Ignite Creation Date:
2025-12-24 @ 6:41 PM
Ignite Modification Date:
2026-02-22 @ 9:32 AM
Study NCT ID:
NCT01951157
Status:
COMPLETED
Last Update Posted:
2019-09-24
First Post:
2013-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Clinical Study in Three-arm of Lurbinectedin (PM01183) Alone or in Combination With Gemcitabine and a Control Arm With Docetaxel as Second Line Treatment in Non-Small Cell Lung Cancer (NSCLC) Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Belgium']}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077143', 'term': 'Docetaxel'}, {'id': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'C568606', 'term': 'PM 01183'}], 'ancestors': [{'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@pharmamar.com', 'phone': '00 34 91846 60 00', 'title': 'Pharma Mar S.A.', 'organization': 'Pharma Mar S.A.'}, 'certainAgreement': {'otherDetails': 'The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the sponsor for review', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Participants were assessed through study completion, approximately 3 years', 'description': "All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population", 'eventGroups': [{'id': 'EG000', 'title': 'A - Docetaxel', 'description': '75 mg/m2 docetaxel day 1, 1-hour intravenous, every three weeks\n\nDocetaxel: Powder for solution for infusion', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 21, 'seriousNumAtRisk': 22, 'deathsNumAffected': 14, 'seriousNumAffected': 12}, {'id': 'EG001', 'title': 'B - Lurbinectedin (PM01183)', 'description': 'In the first protocol version, PM01183 7 mg Flat dose, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles After protocol amedment 3, PM01183 3.2 mg/m2, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles\n\nLurbinectedin (PM01183): Powder for concentrate for solution for infusion', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 20, 'seriousNumAtRisk': 21, 'deathsNumAffected': 17, 'seriousNumAffected': 9}, {'id': 'EG002', 'title': 'C - Gemcitabine + Lurbinectedin (PM01183)', 'description': 'Gemcitabine 800 mg/m2, 30-min i.v. infusion, immediately followed by PM01183 3.0 mg Flat dose, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles (in the first protocol version) or PM01183 1.6 mg/m2, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles (after protocol amedment 3)\n\nGemcitabine: Powder for solution for infusion\n\nLurbinectedin (PM01183): Powder for concentrate for solution for infusion', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 25, 'seriousNumAtRisk': 25, 'deathsNumAffected': 21, 'seriousNumAffected': 18}], 'otherEvents': [{'term': 'Phlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Tumour pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Asthenia/Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 30, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 32, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 35, 'numAffected': 17}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 10, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 14, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'General physical health deterioration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 6, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 11, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 29, 'numAffected': 15}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 8, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 21, 'numAffected': 13}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 13, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 11, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 9, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 5, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 10, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 23, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 13, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 5, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 6, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 13, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 10, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Lung infection', 'stats': [{'groupId': 'EG000', 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{'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Fungal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 1, 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'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Pulmonary sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Staphylococcal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression-free Survival Rate at Four Months (PFS4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'A - Docetaxel', 'description': '75 mg/m2 docetaxel day 1, 1-hour intravenous, every three weeks\n\nDocetaxel: Powder for solution for 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'OG000', 'lowerLimit': '10.7', 'upperLimit': '50.2'}, {'value': '15.8', 'groupId': 'OG001', 'lowerLimit': '3.4', 'upperLimit': '39.6'}, {'value': '26.1', 'groupId': 'OG002', 'lowerLimit': '10.2', 'upperLimit': '48.4'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'The exact binomial estimator', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '29.2', 'ciLowerLimit': '13.2', 'ciUpperLimit': '48.4', 'groupDescription': 'The exact binomial estimator and its 95%CI was used. A pre-planned Bayesian supportive analysis test comparing PFS4 was performed.