Ignite Creation Date:
2025-12-24 @ 11:55 AM
Ignite Modification Date:
2025-12-27 @ 3:22 AM
Study NCT ID:
NCT00969761
Status:
COMPLETED
Last Update Posted:
2019-01-31
First Post:
2009-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
BI 6727 (Volasertib) in Combination With Cisplatin or Carboplatin in Patients With Advanced or Metastatic Solid Tumour
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C541363', 'term': 'BI 6727'}]}}, '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 intake of trial drug to last intake of trial drug plus 21 days, up to 441 days', 'eventGroups': [{'id': 'EG000', 'title': 'V200+Cis75', 'description': 'Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.', 'otherNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'V300+Cis75', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.', 'otherNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'V300+Cis100', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 100mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.', 'otherNumAtRisk': 12, 'otherNumAffected': 12, 'seriousNumAtRisk': 12, 'seriousNumAffected': 6}, {'id': 'EG003', 'title': 'V350+Cis75', 'description': 'Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.', 'otherNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'seriousNumAffected': 3}, {'id': 'EG004', 'title': 'V100+Car4', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC4 (area under the curve of 4) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.', 'otherNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'seriousNumAffected': 1}, {'id': 'EG005', 'title': 'V100+Car5', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.', 'otherNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'V200+Car5', 'description': 'Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.', 'otherNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'seriousNumAffected': 1}, {'id': 'EG007', 'title': 'V300+Car5', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.', 'otherNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'seriousNumAffected': 1}, {'id': 'EG008', 'title': 'V300+Car6', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC6 (area under the curve of 6) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.', 'otherNumAtRisk': 13, 'otherNumAffected': 13, 'seriousNumAtRisk': 13, 'seriousNumAffected': 6}, {'id': 'EG009', 'title': 'V350+Car5', 'description': 'Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.', 'otherNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'seriousNumAffected': 2}, {'id': 'EG010', 'title': 'V100+Cis60', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 60mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.', 'otherNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'seriousNumAffected': 2}, {'id': 'EG011', 'title': 'V100+Cis75', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.', 'otherNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 6}, {'groupId': 'EG008', 'numAtRisk': 13, 'numAffected': 12}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 3}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 3}, {'groupId': 'EG011', 'numAtRisk': 3, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Bone marrow failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 5}, {'groupId': 'EG008', 'numAtRisk': 13, 'numAffected': 11}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG011', 'numAtRisk': 3, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 6}, {'groupId': 'EG008', 'numAtRisk': 13, 'numAffected': 8}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 3, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 5}, {'groupId': 'EG008', 'numAtRisk': 13, 'numAffected': 12}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG011', 'numAtRisk': 3, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 5}, {'groupId': 'EG008', 'numAtRisk': 13, 'numAffected': 12}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Deafness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Eyelid oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Ophthalmoplegia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Anal fissure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 13, 'numAffected': 6}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 13, 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'MedDRA 14.1'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Staphylococcal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 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'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective 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'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Paraparesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hydronephrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Urinary tract obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dyspnoea exertional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Haemothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Axillary vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Jugular vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Maximum Tolerated Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '13', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'V100+Cis60', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 60mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG001', 'title': 'V100+Cis75', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG002', 'title': 'V200+Cis75', 'description': 'Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG003', 'title': 'V300+Cis75', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG004', 'title': 'V300+Cis100', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 100mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG005', 'title': 'V350+Cis75', 'description': 'Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG006', 'title': 'V100+Car4', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC4 (area under the curve of 4) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG007', 'title': 'V100+Car5', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG008', 'title': 'V200+Car5', 'description': 'Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG009', 'title': 'V300+Car5', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG010', 'title': 'V300+Car6', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC6 (area under the curve of 6) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG011', 'title': 'V350+Car5', 'description': 'Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 weeks', 'description': 'The maximum tolerated dose (MTD) was defined as the highest dose studied for which the incidence of DLT was less than 33% (i.e. 1/6 patients) during the first cycle, for Volasertib in combination with cisplatin or carboplatin.\n\n0=not maximum tolerated dose, 1=was maximum tolerated dose.', 'unitOfMeasure': 'Units on a scale', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Dose Limiting Toxicities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '13', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'V100+Cis60', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 60mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG001', 'title': 'V100+Cis75', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG002', 'title': 'V200+Cis75', 'description': 'Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG003', 'title': 'V300+Cis75', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG004', 'title': 'V300+Cis100', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 100mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG005', 'title': 'V350+Cis75', 'description': 'Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG006', 'title': 'V100+Car4', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC4 (area under the curve of 4) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG007', 'title': 'V100+Car5', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG008', 'title': 'V200+Car5', 'description': 'Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG009', 'title': 'V300+Car5', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG010', 'title': 'V300+Car6', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC6 (area under the curve of 6) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG011', 'title': 'V350+Car5', 'description': 'Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '25.0', 'groupId': 'OG004'}, {'value': '33.3', 'groupId': 'OG005'}, {'value': '0.0', 'groupId': 'OG006'}, {'value': '0.0', 'groupId': 'OG007'}, {'value': '0.0', 'groupId': 'OG008'}, {'value': '16.7', 'groupId': 'OG009'}, {'value': '16.7', 'groupId': 'OG010'}, {'value': '66.7', 'groupId': 'OG011'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 weeks', 'description': 'Percentage of participants with dose limiting toxicities (DLTs) during the first treatment cycle.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set.\n\nThere was one patient in the V300+Car6 group whose DLT data was not evaluable, so only 12 patients had evaluable data.'}, {'type': 'SECONDARY', 'title': 'Objective Response Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '13', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'V100+Cis60', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 60mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG001', 'title': 'V100+Cis75', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG002', 'title': 'V200+Cis75', 'description': 'Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG003', 'title': 'V300+Cis75', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG004', 'title': 'V300+Cis100', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 100mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG005', 'title': 'V350+Cis75', 'description': 'Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG006', 'title': 'V100+Car4', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC4 (area under the curve of 4) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG007', 'title': 'V100+Car5', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG008', 'title': 'V200+Car5', 'description': 'Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG009', 'title': 'V300+Car5', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG010', 'title': 'V300+Car6', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC6 (area under the curve of 6) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG011', 'title': 'V350+Car5', 'description': 'Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '33.3', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '33.3', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}, {'value': '0.0', 'groupId': 'OG005'}, {'value': '0.0', 'groupId': 'OG006'}, {'value': '0.0', 'groupId': 'OG007'}, {'value': '0.0', 'groupId': 'OG008'}, {'value': '16.7', 'groupId': 'OG009'}, {'value': '7.7', 'groupId': 'OG010'}, {'value': '0.0', 'groupId': 'OG011'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days', 'description': 'Objective response was defined as the proportion of participants having at least a best response of complete response (CR) or partial response (PR) determined based on RECIST criteria, version 1.0 (V1.0).