Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-27 @ 11:43 PM
Study NCT ID:
NCT02566993
Status:
COMPLETED
Last Update Posted:
2021-10-28
First Post:
2015-09-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Trial of Lurbinectedin (PM01183)/Doxorubicin Versus CAV or Topotecan as Treatment in Patients With Small-Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055752', 'term': 'Small Cell Lung Carcinoma'}], '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': 'C568606', 'term': 'PM 01183'}, {'id': 'D004317', 'term': 'Doxorubicin'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D014750', 'term': 'Vincristine'}, {'id': 'D019772', 'term': 'Topotecan'}], 'ancestors': [{'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': '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': 'D014748', 'term': 'Vinca Alkaloids'}, {'id': 'D046948', 'term': 'Secologanin Tryptamine Alkaloids'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D054836', 'term': 'Indolizidines'}, {'id': 'D007212', 'term': 'Indolizines'}, {'id': 'D002166', 'term': 'Camptothecin'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@pharmamar.com', 'phone': '0034 918466000', 'title': 'Clinical Developtment, Department of PharmaMar´s Oncology., Business Unit.', '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 more than 60 days but less than or equal to 180 days from the time submitted to the sponsor for review.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Patients were assessed through study completion, approximately 2 years', 'description': '21 of 613 randomized patients did not receive the study treatment. Safety population consisted of 592 treated patients. 302 had been randomized to lurbinectedin/DOX and 290 to topotecan or CAV. However, one patient randomized to receive topotecan was treated with lurbinectedin/DOX instead. For safety data analysis, this patient has been moved to the lurbinectedin/DOX Arm, and the safety population thereby comprised 303 patients with lurbinectedin/DOX and 289 patients with topotecan or CAV.', 'eventGroups': [{'id': 'EG000', 'title': 'Lurbinectedin/Doxorubicin', 'description': 'Doxorubicin: 40.0 mg/m2 i.v. on Day 1 through peripheral or central lines (according to local label), followed by, Lurbinectedin: 2.0 mg/m2 i.v. as a 1-hour infusion on Day 1 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines. A minimum volume of 100 mL diluted in 5% glucose or 0.9% sodium chloride solution for infusion, had to be used for administration through a central venous catheter; if a peripheral venous catheter was used, the minimum volume was 250 mL.\n\nThe combination was to be administered for up to a maximum of ten cycles.', 'otherNumAtRisk': 303, 'deathsNumAtRisk': 303, 'otherNumAffected': 292, 'seriousNumAtRisk': 303, 'deathsNumAffected': 264, 'seriousNumAffected': 126}, {'id': 'EG001', 'title': 'Topotecan', 'description': "If the patient was randomized to the Control Arm, the assigned treatment was based on the reported Investigator's preference between topotecan and CAV, until the first of these options had reached 55% of the target patient enrollment in this arm. Once this had occurred, patients in the Control Arm were to receive the other option.\n\nTopotecan: i.v. daily on Days 1-5 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines (according to local label) at the following doses:\n\n* 1.50 mg/m2 daily, for patients with calculated CrCL ≥60 mL/min.\n* 1.25 mg/m2 daily, for patients with calculated CrCL between 40 and 59 mL/min.\n* 0.75 mg/m2 daily, for patients with calculated CrCL between 30 and 39 mL/min.", 'otherNumAtRisk': 121, 'deathsNumAtRisk': 121, 'otherNumAffected': 120, 'seriousNumAtRisk': 121, 'deathsNumAffected': 100, 'seriousNumAffected': 66}, {'id': 'EG002', 'title': 'Cyclophosphamide/Doxorubicin/Vincristine', 'description': "If the patient was randomized to the Control Arm, the assigned treatment was based on the reported Investigator's preference between topotecan and CAV, until the first of these options had reached 55% of the target patient enrollment in this arm. Once this had occurred, patients in the Control Arm were to receive the other option.\n\nCAV: i.v. on Day 1 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines at the following doses:\n\n* Cyclophosphamide: 1000 mg/m2,\n* Doxorubicin: 45.0 mg/m2,\n* Vincristine: 2.0 mg FD. The triple combination was to be administered for up to a maximum of ten cycles", 'otherNumAtRisk': 168, 'deathsNumAtRisk': 168, 'otherNumAffected': 148, 'seriousNumAtRisk': 168, 'deathsNumAffected': 148, 'seriousNumAffected': 75}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numEvents': 341, 'numAffected': 121}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 283, 'numAffected': 84}, {'groupId': 'EG002', 'numAtRisk': 168, 'numEvents': 250, 'numAffected': 89}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numEvents': 106, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 77, 'numAffected': 32}, {'groupId': 'EG002', 'numAtRisk': 168, 'numEvents': 123, 'numAffected': 46}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numEvents': 51, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 21, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 168, 'numEvents': 61, 'numAffected': 13}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numEvents': 316, 'numAffected': 101}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 173, 'numAffected': 74}, {'groupId': 'EG002', 'numAtRisk': 168, 'numEvents': 251, 'numAffected': 107}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numEvents': 246, 'numAffected': 70}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 251, 'numAffected': 71}, {'groupId': 'EG002', 'numAtRisk': 168, 'numEvents': 155, 'numAffected': 61}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numEvents': 17, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 16, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 168, 'numEvents': 13, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numEvents': 90, 'numAffected': 59}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 45, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 168, 'numEvents': 31, 'numAffected': 25}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numEvents': 65, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 30, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 168, 'numEvents': 29, 'numAffected': 23}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numEvents': 219, 'numAffected': 123}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 42, 'numAffected': 33}, {'groupId': 'EG002', 'numAtRisk': 168, 'numEvents': 76, 'numAffected': 