regarded efficacious and safe in patients with resistant ovarian cancer:\n\n* Pegylated liposomal doxorubicin (PLD): 40 mg/m² at Day 1 (1 course = 28 days)\n* Topotecan: 1.25 mg/m² from Days 1 to 5 (1 course = 21 days), or 4 mg/m² at Days 1, 8, and 15 (1 course = 28 days)\n* Paclitaxel: 80 mg/m² at Days 1, 8, 15, and 21 (1 course = 28 days)\n* Gemcitabine: 1000 mg/m² at Days 1 and 8 (1 course = 21 days)'}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}, {'title': 'Not evaluable', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At screening and every 6 weeks thereafter (Up to 213 weeks)', 'description': 'Patients were to have a pre-treatment CA-125 of at least twice the upper limit of normal to be considered for CA-125 response. Patients were not evaluable by CA-125 if they had received mouse antibodies or if they had undergone medical and/or surgical interference with their peritoneum or pleura during the previous 28 days. In eligible patients, a CA-125 response was defined as the moment the CA- 25 was reduced by 50%, with this being confirmed with a consecutive CA-125 assessment not earlier than 28 days after the previous one.\n\nBiological response rate based on serum CA-125 levels was assessed according to the guidelines by the Gynaecologic Cancer Intergroup. Monitoring of blood levels of the tumour marker CA-125 was performed at screening and every 6 weeks thereafter.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'TS'}, {'type': 'SECONDARY', 'title': 'Biological Progression-free Survival Based on Serum Cancer Antigen 125 (CA-125) According to the Gynaecologic Cancer Intergroup (GCIG) Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Volasertib (BI 6727)', 'description': "Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.\n\nTreatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator's choice. The patients were to be followed for survival status."}, {'id': 'OG001', 'title': 'Cytotoxic', 'description': 'Patients received a non-platinum cytotoxic single agent. The investigator chose the most appropriate drug according to patient status (previous chemotherapy effects, cumulative toxic effects, performance status, and nutritional status), the product Summary of Product Characteristics (SPC), and the local standard of care. The following non-platinum regimens were recommended because they are regarded efficacious and safe in patients with resistant ovarian cancer:\n\n* Pegylated liposomal doxorubicin (PLD): 40 mg/m² at Day 1 (1 course = 28 days)\n* Topotecan: 1.25 mg/m² from Days 1 to 5 (1 course = 21 days), or 4 mg/m² at Days 1, 8, and 15 (1 course = 28 days)\n* Paclitaxel: 80 mg/m² at Days 1, 8, 15, and 21 (1 course = 28 days)\n* Gemcitabine: 1000 mg/m² at Days 1 and 8 (1 course = 21 days)'}], 'classes': [{'categories': [{'measurements': [{'value': '13.1', 'groupId': 'OG000', 'lowerLimit': '6.6', 'upperLimit': '25.6'}, {'value': '20.6', 'groupId': 'OG001', 'lowerLimit': '11.6', 'upperLimit': '30.0'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.12', 'ciLowerLimit': '0.73', 'ciUpperLimit': '1.70', 'estimateComment': 'Cox proportional-hazards regression model, stratified by disease status at baseline (measurable vs. non measurable disease) and platinum resistant vs platinum refractory disease at baseline.\n\nHR calculated as Volasertib (BI 6727)/ Cytotoxic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'At screening and every 6 weeks thereafter (Up to 213 weeks )', 'description': 'Biological PFS including assessment of CA-125 levels was defined as the time from randomisation until the first occurrence of progressive disease according to CA-125, progressive disease according to radiological evidence, or death.\n\nAlso according to the below criterias,\n\n* In patients with radiological measurable disease, disease progression during study treatment could not be declared on the basis of CA-125 alone.\n* Patients with elevated CA-125 pre-treatment and normalization of CA-125 had to show evidence of CA-125 ≥ to two times the upper normal limit on two occasions at least one week apart or\n* Patients with elevated CA-125 pre-treatment, which never normalized, had to show evidence of CA-125 ≥ to two times the nadir value on two occasions at least one week apart or\n* Patients with CA-125 in the normal range pre-treatment had to show evidence of CA-125 ≥ to two times the upper normal limit on two occasions at least one week apart.', 'unitOfMeasure': 'weeks', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'TS'}, {'type': 'SECONDARY', 'title': 'Time to Deterioration in Global Health Status/Quality of Life (QOL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Volasertib (BI 6727)', 'description': "Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.\n\nTreatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator's choice. The patients were to be followed for survival status."}, {'id': 'OG001', 'title': 'Cytotoxic', 'description': 'Patients received a non-platinum cytotoxic single agent. The investigator chose the most appropriate drug according to patient status (previous chemotherapy effects, cumulative toxic effects, performance status, and nutritional status), the product Summary of Product Characteristics (SPC), and the local standard of care. The following non-platinum regimens were recommended because they are regarded efficacious and safe in patients with resistant ovarian cancer:\n\n* Pegylated liposomal doxorubicin (PLD): 40 mg/m² at Day 1 (1 course = 28 days)\n* Topotecan: 1.25 mg/m² from Days 1 to 5 (1 course = 21 days), or 4 mg/m² at Days 1, 8, and 15 (1 course = 28 days)\n* Paclitaxel: 80 mg/m² at Days 1, 8, 15, and 21 (1 course = 28 days)\n* Gemcitabine: 1000 mg/m² at Days 1 and 8 (1 course = 21 days)'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Missing median or percentiles signify that a sufficient number of events have not yet occurred to produce these estimates.', 'groupId': 'OG000', 'lowerLimit': '12.3', 'upperLimit': 'NA'}, {'value': '39.6', 'groupId': 'OG001', 'lowerLimit': '13.1', 'upperLimit': '47.2'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.80', 'ciLowerLimit': '0.40', 'ciUpperLimit': '1.61', 'estimateComment': 'Cox proportional-hazards regression model, stratified by disease status at baseline (measurable vs. non measurable disease) and platinum resistant vs platinum refractory disease at baseline.\n\nHR calculated as Volasertib (BI 6727)/ Cytotoxic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Every 6 weeks (Up to 213 weeks )', 'description': 'Time to deterioration in global health status/Quality of life (QOL) and symptom control assessed by the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30, QLQ-OV28, and individual symptom questionnaires.\n\nThe time to deterioration was defined as the time from randomisation to a score increased (i.e. worsened) by at least 10 points from baseline (0-100 point scale). If score is missing, and patient died within 28 days after scheduled time for completion, the patient was considered deteriorated. In this case, time to deterioration is time to death.', 'unitOfMeasure': 'weeks', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'TS'}, {'type': 'SECONDARY', 'title': 'Time to Deterioration in Fatigue/Quality of Life (QOL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Volasertib (BI 6727)', 'description': "Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.\n\nTreatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator's choice. The patients were to be followed for survival status."