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001'], 'paramType': 'The exact binomial estimator', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '19.0', 'ciLowerLimit': '5.7', 'ciUpperLimit': '37.9', 'groupDescription': 'The exact binomial estimator and its 95%CI was used. A pre-planned Bayesian supportive analysis test comparing PFS4 was performed', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG002'], 'paramType': 'The exact binomial estimator', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '28.0', 'ciLowerLimit': '12.6', 'ciUpperLimit': '46.7', 'groupDescription': 'The exact binomial estimator and its 95%CI was used. A pre-planned Bayesian supportive analysis test comparing PFS4 was performed', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'At month four after patient inclusion', 'description': 'The rate estimate of the percentage of patients who are alive and progression-free at 16 weeks (\\~4 months) after randomization. Progession disease was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Arm B: 1 no treated, 1 no tumour assesment, 1 major protocol deviation Arm C: 2 no tumour assesment'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'A - Docetaxel', 'description': '75 mg/m2 docetaxel day 1, 1-hour intravenous, every three weeks\n\nDocetaxel: Powder for solution for infusion'}, {'id': 'OG001', 'title': 'B - Lurbinectedin (PM01183)', 'description': 'In the first protocol version, PM01183 7 mg Flat dose, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles After protocol amendment 3, PM01183 3.2 mg/m2, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles\n\nLurbinectedin (PM01183): Powder for concentrate for solution for infusion'}, {'id': 'OG002', 'title': 'C - Gemcitabine + Lurbinectedin (PM01183)', 'description': 'Gemcitabine 800 mg/m2, 30-min i.v. infusion, immediately followed by PM01183 3.0 mg Flat dose, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles (in the first protocol version) or PM01183 1.6 mg/m2, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles (after protocol amendment 3)\n\nGemcitabine: Powder for solution for infusion\n\nLurbinectedin (PM01183): Powder for concentrate for solution for infusion'}], 'classes': [{'categories': [{'measurements': [{'value': '3.1', 'groupId': 'OG000', 'lowerLimit': '1.8', 'upperLimit': '4'}, {'value': '1.9', 'groupId': 'OG001', 'lowerLimit': '1.5', 'upperLimit': '3'}, {'value': '3.3', 'groupId': 'OG002', 'lowerLimit': '1.9', 'upperLimit': '5.7'}]}]}], 'analyses': [{'pValue': '= 0.3873', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Pre-specified'}], 'paramType': 'MEDIAN', 'timeFrame': 'Time from the date of randomization to the date of PD, death (of any cause), or last tumor evaluation, whichever came first, assessed up to 3 years', 'description': 'PFS, progression-free survival Progression-free survival (PFS), defined as the time from the date of randomization to the date of PD, death (of any cause), or last tumor evaluation. Progession disease was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'B- 1 no treated, 1 no tumour assesment, 1 major protocol deviation C - 2 no tumour assesment'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival Rate at Six Months (PFS6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'A - Docetaxel', 'description': '75 mg/m2 docetaxel day 1, 1-hour intravenous, every three weeks\n\nDocetaxel: Powder for solution for infusion'}, {'id': 'OG001', 'title': 'B - Lurbinectedin (PM01183)', 'description': 'In the first protocol version, PM01183 7 mg Flat dose, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles After protocol amendment 3, PM01183 3.2 mg/m2, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles\n\nLurbinectedin (PM01183): Powder for concentrate for solution for infusion'}, {'id': 'OG002', 'title': 'C - Gemcitabine + Lurbinectedin (PM01183)', 'description': 'Gemcitabine 800 mg/m2, 30-min i.v. infusion, immediately followed by PM01183 3.0 mg Flat dose, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles (in the first protocol version) or PM01183 1.6 mg/m2, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles (after protocol amendment 3)\n\nGemcitabine: Powder for solution for infusion\n\nLurbinectedin (PM01183): Powder for concentrate for solution for infusion'}], 'classes': [{'categories': [{'measurements': [{'value': '18.2', 'groupId': 'OG000', 'lowerLimit': '2.1', 'upperLimit': '34.3'}, {'value': '16.7', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '33.9'}, {'value': '17.5', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '35.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At month six after patient inclusion', 'description': 'The rate estimate of the percentage of patients who are alive and progression-free at 24 weeks (\\~6 months) after randomization. Progession disease was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'B- 1 no treated, 1 no tumour assesment, 1 major protocol deviation C - 2 no tumour assesment'}, {'type': 'SECONDARY', 'title': 'Overall Response Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'A - Docetaxel', 'description': '75 mg/m2 docetaxel day 1, 1-hour intravenous, every three weeks\n\nDocetaxel: Powder for solution for infusion'}, {'id': 'OG001', 'title': 'B - Lurbinectedin (PM01183)', 'description': 'In the first protocol version, PM01183 7 mg Flat dose, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles After protocol amendment 3, PM01183 3.2 mg/m2, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles\n\nLurbinectedin (PM01183): Powder for concentrate for solution for infusion'}, {'id': 'OG002', 'title': 'C - Gemcitabine + Lurbinectedin (PM01183)', 'description': 'Gemcitabine 800 mg/m2, 30-min i.v. infusion, immediately followed by PM01183 3.0 mg Flat dose, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles (in the first protocol version) or PM01183 1.6 mg/m2, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles (after protocol amendment 3)\n\nGemcitabine: Powder for solution for infusion\n\nLurbinectedin (PM01183): Powder for concentrate for solution for infusion'}], 'classes': [{'categories': [{'measurements': [{'value': '9.1', 'groupId': 'OG000', 'lowerLimit': '1.1', 'upperLimit': '29.2'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '17.6'}, {'value': '17.4', 'groupId': 'OG002', 'lowerLimit': '5.0', 'upperLimit': '38.