Ignite Creation Date:
2025-12-25 @ 12:08 AM
Ignite Modification Date:
2025-12-25 @ 10:08 PM
Study NCT ID:
NCT01023958
Status:
COMPLETED
Last Update Posted:
2017-11-22
First Post:
2009-11-24
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Intravenous BI 6727 (Volasertib) in 2nd Line Treatment of Urothelial Cancer
Sponsor:
Organization:
Raw JSON
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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 drug administration until end of study, up to 2 years', 'eventGroups': [{'id': 'EG000', 'title': 'Volasertib (BI 6727)', 'description': 'Volasertib (BI 6727) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course. Single dose, 300 mg as starting dose in first treatment course - possible dose escalation at the beginning of the 2nd course to 350 mg if well tolerated. Repeated administration in patients with clinical benefit until disease progression or intolerability of the study medication', 'otherNumAtRisk': 50, 'otherNumAffected': 49, 'seriousNumAtRisk': 50, 'seriousNumAffected': 13}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 20}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 15}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 19}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 19}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 28}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Oral candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 16}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Hypercalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 11}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Groin pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 6}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 6}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 4}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pollakiuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 4}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 10}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Perirectal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Foreign body', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Urostomy complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Flank pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Metastasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Neoplasm progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Transitional cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Hypercapnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Objective Tumour Response According to RECIST Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Volasertib (BI 6727)', 'description': 'Volasertib (BI 6727) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course. Single dose, 300 mg as starting dose in first treatment course - possible dose escalation at the beginning of the 2nd course to 350 mg if well tolerated. Repeated administration in patients with clinical benefit until disease progression or intolerability of the study medication'}], 'classes': [{'categories': [{'measurements': [{'value': '14.0', 'groupId': 'OG000', 'lowerLimit': '5.8', 'upperLimit': '26.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first drug administration until end of study, up to 2 years', 'description': 'Objective tumor response, defined as complete response (CR) or partial response (PR), according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'TS'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Volasertib (BI 6727)', 'description': 'Volasertib (BI 6727) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course. Single dose, 300 mg as starting dose in first treatment course - possible dose escalation at the beginning of the 2nd course to 350 mg if well tolerated. Repeated administration in patients with clinical benefit until disease progression or intolerability of the study medication'}], 'classes': [{'categories': [{'measurements': [{'value': '6.1', 'groupId': 'OG000', 'lowerLimit': '5.6', 'upperLimit': '11.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Time from first treatment to the occurrence of tumor progression or death, up to 2 years', 'description': "Progression-free survival (PFS) is the time from first treatment to the occurrence of tumor progression or death, whichever occurs first. Disease progression is defined according to the RECIST guideline but also includes the investigators' assessment which may, in some cases, include only clinical progression (deterioration of general health status per investigator). PFS was analyzed with the Kaplan-Meier curve. Greenwood's variance estimate was used to form confidence intervals.\n\nPatients without evidence of disease progression were to be censored at the last image date.", 'unitOfMeasure': 'Weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'TS'}, {'type': 'SECONDARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Volasertib (BI 6727)', 'description': 'Volasertib (BI 6727) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course. Single dose, 300 mg as starting dose in first treatment course - possible dose escalation at the beginning of the 2nd course to 350 mg if well tolerated. Repeated administration in patients with clinical benefit until disease progression or intolerability of the study medication'}], 'classes': [{'categories': [{'measurements': [{'value': '8.5', 'groupId': 'OG000', 'lowerLimit': '3.9', 'upperLimit': '12.