}, {'id': 'OG001', 'title': 'Cytotoxic', 'description': 'Patients received a non-platinum cytotoxic single agent. The investigator chose the most appropriate drug according to patient status (previous chemotherapy effects, cumulative toxic effects, performance status, and nutritional status), the product Summary of Product Characteristics (SPC), and the local standard of care. The following non-platinum regimens were recommended because they are regarded efficacious and safe in patients with resistant ovarian cancer:\n\n* Pegylated liposomal doxorubicin (PLD): 40 mg/m² at Day 1 (1 course = 28 days)\n* Topotecan: 1.25 mg/m² from Days 1 to 5 (1 course = 21 days), or 4 mg/m² at Days 1, 8, and 15 (1 course = 28 days)\n* Paclitaxel: 80 mg/m² at Days 1, 8, 15, and 21 (1 course = 28 days)\n* Gemcitabine: 1000 mg/m² at Days 1 and 8 (1 course = 21 days)'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Missing median or percentiles signify that a sufficient number of events have not yet occurred to produce these estimates.', 'groupId': 'OG000', 'lowerLimit': '18.3', 'upperLimit': 'NA'}, {'value': '67.1', 'comment': 'Missing median or percentiles signify that a sufficient number of events have not yet occurred to produce these estimates.', 'groupId': 'OG001', 'lowerLimit': '12.4', 'upperLimit': 'NA'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.78', 'ciLowerLimit': '0.37', 'ciUpperLimit': '1.65', 'estimateComment': 'Cox proportional-hazards regression model, stratified by disease status at baseline (measurable vs. non measurable disease) and platinum resistant vs platinum refractory disease at baseline.\n\nHR calculated as Volasertib (BI 6727)/ Cytotoxic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Every 6 weeks (Up to 213 weeks )', 'description': 'Time to deterioration in fatigue/Quality of life (QOL) and symptom control assessed by the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30, QLQ-OV28, and individual symptom questionnaires.\n\nThe time to deterioration was defined as the time from randomisation to a score increased (i.e. worsened) by at least 10 points from baseline (0-100 point scale). If score is missing, and patient died within 28 days after scheduled time for completion, the patient was considered deteriorated. In this case, time to deterioration is time to death.', 'unitOfMeasure': 'weeks', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'TS'}, {'type': 'SECONDARY', 'title': 'Time to Deterioration in Pain/ Quality of Life (QOL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Volasertib (BI 6727)', 'description': "Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.\n\nTreatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator's choice. The patients were to be followed for survival status."}, {'id': 'OG001', 'title': 'Cytotoxic', 'description': 'Patients received a non-platinum cytotoxic single agent. The investigator chose the most appropriate drug according to patient status (previous chemotherapy effects, cumulative toxic effects, performance status, and nutritional status), the product Summary of Product Characteristics (SPC), and the local standard of care. The following non-platinum regimens were recommended because they are regarded efficacious and safe in patients with resistant ovarian cancer:\n\n* Pegylated liposomal doxorubicin (PLD): 40 mg/m² at Day 1 (1 course = 28 days)\n* Topotecan: 1.25 mg/m² from Days 1 to 5 (1 course = 21 days), or 4 mg/m² at Days 1, 8, and 15 (1 course = 28 days)\n* Paclitaxel: 80 mg/m² at Days 1, 8, 15, and 21 (1 course = 28 days)\n* Gemcitabine: 1000 mg/m² at Days 1 and 8 (1 course = 21 days)'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Missing median or percentiles signify that a sufficient number of events have not yet occurred to produce these estimates.', 'groupId': 'OG000', 'lowerLimit': '16.6', 'upperLimit': 'NA'}, {'value': '54.1', 'comment': 'Missing median or percentiles signify that a sufficient number of events have not yet occurred to produce these estimates.', 'groupId': 'OG001', 'lowerLimit': '25.0', 'upperLimit': 'NA'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.86', 'ciLowerLimit': '0.39', 'ciUpperLimit': '1.93', 'estimateComment': 'Cox proportional-hazards regression model, stratified by disease status at baseline (measurable vs. non measurable disease) and platinum resistant vs platinum refractory disease at baseline.\n\nHR calculated as Volasertib (BI 6727)/ Cytotoxic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Every 6 weeks (Up to 213 weeks )', 'description': 'Time to deterioration in pain/ Quality of life (QOL) and symptom control assessed by the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30, QLQ-OV28, and individual symptom questionnaires.\n\nThe time to deterioration was defined as the time from randomisation to a score increased (i.e. worsened) by at least 10 points from baseline (0-100 point scale). If score is missing, and patient died within 28 days after scheduled time for completion, the patient was considered deteriorated. In this case, time to deterioration is time to death.', 'unitOfMeasure': 'weeks', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'TS'}, {'type': 'SECONDARY', 'title': 'Time to Deterioration in Abdominal Bloating/ Quality of Life (QOL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Volasertib (BI 6727)', 'description': "Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.\n\nTreatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator's choice. The patients were to be followed for survival status."}, {'id': 'OG001', 'title': 'Cytotoxic', 'description': 'Patients received a non-platinum cytotoxic single agent. The investigator chose the most appropriate drug according to patient status (previous chemotherapy effects, cumulative toxic effects, performance status, and nutritional status), the product Summary of Product Characteristics (SPC), and the local standard of care. The following non-platinum regimens were recommended because they are regarded efficacious and safe in patients with resistant ovarian cancer:\n\n* Pegylated liposomal doxorubicin (PLD): 40 mg/m² at Day 1 (1 course = 28 days)\n* Topotecan: 1.25 mg/m² from Days 1 to 5 (1 course = 21 days), or 4 mg/m² at Days 1, 8, and 15 (1 course = 28 days)\n* Paclitaxel: 80 mg/m² at Days 1, 8, 15, and 21 (1 course = 28 days)\n* Gemcitabine: 1000 mg/m² at Days 1 and 8 (1 course = 21 days)'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Missing median or percentiles signify that a sufficient number of events have not yet occurred to produce these estimates.', 'groupId': 'OG000', 'lowerLimit': '12.9', 'upperLimit': 'NA'}, {'value': '47.2', 'groupId': 'OG001', 'lowerLimit': '17.3', 'upperLimit': '67.1'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.69', 'ciLowerLimit': '0.33', 'ciUpperLimit': '1.47', 'estimateComment': 'Cox proportional-hazards regression model, stratified by disease status at baseline (measurable vs. non measurable disease) and platinum resistant vs platinum refractory disease at baseline.\n\nHR calculated as Volasertib (BI 6727)/ Cytotoxic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Every 6 weeks (Up to 213 weeks )', 'description': 'Time to deterioration in abdominal bloating/ Quality of life (QOL) and symptom control assessed by the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30, QLQ-OV28, and individual symptom questionnaires.\n\nThe time to deterioration was defined as the time from randomisation to a score increased (i.e. worsened) by at least 10 points from baseline (0-100 point scale). If score is missing, and patient died within 28 days after scheduled time for completion, the patient was considered deteriorated. In this case, time to deterioration is time to death.', 'unitOfMeasure': 'weeks', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'TS'}, {'type': 'SECONDARY', 'title': 'Time to Deterioration in the Three Most Troublesome Disease Specific Symptoms/ Quality of Life (QOL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Volasertib (BI 6727)', 'description': "Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.\n\nTreatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator's choice. The patients were to be followed for survival status."