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Time from the date of randomization until 30±7 days after the last treatment infusion, assessed up to 3 years', 'description': 'Overall response rate (ORR) was defined as the percentage of patients with a response, either CR or PR, according to RECIST v.1.1.\n\nComplete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\< 10 mm.\n\nPartial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'B - 1 no treated, 1 no tumour assesment, 1 major protocol deviation C - 2 no tumour assesment'}, {'type': 'SECONDARY', 'title': 'Objective Response Per RECIST v.1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'A - Docetaxel', 'description': '75 mg/m2 docetaxel day 1, 1-hour intravenous, every three weeks\n\nDocetaxel: Powder for solution for infusion'}, {'id': 'OG001', 'title': 'B - Lurbinectedin (PM01183)', 'description': 'In the first protocol version, PM01183 7 mg Flat dose, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles After protocol amendment 3, PM01183 3.2 mg/m2, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles\n\nLurbinectedin (PM01183): Powder for concentrate for solution for infusion'}, {'id': 'OG002', 'title': 'C - Gemcitabine + Lurbinectedin (PM01183)', 'description': 'Gemcitabine 800 mg/m2, 30-min i.v. infusion, immediately followed by PM01183 3.0 mg Flat dose, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles (in the first protocol version) or PM01183 1.6 mg/m2, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles (after protocol amendment 3)\n\nGemcitabine: Powder for solution for infusion\n\nLurbinectedin (PM01183): Powder for concentrate for solution for infusion'}], 'classes': [{'categories': [{'title': 'PR', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}, {'title': 'SD', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}, {'title': 'PD', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}, {'title': 'TF', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Time from the date of randomization until 30±7 days after the last treatment infusion, assessed up to 3 years', 'description': 'RECIST, Response Evaluation Criteria In Solid Tumors Complete Response (CR) Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \\<10mm Partial Response (PR) At least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters Progressive Disease (PD) At least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. Appearance of new lesions was considered PD Stable Disease (SD) Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum diameters while on study Treatment failure (TF) Symptomatic deterioration/death due to progression or treatment discontinuation due to treatment-related toxicity occurred before any appropriate tumor assessments had been performed', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'B- 1 no treated, 1 no tumour assesment, 1 major protocol deviation C- 2 no tumour assesment'}, {'type': 'SECONDARY', 'title': 'Duration of Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'A - Docetaxel', 'description': '75 mg/m2 docetaxel day 1, 1-hour intravenous, every three weeks\n\nDocetaxel: Powder for solution for infusion'}, {'id': 'OG001', 'title': 'B - Lurbinectedin (PM01183)', 'description': 'In the first protocol version, PM01183 7 mg Flat dose, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles After protocol amendment 3, PM01183 3.2 mg/m2, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles Lurbinectedin (PM01183): Powder for concentrate for solution for infusion'}, {'id': 'OG002', 'title': 'C - Gemcitabine + Lurbinectedin (PM01183)', 'description': 'Gemcitabine 800 mg/m2, 30-min i.v. infusion, immediately followed by PM01183 3.0 mg Flat dose, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles (in the first protocol version) or PM01183 1.6 mg/m2, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles (after protocol amendment 3)\n\nGemcitabine: Powder for solution for infusion\n\nLurbinectedin (PM01183): Powder for concentrate for solution for infusion'}], 'classes': [{'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000', 'lowerLimit': '0.8', 'upperLimit': '1.6'}, {'value': '6.1', 'comment': 'upper limit was not estimable due to few participants with events', 'groupId': 'OG002', 'lowerLimit': '2.0', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '= 0.0177', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Pre-specified'}], 'paramType': 'MEDIAN', 'timeFrame': 'The time from the date when the response criteria (PR or CR, whichever was reached first) were fulfilled, to the first date when PD, recurrence or death was documented, up to 3 years', 'description': 'Duration of response (DR) was defined as the time from the date when the response criteria (PR or CR, whichever was reached first) were fulfilled, to the first date when PD, recurrence or death was documented.\n\nComplete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\< 10 mm.