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Time from first infusion to death, up to 2 years', 'description': "Overall survival (OS) is the time from first infusion to death. Patients who were alive at the time of analysis or lost to follow-up were censored at the last follow-up date when they were known to be alive.\n\nOverall survival was analyzed with the Kaplan-Meier curve. Greenwood's variance estimate was used to form confidence intervals.", 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'TS'}, {'type': 'SECONDARY', 'title': 'Duration of Overall Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Volasertib (BI 6727)', 'description': 'Volasertib (BI 6727) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course. Single dose, 300 mg as starting dose in first treatment course - possible dose escalation at the beginning of the 2nd course to 350 mg if well tolerated. Repeated administration in patients with clinical benefit until disease progression or intolerability of the study medication'}], 'classes': [{'categories': [{'measurements': [{'value': '41.0', 'groupId': 'OG000', 'lowerLimit': '29.1', 'upperLimit': '77.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the time of first response (CR or PR) to progression or death, up to 2 years', 'description': 'The duration of overall response is measured from the time of first response (CR or PR) to progression or death whichever occurs first.', 'unitOfMeasure': 'Weeks', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'TS'}, {'type': 'SECONDARY', 'title': 'Disease Control Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Volasertib (BI 6727)', 'description': 'Volasertib (BI 6727) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course. Single dose, 300 mg as starting dose in first treatment course - possible dose escalation at the beginning of the 2nd course to 350 mg if well tolerated. Repeated administration in patients with clinical benefit until disease progression or intolerability of the study medication'}], 'classes': [{'categories': [{'measurements': [{'value': '40.0', 'groupId': 'OG000', 'lowerLimit': '26.4', 'upperLimit': '54.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first drug administration until end of study, up to 2 years', 'description': 'Disease control rate. Disease control is defined as having a best 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': 'Duration of Disease Control', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Volasertib (BI 6727)', 'description': 'Volasertib (BI 6727) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course. Single dose, 300 mg as starting dose in first treatment course - possible dose escalation at the beginning of the 2nd course to 350 mg if well tolerated. Repeated administration in patients with clinical benefit until disease progression or intolerability of the study medication'}], 'classes': [{'categories': [{'measurements': [{'value': '27.0', 'groupId': 'OG000', 'lowerLimit': '10.1', 'upperLimit': '77.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Time of first response to progression or death, up to 2 years', 'description': 'Disease control is defined as having a best overall response of CR, PR, or SD. The duration of disease control is measured from the time of first response to progression or death whichever occurs first.', 'unitOfMeasure': 'Weeks', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who achieved disease control in the TS.'}, {'type': 'SECONDARY', 'title': 'AUC0-∞ of Volasertib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Volasertib (BI 6727)', 'description': 'Volasertib (BI 6727) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course. Single dose, 300 mg as starting dose in first treatment course - possible dose escalation at the beginning of the 2nd course to 350 mg if well tolerated. Repeated administration in patients with clinical benefit until disease progression or intolerability of the study medication'}], 'classes': [{'categories': [{'measurements': [{'value': '5470', 'spread': '30.6', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '5 mins before start of drug infusion and 2h, 3h, 6h, 24h, 168h and 336h after start of drug infusion', 'description': 'Area under the concentration-time curve in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) of volasertib', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic set (PKS) including patients with analyzable data for this endpoint.'}, {'type': 'SECONDARY', 'title': 'Cmax of Volasertib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Volasertib (BI 6727)', 'description': 'Volasertib (BI 6727) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course. Single dose, 300 mg as starting dose in first treatment course - possible dose escalation at the beginning of the 2nd course to 350 mg if well tolerated. Repeated administration in patients with clinical benefit until disease progression or intolerability of the study medication'}], 'classes': [{'categories': [{'measurements': [{'value': '253', 'spread': '51.9', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '5 mins before start of drug infusion and 2h, 3h, 6h, 24h, 168h and 336h after start of drug infusion', 'description': 'Maximum measured concentration in plasma (Cmax) of volasertib', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PKS including patients with analyzable data for this endpoint.'