}, {'id': 'OG001', 'title': 'Cytotoxic', 'description': 'Patients received a non-platinum cytotoxic single agent. The investigator chose the most appropriate drug according to patient status (previous chemotherapy effects, cumulative toxic effects, performance status, and nutritional status), the product Summary of Product Characteristics (SPC), and the local standard of care. The following non-platinum regimens were recommended because they are regarded efficacious and safe in patients with resistant ovarian cancer:\n\n* Pegylated liposomal doxorubicin (PLD): 40 mg/m² at Day 1 (1 course = 28 days)\n* Topotecan: 1.25 mg/m² from Days 1 to 5 (1 course = 21 days), or 4 mg/m² at Days 1, 8, and 15 (1 course = 28 days)\n* Paclitaxel: 80 mg/m² at Days 1, 8, 15, and 21 (1 course = 28 days)\n* Gemcitabine: 1000 mg/m² at Days 1 and 8 (1 course = 21 days)'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Missing median or percentiles signify that a sufficient number of events have not yet occurred to produce these estimates.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '18.9', 'comment': 'Missing median or percentiles signify that a sufficient number of events have not yet occurred to produce these estimates.', 'groupId': 'OG001', 'lowerLimit': '6.3', 'upperLimit': 'NA'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.27', 'ciLowerLimit': '0.09', 'ciUpperLimit': '0.77', 'estimateComment': 'Cox proportional-hazards regression model, stratified by disease status at baseline (measurable vs. non measurable disease) and platinum resistant vs platinum refractory disease at baseline.\n\nHR calculated as Volasertib (BI 6727)/ Cytotoxic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Every 6 weeks (Up to 213 weeks)', 'description': 'Three most troublesome disease specific symptoms, defined by the patient at baseline.\n\nPatients that have defined more than 3 most troublesome symptoms have not been taken into account in the analysis.\n\nQuality of life (QOL) and symptom control assessed by the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30, QLQ-OV28, and individual symptom questionnaires.\n\nThe time to deterioration was defined as the time from randomisation to a score increased (i.e. worsened) by at least 10 points from baseline (0-100 point scale). If score is missing, and patient died within 28 days after scheduled time for completion, the patient was considered deteriorated. In this case, time to deterioration is time to death.', 'unitOfMeasure': 'weeks', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'TS'}, {'type': 'SECONDARY', 'title': 'Incidence and Intensity of Adverse Events According to the United States National Cancer Institute (US NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Volasertib (BI 6727)', 'description': "Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.\n\nTreatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator's choice. The patients were to be followed for survival status."}, {'id': 'OG001', 'title': 'Cytotoxic', 'description': 'Patients received a non-platinum cytotoxic single agent. The investigator chose the most appropriate drug according to patient status (previous chemotherapy effects, cumulative toxic effects, performance status, and nutritional status), the product Summary of Product Characteristics (SPC), and the local standard of care. The following non-platinum regimens were recommended because they are regarded efficacious and safe in patients with resistant ovarian cancer:\n\n* Pegylated liposomal doxorubicin (PLD): 40 mg/m² at Day 1 (1 course = 28 days)\n* Topotecan: 1.25 mg/m² from Days 1 to 5 (1 course = 21 days), or 4 mg/m² at Days 1, 8, and 15 (1 course = 28 days)\n* Paclitaxel: 80 mg/m² at Days 1, 8, 15, and 21 (1 course = 28 days)\n* Gemcitabine: 1000 mg/m² at Days 1 and 8 (1 course = 21 days)'}, {'id': 'OG002', 'title': 'Cytotoxic to Volasertib Switch', 'description': 'Patients of the cytotoxic arm who switched to treatment with Volasertib (BI 6727).'}], 'classes': [{'title': 'Grade 1', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Grade 2', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}, {'title': 'Grade 4', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Grade 5', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first treatment administration to 21 days after the last drug administration (Up to 1403 days)', 'description': 'Incidence and intensity of adverse events according to the United States National Cancer Institute (US NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'TS'}, {'type': 'SECONDARY', 'title': 'Clinically Relevant Changes in Laboratory and ECG Data', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Volasertib (BI 6727)', 'description': "Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.\n\nTreatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator's choice. The patients were to be followed for survival status."}, {'id': 'OG001', 'title': 'Cytotoxic', 'description': 'Patients received a non-platinum cytotoxic single agent. The investigator chose the most appropriate drug according to patient status (previous chemotherapy effects, cumulative toxic effects, performance status, and nutritional status), the product Summary of Product Characteristics (SPC), and the local standard of care. The following non-platinum regimens were recommended because they are regarded efficacious and safe in patients with resistant ovarian cancer:\n\n* Pegylated liposomal doxorubicin (PLD): 40 mg/m² at Day 1 (1 course = 28 days)\n* Topotecan: 1.25 mg/m² from Days 1 to 5 (1 course = 21 days), or 4 mg/m² at Days 1, 8, and 15 (1 course = 28 days)\n* Paclitaxel: 80 mg/m² at Days 1, 8, 15, and 21 (1 course = 28 days)\n* Gemcitabine: 1000 mg/m² at Days 1 and 8 (1 course = 21 days)'}, {'id': 'OG002', 'title': 'Cytotoxic to Volasertib Switch', 'description': 'Patients of the cytotoxic arm who switched to treatment with Volasertib (BI 6727).'}], 'classes': [{'title': 'Blood alkaline phosphatase increased', 'categories': [{'measurements': [{'value': '3.7', 'groupId': 'OG000'}, {'value': '12.7', 'groupId': 'OG001'}, {'value': '8.3', 'groupId': 'OG002'}]}]}, {'title': 'Blood creatinine increased', 'categories': [{'measurements': [{'value': '9.3', 'groupId': 'OG000'}, {'value': '3.6', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}, {'title': 'Platelet count decreased', 'categories': [{'measurements': [{'value': '9.3', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '8.3', 'groupId': 'OG002'}]}]}, {'title': 'Alanine aminotransferase increased', 'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000'}, {'value': '9.1', 'groupId': 'OG001'}, {'value': '4.2', 'groupId': 'OG002'}]}]}, {'title': 'Aspartate aminotransferase increased', 'categories': [{'measurements': [{'value': '3.7', 'groupId': 'OG000'}, {'value': '5.5', 'groupId': 'OG001'}, {'value': '4.2', 'groupId': 'OG002'}]}]}, {'title': 'Blood uric acid increased', 'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000'}, {'value': '5.5', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}, {'title': 'Gamma-glutamyltransferase increased', 'categories': [{'measurements': [{'value': '3.7', 'groupId': 'OG000'}, {'value': '5.5', 'groupId': 'OG001'}, {'value': '4.2', 'groupId': 'OG002'}]}]}, {'title': 'Alanine aminotransferase abnormal', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '4.2', 'groupId': 'OG002'}]}]}, {'title': 'Electrocardiogram QT prolonged', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '4.2', 'groupId': 'OG002'}]}]}, {'title': 'Haemoglobin decreased', 'categories': [{'measurements': [{'value': '3.7', 'groupId': 'OG000'}, {'value': '3.6', 'groupId': 'OG001'}, {'value': '4.2', 'groupId': 'OG002'}]}]}, {'title': 'Neutrophil count decreased', 'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '4.2', 'groupId': 'OG002'}]}]}, {'title': 'Troponin I increased', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '4.2', 'groupId': 'OG002'}]}]}, {'title': 'Blood lactate dehydrogenase increased', 