\n\nPartial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Two patients with CR or PR to treatment as per the RECIST v.1.1 criteria were found in Arm A.\n\nNo patients with CR or PR to treatment as per the RECIST v.1.1 criteria were found in Arm B.\n\nFour patients with CR or PR to treatment as per the RECIST v.1.1 criteria were found in Arm C.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'A - Docetaxel', 'description': '75 mg/m2 docetaxel day 1, 1-hour intravenous, every three weeks\n\nDocetaxel: Powder for solution for infusion'}, {'id': 'OG001', 'title': 'B - Lurbinectedin (PM01183)', 'description': 'In the first protocol version, PM01183 7 mg Flat dose, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles After protocol amendment 3, PM01183 3.2 mg/m2, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles Lurbinectedin (PM01183): Powder for concentrate for solution for infusion'}, {'id': 'OG002', 'title': 'C - Gemcitabine + Lurbinectedin (PM01183)', 'description': 'Gemcitabine 800 mg/m2, 30-min i.v. infusion, immediately followed by PM01183 3.0 mg Flat dose, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles (in the first protocol version) or PM01183 1.6 mg/m2, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles (after protocol amendment 3)\n\nGemcitabine: Powder for solution for infusion\n\nLurbinectedin (PM01183): Powder for concentrate for solution for infusion'}], 'classes': [{'categories': [{'measurements': [{'value': '9.4', 'comment': 'upper limit was not estimable due to few participants with events', 'groupId': 'OG000', 'lowerLimit': '3.1', 'upperLimit': 'NA'}, {'value': '5.5', 'groupId': 'OG001', 'lowerLimit': '3.0', 'upperLimit': '8.0'}, {'value': '7.2', 'groupId': 'OG002', 'lowerLimit': '4.5', 'upperLimit': '10.6'}]}]}], 'analyses': [{'pValue': '0.3526', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'nonInferiorityComment': 'Pre-specified'}], 'paramType': 'MEDIAN', 'timeFrame': 'From the date of first infusion to the date of death or last contact, up to 12 months after last patient inclusion', 'description': 'Overall survival (OS) will be defined as time from the date of first infusion to the date of death or last contact', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Arm B: 1 no treated, 1 no tumour assesment, 1 major protocol deviation Arm C: 2 no tumour assesment'}, {'type': 'SECONDARY', 'title': 'Information on Quality of Life (QoL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'A - Docetaxel', 'description': '75 mg/m2 docetaxel day 1, 1-hour intravenous, every three weeks\n\nDocetaxel: Powder for solution for infusion'}, {'id': 'OG001', 'title': 'B - Lurbinectedin (PM01183)', 'description': 'In the first protocol version, PM01183 7 mg Flat dose, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles After protocol amendment 3, PM01183 3.2 mg/m2, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles\n\nLurbinectedin (PM01183): Powder for concentrate for solution for infusion'}, {'id': 'OG002', 'title': 'C - Gemcitabine + Lurbinectedin (PM01183)', 'description': 'Gemcitabine 800 mg/m2, 30-min i.v. infusion, immediately followed by PM01183 3.0 mg Flat dose, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles (in the first protocol version) or PM01183 1.6 mg/m2, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles (after protocol amendment 3)\n\nGemcitabine: Powder for solution for infusion\n\nLurbinectedin (PM01183): Powder for concentrate for solution for infusion'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '27.2', 'groupId': 'OG000', 'lowerLimit': '18.4', 'upperLimit': '36.1'}, {'value': '36.4', 'groupId': 'OG001', 'lowerLimit': '25.0', 'upperLimit': '47.7'}, {'value': '38.1', 'groupId': 'OG002', 'lowerLimit': '27.7', 'upperLimit': '48.5'}]}]}, {'title': 'Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '29.5', 'groupId': 'OG000', 'lowerLimit': '14.5', 'upperLimit': '44.5'}, {'value': '32.2', 'groupId': 'OG001', 'lowerLimit': '19.5', 'upperLimit': '44.9'}, {'value': '36.4', 'groupId': 'OG002', 'lowerLimit': '25.4', 'upperLimit': '47.5'}]}]}, {'title': 'Cycle 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '24.3', 'groupId': 'OG000', 'lowerLimit': '17.4', 'upperLimit': '31.1'}, {'value': '55.4', 'comment': '95%CI was not calculated due to only one patient was evaluated', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '35.4', 'groupId': 'OG002', 'lowerLimit': '-11.7', 'upperLimit': '82.5'}]}]}, {'title': 'Cycle 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '38.1', 'groupId': 'OG001', 'lowerLimit': '-74.8', 'upperLimit': '151.1'}]}]}], 'analyses': [{'pValue': '0.9026', 'groupIds': ['OG000'], 'groupDescription': 'Changes in QoL scores over time were calculated and tested for statistical significance by means of wilcoxon signed ranks test repeat-measure analyses of variance.', 'statisticalMethod': 'Wilcoxon signed ranks test repeat analys', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Pre-specified'}, {'pValue': '0.9862', 'groupIds': ['OG001'], 'groupDescription': 'Changes in QoL scores over time were calculated and tested for statistical significance by means of wilcoxon signed ranks test repeat-measure analyses of variance.', 'statisticalMethod': 'Wilcoxon signed ranks test repeat analys', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8057', 'groupIds': ['OG002'], 'groupDescription': 'Changes in QoL scores over time were calculated and tested for statistical significance by means of ilcoxon signed ranks test repeat-measure analyses of variance.', 'statisticalMethod': 'Wilcoxon signed ranks test repeat analys', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Cycle 3 (~9 weeks), Cycle 6 (~18 weeks) and Cycle 9 (~27 weeks)', 'description': 'The mean QoL scores self-reported by patients using the Lung Cancer Symptom Scale (LCSS) at baseline and after the start of the therapy in visits 3 or 6 (+/- 1 visit) and visit 9 for those patients in maintenance therapy.