}, {'type': 'SECONDARY', 'title': 't1/2 of Volasertib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Volasertib (BI 6727)', 'description': 'Volasertib (BI 6727) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course. Single dose, 300 mg as starting dose in first treatment course - possible dose escalation at the beginning of the 2nd course to 350 mg if well tolerated. Repeated administration in patients with clinical benefit until disease progression or intolerability of the study medication'}], 'classes': [{'categories': [{'measurements': [{'value': '150', 'spread': '17.0', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '5 mins before start of drug infusion and 2h, 3h, 6h, 24h, 168h and 336h after start of drug infusion', 'description': 'Terminal half-life (t1/2) of volasertib', 'unitOfMeasure': 'hours', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PKS including patients with analyzable data for this endpoint.'}, {'type': 'SECONDARY', 'title': 'CL of Volasertib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Volasertib (BI 6727)', 'description': 'Volasertib (BI 6727) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course. Single dose, 300 mg as starting dose in first treatment course - possible dose escalation at the beginning of the 2nd course to 350 mg if well tolerated. Repeated administration in patients with clinical benefit until disease progression or intolerability of the study medication'}], 'classes': [{'categories': [{'measurements': [{'value': '914', 'spread': '30.6', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '5 mins before start of drug infusion and 2h, 3h, 6h, 24h, 168h and 336h after start of drug infusion', 'description': 'Total plasma clearance after intravascular administration (CL) of volasertib', 'unitOfMeasure': 'mL/min', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PKS including patients with analyzable data for this endpoint.'}, {'type': 'SECONDARY', 'title': 'Vss of Volasertib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Volasertib (BI 6727)', 'description': 'Volasertib (BI 6727) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course. Single dose, 300 mg as starting dose in first treatment course - possible dose escalation at the beginning of the 2nd course to 350 mg if well tolerated. Repeated administration in patients with clinical benefit until disease progression or intolerability of the study medication'}], 'classes': [{'categories': [{'measurements': [{'value': '7470', 'spread': '32.4', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '5 mins before start of drug infusion and 2h, 3h, 6h, 24h, 168h and 336h after start of drug infusion', 'description': 'Apparent volume of distribution at steady state following intravascular administration (Vss) of volasertib', 'unitOfMeasure': 'Litres', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PKS including patients with analyzable data for this endpoint.'}, {'type': 'SECONDARY', 'title': 'Tmax of Volasertib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Volasertib (BI 6727)', 'description': 'Volasertib (BI 6727) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course. Single dose, 300 mg as starting dose in first treatment course - possible dose escalation at the beginning of the 2nd course to 350 mg if well tolerated. Repeated administration in patients with clinical benefit until disease progression or intolerability of the study medication'}], 'classes': [{'categories': [{'measurements': [{'value': '2.03', 'groupId': 'OG000', 'lowerLimit': '1.53', 'upperLimit': '4.17'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '5 mins before start of drug infusion and 2h, 3h, 6h, 24h, 168h and 336h after start of drug infusion', 'description': 'Time from dosing to maximum measured concentration (Tmax) of volasertib', 'unitOfMeasure': 'Hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PKS including patients with analyzable data for this endpoint.'}, {'type': 'SECONDARY', 'title': "Occurrence and Intensity of AE's Graded According to CTCAE", 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Volasertib (BI 6727)', 'description': 'Volasertib (BI 6727) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course. Single dose, 300 mg as starting dose in first treatment course - possible dose escalation at the beginning of the 2nd course to 350 mg if well tolerated. Repeated administration in patients with clinical benefit until disease progression or intolerability of the study medication'}], 'classes': [{'title': 'Grade 1', 'categories': [{'measurements': [{'value': '8.0', 'groupId': 'OG000'}]}]}, {'title': 'Grade 2', 'categories': [{'measurements': [{'value': '28.0', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3', 'categories': [{'measurements': [{'value': '36.0', 'groupId': 'OG000'}]}]}, {'title': 'Grade 4', 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000'}]}]}, {'title': 'Grade 5', 'categories': [{'measurements': [{'value': '6.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first drug administration until end of study, up to 2 years', 'description': 'Occurrence and intensity of adverse events (AEs) graded according to Common Toxicity Criteria of Adverse Events (CTCAE).