55}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numEvents': 125, 'numAffected': 72}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 17, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 168, 'numEvents': 36, 'numAffected': 33}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numEvents': 365, 'numAffected': 164}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 162, 'numAffected': 64}, {'groupId': 'EG002', 'numAtRisk': 168, 'numEvents': 152, 'numAffected': 79}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numEvents': 50, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 168, 'numEvents': 24, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numEvents': 27, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 168, 'numEvents': 16, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numEvents': 24, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 14, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 168, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numEvents': 32, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 19, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 168, 'numEvents': 28, 'numAffected': 21}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numEvents': 24, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 15, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 168, 'numEvents': 14, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numEvents': 26, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 168, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 168, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Ejection fraction decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numEvents': 17, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 168, 'numEvents': 11, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numEvents': 79, 'numAffected': 64}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 19, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 168, 'numEvents': 25, 'numAffected': 24}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numEvents': 129, 'numAffected': 85}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 27, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 168, 'numEvents': 61, 'numAffected': 40}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numEvents': 41, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 25, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 168, 'numEvents': 13, 'numAffected': 12}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numEvents': 25, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 12, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 168, 'numEvents': 20, 'numAffected': 14}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numEvents': 29, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 168, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numEvents': 49, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 19, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 168, 'numEvents': 24, 'numAffected': 20}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numEvents': 31, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 168, 'numEvents': 15, 'numAffected': 13}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numEvents': 33, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 14, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 168, 'numEvents': 19, 'numAffected': 19}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 11, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 168, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numEvents': 80, 'numAffected': 60}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 28, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 168, 'numEvents': 31, 'numAffected': 26}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numEvents': 63, 'numAffected': 52}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 26, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 168, 'numEvents': 30, 'numAffected': 24}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numEvents': 40, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 168, 'numEvents': 36, 'numAffected': 27}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numEvents': 25, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 168, 'numEvents': 14, 'numAffected': 13}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'General physical health deterioration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 168, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Candida infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 168, 'numEvents': 12, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numEvents': 17, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 168, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Hypoalbuminaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 12, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 168, 'numEvents': 9, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numEvents': 14, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 168, 'numEvents': 12, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 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{'term': 'Anuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Hydronephrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Prostatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Acute respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 168, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Mediastinal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 168, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Lung infiltration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Peripheral artery thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Superior vena cava syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '307', 'groupId': 'OG000'}, {'value': '306', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lurbinectedin/Doxorubicin', 'description': 'Doxorubicin: 40.0 mg/m2 i.v. on Day 1 through peripheral or central lines (according to local label), followed by, Lurbinectedin: 2.0 mg/m2 i.v. as a 1-hour infusion on Day 1 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines. A minimum volume of 100 mL diluted in 5% glucose or 0.9% sodium chloride solution for infusion, had to be used for administration through a central venous catheter; if a peripheral venous catheter was used, the minimum volume was 250 mL.\n\nThe combination was to be administered for up to a maximum of ten cycles.'