Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2025-12-26 @ 3:29 AM
Study NCT ID:
NCT00796120
Status:
COMPLETED
Last Update Posted:
2015-12-10
First Post:
2008-11-20
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
An Efficacy and Safety Study of Trabectedin Versus Doxorubicin-Based Chemotherapy in Participants With Translocation-Related Sarcomas (TRS)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012509', 'term': 'Sarcoma'}], 'ancestors': [{'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077606', 'term': 'Trabectedin'}, {'id': 'D004317', 'term': 'Doxorubicin'}, {'id': 'D007069', 'term': 'Ifosfamide'}], 'ancestors': [{'id': 'D004149', 'term': 'Dioxoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D044005', 'term': 'Tetrahydroisoquinolines'}, {'id': 'D007546', 'term': 'Isoquinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D010078', 'term': 'Oxazines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '+34 91 646-6087', 'title': 'Medical Specialist, Clinical Oncology', 'organization': 'PharmaMar SA Av de los Reyes 1, Poligono Industrial La Mina 28770 Colmenar Viejo, Madrid, Spain'}, 'certainAgreement': {'otherDetails': 'Before Investigators of this study publicly disclose information, PharmaMar must be provided with at least 60 days to review and approve disclosure in order to ensure that confidential and proprietary data are protected. If PharmaMar determines that patentable patient matter is disclosed in the proposed disclosure, the latter shall be withheld for period of time considered convenient.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Trabectedin', 'description': 'Trabectedin 1.5 milligram per square meter (mg/m\\^2) given as 24-hour continuous intravenous infusion every 3 weeks until disease progression.', 'otherNumAtRisk': 61, 'otherNumAffected': 55, 'seriousNumAtRisk': 61, 'seriousNumAffected': 24}, {'id': 'EG001', 'title': 'Doxorubicin Plus Ifosfamide', 'description': 'Doxorubicin (as a monotherapy) 75 mg per m\\^2 will be given intravenously every 3 weeks or Doxorubicin 60 mg per m\\^2 will be given intravenously every 3 weeks along with ifosfamide 6 to 9 gram (g)/m\\^2 every 3 weeks until disease progression.', 'otherNumAtRisk': 57, 'otherNumAffected': 52, 'seriousNumAtRisk': 57, 'seriousNumAffected': 16}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 13}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 15}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Eye irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 40}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Oral pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 42}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 15}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Catheter related infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Blood alkaline phosphataseincreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 15}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Joint range of motion decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Tumour pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 33}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 14}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 6}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 10}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Hiccups', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Pharyngolaryngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 25}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Scar', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}], 'seriousEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 7}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Duodenal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Drug withdrawal syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Hypothermia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Injection site extravasation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Liver injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Hepatocellular injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Bacteremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Bronchitis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Catheter related infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Device related infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Erysipelas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Infusion site infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Pneumococcal bacteremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Blood CPK increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Liver function test abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Rhabdomyolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Tumor pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Dyspraxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Syncope vasovagal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Mental disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Myelodysplastic syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression - Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trabectedin', 'description': 'Trabectedin 1.5 milligram per square meter (mg/m\\^2) given as 24-hour continuous intravenous infusion every 3 weeks until disease progression.'