\n\nThe CTCAE grades are: 1 (mild AE), 2 (moderate AE), 3 (severe AE), 4 (life-threatening or disabling AE), 5 (death related to AE).', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'TS'}, {'type': 'SECONDARY', 'title': 'Occurrence of Unacceptable Toxicity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Volasertib (BI 6727)', 'description': 'Volasertib (BI 6727) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course. Single dose, 300 mg as starting dose in first treatment course - possible dose escalation at the beginning of the 2nd course to 350 mg if well tolerated. Repeated administration in patients with clinical benefit until disease progression or intolerability of the study medication'}], 'classes': [{'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first drug administration up to 21 days after final administration, up to 2 years', 'description': 'Occurrence of unacceptable toxicity is defined by CTCAE as as drug related CTCAE Grade 3 or greater non-hematological toxicity (except emesis or diarrhea responding to supportive treatment); drug-related CTCAE Grade 4 neutropenia for seven or more days and / or complicated by infection; or drug-related CTCAE Grade 4 thrombocytopenia.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'TS'}, {'type': 'SECONDARY', 'title': 'Laboratory Investigation: Haemoglobin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Volasertib (BI 6727)', 'description': 'Volasertib (BI 6727) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course. Single dose, 300 mg as starting dose in first treatment course - possible dose escalation at the beginning of the 2nd course to 350 mg if well tolerated. Repeated administration in patients with clinical benefit until disease progression or intolerability of the study medication'}], 'classes': [{'categories': [{'measurements': [{'value': '-19', 'spread': '24', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and last value on treatment (up to 2 years)', 'description': 'Difference from baseline in laboratory parameter Haemoglobin', 'unitOfMeasure': 'g/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'TS. Results displayed for patients with available haemoglobin data.'}, {'type': 'SECONDARY', 'title': 'Laboratory Investigation: White Blood Cell Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Volasertib (BI 6727)', 'description': 'Volasertib (BI 6727) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course. Single dose, 300 mg as starting dose in first treatment course - possible dose escalation at the beginning of the 2nd course to 350 mg if well tolerated. Repeated administration in patients with clinical benefit until disease progression or intolerability of the study medication'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.8', 'spread': '4.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and last value on treatment (up to 2 years)', 'description': 'Difference from baseline in laboratory parameter white blood cell count', 'unitOfMeasure': '10^9 cells/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'TS. Results displayed for patients with available white blood cell count data.'}, {'type': 'SECONDARY', 'title': 'Laboratory Investigation: Platelets', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Volasertib (BI 6727)', 'description': 'Volasertib (BI 6727) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course. Single dose, 300 mg as starting dose in first treatment course - possible dose escalation at the beginning of the 2nd course to 350 mg if well tolerated. Repeated administration in patients with clinical benefit until disease progression or intolerability of the study medication'}], 'classes': [{'categories': [{'measurements': [{'value': '-23', 'spread': '89', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and last value on treatment (up to 2 years)', 'description': 'Difference from baseline in laboratory parameter Platelets', 'unitOfMeasure': '10^9 cells/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'TS. Results displayed for patients with available platelets data.'}, {'type': 'SECONDARY', 'title': 'Laboratory Investigation: Neutrophils', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Volasertib (BI 6727)', 'description': 'Volasertib (BI 6727) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course. Single dose, 300 mg as starting dose in first treatment course - possible dose escalation at the beginning of the 2nd course to 350 mg if well tolerated. Repeated administration in patients with clinical benefit until disease progression or intolerability of the study medication'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.9', 'spread': '6.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and last value on treatment (up to 2 years)', 'description': 'Difference from baseline in laboratory parameter Neutrophils', 'unitOfMeasure': '10^9 cells/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'TS. Results displayed for patients with available neutrophils data.'}, {'type': 'SECONDARY', 'title': 'Laboratory Investigation: Lymphocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Volasertib (BI 6727)', 'description': 'Volasertib (BI 6727) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course. Single dose, 300 mg as starting dose in first treatment course - possible dose escalation at the beginning of the 2nd course to 350 mg if well tolerated. Repeated administration in patients with clinical benefit until disease progression or intolerability of the study medication'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.8', 'spread': '4.