}, {'id': 'OG001', 'title': 'Topotecan or Cyclophosphamide/Doxorubicin/Vincristine', 'description': "If the patient was randomized to the Control Arm, the assigned treatment was based on the reported Investigator's preference between topotecan and CAV, until the first of these options had reached 55% of the target patient enrollment in this arm. Once this had occurred, patients in the Control Arm were to receive the other option.\n\nTopotecan: i.v. daily on Days 1-5 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines (according to local label) at the following doses:\n\n* 1.50 mg/m2 daily, for patients with calculated CrCL ≥60 mL/min.\n* 1.25 mg/m2 daily, for patients with calculated CrCL between 40 and 59 mL/min.\n* 0.75 mg/m2 daily, for patients with calculated CrCL between 30 and 39 mL/min.\n\nor\n\nCAV: i.v. on Day 1 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines at the following doses:\n\n* Cyclophosphamide: 1000 mg/m2,\n* Doxorubicin: 45.0 mg/m2,\n* Vincristine: 2.0 mg flat dose (FD). The triple combination was to be administered for up to a maximum of ten cycles"}], 'classes': [{'categories': [{'measurements': [{'value': '8.6', 'groupId': 'OG000', 'lowerLimit': '7.1', 'upperLimit': '9.4'}, {'value': '7.6', 'groupId': 'OG001', 'lowerLimit': '6.6', 'upperLimit': '8.2'}]}]}], 'analyses': [{'pValue': '0.9029', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.967', 'ciLowerLimit': '0.815', 'ciUpperLimit': '1.148', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified log-rank test'}], 'paramType': 'MEDIAN', 'timeFrame': 'Every three months up to death or study termination, a period of approximately 3.5 years', 'description': 'Overall survival (OS) will be calculated from the date of randomization to the date of death (death event) or last contact(in this case, survival will be censored on that date).', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Difference in Overall Survival Between Lurbinectedin/Doxorubicin (DOX) and CAV in Patients With CAV as Best Investigator's Choice: Overall Survival Rate at 12 Months", 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '179', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lurbinectedin/Doxorubicin', 'description': 'Doxorubicin: 40.0 mg/m2 i.v. on Day 1 through peripheral or central lines (according to local label), followed by, Lurbinectedin: 2.0 mg/m2 i.v. as a 1-hour infusion on Day 1 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines. A minimum volume of 100 mL diluted in 5% glucose or 0.9% sodium chloride solution for infusion, had to be used for administration through a central venous catheter; if a peripheral venous catheter was used, the minimum volume was 250 mL.\n\nThe combination was to be administered for up to a maximum of ten cycles.'}, {'id': 'OG001', 'title': 'Topotecan or Cyclophosphamide/Doxorubicin/Vincristine', 'description': "If the patient was randomized to the Control Arm, the assigned treatment was based on the reported Investigator's preference between topotecan and CAV, until the first of these options had reached 55% of the target patient enrollment in this arm. Once this had occurred, patients in the Control Arm were to receive the other option.\n\nTopotecan: i.v. daily on Days 1-5 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines (according to local label) at the following doses:\n\n* 1.50 mg/m2 daily, for patients with calculated CrCL ≥60 mL/min.\n* 1.25 mg/m2 daily, for patients with calculated CrCL between 40 and 59 mL/min.\n* 0.75 mg/m2 daily, for patients with calculated CrCL between 30 and 39 mL/min.\n\nor\n\nCAV: i.v. on Day 1 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines at the following doses:\n\n* Cyclophosphamide: 1000 mg/m2,\n* Doxorubicin: 45.0 mg/m2,\n* Vincristine: 2.0 mg FD. The triple combination was to be administered for up to a maximum of ten cycles"}], 'classes': [{'categories': [{'measurements': [{'value': '29.6', 'groupId': 'OG000', 'lowerLimit': '22.8', 'upperLimit': '36.3'}, {'value': '24.4', 'groupId': 'OG001', 'lowerLimit': '17.9', 'upperLimit': '31.0'}]}]}], 'analyses': [{'pValue': '0.2826', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Normal test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'At 12 months', 'description': 'Overall survival (OS) will be calculated from the date of randomization to the date of death (death event) or last contact(in this case, survival will be censored on that date).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Patients with Cyclophosphamide, Doxorubicin and Vincristine (CAV) as best Investigator's choice"}, {'type': 'SECONDARY', 'title': "Difference in Overall Survival Between Lurbinectedin/DOX and CAV in Patients With CAV as Best Investigator's Choice: Overall Survival Rate at 18 Months", 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '179', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lurbinectedin/Doxorubicin', 'description': 'Doxorubicin: 40.0 mg/m2 i.v. on Day 1 through peripheral or central lines (according to local label), followed by, Lurbinectedin: 2.0 mg/m2 i.v. as a 1-hour infusion on Day 1 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines. A minimum volume of 100 mL diluted in 5% glucose or 0.9% sodium chloride solution for infusion, had to be used for administration through a central venous catheter; if a peripheral venous catheter was used, the minimum volume was 250 mL.\n\nThe combination was to be administered for up to a maximum of ten cycles.'}, {'id': 'OG001', 'title': 'Topotecan or Cyclophosphamide/Doxorubicin/Vincristine', 'description': "If the patient was randomized to the Control Arm, the assigned treatment was based on the reported Investigator's preference between topotecan and CAV, until the first of these options had reached 55% of the target patient enrollment in this arm. Once this had occurred, patients in the Control Arm were to receive the other option.\n\nTopotecan: i.v. daily on Days 1-5 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines (according to local label) at the following doses:\n\n* 1.50 mg/m2 daily, for patients with calculated CrCL ≥60 mL/min.\n* 1.25 mg/m2 daily, for patients with calculated CrCL between 40 and 59 mL/min.\n* 0.75 mg/m2 daily, for patients with calculated CrCL between 30 and 39 mL/min.\n\nor\n\nCAV: i.v. on Day 1 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines at the following doses:\n\n* Cyclophosphamide: 1000 mg/m2,\n* Doxorubicin: 45.0 mg/m2,\n* Vincristine: 2.0 mg FD. The triple combination was to be administered for up to a maximum of ten cycles"}], 'classes': [{'categories': [{'measurements': [{'value': '13.9', 'groupId': 'OG000', 'lowerLimit': '8.8', 'upperLimit': '19.1'}, {'value': '15.9', 'groupId': 'OG001', 'lowerLimit': '10.3', 'upperLimit': '21.4'}]}]}], 'analyses': [{'pValue': '0.6216', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Normal test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'At 18 months', 'description': 'Overall survival (OS) will be calculated from the date of randomization to the date of death (death event) or last contact(in this case, survival will be censored on that date).