'categories': [{'measurements': [{'value': '3.7', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}, {'title': 'Blood magnesium decreased', 'categories': [{'measurements': [{'value': '3.7', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}, {'title': 'White blood cell count decreased', 'categories': [{'measurements': [{'value': '3.7', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}, {'title': 'Blood urea increased', 'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000'}, {'value': '3.6', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}, {'title': 'Alanine aminotransferase decreased', 'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}, {'title': 'Blood bilirubin increased', 'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}, {'title': 'Blood creatine phosphokinase decreased', 'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}, {'title': 'Blood potassium decreased', 'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}, {'title': 'Hepatic enzyme increased', 'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}, {'title': 'Aspartate aminotransferase abnormal', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.8', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}, {'title': 'Transaminases increased', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.8', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first treatment administration to 21 days after the last drug administration (Up to 1403 days)', 'description': 'Clinically relevant changes in laboratory and ECG data', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'TS'}, {'type': 'SECONDARY', 'title': 'AUC (0-24); Area Under the Concentration-time Curve in Plasma Over the Time Interval From 0 to 24 Hours for BI 6727 BS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Volasertib', 'description': "Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.\n\nTreatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator's choice. The patients were to be followed for survival status."}], 'classes': [{'categories': [{'measurements': [{'value': '2140', 'spread': '25.5', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '-0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration', 'description': 'AUC (0-24); area under the concentration-time curve in plasma over the time interval from 0 to 24 hours for BI 6727 BS', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All evaluable patients were to be included in the pharmacokinetic analysis. A patient was considered not evaluable if they had an important protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.'}, {'type': 'SECONDARY', 'title': 'AUC (0-24); Area Under the Concentration-time Curve in Plasma Over the Time Interval From 0 to 24 Hours for CD 10899 BS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Volasertib', 'description': "Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.\n\nTreatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator's choice. The patients were to be followed for survival status."}], 'classes': [{'categories': [{'measurements': [{'value': '204', 'spread': '65.3', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '-0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration', 'description': 'AUC (0-24); area under the concentration-time curve in plasma over the time interval from 0 to 24 hours for CD 10899 BS (metabolite of Volasertib BI 6727)', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All evaluable patients were to be included in the pharmacokinetic analysis. A patient was considered not evaluable if they had an important protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.'}, {'type': 'SECONDARY', 'title': 'AUC (0-inf); Area Under the Concentration-time Curve in Plasma Over the Time Interval From 0 Extrapolated to Infinity for BI 6727 BS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Volasertib', 'description': "Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.\n\nTreatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator's choice. The patients were to be followed for survival status."}], 'classes': [{'categories': [{'measurements': [{'value': '6240', 'spread': '29.8', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '-0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration', 'description': 'AUC (0-inf); area under the concentration-time curve in plasma over the time interval from 0 extrapolated to infinity for BI 6727 BS', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All evaluable patients were to be included in the pharmacokinetic analysis. A patient was considered not evaluable if they had an important protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.'}, {'type': 'SECONDARY', 'title': 'AUC (0-inf); Area Under the Concentration-time Curve in Plasma Over the Time Interval From 0 Extrapolated to Infinity for CD 10899 BS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Volasertib', 'description': "Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.\n\nTreatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator's choice. The patients were to be followed for survival status."}], 'classes': [{'categories': [{'measurements': [{'value': '1400', 'spread': '35.8', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '-0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration', 'description': 'AUC (0-inf); area under the concentration-time curve in plasma over the time interval from 0 extrapolated to infinity for CD 10899 BS (metabolite of Volasertib BI 6727)', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All evaluable patients were to be included in the pharmacokinetic analysis. A patient was considered not evaluable if they had an important protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.'}, {'type': 'SECONDARY', 'title': 'Cmax; Maximum Measured Concentration of BI 6727 BS in Plasma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Volasertib', 'description': "Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.\n\nTreatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator's choice. The patients were to be followed for survival status."}], 'classes': [{'categories': [{'measurements': [{'value': '341', 'spread': '42.2', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '-0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration', 'description': 'Cmax; maximum measured concentration of BI 6727 BS in plasma', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All evaluable patients were to be included in the pharmacokinetic analysis. A patient was considered not evaluable if they had an important protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.'}, {'type': 'SECONDARY', 'title': 'Cmax; Maximum Measured Concentration of CD 10899 BS in Plasma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Volasertib', 'description': "Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.\n\nTreatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator's choice. The patients were to be followed for survival status."}], 'classes': [{'categories': [{'measurements': [{'value': '10.8', 'spread': '63.4', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '-0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration', 'description': 'Cmax; maximum measured concentration of CD 10899 BS (metabolite of Volasertib BI 6727) in plasma', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All evaluable patients were to be included in the pharmacokinetic analysis. A patient was considered not evaluable if they had an important protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.'}, {'type': 'SECONDARY', 'title': 'Tmax; Time From Dosing to Maximum Measured Concentration of BI 6727 BS in Plasma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Volasertib', 'description': "Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.\n\nTreatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator's choice. The patients were to be followed for survival status."