\n\nTumour response was documented using appropriate techniques', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set'}, {'type': 'SECONDARY', 'title': 'Duration of Objective Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'V100+Cis60', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 60mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG001', 'title': 'V100+Cis75', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG002', 'title': 'V200+Cis75', 'description': 'Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG003', 'title': 'V300+Cis75', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG004', 'title': 'V300+Cis100', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 100mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG005', 'title': 'V350+Cis75', 'description': 'Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG006', 'title': 'V100+Car4', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC4 (area under the curve of 4) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG007', 'title': 'V100+Car5', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG008', 'title': 'V200+Car5', 'description': 'Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG009', 'title': 'V300+Car5', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG010', 'title': 'V300+Car6', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC6 (area under the curve of 6) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG011', 'title': 'V350+Car5', 'description': 'Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '298', 'groupId': 'OG001', 'lowerLimit': '298', 'upperLimit': '298'}, {'value': '359', 'groupId': 'OG003', 'lowerLimit': '359', 'upperLimit': '359'}, {'value': '282', 'groupId': 'OG009', 'lowerLimit': '282', 'upperLimit': '282'}, {'value': '207', 'groupId': 'OG010', 'lowerLimit': '207', 'upperLimit': '207'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days', 'description': 'Duration of objective response was defined as the time from first documented confirmed complete response (CR) or partial response (PR) to first evidence of progressive disease (PD) or death from any cause, whichever occurred first, determined based on RECIST V1.0 criteria.\n\nTumour response was documented using appropriate techniques', 'unitOfMeasure': 'Days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set restricted to participants with confirmed objective response.'}, {'type': 'SECONDARY', 'title': 'Best Overall Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '13', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'V100+Cis60', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 60mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG001', 'title': 'V100+Cis75', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG002', 'title': 'V200+Cis75', 'description': 'Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG003', 'title': 'V300+Cis75', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG004', 'title': 'V300+Cis100', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 100mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG005', 'title': 'V350+Cis75', 'description': 'Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG006', 'title': 'V100+Car4', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC4 (area under the curve of 4) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG007', 'title': 'V100+Car5', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG008', 'title': 'V200+Car5', 'description': 'Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG009', 'title': 'V300+Car5', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG010', 'title': 'V300+Car6', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC6 (area under the curve of 6) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG011', 'title': 'V350+Car5', 'description': 'Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}], 'classes': [{'title': 'Complete response', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}, {'value': '0.0', 'groupId': 'OG005'}, {'value': '0.0', 'groupId': 'OG006'}, {'value': '0.0', 'groupId': 'OG007'}, {'value': '0.0', 'groupId': 'OG008'}, {'value': '0.0', 'groupId': 'OG009'}, {'value': '0.0', 'groupId': 'OG010'}, {'value': '0.0', 'groupId': 'OG011'}]}]}, {'title': 'Partial response', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '33.3', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '33.3', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}, {'value': '0.0', 'groupId': 'OG005'}, {'value': '0.0', 'groupId': 'OG006'}, {'value': '0.0', 'groupId': 'OG007'}, {'value': '0.0', 'groupId': 'OG008'}, {'value': '16.7', 'groupId': 'OG009'}, {'value': '7.7', 'groupId': 'OG010'}, {'value': '0.0', 'groupId': 'OG011'}]}]}, {'title': 'Stable disease', 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}, {'value': '66.7', 'groupId': 'OG001'}, {'value': '33.3', 'groupId': 'OG002'}, {'value': '33.3', 'groupId': 'OG003'}, {'value': '25.0', 'groupId': 'OG004'}, {'value': '33.3', 'groupId': 'OG005'}, {'value': '33.3', 'groupId': 'OG006'}, {'value': '33.3', 'groupId': 'OG007'}, {'value': '0.0', 'groupId': 'OG008'}, {'value': '33.3', 'groupId': 'OG009'}, {'value': '7.7', 'groupId': 'OG010'}, {'value': '33.3', 'groupId': 'OG011'}]}]}, {'title': 'Progressive disease', 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '33.3', 'groupId': 'OG002'}, {'value': '33.3', 'groupId': 'OG003'}, {'value': '58.3', 'groupId': 'OG004'}, {'value': '50.0', 'groupId': 'OG005'}, {'value': '66.7', 'groupId': 'OG006'}, {'value': '66.7', 'groupId': 'OG007'}, {'value': '100.0', 'groupId': 'OG008'}, {'value': '33.3', 'groupId': 'OG009'}, {'value': '61.5', 'groupId': 'OG010'}, {'value': '33.3', 'groupId': 'OG011'}]}]}, {'title': 'Non evaluable', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}, {'value': '0.0', 'groupId': 'OG005'}, {'value': '0.0', 'groupId': 'OG006'}, {'value': '0.0', 'groupId': 'OG007'}, {'value': '0.0', 'groupId': 'OG008'}, {'value': '16.7', 'groupId': 'OG009'}, {'value': '0.0', 'groupId': 'OG010'}, {'value': '0.0', 'groupId': 'OG011'}]}]}, {'title': 'No post-baseline tumour assessment', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '33.3', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '16.7', 'groupId': 'OG004'}, {'value': '16.7', 'groupId': 'OG005'}, {'value': '0.0', 'groupId': 'OG006'}, {'value': '0.0', 'groupId': 'OG007'}, {'value': '0.0', 'groupId': 'OG008'}, {'value': '0.0', 'groupId': 'OG009'}, {'value': '23.1', 'groupId': 'OG010'}, {'value': '33.3', 'groupId': 'OG011'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days', 'description': 'Best overall response was defined as the best response obtained since the start of study treatment until disease progression, determined based on RECIST V1.0 criteria.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set'}, {'type': 'SECONDARY', 'title': 'Disease Control Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '13', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'V100+Cis60', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 60mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG001', 'title': 'V100+Cis75', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG002', 'title': 'V200+Cis75', 'description': 'Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG003', 'title': 'V300+Cis75', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG004', 'title': 'V300+Cis100', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 100mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG005', 'title': 'V350+Cis75', 'description': 'Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG006', 'title': 'V100+Car4', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC4 (area under the curve of 4) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG007', 'title': 'V100+Car5', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG008', 'title': 'V200+Car5', 'description': 'Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG009', 'title': 'V300+Car5', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG010', 'title': 'V300+Car6', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC6 (area under the curve of 6) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG011', 'title': 'V350+Car5', 'description': 'Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}, {'value': '33.3', 'groupId': 'OG002'}, {'value': '66.7', 'groupId': 'OG003'}, {'value': '25.0', 'groupId': 'OG004'}, {'value': '33.3', 'groupId': 'OG005'}, {'value': '33.3', 'groupId': 'OG006'}, {'value': '33.3', 'groupId': 'OG007'}, {'value': '0.0', 'groupId': 'OG008'}, {'value': '50.0', 'groupId': 'OG009'}, {'value': '15.4', 'groupId': 'OG010'}, {'value': '33.3', 'groupId': 'OG011'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days', 'description': 'Percentage of participants with confirmed disease control, defined as the proportion of patients with a best overall response of at least stable disease (SD), determined based on RECIST V1.0 criteria.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set'}, {'type': 'SECONDARY', 'title': 'Duration of Disease Control', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'V100+Cis60', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 60mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG001', 'title': 'V100+Cis75', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG002', 'title': 'V200+Cis75', 'description': 'Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG003', 'title': 'V300+Cis75', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG004', 'title': 'V300+Cis100', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 100mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG005', 'title': 'V350+Cis75', 'description': 'Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG006', 'title': 'V100+Car4', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC4 (area under the curve of 4) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG007', 'title': 'V100+Car5', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG008', 'title': 'V200+Car5', 'description': 'Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG009', 'title': 'V300+Car5', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG010', 'title': 'V300+Car6', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC6 (area under the curve of 6) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG011', 'title': 'V350+Car5', 'description': 'Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '196.5', 'spread': '103.94', 'groupId': 'OG000'}, {'value': '309.0', 'spread': '105.93', 'groupId': 'OG001'}, {'value': '264.0', 'spread': 'NA', 'comment': 'Not calculable as data only available for one patient', 'groupId': 'OG002'}, {'value': '268.0', 'spread': '237.59', 'groupId': 'OG003'}, {'value': '155.0', 'spread': '49.36', 'groupId': 'OG004'}, {'value': '103.5', 'spread': '9.19', 'groupId': 'OG005'}, {'value': '135.0', 'spread': 'NA', 'comment': 'Not calculable as data only available for one patient', 'groupId': 'OG006'}, {'value': '229.0', 'spread': 'NA', 'comment': 'Not calculable as data only available for one patient', 'groupId': 'OG007'}, {'value': '234.0', 'spread': '115.99', 'groupId': 'OG009'}, {'value': '190.5', 'spread': '74.25', 'groupId': 'OG010'}, {'value': '126.0', 'spread': 'NA', 'comment': 'Not calculable as data only available for one patient', 'groupId': 'OG011'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days', 'description': 'Duration of Disease control was defined as the time from the start of study treatment to the time of disease progression or death, whichever occurred first.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set restricted to participants with confirmed disease control.'