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Patients with Cyclophosphamide, Doxorubicin and Vincristine (CAV) as best Investigator's choice"}, {'type': 'SECONDARY', 'title': "Difference in Overall Survival Between Lurbinectedin/DOX and CAV in Patients With CAV as Best Investigator's Choice: Overall Survival Rate at 24 Months", 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '179', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lurbinectedin/Doxorubicin', 'description': 'Doxorubicin: 40.0 mg/m2 i.v. on Day 1 through peripheral or central lines (according to local label), followed by, Lurbinectedin: 2.0 mg/m2 i.v. as a 1-hour infusion on Day 1 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines. A minimum volume of 100 mL diluted in 5% glucose or 0.9% sodium chloride solution for infusion, had to be used for administration through a central venous catheter; if a peripheral venous catheter was used, the minimum volume was 250 mL.\n\nThe combination was to be administered for up to a maximum of ten cycles.'}, {'id': 'OG001', 'title': 'Topotecan or Cyclophosphamide/Doxorubicin/Vincristine', 'description': "If the patient was randomized to the Control Arm, the assigned treatment was based on the reported Investigator's preference between topotecan and CAV, until the first of these options had reached 55% of the target patient enrollment in this arm. Once this had occurred, patients in the Control Arm were to receive the other option.\n\nTopotecan: i.v. daily on Days 1-5 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines (according to local label) at the following doses:\n\n* 1.50 mg/m2 daily, for patients with calculated CrCL ≥60 mL/min.\n* 1.25 mg/m2 daily, for patients with calculated CrCL between 40 and 59 mL/min.\n* 0.75 mg/m2 daily, for patients with calculated CrCL between 30 and 39 mL/min.\n\nor\n\nCAV: i.v. on Day 1 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines at the following doses:\n\n* Cyclophosphamide: 1000 mg/m2,\n* Doxorubicin: 45.0 mg/m2,\n* Vincristine: 2.0 mg FD. The triple combination was to be administered for up to a maximum of ten cycles"}], 'classes': [{'categories': [{'measurements': [{'value': '8.6', 'groupId': 'OG000', 'lowerLimit': '4.1', 'upperLimit': '13.1'}, {'value': '8.7', 'groupId': 'OG001', 'lowerLimit': '4.1', 'upperLimit': '13.4'}]}]}], 'analyses': [{'pValue': '0.9708', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Normal test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'At 24 months', 'description': 'Overall survival (OS) will be calculated from the date of randomization to the date of death (death event) or last contact(in this case, survival will be censored on that date).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Patients with Cyclophosphamide, Doxorubicin and Vincristine (CAV) as best Investigator's choice"}, {'type': 'SECONDARY', 'title': 'Progression-free Survival (PFS) by Independent Review Committee', 'denoms': [{'units': 'Participants', 'counts': [{'value': '307', 'groupId': 'OG000'}, {'value': '306', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lurbinectedin/Doxorubicin', 'description': 'Doxorubicin: 40.0 mg/m2 i.v. on Day 1 through peripheral or central lines (according to local label), followed by, Lurbinectedin: 2.0 mg/m2 i.v. as a 1-hour infusion on Day 1 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines. A minimum volume of 100 mL diluted in 5% glucose or 0.9% sodium chloride solution for infusion, had to be used for administration through a central venous catheter; if a peripheral venous catheter was used, the minimum volume was 250 mL.\n\nThe combination was to be administered for up to a maximum of ten cycles.'}, {'id': 'OG001', 'title': 'Topotecan or Cyclophosphamide/Doxorubicin/Vincristine', 'description': "If the patient was randomized to the Control Arm, the assigned treatment was based on the reported Investigator's preference between topotecan and CAV, until the first of these options had reached 55% of the target patient enrollment in this arm. Once this had occurred, patients in the Control Arm were to receive the other option.\n\nTopotecan: i.v. daily on Days 1-5 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines (according to local label) at the following doses:\n\n* 1.50 mg/m2 daily, for patients with calculated CrCL ≥60 mL/min.\n* 1.25 mg/m2 daily, for patients with calculated CrCL between 40 and 59 mL/min.\n* 0.75 mg/m2 daily, for patients with calculated CrCL between 30 and 39 mL/min.\n\nor\n\nCAV: i.v. on Day 1 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines at the following doses:\n\n* Cyclophosphamide: 1000 mg/m2,\n* Doxorubicin: 45.0 mg/m2,\n* Vincristine: 2.0 mg FD. The triple combination was to be administered for up to a maximum of ten cycles"}], 'classes': [{'categories': [{'measurements': [{'value': '4.0', 'groupId': 'OG000', 'lowerLimit': '2.8', 'upperLimit': '4.2'}, {'value': '4.0', 'groupId': 'OG001', 'lowerLimit': '3.0', 'upperLimit': '4.1'}]}]}], 'analyses': [{'pValue': '0.3257', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.831', 'ciLowerLimit': '0.693', 'ciUpperLimit': '0.996', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified log-rank test'}], 'paramType': 'MEDIAN', 'timeFrame': 'Every six weeks up to progression disease, a period of approximately 3.5 years', 'description': 'Progression-free survival (PFS) is defined as the time from the date of randomization to the date of documented progression per RECIST v.1.1 or death (regardless of the cause of death). If the patient receives further antitumor therapy or is lost to follow-up before PD, PFS will be censored at the date of last tumor assessment before the date of subsequent antitumor therapy.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival Rate at 6 Months by Independent Review Committee', 'denoms': [{'units': 'Participants', 'counts': [{'value': '307', 'groupId': 'OG000'}, {'value': '306', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lurbinectedin/Doxorubicin', 'description': 'Doxorubicin: 40.0 mg/m2 i.v. on Day 1 through peripheral or central lines (according to local label), followed by, Lurbinectedin: 2.0 mg/m2 i.v. as a 1-hour infusion on Day 1 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines. A minimum volume of 100 mL diluted in 5% glucose or 0.9% sodium chloride solution for infusion, had to be used for administration through a central venous catheter; if a peripheral venous catheter was used, the minimum volume was 250 mL.