}], 'classes': [{'categories': [{'measurements': [{'value': '2.00', 'groupId': 'OG000', 'lowerLimit': '1.83', 'upperLimit': '3.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '-0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration', 'description': 'tmax; time from dosing to maximum measured concentration of BI 6727 BS in plasma', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All evaluable patients were to be included in the pharmacokinetic analysis. A patient was considered not evaluable if they had an important protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.'}, {'type': 'SECONDARY', 'title': 'Tmax; Time From Dosing to Maximum Measured Concentration of CD 10899 BS in Plasma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Volasertib', 'description': "Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.\n\nTreatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator's choice. The patients were to be followed for survival status."}], 'classes': [{'categories': [{'measurements': [{'value': '6.07', 'groupId': 'OG000', 'lowerLimit': '3.83', 'upperLimit': '24.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '-0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration', 'description': 'tmax; time from dosing to maximum measured concentration of CD 10899 BS (metabolite of Volasertib BI 6727) in plasma', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All evaluable patients were to be included in the pharmacokinetic analysis. A patient was considered not evaluable if they had an important protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.'}, {'type': 'SECONDARY', 'title': 't1/2; Terminal Half-life of BI 6727 BS in Plasma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Volasertib', 'description': "Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.\n\nTreatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator's choice. The patients were to be followed for survival status."}], 'classes': [{'categories': [{'measurements': [{'value': '143', 'spread': '21.3', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '-0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration', 'description': 't1/2; Terminal half-life of BI 6727 BS in plasma', 'unitOfMeasure': 'hours', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All evaluable patients were to be included in the pharmacokinetic analysis. A patient was considered not evaluable if they had an important protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.'}, {'type': 'SECONDARY', 'title': 't1/2; Terminal Half-life of CD 10899 BS in Plasma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Volasertib', 'description': "Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.\n\nTreatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator's choice. The patients were to be followed for survival status."}], 'classes': [{'categories': [{'measurements': [{'value': '146', 'spread': '21.5', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '-0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration', 'description': 't1/2; Terminal half-life of CD 10899 BS in plasma', 'unitOfMeasure': 'hours', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All evaluable patients were to be included in the pharmacokinetic analysis. A patient was considered not evaluable if they had an important protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.'}, {'type': 'SECONDARY', 'title': 'MRT; Mean Residence Time of BI 6727 BS in the Body', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Volasertib', 'description': "Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.\n\nTreatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator's choice. The patients were to be followed for survival status."}], 'classes': [{'categories': [{'measurements': [{'value': '118', 'spread': '31.2', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '-0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration', 'description': 'MRT; Mean residence time of BI 6727 BS in the body', 'unitOfMeasure': 'hours', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All evaluable patients were to be included in the pharmacokinetic analysis. A patient was considered not evaluable if they had an important protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.'}, {'type': 'SECONDARY', 'title': 'CL; Total Clearance of BI 6727 BS in Plasma After Intravenous Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Volasertib', 'description': "Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.\n\nTreatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator's choice. The patients were to be followed for survival status."}], 'classes': [{'categories': [{'measurements': [{'value': '801', 'spread': '29.8', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '-0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration', 'description': 'CL; total clearance of BI 6727 BS in plasma after intravenous administration', 'unitOfMeasure': 'mL/min', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All evaluable patients were to be included in the pharmacokinetic analysis. A patient was considered not evaluable if they had an important protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.'}, {'type': 'SECONDARY', 'title': 'Vss;Apparent Volume of Distribution at Steady State Following Intravenous Administration for BI 6727 BS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Volasertib', 'description': "Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.\n\nTreatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator's choice. The patients were to be followed for survival status."}], 'classes': [{'categories': [{'measurements': [{'value': '5690', 'spread': '25.8', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '-0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration', 'description': 'Vss;apparent volume of distribution at steady state following intravenous administration for BI 6727 BS', 'unitOfMeasure': 'Litres', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All evaluable patients were to be included in the pharmacokinetic analysis. A patient was considered not evaluable if they had an important protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.'}, {'type': 'SECONDARY', 'title': 'Biomarkers and Pharmacogenetics Analysis (Optional)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Volasertib (BI 6727)', 'description': "Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.\n\nTreatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator's choice. The patients were to be followed for survival status."}, {'id': 'OG001', 'title': 'Cytotoxic', 'description': 'Patients received a non-platinum cytotoxic single agent. The investigator chose the most appropriate drug according to patient status (previous chemotherapy effects, cumulative toxic effects, performance status, and nutritional status), the product Summary of Product Characteristics (SPC), and the local standard of care. The following non-platinum regimens were recommended because they are regarded efficacious and safe in patients with resistant ovarian cancer:\n\n* Pegylated liposomal doxorubicin (PLD): 40 mg/m² at Day 1 (1 course = 28 days)\n* Topotecan: 1.25 mg/m² from Days 1 to 5 (1 course = 21 days), or 4 mg/m² at Days 1, 8, and 15 (1 course = 28 days)\n* Paclitaxel: 80 mg/m² at Days 1, 8, 15, and 21 (1 course = 28 days)\n* Gemcitabine: 1000 mg/m² at Days 1 and 8 (1 course = 21 days)'}], 'timeFrame': '6 months', 'description': 'This endpoint has not been statistically analysed in the study report', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Volasertib (BI 6727)', 'description': "Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.\n\nTreatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator's choice. The patients were to be followed for survival status."