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and last value on treatment (up to 2 years)', 'description': 'Difference from baseline in laboratory parameter Lymphocytes', 'unitOfMeasure': '10^9 cells/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'TS. Results displayed for patients with available lymphocytes data.'}, {'type': 'SECONDARY', 'title': 'Laboratory Investigation: AST/GOT, SGOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Volasertib (BI 6727)', 'description': 'Volasertib (BI 6727) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course. Single dose, 300 mg as starting dose in first treatment course - possible dose escalation at the beginning of the 2nd course to 350 mg if well tolerated. Repeated administration in patients with clinical benefit until disease progression or intolerability of the study medication'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'spread': '26', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and last value on treatment (up to 2 years)', 'description': 'Difference from baseline in laboratory parameter Aspartate aminotransferase(AST)/GOT, SGOT', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'TS. Results displayed for patients with available AST/GOT, SGOT data.'}, {'type': 'SECONDARY', 'title': 'Laboratory Investigation: ALT/GPT, SGPT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Volasertib (BI 6727)', 'description': 'Volasertib (BI 6727) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course. Single dose, 300 mg as starting dose in first treatment course - possible dose escalation at the beginning of the 2nd course to 350 mg if well tolerated. Repeated administration in patients with clinical benefit until disease progression or intolerability of the study medication'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'spread': '19', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and last value on treatment (up to 2 years)', 'description': 'Difference from baseline in laboratory parameter Alanine aminotransferase(ALT)/GPT, SGPT', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'TS. Results displayed for patients with available ALT/GPT, SGPT data.'}, {'type': 'SECONDARY', 'title': 'Laboratory Investigation: Alkaline Phosphatase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Volasertib (BI 6727)', 'description': 'Volasertib (BI 6727) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course. Single dose, 300 mg as starting dose in first treatment course - possible dose escalation at the beginning of the 2nd course to 350 mg if well tolerated. Repeated administration in patients with clinical benefit until disease progression or intolerability of the study medication'}], 'classes': [{'categories': [{'measurements': [{'value': '35', 'spread': '95', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and last value on treatment (up to 2 years)', 'description': 'Difference from baseline in laboratory parameter Alkaline phosphatase', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'TS. Results displayed for patients with available alkaline phosphate data.'}, {'type': 'SECONDARY', 'title': 'Laboratory Investigation: Creatinine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Volasertib (BI 6727)', 'description': 'Volasertib (BI 6727) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course. Single dose, 300 mg as starting dose in first treatment course - possible dose escalation at the beginning of the 2nd course to 350 mg if well tolerated. Repeated administration in patients with clinical benefit until disease progression or intolerability of the study medication'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'spread': '41', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and last value on treatment (up to 2 years)', 'description': 'Difference from baseline in laboratory parameter Creatinine', 'unitOfMeasure': 'umol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'TS. Results displayed for patients with available creatinine data.'}, {'type': 'SECONDARY', 'title': 'Laboratory Investigation: Total Bilirubin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Volasertib (BI 6727)', 'description': 'Volasertib (BI 6727) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course. Single dose, 300 mg as starting dose in first treatment course - possible dose escalation at the beginning of the 2nd course to 350 mg if well tolerated. Repeated administration in patients with clinical benefit until disease progression or intolerability of the study medication'}], 'classes': [{'categories': [{'measurements': [{'value': '4.7', 'spread': '34.