\n\nHigher LCSS scores indicate more severe problems and the scale range is (0-100) Total score was calculated as the mean of the total scores of all nine patient ítems (Appetite, Fatigue, Cough, Dyspnea, Hemoptysis, Pain, Lung cancer symptoms, Normal activities, Global QoL)', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'No patients in cycle 9 in arm A and arm C.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'A - Docetaxel', 'description': '75 mg/m2 docetaxel day 1, 1-hour intravenous, every three weeks\n\nDocetaxel: Powder for solution for infusion'}, {'id': 'FG001', 'title': 'B - Lurbinectedin (PM01183)', 'description': 'In the first protocol version, PM01183 7 mg Flat dose, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles After protocol amendment 3, PM01183 3.2 mg/m2, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles\n\nLurbinectedin (PM01183): Powder for concentrate for solution for infusion'}, {'id': 'FG002', 'title': 'C - Gemcitabine + Lurbinectedin (PM01183)', 'description': 'Gemcitabine 800 mg/m2, 30-min i.v. infusion, immediately followed by PM01183 3.0 mg Flat dose, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles (in the first protocol version) or PM01183 1.6 mg/m2, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles (after protocol amendment 3)\n\nGemcitabine: Powder for solution for infusion\n\nLurbinectedin (PM01183): Powder for concentrate for solution for infusion'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'groupId': 'FG002', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'groupId': 'FG002', 'numSubjects': '25'}]}], 'dropWithdraws': [{'type': 'Progressive Disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '10'}]}, {'type': 'Treatment-unrelated AE', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Study Termination', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Non-treatmentrelated death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'No treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Treatment-related AE', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Consent withdrawn by subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Treatment-related death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '69 patients were enrolled between 11/09/2013 and 2/10/2015 at 13 centers. 68 patients were treated: 22 in Arm A, 21 in Arm B, and 25 in Arm C. The first dose of the first cycle was administered on 17/09/2013 and the last dose of the last cycle was administered on 3/11/2016. The last patient, last follow-up was on 24/11/2016'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '69', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'A - Docetaxel', 'description': '75 mg/m2 docetaxel day 1, 1-hour intravenous, every three weeks\n\nDocetaxel: Powder for solution for infusion'}, {'id': 'BG001', 'title': 'B - Lurbinectedin (PM01183)', 'description': 'In the first protocol version, PM01183 7 mg Flat dose, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles After protocol amendment 3, PM01183 3.2 mg/m2, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles\n\nLurbinectedin (PM01183): Powder for concentrate for solution for infusion'}, {'id': 'BG002', 'title': 'C - Gemcitabine + Lurbinectedin (PM01183)', 'description': 'Gemcitabine 800 mg/m2, 30-min i.v. infusion, immediately followed by PM01183 3.0 mg Flat dose, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles (in the first protocol version) or PM01183 1.6 mg/m2, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles (after protocol amendment 3)\n\nGemcitabine: Powder for solution for infusion\n\nLurbinectedin (PM01183): Powder for concentrate for solution for infusion'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '38', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.5', 'groupId': 'BG000', 'lowerLimit': '49', 'upperLimit': '72'}, {'value': '65', 'groupId': 'BG001', 'lowerLimit': '46', 'upperLimit': '74'}, {'value': '64', 'groupId': 'BG002', 'lowerLimit': '41', 'upperLimit': '75'}, {'value': '63', 'groupId': 'BG003', 'lowerLimit': '41', 'upperLimit': '75'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '50', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'categories': [{'title': 'Caucasian', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '68', 'groupId': 'BG003'}]}, {'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}]}]}, {'title': 'Belgium', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'ECOG PS', 'classes': [{'categories': [{'title': 'PS 0', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}]}, {'title': 'PS 1', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'ECOG PS, Eastern Cooperative Oncology Group performance status PS 0 Fully active, able to carry on all pre-disease performance without restriction PS 1 Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature PS 2 Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours PS 3 Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours PS 4 Completely disabled; cannot carry on any selfcare; totally confined to bed or chair PS 5 Dead', 'unitOfMeasure': 'Participants'}, {'title': 'Histology type', 'classes': [{'categories': [{'title': 'Non-squamous-cell', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '54', 'groupId': 