}, {'id': 'OG001', 'title': 'Doxorubicin Plus Ifosfamide', 'description': 'Doxorubicin (as a monotherapy) 75 mg per m\\^2 will be given intravenously every 3 weeks or Doxorubicin 60 mg per m\\^2 will be given intravenously every 3 weeks along with ifosfamide 6 to 9 gram (g)/m\\^2 every 3 weeks until disease progression.'}], 'classes': [{'categories': [{'measurements': [{'value': '19.6', 'groupId': 'OG000', 'lowerLimit': '5.7', 'upperLimit': '32.3'}, {'value': '8.3', 'groupId': 'OG001', 'lowerLimit': '7.1', 'upperLimit': '25.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Every 6 weeks from randomization during the first 9 months and thereafter, every 9 weeks up to 20 months', 'description': 'The PFS was assessed as median number of days from the date of randomization until the first documented sign of disease progression (increase in disease; radiographic, clinical, or both) or death due to any cause, whichever occurred earlier.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population included all participants randomly assigned to either treatment arm with externally confirmed pathological and molecular diagnosis of translocation-related sarcomas (TRS)'}, {'type': 'SECONDARY', 'title': '6-month Progression - Free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trabectedin', 'description': 'Trabectedin 1.5 milligram per square meter (mg/m\\^2) given as 24-hour continuous intravenous infusion every 3 weeks until disease progression.'}, {'id': 'OG001', 'title': 'Doxorubicin Plus Ifosfamide', 'description': 'Doxorubicin (as a monotherapy) 75 mg per m\\^2 will be given intravenously every 3 weeks or Doxorubicin 60 mg per m\\^2 will be given intravenously every 3 weeks along with ifosfamide 6 to 9 gram (g)/m\\^2 every 3 weeks until disease progression.'}], 'classes': [{'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000', 'lowerLimit': '50.6', 'upperLimit': '82.8'}, {'value': '78.3', 'groupId': 'OG001', 'lowerLimit': '64.0', 'upperLimit': '92.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Percentage of participants survived for 6 months from the start of study treatment without progression of disease. Progression of the disease was associated with increasing symptoms, including pain from new or progressing lesions. Delay in disease progression generally represents a clinical benefit to the participant.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population included all participants randomly assigned to either treatment arm with externally confirmed pathological and molecular diagnosis of TRS.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Objective Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trabectedin', 'description': 'Trabectedin 1.5 milligram per square meter (mg/m\\^2) given as 24-hour continuous intravenous infusion every 3 weeks until disease progression.'}, {'id': 'OG001', 'title': 'Doxorubicin Plus Ifosfamide', 'description': 'Doxorubicin (as a monotherapy) 75 mg per m\\^2 will be given intravenously every 3 weeks or Doxorubicin 60 mg per m\\^2 will be given intravenously every 3 weeks along with ifosfamide 6 to 9 gram (g)/m\\^2 every 3 weeks until disease progression.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000', 'lowerLimit': '1.2', 'upperLimit': '16.2'}, {'value': '27.0', 'groupId': 'OG001', 'lowerLimit': '13.8', 'upperLimit': '44.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Every 6 weeks during first 9 months of the study and thereafter every 9 weeks up to 20 months', 'description': 'Tumor response was assessed according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Partial Response (PR)=at least 30% reduction in the sum of the longest dimensions (LD) of all target lesions in reference to the baseline sum LD, Complete Response (CR) =Disappearance of all non-target lesions. Percentage of participants with objective tumor response was determined by the number of participants with PR or CR divided by the total number of response-evaluable participants.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population included all participants randomly assigned to either treatment arm with externally confirmed pathological and molecular diagnosis of TRS.'}, {'type': 'SECONDARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trabectedin', 'description': 'Trabectedin 1.5 milligram per square meter (mg/m\\^2) given as 24-hour continuous intravenous infusion every 3 weeks until disease progression.'}, {'id': 'OG001', 'title': 'Doxorubicin Plus Ifosfamide', 'description': 'Doxorubicin (as a monotherapy) 75 mg per m\\^2 will be given intravenously every 3 weeks or Doxorubicin 60 mg per m\\^2 will be given intravenously every 3 weeks along with ifosfamide 6 to 9 gram (g)/m\\^2 every 3 weeks until disease progression.'