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and last value on treatment (up to 2 years)', 'description': 'Difference from baseline in laboratory parameter total Bilirubin', 'unitOfMeasure': 'umol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'TS. Results displayed for patients with available total bilirubin data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Volasertib (BI 6727)', 'description': 'Volasertib (BI 6727) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course. Single dose, 300 mg as starting dose in first treatment course - possible dose escalation at the beginning of the 2nd course to 350 mg if well tolerated. Repeated administration in patients with clinical benefit until disease progression or intolerability of the study medication'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}]}], 'dropWithdraws': [{'type': 'Progressive disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '48'}]}, {'type': 'Other adverse event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Refused to continue medication', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'An open-label, single-arm, Phase II trial of intravenous volasertib (BI 6727) in patients with locally advanced, metastatic or recurrent urothelial cancer of the bladder, renal pelvis, or ureters after failure of prior chemotherapy.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Volasertib (BI 6727)', 'description': 'Volasertib (BI 6727) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course. Single dose, 300 mg as starting dose in first treatment course - possible dose escalation at the beginning of the 2nd course to 350 mg if well tolerated. Repeated administration in patients with clinical benefit until disease progression or intolerability of the study medication'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '69.0', 'spread': '7.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '40', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Treated set (TS) which included all patients who received at least one dose of trial medication.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'dispFirstSubmitDate': '2014-04-30', 'completionDateStruct': {'date': '2011-09-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-23', 'studyFirstSubmitDate': '2009-11-24', 'dispFirstSubmitQcDate': '2014-04-30', 'resultsFirstSubmitDate': '2017-10-23', 'studyFirstSubmitQcDate': '2009-12-01', 'dispFirstPostDateStruct': {'date': '2014-05-16', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2017-11-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-10-23', 'studyFirstPostDateStruct': {'date': '2009-12-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-11-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-09-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Tumour Response According to RECIST Criteria', 'timeFrame': 'From first drug administration until end of study, up to 2 years', 'description': 'Objective tumor response, defined as complete response (CR) or partial response (PR), according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.'}], 'secondaryOutcomes': [{'measure': 'Progression-free Survival', 'timeFrame': 'Time from first treatment to the occurrence of tumor progression or death, up to 2 years', 'description': "Progression-free survival (PFS) is the time from first treatment to the occurrence of tumor progression or death, whichever occurs first. Disease progression is defined according to the RECIST guideline but also includes the investigators' assessment which may, in some cases, include only clinical progression (deterioration of general health status per investigator). PFS was analyzed with the Kaplan-Meier curve. Greenwood's variance estimate was used to form confidence intervals.\n\nPatients without evidence of disease progression were to be censored at the last image date."}, {'measure': 'Overall Survival', 'timeFrame': 'Time from first infusion to death, up to 2 years', 'description': "Overall survival (OS) is the time from first infusion to death. Patients who were alive at the time of analysis or lost to follow-up were censored at the last follow-up date when they were known to be alive.\n\nOverall survival was analyzed with the Kaplan-Meier curve. Greenwood's variance estimate was used to form confidence intervals."}, {'measure': 'Duration of Overall Response', 'timeFrame': 'From the time of first response (CR or PR) to progression or death, up to 2 years', 'description': 'The duration of overall response is measured from the time of first response (CR or PR) to progression or death whichever occurs first.'}, {'measure': 'Disease Control Rate', 'timeFrame': 'From first drug administration until end of study, up to 2 years', 'description': 'Disease control rate. Disease control is defined as having a best overall response of complete response (CR), partial response (PR) or stable disease (SD).'}, {'measure': 'Duration of Disease Control', 'timeFrame': 'Time of first response to progression or death, up to 2 years', 'description': 'Disease control is defined as having a best overall response of CR, PR, or SD. The duration of disease control is measured from the time of first response to progression or death whichever occurs first.'