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '13', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'V100+Cis60', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 60mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG001', 'title': 'V100+Cis75', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG002', 'title': 'V200+Cis75', 'description': 'Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG003', 'title': 'V300+Cis75', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG004', 'title': 'V300+Cis100', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 100mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG005', 'title': 'V350+Cis75', 'description': 'Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG006', 'title': 'V100+Car4', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC4 (area under the curve of 4) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG007', 'title': 'V100+Car5', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG008', 'title': 'V200+Car5', 'description': 'Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG009', 'title': 'V300+Car5', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG010', 'title': 'V300+Car6', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC6 (area under the curve of 6) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG011', 'title': 'V350+Car5', 'description': 'Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '123.0', 'groupId': 'OG000', 'lowerLimit': '38', 'upperLimit': '270'}, {'value': '309.0', 'groupId': 'OG001', 'lowerLimit': '143', 'upperLimit': '340'}, {'value': '37.0', 'groupId': 'OG002', 'lowerLimit': '1', 'upperLimit': '264'}, {'value': '100.0', 'groupId': 'OG003', 'lowerLimit': '43', 'upperLimit': '436'}, {'value': '49.5', 'groupId': 'OG004', 'lowerLimit': '1', 'upperLimit': '232'}, {'value': '69.5', 'groupId': 'OG005', 'lowerLimit': '21', 'upperLimit': '169'}, {'value': '80.0', 'groupId': 'OG006', 'lowerLimit': '37', 'upperLimit': '135'}, {'value': '64.0', 'groupId': 'OG007', 'lowerLimit': '36', 'upperLimit': '229'}, {'value': '40.0', 'groupId': 'OG008', 'lowerLimit': '36', 'upperLimit': '43'}, {'value': '71.0', 'groupId': 'OG009', 'lowerLimit': '38', 'upperLimit': '331'}, {'value': '43.0', 'groupId': 'OG010', 'lowerLimit': '1', 'upperLimit': '243'}, {'value': '39.0', 'groupId': 'OG011', 'lowerLimit': '13', 'upperLimit': '126'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days', 'description': 'Progression-free survival based on RECIST V1.0 criteria was defined as the time from start of treatment to the date of evidence of progressive disease (PD) or death from any cause, whichever occurred first.', 'unitOfMeasure': 'Days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set'}, {'type': 'SECONDARY', 'title': 'Incidence and Intensity of Adverse Events According to CTCAE Version 3.0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '13', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'V100+Cis60', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 60mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG001', 'title': 'V100+Cis75', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG002', 'title': 'V200+Cis75', 'description': 'Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG003', 'title': 'V300+Cis75', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG004', 'title': 'V300+Cis100', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 100mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG005', 'title': 'V350+Cis75', 'description': 'Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG006', 'title': 'V100+Car4', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC4 (area under the curve of 4) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG007', 'title': 'V100+Car5', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG008', 'title': 'V200+Car5', 'description': 'Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG009', 'title': 'V300+Car5', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG010', 'title': 'V300+Car6', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC6 (area under the curve of 6) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG011', 'title': 'V350+Car5', 'description': 'Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}], 'classes': [{'title': 'Grade 1', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '8.3', 'groupId': 'OG004'}, {'value': '0.0', 'groupId': 'OG005'}, {'value': '33.3', 'groupId': 'OG006'}, {'value': '0.0', 'groupId': 'OG007'}, {'value': '0.0', 'groupId': 'OG008'}, {'value': '0.0', 'groupId': 'OG009'}, {'value': '0.0', 'groupId': 'OG010'}, {'value': '0.0', 'groupId': 'OG011'}]}]}, {'title': 'Grade 2', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '66.7', 'groupId': 'OG002'}, {'value': '33.3', 'groupId': 'OG003'}, {'value': '8.3', 'groupId': 'OG004'}, {'value': '16.7', 'groupId': 'OG005'}, {'value': '0.0', 'groupId': 'OG006'}, {'value': '33.3', 'groupId': 'OG007'}, {'value': '66.7', 'groupId': 'OG008'}, {'value': '0.0', 'groupId': 'OG009'}, {'value': '0.0', 'groupId': 'OG010'}, {'value': '0.0', 'groupId': 'OG011'}]}]}, {'title': 'Grade 3', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}, {'value': '33.3', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '41.7', 'groupId': 'OG004'}, {'value': '50.0', 'groupId': 'OG005'}, {'value': '66.7', 'groupId': 'OG006'}, {'value': '66.7', 'groupId': 'OG007'}, {'value': '33.3', 'groupId': 'OG008'}, {'value': '50.0', 'groupId': 'OG009'}, {'value': '61.5', 'groupId': 'OG010'}, {'value': '33.3', 'groupId': 'OG011'}]}]}, {'title': 'Grade 4', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '66.7', 'groupId': 'OG003'}, {'value': '41.7', 'groupId': 'OG004'}, {'value': '33.3', 'groupId': 'OG005'}, {'value': '0.0', 'groupId': 'OG006'}, {'value': '0.0', 'groupId': 'OG007'}, {'value': '0.0', 'groupId': 'OG008'}, {'value': '50.0', 'groupId': 'OG009'}, {'value': '23.1', 'groupId': 'OG010'}, {'value': '66.7', 'groupId': 'OG011'}]}]}, {'title': 'Grade 5', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}, {'value': '0.0', 'groupId': 'OG005'}, {'value': '0.0', 'groupId': 'OG006'}, {'value': '0.0', 'groupId': 'OG007'}, {'value': '0.0', 'groupId': 'OG008'}, {'value': '0.0', 'groupId': 'OG009'}, {'value': '15.4', 'groupId': 'OG010'}, {'value': '0.0', 'groupId': 'OG011'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days', 'description': 'Incidence and intensity of adverse events according to common terminology criteria for adverse events (CTCAE) version 3.0', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '13', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'V100+Cis60', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 60mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG001', 'title': 'V100+Cis75', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG002', 'title': 'V200+Cis75', 'description': 'Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG003', 'title': 'V300+Cis75', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG004', 'title': 'V300+Cis100', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 100mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG005', 'title': 'V350+Cis75', 'description': 'Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG006', 'title': 'V100+Car4', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC4 (area under the curve of 4) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG007', 'title': 'V100+Car5', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG008', 'title': 'V200+Car5', 'description': 'Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG009', 'title': 'V300+Car5', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG010', 'title': 'V300+Car6', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC6 (area under the curve of 6) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG011', 'title': 'V350+Car5', 'description': 'Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}, {'value': '33.3', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '33.3', 'groupId': 'OG003'}, {'value': '50.0', 'groupId': 'OG004'}, {'value': '50.0', 'groupId': 'OG005'}, {'value': '33.3', 'groupId': 'OG006'}, {'value': '0.0', 'groupId': 'OG007'}, {'value': '33.3', 'groupId': 'OG008'}, {'value': '16.7', 'groupId': 'OG009'}, {'value': '46.2', 'groupId': 'OG010'}, {'value': '66.7', 'groupId': 'OG011'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days', 'description': 'Percentage of participants with serious adverse events (AEs)', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Significant Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '13', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'V100+Cis60', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 60mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG001', 'title': 'V100+Cis75', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG002', 'title': 'V200+Cis75', 'description': 'Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG003', 'title': 'V300+Cis75', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG004', 'title': 'V300+Cis100', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 100mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG005', 'title': 'V350+Cis75', 'description': 'Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG006', 'title': 'V100+Car4', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC4 (area under the curve of 4) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG007', 'title': 'V100+Car5', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG008', 'title': 'V200+Car5', 'description': 'Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG009', 'title': 'V300+Car5', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG010', 'title': 'V300+Car6', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC6 (area under the curve of 6) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG011', 'title': 'V350+Car5', 'description': 'Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '66.7', 'groupId': 'OG003'}, {'value': '25.0', 'groupId': 'OG004'}, {'value': '33.3', 'groupId': 'OG005'}, {'value': '0.0', 'groupId': 'OG006'}, {'value': '0.0', 'groupId': 'OG007'}, {'value': '0.0', 'groupId': 'OG008'}, {'value': '16.7', 'groupId': 'OG009'}, {'value': '15.4', 'groupId': 'OG010'}, {'value': '0.0', 'groupId': 'OG011'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days', 'description': 'Percentage of participants with significant adverse events (AEs): dose limiting toxicity (DLT) was defined as significant AE.\n\nDLTs (i.e. significant AEs) per protocol were:\n\n* drug related CTCAE grade 3 or 4 non haematological toxicity (except vomiting or diarrhoea responding to supportive treatment and ototoxicity)\n* drug related CTCAE grade 4 neutropenia for seven or more days and / or complicated by infection\n* drug related CTCAE Grade 4 thrombocytopenia\n* drug related febrile neutropenia grade 3 (ANC\\<1000/mm³ and fever≥ 38.5°C)', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set'}, {'type': 'SECONDARY', 'title': 'Total Plasma Clearance After Intravascular Administration (CL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '10', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'V100+Cis60', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 60mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG001', 'title': 'V100+Cis75', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG002', 'title': 'V200+Cis75', 'description': 'Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG003', 'title': 'V300+Cis75', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG004', 'title': 'V300+Cis100', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 100mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG005', 'title': 'V350+Cis75', 'description': 'Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG006', 'title': 'V100+Car4', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC4 (area under the curve of 4) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG007', 'title': 'V100+Car5', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG008', 'title': 'V200+Car5', 'description': 'Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG009', 'title': 'V300+Car5', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG010', 'title': 'V300+Car6', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC6 (area under the curve of 6) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG011', 'title': 'V350+Car5', 'description': 'Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '852', 'spread': '28.1', 'groupId': 'OG000'}, {'value': '1130', 'spread': '28.1', 'groupId': 'OG001'}, {'value': '1090', 'spread': '7.60', 'groupId': 'OG002'}, {'value': '1050', 'spread': '22.7', 'groupId': 'OG003'}, {'value': '971', 'spread': '28.6', 'groupId': 'OG004'}, {'value': '1010', 'spread': '47.9', 'groupId': 'OG005'}, {'value': '1110', 'spread': '33.6', 'groupId': 'OG006'}, {'value': '812', 'spread': '11.7', 'groupId': 'OG007'}, {'value': '881', 'spread': '6.92', 'groupId': 'OG008'}, {'value': '808', 'spread': '20.7', 'groupId': 'OG009'}, {'value': '974', 'spread': '19.1', 'groupId': 'OG010'}, {'value': '546', 'spread': '16.7', 'groupId': 'OG011'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 hour (h) 35 minutes (min) before start of volasertib infusion and 1h, 2h, 8h, 24h, 48h, 168h and 336h after start of volasertib infusion', 'description': 'Total plasma clearance after intravascular administration (CL) of Volasertib in combination with cisplatin or carboplatin during treatment cycle 1.', 