}], 'classes': [{'categories': [{'measurements': [{'value': '46.6', 'comment': 'Upper limit of confidence interval was not reached because of high censorship rate that is smaller number of events.', 'groupId': 'OG000', 'lowerLimit': '27.5', 'upperLimit': 'NA'}, {'value': '33.5', 'comment': 'Upper limit of confidence interval was not reached because of high censorship rate that is smaller number of events.', 'groupId': 'OG001', 'lowerLimit': '21.6', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline up to End of Study (an average of 4 years)', 'description': 'Overall survival defined as time from the date of randomization to the date of death. For participants who were alive at the time of analysis, overall survival was censored at the last contact date.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population included all participants randomly assigned to either treatment arm with externally confirmed pathological and molecular diagnosis of TRS.'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DOR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trabectedin', 'description': 'Trabectedin 1.5 milligram per square meter (mg/m\\^2) given as 24-hour continuous intravenous infusion every 3 weeks until disease progression.'}, {'id': 'OG001', 'title': 'Doxorubicin Plus Ifosfamide', 'description': 'Doxorubicin (as a monotherapy) 75 mg per m\\^2 will be given intravenously every 3 weeks or Doxorubicin 60 mg per m\\^2 will be given intravenously every 3 weeks along with ifosfamide 6 to 9 gram (g)/m\\^2 every 3 weeks until disease progression.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median and upper confidence interval point estimates were not reached because of high censorship rate that is smaller number of events.', 'groupId': 'OG000', 'lowerLimit': '7.0', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median and upper confidence interval point estimates were not reached because of high censorship rate that is smaller number of events.', 'groupId': 'OG001', 'lowerLimit': '4.4', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 20 months', 'description': 'The DOR is defined as the time from date of first documentation of response (CR or PR, whichever comes first) to the date of documented PD or death. PR=at least 30% reduction in the sum of the longest dimensions (LD) of all target lesions in reference to the baseline sum LD, CR =Disappearance of all non-target lesions.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Efficacy population included all participants randomly assigned to either treatment arm with externally confirmed pathological and molecular diagnosis of TRS. 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Trabectedin', 'description': 'Trabectedin 1.5 milligram per square meter (mg/m\\^2) given as 24-hour continuous intravenous infusion every 3 weeks until disease progression.'}, {'id': 'FG001', 'title': 'Doxorubicin Plus Ifosfamide', 'description': 'Doxorubicin (as a monotherapy) 75 mg per m\\^2 will be given intravenously every 3 weeks or Doxorubicin 60 mg per m\\^2 will be given intravenously every 3 weeks along with ifosfamide 6 to 9 gram (g)/m\\^2 every 3 weeks until disease progression.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '61'}, {'groupId': 'FG001', 'numSubjects': '60'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '61'}, {'groupId': 'FG001', 'numSubjects': '57'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '61'}, {'groupId': 'FG001', 'numSubjects': '60'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Progressive disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'Participant refusal', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'Randomized but not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '121', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Trabectedin', 'description': 'Trabectedin 1.5 milligram per square meter (mg/m\\^2) given as 24-hour continuous intravenous infusion every 3 weeks until disease progression.'}, {'id': 'BG001', 'title': 'Doxorubicin Plus Ifosfamide', 'description': 'Doxorubicin (as a monotherapy) 75 mg per m\\^2 will be given intravenously every 3 weeks or Doxorubicin 60 mg per m\\^2 will be given intravenously every 3 weeks along with ifosfamide 6 to 9 gram (g)/m\\^2 every 3 weeks until disease progression.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '>=18 to <=49 years', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}]}, {'title': '>=50 to <=65 years', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}, {'title': '>=65 years', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 121}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'dispFirstSubmitDate': '2013-04-18', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-09', 'studyFirstSubmitDate': '2008-11-20', 'dispFirstSubmitQcDate': '2013-04-18', 'resultsFirstSubmitDate': '2014-03-25', 'studyFirstSubmitQcDate': '2008-11-20', 'dispFirstPostDateStruct': {'date': '2013-04-26', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2015-12-10', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-09-15', 'studyFirstPostDateStruct': {'date': '2008-11-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression - Free Survival (PFS)', 'timeFrame': 'Every 6 weeks from randomization during the first 9 months and thereafter, every 9 weeks up to 20 months', 'description': 'The PFS was assessed as median number of days from the date of randomization until the first documented sign of disease progression (increase in disease; radiographic, clinical, or both) or death due to any cause, whichever occurred earlier.'