}, {'measure': 'AUC0-∞ of Volasertib', 'timeFrame': '5 mins before start of drug infusion and 2h, 3h, 6h, 24h, 168h and 336h after start of drug infusion', 'description': 'Area under the concentration-time curve in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) of volasertib'}, {'measure': 'Cmax of Volasertib', 'timeFrame': '5 mins before start of drug infusion and 2h, 3h, 6h, 24h, 168h and 336h after start of drug infusion', 'description': 'Maximum measured concentration in plasma (Cmax) of volasertib'}, {'measure': 't1/2 of Volasertib', 'timeFrame': '5 mins before start of drug infusion and 2h, 3h, 6h, 24h, 168h and 336h after start of drug infusion', 'description': 'Terminal half-life (t1/2) of volasertib'}, {'measure': 'CL of Volasertib', 'timeFrame': '5 mins before start of drug infusion and 2h, 3h, 6h, 24h, 168h and 336h after start of drug infusion', 'description': 'Total plasma clearance after intravascular administration (CL) of volasertib'}, {'measure': 'Vss of Volasertib', 'timeFrame': '5 mins before start of drug infusion and 2h, 3h, 6h, 24h, 168h and 336h after start of drug infusion', 'description': 'Apparent volume of distribution at steady state following intravascular administration (Vss) of volasertib'}, {'measure': 'Tmax of Volasertib', 'timeFrame': '5 mins before start of drug infusion and 2h, 3h, 6h, 24h, 168h and 336h after start of drug infusion', 'description': 'Time from dosing to maximum measured concentration (Tmax) of volasertib'}, {'measure': "Occurrence and Intensity of AE's Graded According to CTCAE", 'timeFrame': 'From first drug administration until end of study, up to 2 years', 'description': 'Occurrence and intensity of adverse events (AEs) graded according to Common Toxicity Criteria of Adverse Events (CTCAE).\n\nThe CTCAE grades are: 1 (mild AE), 2 (moderate AE), 3 (severe AE), 4 (life-threatening or disabling AE), 5 (death related to AE).'}, {'measure': 'Occurrence of Unacceptable Toxicity', 'timeFrame': 'From first drug administration up to 21 days after final administration, up to 2 years', 'description': 'Occurrence of unacceptable toxicity is defined by CTCAE as as drug related CTCAE Grade 3 or greater non-hematological toxicity (except emesis or diarrhea responding to supportive treatment); drug-related CTCAE Grade 4 neutropenia for seven or more days and / or complicated by infection; or drug-related CTCAE Grade 4 thrombocytopenia.'}, {'measure': 'Laboratory Investigation: Haemoglobin', 'timeFrame': 'Baseline and last value on treatment (up to 2 years)', 'description': 'Difference from baseline in laboratory parameter Haemoglobin'}, {'measure': 'Laboratory Investigation: White Blood Cell Count', 'timeFrame': 'Baseline and last value on treatment (up to 2 years)', 'description': 'Difference from baseline in laboratory parameter white blood cell count'}, {'measure': 'Laboratory Investigation: Platelets', 'timeFrame': 'Baseline and last value on treatment (up to 2 years)', 'description': 'Difference from baseline in laboratory parameter Platelets'}, {'measure': 'Laboratory Investigation: Neutrophils', 'timeFrame': 'Baseline and last value on treatment (up to 2 years)', 'description': 'Difference from baseline in laboratory parameter Neutrophils'}, {'measure': 'Laboratory Investigation: Lymphocytes', 'timeFrame': 'Baseline and last value on treatment (up to 2 years)', 'description': 'Difference from baseline in laboratory parameter Lymphocytes'}, {'measure': 'Laboratory Investigation: AST/GOT, SGOT', 'timeFrame': 'Baseline and last value on treatment (up to 2 years)', 'description': 'Difference from baseline in laboratory parameter Aspartate aminotransferase(AST)/GOT, SGOT'}, {'measure': 'Laboratory Investigation: ALT/GPT, SGPT', 'timeFrame': 'Baseline and last value on treatment (up to 2 years)', 'description': 'Difference from baseline in laboratory parameter Alanine aminotransferase(ALT)/GPT, SGPT'}, {'measure': 'Laboratory Investigation: Alkaline Phosphatase', 'timeFrame': 'Baseline and last value on treatment (up to 2 years)', 'description': 'Difference from baseline in laboratory parameter Alkaline phosphatase'}, {'measure': 'Laboratory Investigation: Creatinine', 'timeFrame': 'Baseline and last value on treatment (up to 2 years)', 'description': 'Difference from baseline in laboratory parameter Creatinine'}, {'measure': 'Laboratory Investigation: Total Bilirubin', 'timeFrame': 'Baseline and last value on treatment (up to 2 years)', 'description': 'Difference from baseline in laboratory parameter total Bilirubin'}]}, 'conditionsModule': {'conditions': ['Neoplasms']}, 'referencesModule': {'references': [{'pmid': '24339028', 'type': 'DERIVED', 'citation': 'Stadler WM, Vaughn DJ, Sonpavde G, Vogelzang NJ, Tagawa ST, Petrylak DP, Rosen P, Lin CC, Mahoney J, Modi S, Lee P, Ernstoff MS, Su WC, Spira A, Pilz K, Vinisko R, Schloss C, Fritsch H, Zhao C, Carducci MA. An open-label, single-arm, phase 2 trial of the Polo-like kinase inhibitor volasertib (BI 6727) in patients with locally advanced or metastatic urothelial cancer. Cancer. 2014 Apr 1;120(7):976-82. doi: 10.1002/cncr.28519. Epub 2013 Dec 11.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this trial is to evaluate the efficacy and safety of BI 6727 in patients with locally advanced, metastatic or recurrent urothelial cancer after failure of first line or adjuvant/neoadjuvant chemotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. Histologically or cytologically confirmed urothelial cancer of the bladder, ureters or renal pelvis.\n2. Patients with stage III, IV or recurrent urothelial cancer of the bladder, ureter or renal pelvis after failure or recurrence after first line or adjuvant/neoadjuvant chemotherapy. Recurrence is defined as relapse within 2 years after cessation of prior first-line chemotherapy.