'unitOfMeasure': 'mL/min', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) set which included all participants in the treated set with evaluable PK data'}, {'type': 'SECONDARY', 'title': 'Apparent Volume of Distribution at Steady State Following Intravascular Administration (Vss)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '10', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'V100+Cis60', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 60mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG001', 'title': 'V100+Cis75', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG002', 'title': 'V200+Cis75', 'description': 'Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG003', 'title': 'V300+Cis75', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG004', 'title': 'V300+Cis100', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 100mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG005', 'title': 'V350+Cis75', 'description': 'Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG006', 'title': 'V100+Car4', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC4 (area under the curve of 4) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG007', 'title': 'V100+Car5', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG008', 'title': 'V200+Car5', 'description': 'Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG009', 'title': 'V300+Car5', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG010', 'title': 'V300+Car6', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC6 (area under the curve of 6) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG011', 'title': 'V350+Car5', 'description': 'Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '6580', 'spread': '66.9', 'groupId': 'OG000'}, {'value': '11100', 'spread': '20.1', 'groupId': 'OG001'}, {'value': '5570', 'spread': '18.9', 'groupId': 'OG002'}, {'value': '7140', 'spread': '42.5', 'groupId': 'OG003'}, {'value': '5880', 'spread': '67.6', 'groupId': 'OG004'}, {'value': '7270', 'spread': '41.5', 'groupId': 'OG005'}, {'value': '8810', 'spread': '38.7', 'groupId': 'OG006'}, {'value': '9960', 'spread': '44.7', 'groupId': 'OG007'}, {'value': '8950', 'spread': '36.9', 'groupId': 'OG008'}, {'value': '8270', 'spread': '42.2', 'groupId': 'OG009'}, {'value': '7440', 'spread': '31.9', 'groupId': 'OG010'}, {'value': '3640', 'spread': '35.9', 'groupId': 'OG011'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 hour (h) 35 minutes (min) before start of volasertib infusion and 1h, 2h, 8h, 24h, 48h, 168h and 336h after start of volasertib infusion', 'description': 'Apparent volume of distribution at steady state following intravascular administration (Vss) of Volasertib in combination with cisplatin or carboplatin during treatment cycle 1.', 'unitOfMeasure': 'Litres', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK set'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Pulse Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '13', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'V100+Cis60', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 60mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG001', 'title': 'V100+Cis75', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG002', 'title': 'V200+Cis75', 'description': 'Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG003', 'title': 'V300+Cis75', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG004', 'title': 'V300+Cis100', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 100mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG005', 'title': 'V350+Cis75', 'description': 'Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG006', 'title': 'V100+Car4', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC4 (area under the curve of 4) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG007', 'title': 'V100+Car5', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG008', 'title': 'V200+Car5', 'description': 'Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG009', 'title': 'V300+Car5', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG010', 'title': 'V300+Car6', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC6 (area under the curve of 6) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG011', 'title': 'V350+Car5', 'description': 'Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.0', 'spread': '10.00', 'groupId': 'OG000'}, {'value': '23.3', 'spread': '15.01', 'groupId': 'OG001'}, {'value': '6.7', 'spread': '17.24', 'groupId': 'OG002'}, {'value': '-11.7', 'spread': '14.29', 'groupId': 'OG003'}, {'value': '10.3', 'spread': '14.35', 'groupId': 'OG004'}, {'value': '5.2', 'spread': '10.34', 'groupId': 'OG005'}, {'value': '3.7', 'spread': '26.50', 'groupId': 'OG006'}, {'value': '0.7', 'spread': '7.37', 'groupId': 'OG007'}, {'value': '12.0', 'spread': '7.55', 'groupId': 'OG008'}, {'value': '5.7', 'spread': '10.61', 'groupId': 'OG009'}, {'value': '14.4', 'spread': '10.97', 'groupId': 'OG010'}, {'value': '-21.7', 'spread': '17.79', 'groupId': 'OG011'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and from first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days', 'description': 'Change from baseline in pulse rate at last value on treatment', 'unitOfMeasure': 'bpm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Neutrophils', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '13', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'V100+Cis60', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 60mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG001', 'title': 'V100+Cis75', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG002', 'title': 'V200+Cis75', 'description': 'Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG003', 'title': 'V300+Cis75', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG004', 'title': 'V300+Cis100', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 100mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG005', 'title': 'V350+Cis75', 'description': 'Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG006', 'title': 'V100+Car4', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC4 (area under the curve of 4) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG007', 'title': 'V100+Car5', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG008', 'title': 'V200+Car5', 'description': 'Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG009', 'title': 'V300+Car5', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG010', 'title': 'V300+Car6', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC6 (area under the curve of 6) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG011', 'title': 'V350+Car5', 'description': 'Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.6', 'spread': '7.3', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '1.9', 'groupId': 'OG001'}, {'value': '3.4', 'spread': '2.3', 'groupId': 'OG002'}, {'value': '3.0', 'spread': '2.6', 'groupId': 'OG003'}, {'value': '6.0', 'spread': '4.3', 'groupId': 'OG004'}, {'value': '5.2', 'spread': '6.5', 'groupId': 'OG005'}, {'value': '2.1', 'spread': '3.1', 'groupId': 'OG006'}, {'value': '6.8', 'spread': '8.2', 'groupId': 'OG007'}, {'value': '3.6', 'spread': '2.7', 'groupId': 'OG008'}, {'value': '5.9', 'spread': '6.9', 'groupId': 'OG009'}, {'value': '5.5', 'spread': '2.4', 'groupId': 'OG010'}, {'value': '4.7', 'spread': '2.8', 'groupId': 'OG011'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and from first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days', 'description': 'Change from baseline in neutrophils with the maximum value on treatment', 'unitOfMeasure': '10^9 cells /L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Platelets', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '13', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'V100+Cis60', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 60mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG001', 'title': 'V100+Cis75', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG002', 'title': 'V200+Cis75', 'description': 'Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG003', 'title': 'V300+Cis75', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG004', 'title': 'V300+Cis100', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 100mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG005', 'title': 'V350+Cis75', 'description': 'Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG006', 'title': 'V100+Car4', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC4 (area under the curve of 4) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG007', 'title': 'V100+Car5', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG008', 'title': 'V200+Car5', 'description': 'Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG009', 'title': 'V300+Car5', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG010', 'title': 'V300+Car6', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC6 (area under the curve of 6) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG011', 'title': 'V350+Car5', 'description': 'Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '57', 'spread': '48', 'groupId': 'OG000'}, {'value': '65', 'spread': '78', 'groupId': 'OG001'}, {'value': '96', 'spread': '94', 'groupId': 'OG002'}, {'value': '71', 'spread': '58', 'groupId': 'OG003'}, {'value': '67', 'spread': '58', 'groupId': 'OG004'}, {'value': '89', 'spread': '95', 'groupId': 'OG005'}, {'value': '186', 'spread': '96', 'groupId': 'OG006'}, {'value': '50', 'spread': '38', 'groupId': 'OG007'}, {'value': '49', 'spread': '65', 'groupId': 'OG008'}, {'value': '39', 'spread': '20', 'groupId': 'OG009'}, {'value': '73', 'spread': '58', 'groupId': 'OG010'}, {'value': '104', 'spread': '53', 'groupId': 'OG011'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and from first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days', 'description': 'Change from baseline in platelets with the maximum value on treatment', 'unitOfMeasure': '10^9 cells /L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set'}, {'type': 'SECONDARY', 'title': 'Frequency of Participants (%) With Possible Clinically Significant Abnormalities for Neutrophils', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '13', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'V100+Cis60', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 60mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG001', 'title': 'V100+Cis75', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG002', 'title': 'V200+Cis75', 'description': 'Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG003', 'title': 'V300+Cis75', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG004', 'title': 'V300+Cis100', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 100mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG005', 'title': 'V350+Cis75', 'description': 'Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG006', 'title': 'V100+Car4', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC4 (area under the curve of 4) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG007', 'title': 'V100+Car5', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG008', 'title': 'V200+Car5', 'description': 'Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG009', 'title': 'V300+Car5', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG010', 'title': 'V300+Car6', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC6 (area under the curve of 6) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG011', 'title': 'V350+Car5', 'description': 'Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '33.