}, {'id': 'FG001', 'title': 'Cytotoxic', 'description': 'Patients received a non-platinum cytotoxic single agent. The investigator chose the most appropriate drug according to patient status (previous chemotherapy effects, cumulative toxic effects, performance status, and nutritional status), the product Summary of Product Characteristics (SPC), and the local standard of care. The following non-platinum regimens were recommended because they are regarded efficacious and safe in patients with resistant ovarian cancer:\n\n* Pegylated liposomal doxorubicin (PLD): 40 mg/m² at Day 1 (1 course = 28 days)\n* Topotecan: 1.25 mg/m² from Days 1 to 5 (1 course = 21 days), or 4 mg/m² at Days 1, 8, and 15 (1 course = 28 days)\n* Paclitaxel: 80 mg/m² at Days 1, 8, 15, and 21 (1 course = 28 days)\n* Gemcitabine: 1000 mg/m² at Days 1 and 8 (1 course = 21 days)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}, {'comment': '24 patients switched to Volasertib (BI 6727) due to disease progression or occurrence of toxicity', 'groupId': 'FG001', 'numSubjects': '55'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}, {'groupId': 'FG001', 'numSubjects': '55'}]}], 'dropWithdraws': [{'type': 'Progressive disease RECIST', 'reasons': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'Wors. or AE of underlying cancer disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Other AE', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Non-compliant with protocol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Refused continuation of study med.', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Reason other than specified above', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Overall 54 patients were treated in Volasertib arm and 55 patients were treated in Cytotoxic arm. The "Not completed" category in the Subject Disposition table represents " Treatment permanently discontinued" and "The reasons for non-completion" in the table represent "Reason for treatment discontinuation".'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Volasertib (BI 6727)', 'description': "Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.\n\nTreatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator's choice. The patients were to be followed for survival status."}, {'id': 'BG001', 'title': 'Cytotoxic', 'description': 'Patients received a non-platinum cytotoxic single agent. The investigator chose the most appropriate drug according to patient status (previous chemotherapy effects, cumulative toxic effects, performance status, and nutritional status), the product Summary of Product Characteristics (SPC), and the local standard of care. The following non-platinum regimens were recommended because they are regarded efficacious and safe in patients with resistant ovarian cancer:\n\n* Pegylated liposomal doxorubicin (PLD): 40 mg/m² at Day 1 (1 course = 28 days)\n* Topotecan: 1.25 mg/m² from Days 1 to 5 (1 course = 21 days), or 4 mg/m² at Days 1, 8, and 15 (1 course = 28 days)\n* Paclitaxel: 80 mg/m² at Days 1, 8, 15, and 21 (1 course = 28 days)\n* Gemcitabine: 1000 mg/m² at Days 1 and 8 (1 course = 21 days)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.3', 'spread': '9.88', 'groupId': 'BG000'}, {'value': '60.9', 'spread': '9.26', 'groupId': 'BG001'}, {'value': '61.1', 'spread': '9.53', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Treated set (TS): The treated set consisted of all patients who received at least one administration of the trial drug.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'dispFirstSubmitDate': '2014-04-30', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-17', 'studyFirstSubmitDate': '2010-04-13', 'dispFirstSubmitQcDate': '2014-04-30', 'resultsFirstSubmitDate': '2015-07-17', 'studyFirstSubmitQcDate': '2010-05-10', 'dispFirstPostDateStruct': {'date': '2014-05-16', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2015-08-13', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-07-17', 'studyFirstPostDateStruct': {'date': '2010-05-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-08-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease Control Rate (DCR) at Week 24 According to Response Evaluation Criteria In Solid Tumours (RECIST) Version 1.1', 'timeFrame': 'Week 24', 'description': 'DCR was defined as the proportion of patients who had an overall response of complete response (CR), partial response (PR), or stable disease (SD).'}], 'secondaryOutcomes': [{'measure': 'Progression Free Survival (PFS)', 'timeFrame': 'From randomization until disease progression, death or study discontinuation; Up to 213 weeks', 'description': "Progression-free survival of a patient was based on the investigator's assessment; it was defined as the number of days from the date of randomisation until the date of either disease progression or death from any cause, whichever occurred first.\n\nDefinition of disease progression according to RECIST version 1.1; Patients with measurable tumour lesions at baseline, Target-lesions: at least a 20% increase in the sum of diameters of target lesions, the sum of diameters must also demonstrate an absolute increase of at least 5 mm,taking as reference the smallest sum on study, or appearance of 1 or more new lesions.\n\nNon-target lesions: unequivocal progression of existing non-target lesions or appearance of 1 or more new lesions Patients with non-measurable tumour lesions at baseline, Non-target lesions: requires unequivocal progression of existing non-target lesions or appearance of 1 or more new lesions"}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'From randomization until death or study discontinuation; Up to 213 weeks', 'description': 'OS is defined as time from randomisation to death irrespective of the cause of the death.'}, {'measure': 'Best Overall Response', 'timeFrame': 'time from the date of randomisation until study completion/discontinuation; Up to 213 weeks', 'description': 'Best overall response (BOR) is defined as the best response recorded at any time from the date of randomisation until the end of treatment.\n\nMissing categories signify that no tumour imaging has been performed post baseline, and therefore the response status could not be assessed.'}, {'measure': 'Biological Tumour Response Based on Serum Cancer Antigen 125 (CA-125) According to the Gynaecologic Cancer Intergroup (GCIG) Criteria', 'timeFrame': 'At screening and every 6 weeks thereafter (Up to 213 weeks)', 'description': 'Patients were to have a pre-treatment CA-125 of at least twice the upper limit of normal to be considered for CA-125 response. Patients were not evaluable by CA-125 if they had received mouse antibodies or if they had undergone medical and/or surgical interference with their peritoneum or pleura during the previous 28 days. In eligible patients, a CA-125 response was defined as the moment the CA- 25 was reduced by 50%, with this being confirmed with a consecutive CA-125 assessment not earlier than 28 days after the previous one.\n\nBiological response rate based on serum CA-125 levels was assessed according to the guidelines by the Gynaecologic Cancer Intergroup. Monitoring of blood levels of the tumour marker CA-125 was performed at screening and every 6 weeks thereafter.'}, {'measure': 'Biological Progression-free Survival Based on Serum Cancer Antigen 125 (CA-125) According to the Gynaecologic Cancer Intergroup (GCIG) Criteria', 'timeFrame': 'At screening and every 6 weeks thereafter (Up to 213 weeks )', 'description': 'Biological PFS including assessment of CA-125 levels was defined as the time from randomisation until the first occurrence of progressive disease according to CA-125, progressive disease according to radiological evidence, or death.\n\nAlso according to the below criterias,\n\n* In patients with radiological measurable disease, disease progression during study treatment could not be declared on the basis of CA-125 alone.