\n\nThe combination was to be administered for up to a maximum of ten cycles.'}, {'id': 'OG001', 'title': 'Topotecan or Cyclophosphamide/Doxorubicin/Vincristine', 'description': "If the patient was randomized to the Control Arm, the assigned treatment was based on the reported Investigator's preference between topotecan and CAV, until the first of these options had reached 55% of the target patient enrollment in this arm. Once this had occurred, patients in the Control Arm were to receive the other option.\n\nTopotecan: i.v. daily on Days 1-5 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines (according to local label) at the following doses:\n\n* 1.50 mg/m2 daily, for patients with calculated CrCL ≥60 mL/min.\n* 1.25 mg/m2 daily, for patients with calculated CrCL between 40 and 59 mL/min.\n* 0.75 mg/m2 daily, for patients with calculated CrCL between 30 and 39 mL/min.\n\nor\n\nCAV: i.v. on Day 1 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines at the following doses:\n\n* Cyclophosphamide: 1000 mg/m2,\n* Doxorubicin: 45.0 mg/m2,\n* Vincristine: 2.0 mg FD. The triple combination was to be administered for up to a maximum of ten cycles"}], 'classes': [{'categories': [{'measurements': [{'value': '31.3', 'groupId': 'OG000', 'lowerLimit': '25.7', 'upperLimit': '36.8'}, {'value': '24.4', 'groupId': 'OG001', 'lowerLimit': '18.9', 'upperLimit': '29.9'}]}]}], 'analyses': [{'pValue': '0.0851', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Normal test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'At 6 months', 'description': 'Progression-free survival (PFS) is defined as the time from the date of randomization to the date of documented progression per RECIST v.1.1 or death (regardless of the cause of death). If the patient receives further antitumor therapy or is lost to follow-up before PD, PFS will be censored at the date of last tumor assessment before the date of subsequent antitumor therapy.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival Rate at 12 Months by Independent Review Committee', 'denoms': [{'units': 'Participants', 'counts': [{'value': '307', 'groupId': 'OG000'}, {'value': '306', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lurbinectedin/Doxorubicin', 'description': 'Doxorubicin: 40.0 mg/m2 i.v. on Day 1 through peripheral or central lines (according to local label), followed by, Lurbinectedin: 2.0 mg/m2 i.v. as a 1-hour infusion on Day 1 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines. A minimum volume of 100 mL diluted in 5% glucose or 0.9% sodium chloride solution for infusion, had to be used for administration through a central venous catheter; if a peripheral venous catheter was used, the minimum volume was 250 mL.\n\nThe combination was to be administered for up to a maximum of ten cycles.'}, {'id': 'OG001', 'title': 'Topotecan or Cyclophosphamide/Doxorubicin/Vincristine', 'description': "If the patient was randomized to the Control Arm, the assigned treatment was based on the reported Investigator's preference between topotecan and CAV, until the first of these options had reached 55% of the target patient enrollment in this arm. Once this had occurred, patients in the Control Arm were to receive the other option.\n\nTopotecan: i.v. daily on Days 1-5 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines (according to local label) at the following doses:\n\n* 1.50 mg/m2 daily, for patients with calculated CrCL ≥60 mL/min.\n* 1.25 mg/m2 daily, for patients with calculated CrCL between 40 and 59 mL/min.\n* 0.75 mg/m2 daily, for patients with calculated CrCL between 30 and 39 mL/min.\n\nor\n\nCAV: i.v. on Day 1 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines at the following doses:\n\n* Cyclophosphamide: 1000 mg/m2,\n* Doxorubicin: 45.0 mg/m2,\n* Vincristine: 2.0 mg FD. The triple combination was to be administered for up to a maximum of ten cycles"}], 'classes': [{'categories': [{'measurements': [{'value': '10.8', 'groupId': 'OG000', 'lowerLimit': '6.7', 'upperLimit': '14.9'}, {'value': '4.4', 'groupId': 'OG001', 'lowerLimit': '1.4', 'upperLimit': '7.4'}]}]}], 'analyses': [{'pValue': '0.0129', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Normal test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'at 12 months', 'description': 'Progression-free survival (PFS) is defined as the time from the date of randomization to the date of documented progression per RECIST v.1.1 or death (regardless of the cause of death). If the patient receives further antitumor therapy or is lost to follow-up before PD, PFS will be censored at the date of last tumor assessment before the date of subsequent antitumor therapy.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Best Antitumor Response by Independent Review Committee', 'denoms': [{'units': 'Participants', 'counts': [{'value': '307', 'groupId': 'OG000'}, {'value': '306', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lurbinectedin/Doxorubicin', 'description': 'Doxorubicin: 40.0 mg/m2 i.v. on Day 1 through peripheral or central lines (according to local label), followed by, Lurbinectedin: 2.0 mg/m2 i.v. as a 1-hour infusion on Day 1 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines. A minimum volume of 100 mL diluted in 5% glucose or 0.9% sodium chloride solution for infusion, had to be used for administration through a central venous catheter; if a peripheral venous catheter was used, the minimum volume was 250 mL.\n\nThe combination was to be administered for up to a maximum of ten cycles.'}, {'id': 'OG001', 'title': 'Topotecan or Cyclophosphamide/Doxorubicin/Vincristine', 'description': "If the patient was randomized to the Control Arm, the assigned treatment was based on the reported Investigator's preference between topotecan and CAV, until the first of these options had reached 55% of the target patient enrollment in this arm. Once this had occurred, patients in the Control Arm were to receive the other option.\n\nTopotecan: i.v. daily on Days 1-5 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines (according to local label) at the following doses:\n\n* 1.50 mg/m2 daily, for patients with calculated CrCL ≥60 mL/min.\n* 1.25 mg/m2 daily, for patients with calculated CrCL between 40 and 59 mL/min.\n* 0.75 mg/m2 daily, for patients with calculated CrCL between 30 and 39 mL/min.