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '66.7', 'groupId': 'OG003'}, {'value': '75.0', 'groupId': 'OG004'}, {'value': '50.0', 'groupId': 'OG005'}, {'value': '33.3', 'groupId': 'OG006'}, {'value': '33.3', 'groupId': 'OG007'}, {'value': '33.3', 'groupId': 'OG008'}, {'value': '83.3', 'groupId': 'OG009'}, {'value': '76.9', 'groupId': 'OG010'}, {'value': '100.0', 'groupId': 'OG011'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days', 'description': 'Frequency of participants (%) with possible clinically significant abnormalities for neutrophils: : defined as neutrophils \\>=CTCAE grade 2 (CTCAE v3.0), with worsening from baseline. The CTCAE scale measures the severity of adverse events which goes from 1 (mild AE) to 5 (death related AE).', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set'}, {'type': 'SECONDARY', 'title': 'Frequency of Participants (%) With Possible Clinically Significant Abnormalities for Platelets', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '13', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'V100+Cis60', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 60mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG001', 'title': 'V100+Cis75', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG002', 'title': 'V200+Cis75', 'description': 'Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG003', 'title': 'V300+Cis75', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG004', 'title': 'V300+Cis100', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 100mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG005', 'title': 'V350+Cis75', 'description': 'Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG006', 'title': 'V100+Car4', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC4 (area under the curve of 4) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG007', 'title': 'V100+Car5', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG008', 'title': 'V200+Car5', 'description': 'Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG009', 'title': 'V300+Car5', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG010', 'title': 'V300+Car6', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC6 (area under the curve of 6) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG011', 'title': 'V350+Car5', 'description': 'Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '33.0', 'groupId': 'OG003'}, {'value': '41.7', 'groupId': 'OG004'}, {'value': '83.3', 'groupId': 'OG005'}, {'value': '0.0', 'groupId': 'OG006'}, {'value': '33.3', 'groupId': 'OG007'}, {'value': '0.0', 'groupId': 'OG008'}, {'value': '83.3', 'groupId': 'OG009'}, {'value': '76.9', 'groupId': 'OG010'}, {'value': '100.0', 'groupId': 'OG011'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days', 'description': 'Frequency of participants (%) with possible clinically significant abnormalities for platelets : defined as platelets \\>=CTCAE grade 2 (based on CTCAE v3.0), with worsening from baseline.\n\nThe CTCAE scale measures the severity of adverse events which goes from 1 (mild AE) to 5 (death related AE).', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set'}, {'type': 'SECONDARY', 'title': 'Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Last Value on Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '13', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'V100+Cis60', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 60mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG001', 'title': 'V100+Cis75', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG002', 'title': 'V200+Cis75', 'description': 'Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG003', 'title': 'V300+Cis75', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG004', 'title': 'V300+Cis100', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 100mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG005', 'title': 'V350+Cis75', 'description': 'Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG006', 'title': 'V100+Car4', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC4 (area under the curve of 4) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG007', 'title': 'V100+Car5', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG008', 'title': 'V200+Car5', 'description': 'Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG009', 'title': 'V300+Car5', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG010', 'title': 'V300+Car6', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC6 (area under the curve of 6) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG011', 'title': 'V350+Car5', 'description': 'Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}], 'classes': [{'title': 'Baseline=0, last value=0', 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}, {'value': '66.7', 'groupId': 'OG001'}, {'value': '100.0', 'groupId': 'OG002'}, {'value': '100.0', 'groupId': 'OG003'}, {'value': '83.3', 'groupId': 'OG004'}, {'value': '100.0', 'groupId': 'OG005'}, {'value': '100.0', 'groupId': 'OG006'}, {'value': '66.7', 'groupId': 'OG007'}, {'value': '66.7', 'groupId': 'OG008'}, {'value': '83.3', 'groupId': 'OG009'}, {'value': '84.6', 'groupId': 'OG010'}, {'value': '100.0', 'groupId': 'OG011'}]}]}, {'title': 'Baseline=0, last value=1', 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}, {'value': '33.3', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '16.7', 'groupId': 'OG004'}, {'value': '0.0', 'groupId': 'OG005'}, {'value': '0.0', 'groupId': 'OG006'}, {'value': '33.3', 'groupId': 'OG007'}, {'value': '33.3', 'groupId': 'OG008'}, {'value': '0.0', 'groupId': 'OG009'}, {'value': '7.7', 'groupId': 'OG010'}, {'value': '0.0', 'groupId': 'OG011'}]}]}, {'title': 'Baseline=1, last value=0', 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}, {'value': '0.0', 'groupId': 'OG005'}, {'value': '0.0', 'groupId': 'OG006'}, {'value': '0.0', 'groupId': 'OG007'}, {'value': '0.0', 'groupId': 'OG008'}, {'value': '0.0', 'groupId': 'OG009'}, {'value': '0.0', 'groupId': 'OG010'}, {'value': '0.0', 'groupId': 'OG011'}]}]}, {'title': 'Baseline=0, last value=2', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}, {'value': '0.0', 'groupId': 'OG005'}, {'value': '0.0', 'groupId': 'OG006'}, {'value': '0.0', 'groupId': 'OG007'}, {'value': '0.0', 'groupId': 'OG008'}, {'value': '0.0', 'groupId': 'OG009'}, {'value': '7.7', 'groupId': 'OG010'}, {'value': '0.0', 'groupId': 'OG011'}]}]}, {'title': 'Baseline=0, last value=3', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}, {'value': '0.0', 'groupId': 'OG005'}, {'value': '0.0', 'groupId': 'OG006'}, {'value': '0.0', 'groupId': 'OG007'}, {'value': '0.0', 'groupId': 'OG008'}, {'value': '0.0', 'groupId': 'OG009'}, {'value': '0.0', 'groupId': 'OG010'}, {'value': '0.0', 'groupId': 'OG011'}]}]}, {'title': 'Baseline=1, last value=1', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}, {'value': '0.0', 'groupId': 'OG005'}, {'value': '0.0', 'groupId': 'OG006'}, {'value': '0.0', 'groupId': 'OG007'}, {'value': '0.0', 'groupId': 'OG008'}, {'value': '16.7', 'groupId': 'OG009'}, {'value': '0.0', 'groupId': 'OG010'}, {'value': '0.0', 'groupId': 'OG011'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days', 'description': 'Percentage of participants with transitions relative to the baseline CTC grade (version 3) for platelets based on last value on treatment.\n\nCommon terminology criteria for adverse events (CTCAE) grade on treatment for platelets (CTC version 3). The CTCAE scale measures the severity of adverse events which goes from 1 (mild AE) to 5 (death related AE).', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set'}, {'type': 'SECONDARY', 'title': 'Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '13', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'V100+Cis60', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 60mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG001', 'title': 'V100+Cis75', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG002', 'title': 'V200+Cis75', 'description': 'Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG003', 'title': 'V300+Cis75', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG004', 'title': 'V300+Cis100', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 100mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG005', 'title': 'V350+Cis75', 'description': 'Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG006', 'title': 'V100+Car4', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC4 (area under the curve of 4) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG007', 'title': 'V100+Car5', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG008', 'title': 'V200+Car5', 'description': 'Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG009', 'title': 'V300+Car5', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG010', 'title': 'V300+Car6', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC6 (area under the curve of 6) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG011', 'title': 'V350+Car5', 'description': 'Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}], 'classes': [{'title': 'Baseline=0, last value=0', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '66.7', 'groupId': 'OG001'}, {'value': '100.0', 'groupId': 'OG002'}, {'value': '66.7', 'groupId': 'OG003'}, {'value': '91.7', 'groupId': 'OG004'}, {'value': '66.7', 'groupId': 'OG005'}, {'value': '100.0', 'groupId': 'OG006'}, {'value': '100.0', 'groupId': 'OG007'}, {'value': '100.0', 'groupId': 'OG008'}, {'value': '83.3', 'groupId': 'OG009'}, {'value': '69.2', 'groupId': 'OG010'}, {'value': '100.0', 'groupId': 'OG011'}]}]}, {'title': 'Baseline=0, last value=1', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '33.3', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}, {'value': '0.0', 'groupId': 'OG005'}, {'value': '0.0', 'groupId': 'OG006'}, {'value': '0.0', 'groupId': 'OG007'}, {'value': '0.0', 'groupId': 'OG008'}, {'value': '0.0', 'groupId': 'OG009'}, {'value': '30.8', 'groupId': 'OG010'}, {'value': '0.0', 'groupId': 'OG011'}]}]}, {'title': 'Baseline=0, last value=3', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '8.3', 'groupId': 'OG004'}, {'value': '0.0', 'groupId': 'OG005'}, {'value': '0.0', 'groupId': 'OG006'}, {'value': '0.0', 'groupId': 'OG007'}, {'value': '0.0', 'groupId': 'OG008'}, {'value': '0.0', 'groupId': 'OG009'}, {'value': '0.0', 'groupId': 'OG010'}, {'value': '0.0', 'groupId': 'OG011'}]}]}, {'title': 'Baseline=1, last value=1', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '33.3', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}, {'value': '0.0', 'groupId': 'OG005'}, {'value': '0.0', 'groupId': 'OG006'}, {'value': '0.0', 'groupId': 'OG007'}, {'value': '0.0', 'groupId': 'OG008'}, {'value': '0.0', 'groupId': 'OG009'}, {'value': '0.0', 'groupId': 'OG010'}, {'value': '0.0', 'groupId': 'OG011'}]}]}, {'title': 'Baseline=0, last value=2', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}, {'value': '0.0', 'groupId': 'OG005'}, {'value': '0.0', 'groupId': 'OG006'}, {'value': '0.0', 'groupId': 'OG007'}, {'value': '0.0', 'groupId': 'OG008'}, {'value': '16.7', 'groupId': 'OG009'}, {'value': '0.0', 'groupId': 'OG010'}, {'value': '0.0', 'groupId': 'OG011'}]}]}, {'title': 'Baseline=0, last value=4', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}, {'value': '0.0', 'groupId': 'OG005'}, {'value': '0.0', 'groupId': 'OG006'}, {'value': '0.0', 'groupId': 'OG007'}, {'value': '0.0', 'groupId': 'OG008'}, {'value': '0.0', 'groupId': 'OG009'}, {'value': '0.0', 'groupId': 'OG010'}, {'value': '0.0', 'groupId': 'OG011'}]}]}, {'title': 'Baseline=1, last value=0', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}, {'value': '33.3', 'groupId': 'OG005'}, {'value': '0.0', 'groupId': 'OG006'}, {'value': '0.0', 'groupId': 'OG007'}, {'value': '0.0', 'groupId': 'OG008'}, {'value': '0.0', 'groupId': 'OG009'}, {'value': '0.0', 'groupId': 'OG010'}, {'value': '0.0', 'groupId': 'OG011'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days', 'description': 'Percentage of participants with transitions relative to the baseline CTC grade (version 3) for neutrophils based on last value on treatment.