'BG003'}]}, {'title': 'Squamous-cell', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}, {'title': 'Not specified', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Histology grade', 'classes': [{'categories': [{'title': 'Well differentiated', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Moderately differentiated', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}, {'title': 'Poorly differentiated', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}]}, {'title': 'Unknown', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '41', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Stage at diagnosis', 'classes': [{'categories': [{'title': 'Early', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}, {'title': 'Locally advanced', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}, {'title': 'Metastatic', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '47', 'groupId': 'BG003'}]}, {'title': 'Unknown', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Stage at study entry', 'classes': [{'categories': [{'title': 'Locally advanced', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Metastatic', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '66', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Surgery', 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}, {'title': 'No', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '58', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Radiotherapy', 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}]}, {'title': 'No', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '40', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Prior chemotherapy', 'classes': [{'categories': [{'title': '1 line', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '63', 'groupId': 'BG003'}]}, {'title': '2 lines', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Number of prior lines', 'unitOfMeasure': 'Participants'}, {'title': 'Best response to last prior platinum', 'classes': [{'categories': [{'title': 'PR', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}]}, {'title': 'SD', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}]}, {'title': 'PD', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}, {'title': 'NA', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'UK', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Best response to last prior platinum based chemotherapy NA, not applicable; PD, progressive disease; PR, partial response; SD, stable disease; UK, unknown', 'unitOfMeasure': 'Participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '70.5', 'groupId': 'BG000', 'lowerLimit': '45', 'upperLimit': '90.8'}, {'value': '74', 'groupId': 'BG001', 'lowerLimit': '39', 'upperLimit': '124'}, {'value': '77', 'groupId': 'BG002', 'lowerLimit': '40', 'upperLimit': '136'}, {'value': '73.6', 'groupId': 'BG003', 'lowerLimit': '39', 'upperLimit': '136'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Kg', 'dispersionType': 'FULL_RANGE'}, {'title': 'Body Surface Area', 'classes': [{'categories': [{'measurements': [{'value': '1.8', 'groupId': 'BG000', 'lowerLimit': '1.4', 'upperLimit': '2.1'}, {'value': '1.9', 'groupId': 'BG001', 'lowerLimit': '1.4', 'upperLimit': '2.3'}, {'value': '1.9', 'groupId': 'BG002', 'lowerLimit': '1.3', 'upperLimit': '2.5'}, {'value': '1.8', 'groupId': 'BG003', 'lowerLimit': '1.3', 'upperLimit': '2.5'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'm^2', 'dispersionType': 'FULL_RANGE'}, {'title': 'Signs and symptoms per patient', 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '4'}, {'value': '1', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '4'}, {'value': '1', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '5'}, {'value': '1', 'groupId': 'BG003', 'lowerLimit': '0', 'upperLimit': '5'}]}]}], 'paramType': 'MEDIAN', 'description': 'Prior history per patient by MedDRA category, eg., cough, dyspnea, fatigue...', 'unitOfMeasure': 'Signs and symptoms', 'dispersionType': 'FULL_RANGE'}, {'title': 'Albumin', 'classes': [{'categories': [{'measurements': [{'value': '4.3', 'groupId': 'BG000', 'lowerLimit': '3.1', 'upperLimit': '4.7'}, {'value': '3.9', 'groupId': 'BG001', 'lowerLimit': '3.2', 'upperLimit': '5'}, {'value': '4', 'groupId': 'BG002', 'lowerLimit': '3.3', 'upperLimit': '4.8'}, {'value': '4', 'groupId': 'BG003', 'lowerLimit': '3.1', 'upperLimit': '5'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'g/dL', 'dispersionType': 'FULL_RANGE'}, {'title': 'Alpha-1-acid glycoprotein', 'classes': [{'categories': [{'measurements': [{'value': '172', 'groupId': 'BG000', 'lowerLimit': '144', 'upperLimit': '251'}, {'value': '141', 'groupId': 'BG001', 'lowerLimit': '65', 'upperLimit': '243'}, {'value': '159', 'groupId': 'BG002', 'lowerLimit': '57', 'upperLimit': '247'}, {'value': '161', 'groupId': 'BG003', 'lowerLimit': '57', 'upperLimit': '251'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'FULL_RANGE'}, {'title': 'Time from first diagnosis to first infusion', 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000', 'lowerLimit': '2.4', 'upperLimit': '48'}, {'value': '11.4', 'groupId': 'BG001', 'lowerLimit': '3.3', 'upperLimit': '42.7'}, {'value': '9.2', 'groupId': 'BG002', 'lowerLimit': '1.9', 'upperLimit': '109.3'}, {'value': '9.8', 'groupId': 'BG003', 'lowerLimit': '1.9', 'upperLimit': '109.3'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'months', 'dispersionType': 'FULL_RANGE'}, {'title': 'Number of sites involved at baseline', 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000', 'lowerLimit': '1', 'upperLimit': '6'}, {'value': '3', 'groupId': 'BG001', 'lowerLimit': '1', 