\n\nor\n\nCAV: i.v. on Day 1 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines at the following doses:\n\n* Cyclophosphamide: 1000 mg/m2,\n* Doxorubicin: 45.0 mg/m2,\n* Vincristine: 2.0 mg FD. The triple combination was to be administered for up to a maximum of ten cycles"}], 'classes': [{'categories': [{'title': 'Complete response', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'Partial response', 'measurements': [{'value': '89', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}, {'title': 'Stable disease', 'measurements': [{'value': '111', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}, {'title': 'Progressive disease', 'measurements': [{'value': '74', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}, {'title': 'Unknown', 'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Every three months up to death or study termination, a period of approximately 3.5 years', 'description': 'Best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1.\n\nCR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Overall Response Rate by Independent Review Committee', 'denoms': [{'units': 'Participants', 'counts': [{'value': '307', 'groupId': 'OG000'}, {'value': '306', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lurbinectedin/Doxorubicin', 'description': 'Doxorubicin: 40.0 mg/m2 i.v. on Day 1 through peripheral or central lines (according to local label), followed by, Lurbinectedin: 2.0 mg/m2 i.v. as a 1-hour infusion on Day 1 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines. A minimum volume of 100 mL diluted in 5% glucose or 0.9% sodium chloride solution for infusion, had to be used for administration through a central venous catheter; if a peripheral venous catheter was used, the minimum volume was 250 mL.\n\nThe combination was to be administered for up to a maximum of ten cycles.'}, {'id': 'OG001', 'title': 'Topotecan or Cyclophosphamide/Doxorubicin/Vincristine', 'description': "If the patient was randomized to the Control Arm, the assigned treatment was based on the reported Investigator's preference between topotecan and CAV, until the first of these options had reached 55% of the target patient enrollment in this arm. Once this had occurred, patients in the Control Arm were to receive the other option.\n\nTopotecan: i.v. daily on Days 1-5 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines (according to local label) at the following doses:\n\n* 1.50 mg/m2 daily, for patients with calculated CrCL ≥60 mL/min.\n* 1.25 mg/m2 daily, for patients with calculated CrCL between 40 and 59 mL/min.\n* 0.75 mg/m2 daily, for patients with calculated CrCL between 30 and 39 mL/min.\n\nor\n\nCAV: i.v. on Day 1 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines at the following doses:\n\n* Cyclophosphamide: 1000 mg/m2,\n* Doxorubicin: 45.0 mg/m2,\n* Vincristine: 2.0 mg FD. The triple combination was to be administered for up to a maximum of ten cycles"}], 'classes': [{'categories': [{'measurements': [{'value': '31.6', 'groupId': 'OG000', 'lowerLimit': '26.4', 'upperLimit': '37.1'}, {'value': '29.7', 'groupId': 'OG001', 'lowerLimit': '24.7', 'upperLimit': '35.2'}]}]}], 'analyses': [{'pValue': '0.6616', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Binomial test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Every three months up to death or study termination, a period of approximately 3.5 years', 'description': 'Overall response rate is defined as the proportion of patients who have a partial or complete response in the best antitumor response. The best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1.\n\nCR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Duration of Response by Independent Review Committee', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lurbinectedin/Doxorubicin', 'description': 'Doxorubicin: 40.0 mg/m2 i.v. on Day 1 through peripheral or central lines (according to local label), followed by, Lurbinectedin: 2.0 mg/m2 i.v. as a 1-hour infusion on Day 1 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines. A minimum volume of 100 mL diluted in 5% glucose or 0.9% sodium chloride solution for infusion, had to be used for administration through a central venous catheter; if a peripheral venous catheter was used, the minimum volume was 250 mL.\n\nThe combination was to be administered for up to a maximum of ten cycles.'}, {'id': 'OG001', 'title': 'Topotecan or Cyclophosphamide/Doxorubicin/Vincristine', 'description': "If the patient was randomized to the Control Arm, the assigned treatment was based on the reported Investigator's preference between topotecan and CAV, until the first of these options had reached 55% of the target patient enrollment in this arm. Once this had occurred, patients in the Control Arm were to receive the other option.\n\nTopotecan: i.v. daily on Days 1-5 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines (according to local label) at the following doses:\n\n* 1.50 mg/m2 daily, for patients with calculated CrCL ≥60 mL/min.\n* 1.25 mg/m2 daily, for patients with calculated CrCL between 40 and 59 mL/min.\n* 0.75 mg/m2 daily, for patients with calculated CrCL between 30 and 39 mL/min.\n\nor\n\nCAV: i.v. on Day 1 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines at the following doses:\n\n* Cyclophosphamide: 1000 mg/m2,\n* Doxorubicin: 45.0 mg/m2,\n* Vincristine: 2.0 mg FD. The triple combination was to be administered for up to a maximum of ten cycles"}], 'classes': [{'categories': [{'measurements': [{'value': '5.7', 'groupId': 'OG000', 'lowerLimit': '4.1', 'upperLimit': '7.1'}, {'value': '3.8', 'groupId': 'OG001', 'lowerLimit': '2.8', 'upperLimit': '4.3'}]}]}], 'analyses': [{'pValue': '0.0012', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.581', 'ciLowerLimit': '0.416', 'ciUpperLimit': '0.812', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Every three months up to death or study termination, a period of approximately 3.5 years', 'description': 'Duration of Response is defined as the time that patients who have a partial or complete response in the best antitumor response. The best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1.\n\nCR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who have a partial or complete response in the best antitumor response'}, {'type': 'SECONDARY', 'title': 'Overall Survival in Patients With Chemotherapy-free Interval ≥ 90 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lurbinectedin/Doxorubicin', 'description': 'Doxorubicin: 40.0 mg/m2 i.v. on Day 1 through peripheral or central lines (according to local label), followed by, Lurbinectedin: 2.0 mg/m2 i.v. as a 1-hour infusion on Day 1 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines. A minimum volume of 100 mL diluted in 5% glucose or 0.9% sodium chloride solution for infusion, had to be used for administration through a central venous catheter; if a peripheral venous catheter was used, the minimum volume was 250 mL.