\n\nCommon terminology criteria for adverse events (CTCAE) grade on treatment for neutrophils (CTC version 3). The CTCAE scale measures the severity of adverse events which goes from 1 (mild AE) to 5 (death related AE)', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set'}, {'type': 'SECONDARY', 'title': 'Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '13', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'V100+Cis60', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 60mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG001', 'title': 'V100+Cis75', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG002', 'title': 'V200+Cis75', 'description': 'Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG003', 'title': 'V300+Cis75', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG004', 'title': 'V300+Cis100', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 100mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG005', 'title': 'V350+Cis75', 'description': 'Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG006', 'title': 'V100+Car4', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC4 (area under the curve of 4) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG007', 'title': 'V100+Car5', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG008', 'title': 'V200+Car5', 'description': 'Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG009', 'title': 'V300+Car5', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG010', 'title': 'V300+Car6', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC6 (area under the curve of 6) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG011', 'title': 'V350+Car5', 'description': 'Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}], 'classes': [{'title': 'Baseline=0, worst value=0', 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}, {'value': '66.7', 'groupId': 'OG001'}, {'value': '66.7', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '25.0', 'groupId': 'OG004'}, {'value': '16.7', 'groupId': 'OG005'}, {'value': '66.7', 'groupId': 'OG006'}, {'value': '33.3', 'groupId': 'OG007'}, {'value': '33.3', 'groupId': 'OG008'}, {'value': '16.7', 'groupId': 'OG009'}, {'value': '7.7', 'groupId': 'OG010'}, {'value': '0.0', 'groupId': 'OG011'}]}]}, {'title': 'Baseline=0, worst value=1', 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}, {'value': '33.3', 'groupId': 'OG001'}, {'value': '33.3', 'groupId': 'OG002'}, {'value': '66.7', 'groupId': 'OG003'}, {'value': '33.3', 'groupId': 'OG004'}, {'value': '0.0', 'groupId': 'OG005'}, {'value': '33.3', 'groupId': 'OG006'}, {'value': '33.3', 'groupId': 'OG007'}, {'value': '66.7', 'groupId': 'OG008'}, {'value': '0.0', 'groupId': 'OG009'}, {'value': '15.4', 'groupId': 'OG010'}, {'value': '0.0', 'groupId': 'OG011'}]}]}, {'title': 'Baseline=0, worst value=2', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '33.3', 'groupId': 'OG003'}, {'value': '8.3', 'groupId': 'OG004'}, {'value': '66.7', 'groupId': 'OG005'}, {'value': '0.0', 'groupId': 'OG006'}, {'value': '0.0', 'groupId': 'OG007'}, {'value': '0.0', 'groupId': 'OG008'}, {'value': '33.3', 'groupId': 'OG009'}, {'value': '15.4', 'groupId': 'OG010'}, {'value': '33.3', 'groupId': 'OG011'}]}]}, {'title': 'Baseline=0, worst value=3', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '33.3', 'groupId': 'OG004'}, {'value': '16.7', 'groupId': 'OG005'}, {'value': '0.0', 'groupId': 'OG006'}, {'value': '33.3', 'groupId': 'OG007'}, {'value': '0.0', 'groupId': 'OG008'}, {'value': '33.3', 'groupId': 'OG009'}, {'value': '38.5', 'groupId': 'OG010'}, {'value': '0.0', 'groupId': 'OG011'}]}]}, {'title': 'Baseline=1, worst value=1', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}, {'value': '0.0', 'groupId': 'OG005'}, {'value': '0.0', 'groupId': 'OG006'}, {'value': '0.0', 'groupId': 'OG007'}, {'value': '0.0', 'groupId': 'OG008'}, {'value': '0.0', 'groupId': 'OG009'}, {'value': '0.0', 'groupId': 'OG010'}, {'value': '0.0', 'groupId': 'OG011'}]}]}, {'title': 'Baseline=0, worst value=4', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}, {'value': '0.0', 'groupId': 'OG005'}, {'value': '0.0', 'groupId': 'OG006'}, {'value': '0.0', 'groupId': 'OG007'}, {'value': '0.0', 'groupId': 'OG008'}, {'value': '0.0', 'groupId': 'OG009'}, {'value': '23.1', 'groupId': 'OG010'}, {'value': '66.7', 'groupId': 'OG011'}]}]}, {'title': 'Baseline=1, worst value=4', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}, {'value': '0.0', 'groupId': 'OG005'}, {'value': '0.0', 'groupId': 'OG006'}, {'value': '0.0', 'groupId': 'OG007'}, {'value': '0.0', 'groupId': 'OG008'}, {'value': '16.7', 'groupId': 'OG009'}, {'value': '0.0', 'groupId': 'OG010'}, {'value': '0.0', 'groupId': 'OG011'}]}]}, {'title': 'Baseline=1, worst value=0', 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}, {'value': '0.0', 'groupId': 'OG005'}, {'value': '0.0', 'groupId': 'OG006'}, {'value': '0.0', 'groupId': 'OG007'}, {'value': '0.0', 'groupId': 'OG008'}, {'value': '0.0', 'groupId': 'OG009'}, {'value': '0.0', 'groupId': 'OG010'}, {'value': '0.0', 'groupId': 'OG011'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days', 'description': 'Percentage of participants with transitions relative to the baseline CTC grade (version 3) for platelets based on worst value on treatment.\n\nWorst Common terminology criteria for adverse events (CTCAE) grade on treatment for platelets (CTC version 3). The CTCAE scale measures the severity of adverse events which goes from 1 (mild AE) to 5 (death related AE).', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set'}, {'type': 'SECONDARY', 'title': 'Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '13', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'V100+Cis60', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 60mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG001', 'title': 'V100+Cis75', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG002', 'title': 'V200+Cis75', 'description': 'Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG003', 'title': 'V300+Cis75', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG004', 'title': 'V300+Cis100', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 100mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG005', 'title': 'V350+Cis75', 'description': 'Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG006', 'title': 'V100+Car4', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC4 (area under the curve of 4) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG007', 'title': 'V100+Car5', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG008', 'title': 'V200+Car5', 'description': 'Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG009', 'title': 'V300+Car5', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG010', 'title': 'V300+Car6', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC6 (area under the curve of 6) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG011', 'title': 'V350+Car5', 'description': 'Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}], 'classes': [{'title': 'Baseline=0, worst value=0', 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '100.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '16.7', 'groupId': 'OG004'}, {'value': '16.7', 'groupId': 'OG005'}, {'value': '66.7', 'groupId': 'OG006'}, {'value': '66.7', 'groupId': 'OG007'}, {'value': '66.7', 'groupId': 'OG008'}, {'value': '16.7', 'groupId': 'OG009'}, {'value': '7.7', 'groupId': 'OG010'}, {'value': '0.0', 'groupId': 'OG011'}]}]}, {'title': 'Baseline=0, worst value=1', 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '33.3', 'groupId': 'OG003'}, {'value': '8.3', 'groupId': 'OG004'}, {'value': '33.3', 'groupId': 'OG005'}, {'value': '0.0', 'groupId': 'OG006'}, {'value': '0.0', 'groupId': 'OG007'}, {'value': '0.0', 'groupId': 'OG008'}, {'value': '0.0', 'groupId': 'OG009'}, {'value': '15.4', 'groupId': 'OG010'}, {'value': '0.0', 'groupId': 'OG011'}]}]}, {'title': 'Baseline=0, worst value=2', 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}, {'value': '33.3', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '25.0', 'groupId': 'OG004'}, {'value': '0.0', 'groupId': 'OG005'}, {'value': '0.0', 'groupId': 'OG006'}, {'value': '0.0', 'groupId': 'OG007'}, {'value': '33.3', 'groupId': 'OG008'}, {'value': '16.7', 'groupId': 'OG009'}, {'value': '15.4', 'groupId': 'OG010'}, {'value': '0.0', 'groupId': 'OG011'}]}]}, {'title': 'Baseline=0, worst value=3', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '66.7', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '16.7', 'groupId': 'OG004'}, {'value': '0.0', 'groupId': 'OG005'}, {'value': '33.3', 'groupId': 'OG006'}, {'value': '33.3', 'groupId': 'OG007'}, {'value': '0.0', 'groupId': 'OG008'}, {'value': '16.7', 'groupId': 'OG009'}, {'value': '53.8', 'groupId': 'OG010'}, {'value': '66.7', 'groupId': 'OG011'}]}]}, {'title': 'Baseline=0, worst value=4', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '33.3', 'groupId': 'OG003'}, {'value': '33.3', 'groupId': 'OG004'}, {'value': '16.7', 'groupId': 'OG005'}, {'value': '0.0', 'groupId': 'OG006'}, {'value': '0.0', 'groupId': 'OG007'}, {'value': '0.0', 'groupId': 'OG008'}, {'value': '50.0', 'groupId': 'OG009'}, {'value': '7.7', 'groupId': 'OG010'}, {'value': '33.3', 'groupId': 'OG011'}]}]}, {'title': 'Baseline=1, worst value=3', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}, {'value': '16.7', 'groupId': 'OG005'}, {'value': '0.0', 'groupId': 'OG006'}, {'value': '0.0', 'groupId': 'OG007'}, {'value': '0.0', 'groupId': 'OG008'}, {'value': '0.0', 'groupId': 'OG009'}, {'value': '0.0', 'groupId': 'OG010'}, {'value': '0.0', 'groupId': 'OG011'}]}]}, {'title': 'Baseline=1, worst value=4', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '33.3', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}, {'value': '16.7', 'groupId': 'OG005'}, {'value': '0.0', 'groupId': 'OG006'}, {'value': '0.0', 'groupId': 'OG007'}, {'value': '0.0', 'groupId': 'OG008'}, {'value': '0.0', 'groupId': 'OG009'}, {'value': '0.0', 'groupId': 'OG010'}, {'value': '0.0', 'groupId': 'OG011'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days', 'description': 'Percentage of participants with transitions relative to the baseline CTC grade (version 3) for neutrophils based on worst value on treatment.\n\nWorst Common terminology criteria for adverse events (CTCAE) grade on treatment for neutrophils (CTC version 3). The CTCAE scale measures the severity of adverse events which goes from 1 (mild AE) to 5 (death related AE)', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set'}, {'type': 'SECONDARY', 'title': 'Worst CTCAE Grade on Treatment for Platelets', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '13', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'V100+Cis60', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 60mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG001', 'title': 'V100+Cis75', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG002', 'title': 'V200+Cis75', 'description': 'Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG003', 'title': 'V300+Cis75', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG004', 'title': 'V300+Cis100', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 100mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG005', 'title': 'V350+Cis75', 'description': 'Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG006', 'title': 'V100+Car4', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC4 (area under the curve of 4) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG007', 'title': 'V100+Car5', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG008', 'title': 'V200+Car5', 'description': 'Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG009', 'title': 'V300+Car5', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG010', 'title': 'V300+Car6', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC6 (area under the curve of 6) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG011', 'title': 'V350+Car5', 'description': 'Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'spread': '48', 'groupId': 'OG000'}, {'value': '1', 'spread': '78', 'groupId': 'OG001'}, {'value': '1', 'spread': '94', 'groupId': 'OG002'}, {'value': '2', 'spread': '58', 'groupId': 'OG003'}, {'value': '3', 'spread': '58', 'groupId': 'OG004'}, {'value': '3', 'spread': '95', 'groupId': 'OG005'}, {'value': '1', 'spread': '96', 'groupId': 'OG006'}, {'value': '3', 'spread': '38', 'groupId': 'OG007'}, {'value': '1', 'spread': '65', 'groupId': 'OG008'}, {'value': '4', 'spread': '20', 'groupId': 'OG009'}, {'value': '4', 'spread': '58', 'groupId': 'OG010'}, {'value': '4', 'spread': '53', 'groupId': 'OG011'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days', 