\n* Patients with elevated CA-125 pre-treatment and normalization of CA-125 had to show evidence of CA-125 ≥ to two times the upper normal limit on two occasions at least one week apart or\n* Patients with elevated CA-125 pre-treatment, which never normalized, had to show evidence of CA-125 ≥ to two times the nadir value on two occasions at least one week apart or\n* Patients with CA-125 in the normal range pre-treatment had to show evidence of CA-125 ≥ to two times the upper normal limit on two occasions at least one week apart.'}, {'measure': 'Time to Deterioration in Global Health Status/Quality of Life (QOL)', 'timeFrame': 'Every 6 weeks (Up to 213 weeks )', 'description': 'Time to deterioration in global health status/Quality of life (QOL) and symptom control assessed by the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30, QLQ-OV28, and individual symptom questionnaires.\n\nThe time to deterioration was defined as the time from randomisation to a score increased (i.e. worsened) by at least 10 points from baseline (0-100 point scale). If score is missing, and patient died within 28 days after scheduled time for completion, the patient was considered deteriorated. In this case, time to deterioration is time to death.'}, {'measure': 'Time to Deterioration in Fatigue/Quality of Life (QOL)', 'timeFrame': 'Every 6 weeks (Up to 213 weeks )', 'description': 'Time to deterioration in fatigue/Quality of life (QOL) and symptom control assessed by the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30, QLQ-OV28, and individual symptom questionnaires.\n\nThe time to deterioration was defined as the time from randomisation to a score increased (i.e. worsened) by at least 10 points from baseline (0-100 point scale). If score is missing, and patient died within 28 days after scheduled time for completion, the patient was considered deteriorated. In this case, time to deterioration is time to death.'}, {'measure': 'Time to Deterioration in Pain/ Quality of Life (QOL)', 'timeFrame': 'Every 6 weeks (Up to 213 weeks )', 'description': 'Time to deterioration in pain/ Quality of life (QOL) and symptom control assessed by the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30, QLQ-OV28, and individual symptom questionnaires.\n\nThe time to deterioration was defined as the time from randomisation to a score increased (i.e. worsened) by at least 10 points from baseline (0-100 point scale). If score is missing, and patient died within 28 days after scheduled time for completion, the patient was considered deteriorated. In this case, time to deterioration is time to death.'}, {'measure': 'Time to Deterioration in Abdominal Bloating/ Quality of Life (QOL)', 'timeFrame': 'Every 6 weeks (Up to 213 weeks )', 'description': 'Time to deterioration in abdominal bloating/ Quality of life (QOL) and symptom control assessed by the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30, QLQ-OV28, and individual symptom questionnaires.\n\nThe time to deterioration was defined as the time from randomisation to a score increased (i.e. worsened) by at least 10 points from baseline (0-100 point scale). If score is missing, and patient died within 28 days after scheduled time for completion, the patient was considered deteriorated. In this case, time to deterioration is time to death.'}, {'measure': 'Time to Deterioration in the Three Most Troublesome Disease Specific Symptoms/ Quality of Life (QOL)', 'timeFrame': 'Every 6 weeks (Up to 213 weeks)', 'description': 'Three most troublesome disease specific symptoms, defined by the patient at baseline.\n\nPatients that have defined more than 3 most troublesome symptoms have not been taken into account in the analysis.\n\nQuality of life (QOL) and symptom control assessed by the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30, QLQ-OV28, and individual symptom questionnaires.\n\nThe time to deterioration was defined as the time from randomisation to a score increased (i.e. worsened) by at least 10 points from baseline (0-100 point scale). If score is missing, and patient died within 28 days after scheduled time for completion, the patient was considered deteriorated. In this case, time to deterioration is time to death.'}, {'measure': 'Incidence and Intensity of Adverse Events According to the United States National Cancer Institute (US NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0', 'timeFrame': 'From first treatment administration to 21 days after the last drug administration (Up to 1403 days)', 'description': 'Incidence and intensity of adverse events according to the United States National Cancer Institute (US NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0'}, {'measure': 'Clinically Relevant Changes in Laboratory and ECG Data', 'timeFrame': 'From first treatment administration to 21 days after the last drug administration (Up to 1403 days)', 'description': 'Clinically relevant changes in laboratory and ECG data'}, {'measure': 'AUC (0-24); Area Under the Concentration-time Curve in Plasma Over the Time Interval From 0 to 24 Hours for BI 6727 BS', 'timeFrame': '-0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration', 'description': 'AUC (0-24); area under the concentration-time curve in plasma over the time interval from 0 to 24 hours for BI 6727 BS'}, {'measure': 'AUC (0-24); Area Under the Concentration-time Curve in Plasma Over the Time Interval From 0 to 24 Hours for CD 10899 BS', 'timeFrame': '-0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration', 'description': 'AUC (0-24); area under the concentration-time curve in plasma over the time interval from 0 to 24 hours for CD 10899 BS (metabolite of Volasertib BI 6727)'}, {'measure': 'AUC (0-inf); Area Under the Concentration-time Curve in Plasma Over the Time Interval From 0 Extrapolated to Infinity for BI 6727 BS', 'timeFrame': '-0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration', 'description': 'AUC (0-inf); area under the concentration-time curve in plasma over the time interval from 0 extrapolated to infinity for BI 6727 BS'}, {'measure': 'AUC (0-inf); Area Under the Concentration-time Curve in Plasma Over the Time Interval From 0 Extrapolated to Infinity for CD 10899 BS', 'timeFrame': '-0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration', 'description': 'AUC (0-inf); area under the concentration-time curve in plasma over the time interval from 0 extrapolated to infinity for CD 10899 BS (metabolite of Volasertib BI 6727)'}, {'measure': 'Cmax; Maximum Measured Concentration of BI 6727 BS in Plasma', 'timeFrame': '-0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration', 'description': 'Cmax; maximum measured concentration of BI 6727 BS in plasma'}, {'measure': 'Cmax; Maximum Measured Concentration of CD 10899 BS in Plasma', 'timeFrame': '-0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration', 'description': 'Cmax; maximum measured concentration of CD 10899 BS (metabolite of Volasertib BI 6727) in plasma'}, {'measure': 'Tmax; Time From Dosing to Maximum Measured Concentration of BI 6727 BS in Plasma', 'timeFrame': '-0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration', 'description': 'tmax; time from dosing to maximum measured concentration of BI 6727 BS in plasma'}, {'measure': 'Tmax; Time From Dosing to Maximum Measured Concentration of CD 10899 BS in Plasma', 'timeFrame': '-0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration', 'description': 'tmax; time from dosing to maximum measured concentration of CD 10899 BS (metabolite of Volasertib BI 6727) in plasma'}, {'measure': 't1/2; Terminal Half-life of BI 6727 BS in Plasma', 'timeFrame': '-0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration', 'description': 't1/2; Terminal half-life of BI 6727 BS in plasma'}, {'measure': 't1/2; Terminal Half-life of CD 10899 BS in Plasma', 'timeFrame': '-0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration', 'description': 't1/2; Terminal half-life of CD 10899 BS in plasma'}, {'measure': 'MRT; Mean