\n\nThe combination was to be administered for up to a maximum of ten cycles.'}, {'id': 'OG001', 'title': 'Topotecan or Cyclophosphamide/Doxorubicin/Vincristine', 'description': "If the patient was randomized to the Control Arm, the assigned treatment was based on the reported Investigator's preference between topotecan and CAV, until the first of these options had reached 55% of the target patient enrollment in this arm. Once this had occurred, patients in the Control Arm were to receive the other option.\n\nTopotecan: i.v. daily on Days 1-5 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines (according to local label) at the following doses:\n\n* 1.50 mg/m2 daily, for patients with calculated CrCL ≥60 mL/min.\n* 1.25 mg/m2 daily, for patients with calculated CrCL between 40 and 59 mL/min.\n* 0.75 mg/m2 daily, for patients with calculated CrCL between 30 and 39 mL/min.\n\nor\n\nCAV: i.v. on Day 1 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines at the following doses:\n\n* Cyclophosphamide: 1000 mg/m2,\n* Doxorubicin: 45.0 mg/m2,\n* Vincristine: 2.0 mg FD. The triple combination was to be administered for up to a maximum of ten cycles"}], 'classes': [{'categories': [{'measurements': [{'value': '10.3', 'groupId': 'OG000', 'lowerLimit': '9.0', 'upperLimit': '11.8'}, {'value': '8.7', 'groupId': 'OG001', 'lowerLimit': '7.8', 'upperLimit': '9.8'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.921', 'ciLowerLimit': '0.744', 'ciUpperLimit': '1.140', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Every three months up to death or study termination, a period of approximately 3.5 years', 'description': 'Overall survival (OS) will be calculated from the date of randomization to the date of death (death event) or last contact(in this case, survival will be censored on that date).', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'A preplanned exploratory efficacy subgroup analysis was focused on patients had chemotherapy-free interval ≥90 days after first-line chemotherapy'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival in Patients With Chemotherapy-free Interval ≥90 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lurbinectedin/Doxorubicin', 'description': 'Doxorubicin: 40.0 mg/m2 i.v. on Day 1 through peripheral or central lines (according to local label), followed by, Lurbinectedin: 2.0 mg/m2 i.v. as a 1-hour infusion on Day 1 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines. A minimum volume of 100 mL diluted in 5% glucose or 0.9% sodium chloride solution for infusion, had to be used for administration through a central venous catheter; if a peripheral venous catheter was used, the minimum volume was 250 mL.\n\nThe combination was to be administered for up to a maximum of ten cycles.'}, {'id': 'OG001', 'title': 'Topotecan or Cyclophosphamide/Doxorubicin/Vincristine', 'description': "If the patient was randomized to the Control Arm, the assigned treatment was based on the reported Investigator's preference between topotecan and CAV, until the first of these options had reached 55% of the target patient enrollment in this arm. Once this had occurred, patients in the Control Arm were to receive the other option.\n\nTopotecan: i.v. daily on Days 1-5 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines (according to local label) at the following doses:\n\n* 1.50 mg/m2 daily, for patients with calculated CrCL ≥60 mL/min.\n* 1.25 mg/m2 daily, for patients with calculated CrCL between 40 and 59 mL/min.\n* 0.75 mg/m2 daily, for patients with calculated CrCL between 30 and 39 mL/min.\n\nor\n\nCAV: i.v. on Day 1 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines at the following doses:\n\n* Cyclophosphamide: 1000 mg/m2,\n* Doxorubicin: 45.0 mg/m2,\n* Vincristine: 2.0 mg FD. The triple combination was to be administered for up to a maximum of ten cycles"}], 'classes': [{'categories': [{'measurements': [{'value': '4.8', 'groupId': 'OG000', 'lowerLimit': '4.1', 'upperLimit': '5.6'}, {'value': '4.4', 'groupId': 'OG001', 'lowerLimit': '4.0', 'upperLimit': '5.3'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.688', 'ciLowerLimit': '0.549', 'ciUpperLimit': '0.863', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Every six weeks up to progression disease, a period of approximately 3.5 years', 'description': 'Progression-free survival (PFS) is defined as the time from the date of randomization to the date of documented progression per RECIST v.1.1 or death (regardless of the cause of death). If the patient receives further antitumor therapy or is lost to follow-up before PD, PFS will be censored at the date of last tumor assessment before the date of subsequent antitumor therapy.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'A preplanned exploratory efficacy subgroup analysis was focused on patients had chemotherapy-free interval ≥90 days after first-line chemotherapy'}, {'type': 'SECONDARY', 'title': 'Best Antitumor Response in Patients With Chemotherapy-free Interval ≥ 90 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lurbinectedin/Doxorubicin', 'description': 'Doxorubicin: 40.0 mg/m2 i.v. on Day 1 through peripheral or central lines (according to local label), followed by, Lurbinectedin: 2.0 mg/m2 i.v. as a 1-hour infusion on Day 1 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines. A minimum volume of 100 mL diluted in 5% glucose or 0.9% sodium chloride solution for infusion, had to be used for administration through a central venous catheter; if a peripheral venous catheter was used, the minimum volume was 250 mL.\n\nThe combination was to be administered for up to a maximum of ten cycles.'}, {'id': 'OG001', 'title': 'Topotecan or Cyclophosphamide/Doxorubicin/Vincristine', 'description': "If the patient was randomized to the Control Arm, the assigned treatment was based on the reported Investigator's preference between topotecan and CAV, until the first of these options had reached 55% of the target patient enrollment in this arm. Once this had occurred, patients in the Control Arm were to receive the other option.\n\nTopotecan: i.v. daily on Days 1-5 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines (according to local label) at the following doses:\n\n* 1.50 mg/m2 daily, for patients with calculated CrCL ≥60 mL/min.\n* 1.25 mg/m2 daily, for patients with calculated CrCL between 40 and 59 mL/min.\n* 0.75 mg/m2 daily, for patients with calculated CrCL between 30 and 39 mL/min.