'description': 'Worst Common terminology criteria for adverse events (CTCAE) grade on treatment for platelets (CTC version 3). The CTCAE scale measures the severity of adverse events which goes from 1 (mild AE) to 5 (death related AE).', 'unitOfMeasure': 'Units on a scale', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set'}, {'type': 'SECONDARY', 'title': 'Worst CTCAE Grade on Treatment for Neutrophils', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '13', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'V100+Cis60', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 60mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG001', 'title': 'V100+Cis75', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG002', 'title': 'V200+Cis75', 'description': 'Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG003', 'title': 'V300+Cis75', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG004', 'title': 'V300+Cis100', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 100mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG005', 'title': 'V350+Cis75', 'description': 'Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG006', 'title': 'V100+Car4', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC4 (area under the curve of 4) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG007', 'title': 'V100+Car5', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG008', 'title': 'V200+Car5', 'description': 'Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG009', 'title': 'V300+Car5', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG010', 'title': 'V300+Car6', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC6 (area under the curve of 6) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'OG011', 'title': 'V350+Car5', 'description': 'Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}, {'value': '4', 'groupId': 'OG010'}, {'value': '4', 'groupId': 'OG011'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days', 'description': 'Worst Common terminology criteria for adverse events (CTCAE) grade on treatment for neutrophils (CTC version 3). The CTCAE scale measures the severity of adverse events which goes from 1 (mild AE) to 5 (death related AE).', 'unitOfMeasure': 'Units on a scale', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'V200+Cis75', 'description': 'Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'FG001', 'title': 'V300+Cis75', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'FG002', 'title': 'V300+Cis100', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 100mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'FG003', 'title': 'V350+Cis75', 'description': 'Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'FG004', 'title': 'V100+Car4', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC4 (area under the curve of 4) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'FG005', 'title': 'V100+Car5', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'FG006', 'title': 'V200+Car5', 'description': 'Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'FG007', 'title': 'V300+Car5', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'FG008', 'title': 'V300+Car6', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC6 (area under the curve of 6) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'FG009', 'title': 'V350+Car5', 'description': 'Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'FG010', 'title': 'V100+Cis60', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 60mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'FG011', 'title': 'V100+Cis75', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}], 'periods': [{'title': 'Discont. Before Start of Treat. Cycle 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '3'}, {'groupId': 'FG007', 'numSubjects': '6'}, {'groupId': 'FG008', 'numSubjects': '13'}, {'groupId': 'FG009', 'numSubjects': '3'}, {'groupId': 'FG010', 'numSubjects': '3'}, {'groupId': 'FG011', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '3'}, {'groupId': 'FG007', 'numSubjects': '6'}, {'groupId': 'FG008', 'numSubjects': '11'}, {'groupId': 'FG009', 'numSubjects': '2'}, {'groupId': 'FG010', 'numSubjects': '3'}, {'groupId': 'FG011', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '2'}, {'groupId': 'FG009', 'numSubjects': '1'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Progressive Disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '1'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'type': 'Dose Limiting Toxicity (DLT)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'type': 'Other adverse events', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}]}, {'title': 'Treated in and Beyond Treat. Cycle 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '3'}, {'groupId': 'FG007', 'numSubjects': '6'}, {'groupId': 'FG008', 'numSubjects': '11'}, {'groupId': 'FG009', 'numSubjects': '2'}, {'groupId': 'FG010', 'numSubjects': '3'}, {'groupId': 'FG011', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '3'}, {'groupId': 'FG007', 'numSubjects': '6'}, {'groupId': 'FG008', 'numSubjects': '11'}, {'groupId': 'FG009', 'numSubjects': '2'}, {'groupId': 'FG010', 'numSubjects': '3'}, {'groupId': 'FG011', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Progressive disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '3'}, {'groupId': 'FG007', 'numSubjects': '6'}, {'groupId': 'FG008', 'numSubjects': '9'}, {'groupId': 'FG009', 'numSubjects': '2'}, {'groupId': 'FG010', 'numSubjects': '3'}, {'groupId': 'FG011', 'numSubjects': '3'}]}, {'type': 'Other adverse events', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '2'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'An open-label, parallel group, 3+3 dose escalation trial Volasertib and cisplatin or carboplatin combination therapy was given on Day 1 of up to 6, 3-week cycles.', 'preAssignmentDetails': 'For the carboplatin arm, the target doses were calculated using the Calvert formula to achieve AUC 4, AUC 5 and AUC 6. Calvert formula: Dose (mg) = target AUC x (glomerular filtration rate (GFR) + 25); GFR = (140 - age \\[years\\]) x (actual weight \\[kg\\])/(72 x serum creatinine \\[mg/dL\\]). Multiply by another factor of 0.85 if female).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '6', 'groupId': 'BG007'}, {'value': '13', 'groupId': 'BG008'}, {'value': '3', 'groupId': 'BG009'}, {'value': '3', 'groupId': 'BG010'}, {'value': '3', 'groupId': 'BG011'}, {'value': '61', 'groupId': 'BG012'}]}], 'groups': [{'id': 'BG000', 'title': 'V200+Cis75', 'description': 'Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'BG001', 'title': 'V300+Cis75', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'BG002', 'title': 'V300+Cis100', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 100mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'BG003', 'title': 'V350+Cis75', 'description': 'Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'BG004', 'title': 'V100+Car4', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC4 (area under the curve of 4) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'BG005', 'title': 'V100+Car5', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'BG006', 'title': 'V200+Car5', 'description': 'Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'BG007', 'title': 'V300+Car5', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'BG008', 'title': 'V300+Car6', 'description': 'Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC6 (area under the curve of 6) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'BG009', 'title': 'V350+Car5', 'description': 'Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'BG010', 'title': 'V100+Cis60', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 60mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'BG011', 'title': 'V100+Cis75', 'description': 'Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.'}, {'id': 'BG012', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40.7', 'spread': '7.51', 'groupId': 'BG000'}, {'value': '55.0', 'spread': '12.53', 'groupId': 'BG001'}, {'value': '52.5', 'spread': '16.67', 'groupId': 'BG002'}, {'value': '60.0', 'spread': '9.53', 'groupId': 'BG003'}, {'value': '56.3', 'spread': '11.72', 'groupId': 'BG004'}, {'value': '54.0', 'spread': '5.57', 'groupId': 'BG005'}, {'value': '58.0', 'spread': '13.75', 'groupId': 'BG006'}, {'value': '66.3', 'spread': '10.07', 'groupId': 'BG007'}, {'value': '51.8', 'spread': '13.03', 'groupId': 'BG008'}, {'value': '58.3', 'spread': '6.66', 'groupId': 'BG009'}, {'value': '45.0', 'spread': '19.16', 'groupId': 'BG010'}, {'value': '58.3', 'spread': '7.37', 'groupId': 'BG011'}, {'value': '54.7', 'spread': '13.08', 'groupId': 'BG012'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '6', 'groupId': 'BG008'}, {'value': '2', 'groupId': 'BG009'}, {'value': '2', 'groupId': 'BG010'}, {'value': '2', 'groupId': 'BG011'}, {'value': '27', 'groupId': 'BG012'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '4', 'groupId': 'BG007'}, {'value': '7', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '1', 'groupId': 'BG010'}, {'value': '1', 'groupId': 'BG011'}, {'value': '34', 'groupId': 'BG012'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Treated set which included all patients who received at least one administration of volasertib and cisplatin or carboplatin.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-21', 'studyFirstSubmitDate': '2009-08-31', 'resultsFirstSubmitDate': '2017-10-23', 'studyFirstSubmitQcDate': '2009-08-31', 'lastUpdatePostDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-08-21', 'studyFirstPostDateStruct': {'date': '2009-09-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Tolerated Dose', 'timeFrame': '3 weeks', 'description': 'The maximum tolerated dose (MTD) was defined as the highest dose studied for which the incidence of DLT was less than 33% (i.e. 1/6 patients) during the first cycle, for Volasertib in combination with cisplatin or carboplatin.\n\n0=not maximum tolerated dose, 1=was maximum tolerated dose.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Dose Limiting Toxicities', 'timeFrame': '3 weeks', 'description': 'Percentage of participants with dose limiting toxicities (DLTs) during the first treatment cycle.'}, {'measure': 'Objective Response Rate', 'timeFrame': 'From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days', 'description': 'Objective response was defined as the proportion of participants having at least a best response of complete response (CR) or partial response (PR) determined based on RECIST criteria, version 1.0 (V1.0).\n\nTumour response was documented using appropriate techniques'}, {'measure': 'Duration of Objective Response', 'timeFrame': 'From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days', 'description': 'Duration of objective response was defined as the time from first documented confirmed complete response (CR) or partial response (PR) to first evidence of progressive disease (PD) or death from any cause, whichever occurred first, determined based on RECIST V1.0 criteria.\n\nTumour response was documented using appropriate techniques'}, {'measure': 'Best Overall Response', 'timeFrame': 'From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days', 'description': 'Best overall response was defined as the best response obtained since the start of study treatment until disease progression, determined based on RECIST V1.0 criteria.'}, {'measure': 'Disease Control Rate', 'timeFrame': 'From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days', 'description': 'Percentage of participants with confirmed disease control, defined as the proportion of patients with a best overall response of at least stable disease (SD), determined based on RECIST V1.0 criteria.'}, {'measure': 'Duration of Disease Control', 'timeFrame': 'From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days', 'description': 'Duration of Disease control was defined as the time from the start of study treatment to the time of disease progression or death, whichever occurred first.'