}], 'secondaryOutcomes': [{'measure': '6-month Progression - Free Survival', 'timeFrame': '6 months', 'description': 'Percentage of participants survived for 6 months from the start of study treatment without progression of disease. Progression of the disease was associated with increasing symptoms, including pain from new or progressing lesions. Delay in disease progression generally represents a clinical benefit to the participant.'}, {'measure': 'Percentage of Participants With Objective Response', 'timeFrame': 'Every 6 weeks during first 9 months of the study and thereafter every 9 weeks up to 20 months', 'description': 'Tumor response was assessed according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Partial Response (PR)=at least 30% reduction in the sum of the longest dimensions (LD) of all target lesions in reference to the baseline sum LD, Complete Response (CR) =Disappearance of all non-target lesions. Percentage of participants with objective tumor response was determined by the number of participants with PR or CR divided by the total number of response-evaluable participants.'}, {'measure': 'Overall Survival', 'timeFrame': 'Baseline up to End of Study (an average of 4 years)', 'description': 'Overall survival defined as time from the date of randomization to the date of death. For participants who were alive at the time of analysis, overall survival was censored at the last contact date.'}, {'measure': 'Duration of Response (DOR)', 'timeFrame': 'Up to 20 months', 'description': 'The DOR is defined as the time from date of first documentation of response (CR or PR, whichever comes first) to the date of documented PD or death. PR=at least 30% reduction in the sum of the longest dimensions (LD) of all target lesions in reference to the baseline sum LD, CR =Disappearance of all non-target lesions.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Sarcomas', 'Trabectedin', 'Doxorubicin', 'Ifosfamide', 'YONDELIS'], 'conditions': ['Sarcoma']}, 'referencesModule': {'references': [{'pmid': '24512981', 'type': 'DERIVED', 'citation': 'Blay JY, Leahy MG, Nguyen BB, Patel SR, Hohenberger P, Santoro A, Staddon AP, Penel N, Piperno-Neumann S, Hendifar A, Lardelli P, Nieto A, Alfaro V, Chawla SP. Randomised phase III trial of trabectedin versus doxorubicin-based chemotherapy as first-line therapy in translocation-related sarcomas. Eur J Cancer. 2014 Apr;50(6):1137-47. doi: 10.1016/j.ejca.2014.01.012. Epub 2014 Feb 7.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of trabectedin compared to standard doxorubicin in participants with advanced translocation-related sarcomas (cancer of connective tissue cells) (TRS).', 'detailedDescription': "This is a randomized (study drug assigned by chance), multicenter (when more than one hospital or medical school team work on a medical research study), Phase 3 trial to evaluate the efficacy and safety of trabectedin as compared to standard doxorubicin in participants with advanced TRS. Participants will be randomized in a 1:1 ratio to either of the 2 treatment groups, that is, trabectedin or doxorubicin plus ifosfamide group. Participants in trabectedin group will receive trabectedin 1.5 milligram per square meter (mg/m\\^2) given as a 24-hour continuous intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) every 3 weeks and in doxorubicin plus ifosfamide group participants will receive doxorubicin 60 or 75 mg/m\\^2 intravenously every 3 weeks followed by ifosfamide 6 to 9 gram (g)/m\\^2 every 3 weeks. Participants in either treatment arm will continue receiving therapy in the absence of progressive disease (PD) or intolerable side effects, until the participants' consent is withdrawn or the eligibility criteria for continuing treatment are no longer fulfilled, or when a concurrent condition precludes continuation of treatment. Efficacy will be assessed primarily by evaluating progression-free survival (PFS). Participants' safety will be monitored throughout the trial."