\n3. Male or female patient aged 18 years or older\n4. Life expectancy of at least three (3) months\n5. Eastern Co-operative Oncology Group performance score of 2 or less\n6. At least one target tumor lesion that has not been irradiated within the past three months and that can accurately be measured by magnetic resonance imaging (MRI) or computed tomography (CT) in at least one dimension (longest diameter to be recorded) as \\>20 mm with conventional techniques or as \\>10 mm with spiral CT\n7. The patient must have given written informed consent prior to inclusion into the trial which must be consistent with the International Conference on Harmonization, Good Clinical Practice (ICH-GCP) and local legislation\n\nExclusion criteria:\n\n1. More than one prior regimen of chemotherapy including prior adjuvant therapy\n2. Brain metastases\n3. Patients with bone metastasis as the only site of disease are excluded\n4. Serious illness or organ system dysfunction, which in the opinion of the investigator, would either compromise patient safety, interfere with the evaluation of the safety of the test drug or limit compliance with trial requirements.\n5. QTc prolongation deemed clinically relevant by the investigator\n6. Second malignancy currently requiring active therapy\n7. Other active malignancy diagnosed within the past 3 years (other than non melanomatous skin cancer and cervical intraepithelial neoplasia)\n8. Absolute neutrophil count (ANC) \\<1,500/µl\n9. Platelet count \\<100,000/µl\n10. Hemoglobin \\<9 g/dl\n11. Total bilirubin \\>1.5 mg/dl\n12. Aspartate amino transferase (AST) and/or alanine amino transferase (ALT) \\>2.5 x ULN, or aspartate amino transferase (AST) and/or alanine amino transferase (ALT) \\>5 x ULN in case of known liver metastases\n13. Serum creatinine \\>1.5 x ULN\n14. Chemo-, Radio- or immunotherapy within the past 4 weeks. This does not apply to steroids and bisphosphonates.\n15. Active infectious disease, or HIV, Hepatitis-B or -C infection\n16. Active drug or alcohol abuse\n17. Women and men who are sexually active and unwilling to use a medically acceptable method of contraception (e.g. such as implants, injectables, combined oral contraceptives, some intrauterine devices or vasectomized partner for participating females, condoms for participating males) during the trial\n18. Pregnancy or breast feeding\n19. Treatment with any investigational drug within the past 4 weeks or within less than four half-life times of the investigational drug before treatment with the trial drug and/or persistence of toxicities of prior anticancer therapies which are deemed to be clinically relevant.\n20. Prior treatment with Polo-like kinase 1 (Plk1) inhibitor\n21. Patient unable to comply with the protocol\n22. Any known hypersensitivity to the trial drugs or their excipients'}, 'identificationModule': {'nctId': 'NCT01023958', 'briefTitle': 'Intravenous BI 6727 (Volasertib) in 2nd Line Treatment of Urothelial Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'An Open-label, Single-arm, Phase II Trial of Intravenous BI 6727 in Patients With Locally Advanced, Metastatic or Recurrent Urothelial Cancer of the Bladder, Renal Pelvis, or Ureters After Failure of Prior Chemotherapy', 'orgStudyIdInfo': {'id': '1230.2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'single arm', 'description': 'open label', 'interventionNames': ['Drug: BI 6727, IV infusion']}], 'interventions': [{'name': 'BI 6727, IV infusion', 'type': 'DRUG', 'description': 'phase II', 'armGroupLabels': ['single arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': '1230.2.5 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': '1230.2.10 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': '1230.2.34 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': '1230.2.29 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': '1230.2.6 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'city': 'Joliet', 'state': 'Illinois', 'country': 'United States', 'facility': '1230.2.17 Boehringer Ingelheim Investigational Site', 'geoPoint': 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'state': 'New York', 'country': 'United States', 'facility': '1230.2.20 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': '1230.2.23 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': '1230.2.12 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': '1230.2.4 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'city': 'Beaumont', 'state': 'Texas', 'country': 'United States', 'facility': '1230.2.38 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 30.08605, 'lon': -94.10185}}, {'city': 'Tyler', 'state': 'Texas', 'country': 'United States', 'facility': '1230.2.41 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 32.35126, 'lon': -95.30106}}, {'city': 'Webster', 'state': 'Texas', 'country': 'United States', 'facility': '1230.2.43 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 29.53773, 'lon': -95.11826}}, {'city': 'Fairfax', 'state': 'Virginia', 'country': 'United States', 'facility': '1230.2.44 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 38.84622, 'lon': -77.30637}}, {'city': 'Tainan', 'country': 'Taiwan', 'facility': '1230.2.51 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 22.99083, 'lon': 120.21333}}, {'city': 'Taipei', 'country': 'Taiwan', 'facility': '1230.2.50 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Boehringer Ingelheim', 'role': 'STUDY_CHAIR', 'affiliation': 'Boehringer Ingelheim'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}