}, {'measure': 'Progression-free Survival', 'timeFrame': 'From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days', 'description': 'Progression-free survival based on RECIST V1.0 criteria was defined as the time from start of treatment to the date of evidence of progressive disease (PD) or death from any cause, whichever occurred first.'}, {'measure': 'Incidence and Intensity of Adverse Events According to CTCAE Version 3.0', 'timeFrame': 'From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days', 'description': 'Incidence and intensity of adverse events according to common terminology criteria for adverse events (CTCAE) version 3.0'}, {'measure': 'Percentage of Participants With Serious Adverse Events', 'timeFrame': 'From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days', 'description': 'Percentage of participants with serious adverse events (AEs)'}, {'measure': 'Percentage of Participants With Significant Adverse Events', 'timeFrame': 'From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days', 'description': 'Percentage of participants with significant adverse events (AEs): dose limiting toxicity (DLT) was defined as significant AE.\n\nDLTs (i.e. significant AEs) per protocol were:\n\n* drug related CTCAE grade 3 or 4 non haematological toxicity (except vomiting or diarrhoea responding to supportive treatment and ototoxicity)\n* drug related CTCAE grade 4 neutropenia for seven or more days and / or complicated by infection\n* drug related CTCAE Grade 4 thrombocytopenia\n* drug related febrile neutropenia grade 3 (ANC\\<1000/mm³ and fever≥ 38.5°C)'}, {'measure': 'Total Plasma Clearance After Intravascular Administration (CL)', 'timeFrame': '1 hour (h) 35 minutes (min) before start of volasertib infusion and 1h, 2h, 8h, 24h, 48h, 168h and 336h after start of volasertib infusion', 'description': 'Total plasma clearance after intravascular administration (CL) of Volasertib in combination with cisplatin or carboplatin during treatment cycle 1.'}, {'measure': 'Apparent Volume of Distribution at Steady State Following Intravascular Administration (Vss)', 'timeFrame': '1 hour (h) 35 minutes (min) before start of volasertib infusion and 1h, 2h, 8h, 24h, 48h, 168h and 336h after start of volasertib infusion', 'description': 'Apparent volume of distribution at steady state following intravascular administration (Vss) of Volasertib in combination with cisplatin or carboplatin during treatment cycle 1.'}, {'measure': 'Change From Baseline in Pulse Rate', 'timeFrame': 'Baseline and from first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days', 'description': 'Change from baseline in pulse rate at last value on treatment'}, {'measure': 'Change From Baseline in Neutrophils', 'timeFrame': 'Baseline and from first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days', 'description': 'Change from baseline in neutrophils with the maximum value on treatment'}, {'measure': 'Change From Baseline in Platelets', 'timeFrame': 'Baseline and from first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days', 'description': 'Change from baseline in platelets with the maximum value on treatment'}, {'measure': 'Frequency of Participants (%) With Possible Clinically Significant Abnormalities for Neutrophils', 'timeFrame': 'From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days', 'description': 'Frequency of participants (%) with possible clinically significant abnormalities for neutrophils: : defined as neutrophils \\>=CTCAE grade 2 (CTCAE v3.0), with worsening from baseline. The CTCAE scale measures the severity of adverse events which goes from 1 (mild AE) to 5 (death related AE).'}, {'measure': 'Frequency of Participants (%) With Possible Clinically Significant Abnormalities for Platelets', 'timeFrame': 'From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days', 'description': 'Frequency of participants (%) with possible clinically significant abnormalities for platelets : defined as platelets \\>=CTCAE grade 2 (based on CTCAE v3.0), with worsening from baseline.\n\nThe CTCAE scale measures the severity of adverse events which goes from 1 (mild AE) to 5 (death related AE).'}, {'measure': 'Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Last Value on Treatment', 'timeFrame': 'From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days', 'description': 'Percentage of participants with transitions relative to the baseline CTC grade (version 3) for platelets based on last value on treatment.\n\nCommon terminology criteria for adverse events (CTCAE) grade on treatment for platelets (CTC version 3). The CTCAE scale measures the severity of adverse events which goes from 1 (mild AE) to 5 (death related AE).'}, {'measure': 'Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment', 'timeFrame': 'From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days', 'description': 'Percentage of participants with transitions relative to the baseline CTC grade (version 3) for neutrophils based on last value on treatment.\n\nCommon terminology criteria for adverse events (CTCAE) grade on treatment for neutrophils (CTC version 3). The CTCAE scale measures the severity of adverse events which goes from 1 (mild AE) to 5 (death related AE)'}, {'measure': 'Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment', 'timeFrame': 'From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days', 'description': 'Percentage of participants with transitions relative to the baseline CTC grade (version 3) for platelets based on worst value on treatment.\n\nWorst Common terminology criteria for adverse events (CTCAE) grade on treatment for platelets (CTC version 3). The CTCAE scale measures the severity of adverse events which goes from 1 (mild AE) to 5 (death related AE).'}, {'measure': 'Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment', 'timeFrame': 'From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days', 'description': 'Percentage of participants with transitions relative to the baseline CTC grade (version 3) for neutrophils based on worst value on treatment.\n\nWorst Common terminology criteria for adverse events (CTCAE) grade on treatment for neutrophils (CTC version 3). The CTCAE scale measures the severity of adverse events which goes from 1 (mild AE) to 5 (death related AE)'}, {'measure': 'Worst CTCAE Grade on Treatment for Platelets', 'timeFrame': 'From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days', 'description': 'Worst Common terminology criteria for adverse events (CTCAE) grade on treatment for platelets (CTC version 3). The CTCAE scale measures the severity of adverse events which goes from 1 (mild AE) to 5 (death related AE).'}, {'measure': 'Worst CTCAE Grade on Treatment for Neutrophils', 'timeFrame': 'From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days', 'description': 'Worst Common terminology criteria for adverse events (CTCAE) grade on treatment for neutrophils (CTC version 3). The CTCAE scale measures the severity of adverse events which goes from 1 (mild AE) to 5 (death related AE).'}]}, 'conditionsModule': {'conditions': ['Neoplasms']}, 'referencesModule': {'references': [{'pmid': '25794535', 'type': 'DERIVED', 'citation': 'Awada A, Dumez H, Aftimos PG, Costermans J, Bartholomeus S, Forceville K, Berghmans T, Meeus MA, Cescutti J, Munzert G, Pilz K, Liu D, Schoffski P. Phase I trial of volasertib, a Polo-like kinase inhibitor, plus platinum agents in solid tumors: safety, pharmacokinetics and activity. Invest New Drugs. 2015 Jun;33(3):611-20. doi: 10.1007/s10637-015-0223-9. Epub 2015 Mar 22.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this trial is to identify the maximum tolerated dose (MTD) of BI 6727 therapy in terms of drug-related adverse events when combined with a platinum therapy (cisplatin or carboplatin).\n\nSecondary objectives are the collection of overall safety and antitumour efficacy data and the determination of the pharmacokinetic profile of BI 6727 combination treatment with cisplatin and carboplatin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n1. Patients with confirmed diagnosis of advanced, non resectable and / or metastatic solid tumours, who have failed conventional treatment, or for whom no therapy of proven efficacy exists, or who are not amenable to established forms of treatment\n2. Indication for a treatment with platinum therapy as judged by the investigator\n3. Age 18 years or older\n4. Written informed consent consistent with ICH-GCP and local legislation\n5. ECOG performance score lower or equal 2\n6. Recovery from CTCAE Grade 2 - 4 therapy-related toxicities from previous systemic anti-cancer therapies or radiotherapies (except alopecia grade 2)\n\nExclusion criteria:\n\n1. Serious illness or concomitant non-oncological disease considered by the investigator to be incompatible with the protocol\n2. Pregnancy or breastfeeding\n3. Active infectious disease or known chronic Hepatitis B/Hepatitis C infection and HIV I/II\n4. Clinical evidence of symptomatic progressive brain or leptomeningeal disease during the past 6 months\n5. Second malignancy currently requiring another anti-cancer therapy\n6. ANC less than 1500 / mm3\n7. Platelet count less than 100 000 / mm3\n8. Bilirubin greater than 1.5 mg / dl (\\> 26 micromol / L, SI unit equivalent) (except Gilbert's syndrome)\n9. Aspartate amino transferase (AST) and / or alanine amino transferase (ALT) greater than 2.5 times the upper limit of normal (if related to liver metastases greater than five times the upper limit of normal)\n10. Serum creatinine greater than 1.5 mg / dl (\\> 132 micromol / L, SI unit equivalent) or creatinine clearance \\<70ml/min (as calculated according to Cockcroft-Gault formula for GFR estimate)\n11. Known history of relevant QT-prolongation, e.g. long QT-syndrome\n12. Pre-existing clinically relevant hearing loss\n13. Women and men who are sexually active and unwilling to use a medically acceptable method of contraception\n14. Treatment with other investigational drugs or participation in another clinical interventional trial within the past four weeks before start of therapy or concomitantly with this trial\n15. Systemic anti-cancer therapy or radiotherapy within the past four weeks before start of therapy or concomitantly with this trial. This restriction does not apply to steroids and bisphosphonates.\n16. Patients unable to comply with the protocol\n17. Active alcohol or drug abuse"}, 'identificationModule': {'nctId': 'NCT00969761', 'briefTitle': 'BI 6727 (Volasertib) in Combination With Cisplatin or Carboplatin in Patients With Advanced or Metastatic Solid Tumour', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'A Phase I Dose Escalation Trial of BI 6727 in Combination With Cisplatin or Carboplatin in Patients With Advanced or Metastatic Solid Tumors', 'orgStudyIdInfo': {'id': '1230.6'}, 'secondaryIdInfos': [{'id': '2008-003926-40', 'type': 'EUDRACT_NUMBER', 'domain': 'EudraCT'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A. BI 6727-cisplatin', 'description': 'patient to receive 3-weekly infusion escalating dose of BI 6727 combined to cisplatin', 'interventionNames': ['Drug: BI 6727']}, {'type': 'EXPERIMENTAL', 'label': 'B. BI 6727-carboplatin', 'description': 'patient to receive 3-weekly infusion escalating dose of BI 6727 combined to carboplatin', 'interventionNames': ['Drug: BI-6727']}], 'interventions': [{'name': 'BI-6727', 'type': 'DRUG', 'description': 'Low to high dose (administered every 3 weeks). Depending on the toxicities observed, intermediary dose levels may be added', 'armGroupLabels': ['B. BI 6727-carboplatin']}, {'name': 'BI 6727', 'type': 'DRUG', 'description': 'low to high dose', 'armGroupLabels': ['A. BI 6727-cisplatin']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Brussels', 'country': 'Belgium', 'facility': '1230.6.3201 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'city': 'Leuven', 'country': 'Belgium', 'facility': '1230.6.3202 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}], 'overallOfficials': [{'name': 'Boehringer Ingelheim', 'role': 'STUDY_CHAIR', 'affiliation': 'Boehringer Ingelheim'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}