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pathological diagnosis of translocation-related sarcomas (TRS) including the following subtypes: alveolar soft part sarcoma, angiomatoid fibrous histiocytoma, clear cell sarcoma, desmoplastic small round cell tumor, low grade endometrial stromal sarcoma (prior hormone therapy allowed), low grade fibromyxoid sarcoma, myxoid chondrosarcoma, myxoid/round cell liposarcoma (MRCL) and synovial sarcoma\n* Participants must have unresectable locally advanced or metastatic progressive disease prior to enrolment\n* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-2\n* Adequate cardiac function, defined as left ventricular ejection fraction (LVEF) within normal limits according to institutional standards, as shown by echocardiography or scintigraphy multiple-gated acquisition scan \\[MUGA\\]\n* Measurable disease as defined by the radiological (computed tomography \\[CT\\] scan and magnetic resonance imaging \\[MRI\\]) Response Evaluation Criteria in Solid Tumors (RECIST v.1.0) guidelines\n\nExclusion Criteria:\n\n* Known hypersensitivity to any components of the intravenous formulation of trabectedin or the comparators\n* Prior chemotherapy treatment or irradiation of the lesion if only one target lesion is available\n* Brain metastases and/or leptomeningeal metastases, even if treated\n* Pregnant or lactating women or men and women of reproductive potential who are not using effective contraceptive methods\n* History of another neoplastic disease (except basal cell carcinoma or cervical carcinoma in situ adequately treated) unless in remission for five years or more'}, 'identificationModule': {'nctId': 'NCT00796120', 'briefTitle': 'An Efficacy and Safety Study of Trabectedin Versus Doxorubicin-Based Chemotherapy in Participants With Translocation-Related Sarcomas (TRS)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Johnson & Johnson Pharmaceutical Research & Development, L.L.C.'}, 'officialTitle': 'A Randomized, Multicenter, Phase III Trial of Trabectedin (Yondelis) Versus Doxorubicin-based Chemotherapy as First-Line Therapy in Patients With Translocation-Related Sarcomas (TRS)', 'orgStudyIdInfo': {'id': 'CR015769'}, 'secondaryIdInfos': [{'id': 'ET-C-002-07', 'type': 'OTHER', 'domain': 'Johnson & Johnson Pharmaceutical Research and Development, L.L.C.'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Trabectedin', 'description': 'Trabectedin 1.5 milligram per square meter (mg/m\\^2) will be given as 24-hour continuous intravenous infusion every 3 weeks until disease progression.', 'interventionNames': ['Drug: Trabectedin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Doxorubicin plus Ifosfamide', 'description': 'Doxorubicin (as a monotherapy) 75 mg per m\\^2 will be given intravenously every 3 weeks or Doxorubicin 60 mg per m\\^2 will be given intravenously every 3 weeks followed by ifosfamide 6 to 9 gram (g)/m\\^2 every 3 weeks until disease progression.', 'interventionNames': ['Drug: Doxorubicin', 'Drug: Ifosfamide']}], 'interventions': [{'name': 'Trabectedin', 'type': 'DRUG', 'description': 'Trabectedin 1.5 milligram per square meter (mg/m\\^2) will be given as 24-hour continuous intravenous infusion every 3 weeks until disease progression.', 'armGroupLabels': ['Trabectedin']}, {'name': 'Doxorubicin', 'type': 'DRUG', 'description': 'Doxorubicin 60 or 75 mg/m\\^2 will be given intravenously every 3 weeks until disease progression.', 'armGroupLabels': ['Doxorubicin plus Ifosfamide']}, {'name': 'Ifosfamide', 'type': 'DRUG', 'description': 'Ifosfamide 6 to 9 g/m\\^2 will be given intravenously every 3 weeks until disease progression.', 'armGroupLabels': ['Doxorubicin plus Ifosfamide']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'city': 'Boreaux', 'country': 'France'}, {'city': 'Lille', 'country': 'France', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Lyon', 'country': 'France', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Paris', 'country': 'France', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Villejuif', 'country': 'France', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}, {'city': 'Bad Saarow', 'country': 'Germany', 'geoPoint': {'lat': 52.28333, 'lon': 14.06667}}, {'city': 'Cologne', 'country': 'Germany', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'city': 'Mannheim', 'country': 'Germany', 'geoPoint': {'lat': 49.4891, 'lon': 8.46694}}, {'city': 'Barcelona', 'country': 'Spain', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Palma', 'country': 'Spain', 'geoPoint': {'lat': 39.56939, 'lon': 2.65024}}, {'city': 'Valencia', 'country': 'Spain', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'city': 'Edinburgh', 'country': 'United Kingdom', 'geoPoint': {'lat': 55.95206, 'lon': -3.19648}}, {'city': 'Glasgow', 'country': 'United Kingdom', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'city': 'London', 'country': 'United Kingdom', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'Manchester', 'country': 'United Kingdom', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}], 'overallOfficials': [{'name': 'Johnson & Johnson Pharmaceutical Research & Development, LLC Clinical Trial', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Johnson & Johnson Pharmaceutical Research & Development, L.L.C.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johnson & Johnson Pharmaceutical Research & Development, L.L.C.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'PharmaMar', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}