Residence Time of BI 6727 BS in the Body', 'timeFrame': '-0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration', 'description': 'MRT; Mean residence time of BI 6727 BS in the body'}, {'measure': 'CL; Total Clearance of BI 6727 BS in Plasma After Intravenous Administration', 'timeFrame': '-0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration', 'description': 'CL; total clearance of BI 6727 BS in plasma after intravenous administration'}, {'measure': 'Vss;Apparent Volume of Distribution at Steady State Following Intravenous Administration for BI 6727 BS', 'timeFrame': '-0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration', 'description': 'Vss;apparent volume of distribution at steady state following intravenous administration for BI 6727 BS'}, {'measure': 'Biomarkers and Pharmacogenetics Analysis (Optional)', 'timeFrame': '6 months', 'description': 'This endpoint has not been statistically analysed in the study report'}]}, 'conditionsModule': {'conditions': ['Ovarian Neoplasms']}, 'referencesModule': {'references': [{'pmid': '37407274', 'type': 'DERIVED', 'citation': 'Newhouse R, Nelissen E, El-Shakankery KH, Rogozinska E, Bain E, Veiga S, Morrison J. Pegylated liposomal doxorubicin for relapsed epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Jul 5;7(7):CD006910. doi: 10.1002/14651858.CD006910.pub3.'}, {'pmid': '26755507', 'type': 'DERIVED', 'citation': "Pujade-Lauraine E, Selle F, Weber B, Ray-Coquard IL, Vergote I, Sufliarsky J, Del Campo JM, Lortholary A, Lesoin A, Follana P, Freyer G, Pardo B, Vidal L, Tholander B, Gladieff L, Sassi M, Garin-Chesa P, Nazabadioko S, Marzin K, Pilz K, Joly F. Volasertib Versus Chemotherapy in Platinum-Resistant or -Refractory Ovarian Cancer: A Randomized Phase II Groupe des Investigateurs Nationaux pour l'Etude des Cancers de l'Ovaire Study. J Clin Oncol. 2016 Mar 1;34(7):706-13. doi: 10.1200/JCO.2015.62.1474. Epub 2016 Jan 11."}]}, 'descriptionModule': {'briefSummary': "This is an international, randomized phase II trial. The aim is to assess the efficacy and the safety of BI 6727 Versus investigator's best choice single agent cytotoxic in recurrent third and fourth lines platinum resistant/refractory ovarian cancer.\n\n100 patients will be randomised at the study entry to receive either BI 6727 (Arm A: 50 patients) or non-platinum single agent cytotoxic (Arm B: 50 patients) Treatment will be continued until disease progression or unacceptable toxicity. Primary endpoint: disease control rate at week 24 according to Response Evaluation Criteria In Solid Tumours version 1.1.\n\nSecondary endpoints: efficacy (progression free survival, overall survival, biological tumour response, biological progression free survival assessed by serum CA 125 according to Gynecologic Cancer Intergroup criteria, safety according to the NCI CTCAE v.3, disease symptoms control assessed by the EORTC QLQ-C30, QLQ-OV28 and individual symptoms questionnaires, pharmacokinetics of BI 6727.\n\nOthers endpoints: biomarkers and pharmacogenetics analysis (optional)"}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. Confirmed recurrent epithelial ovarian carcinoma, peritoneal carcinoma or fallopian tube carcinoma.\n2. Platinum resistant or platinum refractory disease.\n3. Eastern Collaborative Oncology Group performance status \\< = 2.\n4. Life expectancy \\> = 3 months.\n5. At least one measurable lesion (Response Evaluation Criteria In Solid Tumours version 1.1).\n6. Adequate hepatic, renal and bone marrow functions.\n7. signed written informed consent prior to admission to the study.\n\nExclusion criteria:\n\n1. Contre-indications for cytotoxic treatment according to the Summary of Product Characteristics (Arm B).\n2. Clinical evidence of active brain metastasis or leptomeningeal involvement.\n3. Other malignancy currently requiring active therapy.\n4. QTc prolongation according to Fridericia formula deemed clinically relevant by the investigator (e.g., congenital long QT syndrome, QTc according to Fridericia formula \\> 470 ms).\n5. Hypersensitivity to one of the trial drugs or the excipients.\n6. Serious illness or concomitant non- oncological disease.\n7. Systemic anticancer therapy within 4 weeks before the start of the study.\n8. Evidence of ileus sor sub ileus.'}, 'identificationModule': {'nctId': 'NCT01121406', 'briefTitle': 'BI 6727 (Volasertib) Randomised Trial in Ovarian Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Phase II Randomized Trial of the Polo-like Kinase 1 Inhibitor BI 6727 Monotherapy Versus Investigator´s Choice Chemotherapy in Ovarian Cancer Patients Resistant or Refractory to Platinum-based Cytotoxic Therapy', 'orgStudyIdInfo': {'id': '1230.18'}, 'secondaryIdInfos': [{'id': '2009-015770-35', 'type': 'EUDRACT_NUMBER', 'domain': 'EudraCT'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BI 6727', 'description': 'Patients receive BI 6727 infusion every 3 weeks', 'interventionNames': ['Drug: BI 6727']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cytotoxic', 'description': 'At the investigator discretion, patient will receive one of the following cytotoxics: topotecan, paclitaxel, gemcitabine or liposomal doxorubicin', 'interventionNames': ['Drug: Paclitaxel', 'Drug: Gemcitabine', 'Drug: Topotecan', 'Drug: Pegylated liposomal doxorubicin (PLD)']}], 'interventions': [{'name': 'Paclitaxel', 'type': 'DRUG', 'description': 'Patients receive paclitaxel in a 4 week schedule', 'armGroupLabels': ['Cytotoxic']}, {'name': 'Gemcitabine', 'type': 'DRUG', 'description': 'Patients receive gemcitabine in a 3 week schedule', 'armGroupLabels': ['Cytotoxic']}, {'name': 'Topotecan', 'type': 'DRUG', 'description': 'Patients receive topotecan in 3 or 4 week schedule', 'armGroupLabels': ['Cytotoxic']}, {'name': 'Pegylated liposomal doxorubicin (PLD)', 'type': 'DRUG', 'description': 'Patients receive PLD in a 4 week schedule', 'armGroupLabels': ['Cytotoxic']}, {'name': 'BI 6727', 'type': 'DRUG', 'description': 'Patients receive BI 6727 infusion every 3 weeks', 'armGroupLabels': ['BI 6727']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Brussels', 'country': 'Belgium', 'facility': '1230.18.32003 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'city': 'Edegem', 'country': 'Belgium', 'facility': '1230.18.32004 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 51.15662, 'lon': 4.44504}}, {'city': 'Ghent', 'country': 'Belgium', 'facility': '1230.18.32002 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'city': 'Leuven', 'country': 'Belgium', 'facility': '1230.18.32001 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'city': 'Angers', 'country': 'France', 'facility': '1230.18.3321A Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'city': 'Bordeaux', 'country': 'France', 'facility': '1230.18.3307A Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Caen', 'country': 'France', 'facility': '1230.18.3301A Boehringer Ingelheim Investigational Site', 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{'city': 'Pierre-Bénite', 'country': 'France', 'facility': '1230.18.3309A Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}, {'city': 'Reims', 'country': 'France', 'facility': '1230.18.3305A Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}, {'city': 'Saint-Brieuc', 'country': 'France', 'facility': '1230.18.3320A Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 48.51513, 'lon': -2.76838}}, {'city': 'Strasbourg', 'country': 'France', 'facility': '1230.18.3311A Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'city': 'Toulouse', 'country': 'France', 'facility': '1230.18.3310A Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'city': 'Vandœuvre-lès-Nancy', 'country': 'France', 'facility': '1230.18.3315A Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}, {'city': 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'role': 'STUDY_CHAIR', 'affiliation': 'Boehringer Ingelheim'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}