'upperLimit': '6'}, {'value': '3', 'groupId': 'BG002', 'lowerLimit': '1', 'upperLimit': '6'}, {'value': '3', 'groupId': 'BG003', 'lowerLimit': '1', 'upperLimit': '6'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'sites', 'dispersionType': 'FULL_RANGE'}, {'title': 'Platinum-free interval', 'classes': [{'categories': [{'measurements': [{'value': '3.5', 'groupId': 'BG000', 'lowerLimit': '1', 'upperLimit': '16.3'}, {'value': '5.6', 'groupId': 'BG001', 'lowerLimit': '0.7', 'upperLimit': '36.8'}, {'value': '3.9', 'groupId': 'BG002', 'lowerLimit': '1', 'upperLimit': '20.8'}, {'value': '4.4', 'groupId': 'BG003', 'lowerLimit': '0.7', 'upperLimit': '36.8'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'months', 'dispersionType': 'FULL_RANGE'}, {'title': 'PFS to last prior line', 'classes': [{'categories': [{'measurements': [{'value': '5.7', 'groupId': 'BG000', 'lowerLimit': '0.1', 'upperLimit': '18.2'}, {'value': '6.7', 'groupId': 'BG001', 'lowerLimit': '1.1', 'upperLimit': '36.9'}, {'value': '5.4', 'groupId': 'BG002', 'lowerLimit': '1.1', 'upperLimit': '17.4'}, {'value': '5.8', 'groupId': 'BG003', 'lowerLimit': '0.1', 'upperLimit': '36.9'}]}]}], 'paramType': 'MEDIAN', 'description': 'PFS, progression-free survival Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression', 'unitOfMeasure': 'mohths', 'dispersionType': 'FULL_RANGE'}], 'populationDescription': '69 patients were enrolled between 11/09/2013 and 2/10/2015 at 13 centers. 68 patients were treated: 22 in Arm A, 21 in Arm B, and 25 in Arm C. The first dose of the first cycle was administered on 17/09/2013 and the last dose of the last cycle was administered on 3/11/2016. The last patient, last follow-up was on 24/11/2016'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 69}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-04', 'studyFirstSubmitDate': '2013-09-17', 'resultsFirstSubmitDate': '2019-05-21', 'studyFirstSubmitQcDate': '2013-09-23', 'lastUpdatePostDateStruct': {'date': '2019-09-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-09-04', 'studyFirstPostDateStruct': {'date': '2013-09-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-09-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free Survival Rate at Four Months (PFS4)', 'timeFrame': 'At month four after patient inclusion', 'description': 'The rate estimate of the percentage of patients who are alive and progression-free at 16 weeks (\\~4 months) after randomization. Progession disease was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression.'}], 'secondaryOutcomes': [{'measure': 'Progression-free Survival', 'timeFrame': 'Time from the date of randomization to the date of PD, death (of any cause), or last tumor evaluation, whichever came first, assessed up to 3 years', 'description': 'PFS, progression-free survival Progression-free survival (PFS), defined as the time from the date of randomization to the date of PD, death (of any cause), or last tumor evaluation. Progession disease was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression.'}, {'measure': 'Progression-free Survival Rate at Six Months (PFS6)', 'timeFrame': 'At month six after patient inclusion', 'description': 'The rate estimate of the percentage of patients who are alive and progression-free at 24 weeks (\\~6 months) after randomization. Progession disease was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression.'}, {'measure': 'Overall Response Rate', 'timeFrame': 'Time from the date of randomization until 30±7 days after the last treatment infusion, assessed up to 3 years', 'description': 'Overall response rate (ORR) was defined as the percentage of patients with a response, either CR or PR, according to RECIST v.1.1.\n\nComplete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\< 10 mm.\n\nPartial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.'}, {'measure': 'Objective Response Per RECIST v.1.1', 'timeFrame': 'Time from the date of randomization until 30±7 days after the last treatment infusion, assessed up to 3 years', 'description': 'RECIST, Response Evaluation Criteria In Solid Tumors Complete Response (CR) Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \\<10mm Partial Response (PR) At least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters Progressive Disease (PD) At least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. Appearance of new lesions was considered PD Stable Disease (SD) Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum diameters while on study Treatment failure (TF) Symptomatic deterioration/death due to progression or treatment discontinuation due to treatment-related toxicity occurred before any appropriate tumor assessments had been performed'}, {'measure': 'Duration of Response', 'timeFrame': 'The time from the date when the response criteria (PR or CR, whichever was reached first) were fulfilled, to the first date when PD, recurrence or death was documented, up to 3 years', 'description': 'Duration of response (DR) was defined as the time from the date when the response criteria (PR or CR, whichever was reached first) were fulfilled, to the first date when PD, recurrence or death was documented.\n\nComplete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\< 10 mm.\n\nPartial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'From the date of first infusion to the date of death or last contact, up to 12 months after last patient inclusion', 'description': 'Overall survival (OS) will be defined as time from the date of first infusion to the date of death or last contact'}, {'measure': 'Information on Quality of Life (QoL)', 'timeFrame': 'Baseline, Cycle 3 (~9 weeks), Cycle 6 (~18 weeks) and Cycle 9 (~27 weeks)', 'description': 'The mean QoL scores self-reported by patients using the Lung Cancer Symptom Scale (LCSS) at baseline and after the start of the therapy in visits 3 or 6 (+/- 1 visit) and visit 9 for those patients in maintenance therapy.\n\nHigher LCSS scores indicate more severe problems and the scale range is (0-100) Total score was calculated as the mean of the total scores of all nine patient ítems (Appetite, Fatigue, Cough, Dyspnea, Hemoptysis, Pain, Lung cancer symptoms, Normal activities, Global QoL)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Non-Small Cell Lung Cancer (NSCLC)']}, 'descriptionModule': {'briefSummary': 'A clinical study of lurbinectedin(PM01183) alone or in combination with gemcitabine in comparison to docetaxel for the treatment of unresectable non-small cell lung cancer (NSCLC)patients', 'detailedDescription': "A randomized-controlled, three-arm, phase II study of lurbinectedin (PM01183) alone or in combination with gemcitabine and a control arm with docetaxel as second-line treatment in unresectable non-small cell lung cancer (NSCLC)patients to evaluate the antitumor activity as progression-free survival at four months (PFS4) of PM01183 alone or in combination with gemcitabine as using single agent docetaxel as a reference in the control arm as current standard of care and to analyze overall survival (OS), overall survival rate at 1-year (OS12), duration of response (DR), antitumor activity, as response rate (RR), safety and efficacy profiles of PM01183 alone and in combination with gemcitabine, to be preliminary compared with docetaxel, patients' quality of life (QoL), pharmacokinetics (PK) of PM01183, pharmacokinetic/pharmacodynamic (PK/PD)correlation and pharmacogenomics (PGx)to explore potential correlations between clinical outcomes and molecular parameters found in tumor and blood samples"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Histologically or cytologically confirmed unresectable NSCLC\n* Patients must have failed one prior line of CT-based therapy for unresectable disease\n* Age between 18 and 75 years\n* Eastern Cooperative Oncology Group (ECOG)performance status (PS) ≤ 1\n* Adequate hematological, renal, metabolic and hepatic function\n* At least three weeks since the last prior therapy, at least four weeks since completion of any prior radiotherapy\n* Negative pregnancy test for pre-menopausal women\n\nExclusion Criteria:\n\n* Concomitant diseases/conditions as unstable angina, myocardial infarction, symptomatic congestive heart failure or asymptomatic with left ventricular ejection fraction (LVEF) ≤ 50%, dyspnea, infection by human immunodeficiency virus (HIV), active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, active uncontrolled infection, pleural or pericardial effusions, myopathy, limitation of the patient's ability to comply with the treatment or to follow-up the protocol, any other major illness\n* Histological features of neuroendocrine or bronchioalveolar differentiation.\n* Unknown epidermal growth factor receptor (EGFR)mutation status or previously known EGFR mutated status in patients with adenocarcinoma.\n* Prior or concurrent invasive malignant disease, unless in complete remission for more than three years.\n* Significant cancer-related weight loss (≥10%)within four weeks prior to treatment start\n* Prior treatment with docetaxel-containing therapy\n* Symptomatic, steroid-requiring or progressive central nervous system (CNS) involvement\n* Paraneoplastic syndromes"}, 'identificationModule': {'nctId': 'NCT01951157', 'briefTitle': 'A Clinical Study in Three-arm of Lurbinectedin (PM01183) Alone or in Combination With Gemcitabine and a Control Arm With Docetaxel as Second Line Treatment in Non-Small Cell Lung Cancer (NSCLC) Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'PharmaMar'}, 'officialTitle': 'A Randomized-Controlled Three-arm Phase II Study of Lurbinectedin (PM01183) Alone or In Combination With Gemcitabine and a Control Arm With Docetaxel as Second-Line Treatment in Unresectable Non-Small Cell Lung Cancer (NSCLC) Patients', 'orgStudyIdInfo': {'id': 'PM1183-B-004-13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'A - docetaxel', 'description': '75 mg/m2 docetaxel day 1, 1-hour intravenous, every three weeks', 'interventionNames': ['Drug: Docetaxel']}, {'type': 'EXPERIMENTAL', 'label': 'B - lurbinectedin (PM01183)', 'description': '3.2 mg/m2 PM01183, day 1, 1-hour intravenous, every three weeks', 'interventionNames': ['Drug: Lurbinectedin (PM01183)']}, {'type': 'EXPERIMENTAL', 'label': 'C - gemcitabine + lurbinectedin (PM01183)', 'description': '800 mg/m2 gemcitabine / 1.6 mg/m2 PM01183 both on day 1 and day 8, 30-minutes gemcitabine/1-hour PM01183 intravenous, every three weeks', 'interventionNames': ['Drug: Gemcitabine', 'Drug: Lurbinectedin (PM01183)']}], 'interventions': [{'name': 'Docetaxel', 'type': 'DRUG', 'description': 'Powder for solution for infusion', 'armGroupLabels': ['A - docetaxel']}, {'name': 'Gemcitabine', 'type': 'DRUG', 'description': 'Powder for solution for infusion', 'armGroupLabels': ['C - gemcitabine + lurbinectedin (PM01183)']}, {'name': 'Lurbinectedin (PM01183)', 'type': 'DRUG', 'description': 'Powder for concentrate for solution for infusion', 'armGroupLabels': ['B - lurbinectedin (PM01183)', 'C - gemcitabine + lurbinectedin (PM01183)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'New York', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PharmaMar', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}