\n\nor\n\nCAV: i.v. on Day 1 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines at the following doses:\n\n* Cyclophosphamide: 1000 mg/m2,\n* Doxorubicin: 45.0 mg/m2,\n* Vincristine: 2.0 mg FD. The triple combination was to be administered for up to a maximum of ten cycles"}], 'classes': [{'categories': [{'title': 'Complete response', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'Partial response', 'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}, {'title': 'Stable disease', 'measurements': [{'value': '85', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}, {'title': 'Progression disease', 'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}, {'title': 'Unknown', 'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Every three months up to death or study termination, a period of approximately 3.5 years', 'description': 'Best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1.\n\nCR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'A preplanned exploratory efficacy subgroup analysis was focused on patients had chemotherapy-free interval ≥90 days after first-line chemotherapy'}, {'type': 'SECONDARY', 'title': 'Overall Response Rate in Patients With Chemotherapy-free Interval ≥ 90 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lurbinectedin/Doxorubicin', 'description': 'Doxorubicin: 40.0 mg/m2 i.v. on Day 1 through peripheral or central lines (according to local label), followed by, Lurbinectedin: 2.0 mg/m2 i.v. as a 1-hour infusion on Day 1 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines. A minimum volume of 100 mL diluted in 5% glucose or 0.9% sodium chloride solution for infusion, had to be used for administration through a central venous catheter; if a peripheral venous catheter was used, the minimum volume was 250 mL.\n\nThe combination was to be administered for up to a maximum of ten cycles.'}, {'id': 'OG001', 'title': 'Topotecan or Cyclophosphamide/Doxorubicin/Vincristine', 'description': "If the patient was randomized to the Control Arm, the assigned treatment was based on the reported Investigator's preference between topotecan and CAV, until the first of these options had reached 55% of the target patient enrollment in this arm. Once this had occurred, patients in the Control Arm were to receive the other option.\n\nTopotecan: i.v. daily on Days 1-5 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines (according to local label) at the following doses:\n\n* 1.50 mg/m2 daily, for patients with calculated CrCL ≥60 mL/min.\n* 1.25 mg/m2 daily, for patients with calculated CrCL between 40 and 59 mL/min.\n* 0.75 mg/m2 daily, for patients with calculated CrCL between 30 and 39 mL/min.\n\nor\n\nCAV: i.v. on Day 1 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines at the following doses:\n\n* Cyclophosphamide: 1000 mg/m2,\n* Doxorubicin: 45.0 mg/m2,\n* Vincristine: 2.0 mg FD. The triple combination was to be administered for up to a maximum of ten cycles"}], 'classes': [{'categories': [{'measurements': [{'value': '37.0', 'groupId': 'OG000', 'lowerLimit': '30.4', 'upperLimit': '44.0'}, {'value': '35.1', 'groupId': 'OG001', 'lowerLimit': '28.6', 'upperLimit': '42.1'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.921', 'ciLowerLimit': '0.616', 'ciUpperLimit': '1.376', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Every three months up to death or study termination, a period of approximately 3.5 years', 'description': 'Overall response rate is defined as the proportion of patients who have a partial or complete response in the best antitumor response. The best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1.\n\nCR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'A preplanned exploratory efficacy subgroup analysis was focused on patients had chemotherapy-free interval ≥90 days after first-line chemotherapy'}, {'type': 'SECONDARY', 'title': 'Duration of Response in Patients With Chemotherapy-free Interval ≥ 90 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lurbinectedin/Doxorubicin', 'description': 'Doxorubicin: 40.0 mg/m2 i.v. on Day 1 through peripheral or central lines (according to local label), followed by, Lurbinectedin: 2.0 mg/m2 i.v. as a 1-hour infusion on Day 1 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines. A minimum volume of 100 mL diluted in 5% glucose or 0.9% sodium chloride solution for infusion, had to be used for administration through a central venous catheter; if a peripheral venous catheter was used, the minimum volume was 250 mL.\n\nThe combination was to be administered for up to a maximum of ten cycles.'}, {'id': 'OG001', 'title': 'Topotecan or Cyclophosphamide/Doxorubicin/Vincristine', 'description': "If the patient was randomized to the Control Arm, the assigned treatment was based on the reported Investigator's preference between topotecan and CAV, until the first of these options had reached 55% of the target patient enrollment in this arm. Once this had occurred, patients in the Control Arm were to receive the other option.\n\nTopotecan: i.v. daily on Days 1-5 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines (according to local label) at the following doses:\n\n* 1.50 mg/m2 daily, for patients with calculated CrCL ≥60 mL/min.\n* 1.25 mg/m2 daily, for patients with calculated CrCL between 40 and 59 mL/min.\n* 0.75 mg/m2 daily, for patients with calculated CrCL between 30 and 39 mL/min.\n\nor\n\nCAV: i.v. on Day 1 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines at the following doses:\n\n* Cyclophosphamide: 1000 mg/m2,\n* Doxorubicin: 45.0 mg/m2,\n* Vincristine: 2.0 mg FD. The triple combination was to be administered for up to a maximum of ten cycles"}], 'classes': [{'categories': [{'measurements': [{'value': '6.9', 'groupId': 'OG000', 'lowerLimit': '4.1', 'upperLimit': '8.3'}, {'value': '4.0', 'groupId': 'OG001', 'lowerLimit': '3.0', 'upperLimit': '4.8'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.504', 'ciLowerLimit': '0.346', 'ciUpperLimit': '0.736', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Every three months up to death or study termination, a period of approximately 3.5 years', 'description': 'Duration of Response is defined as the time that patients who have a partial or complete response in the best antitumor response. The best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1.\n\nCR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who have a partial or complete response in the best antitumor response. A preplanned exploratory efficacy subgroup analysis was focused on patients had chemotherapy-free interval ≥90 days after first-line chemotherapy.'}, {'type': 'SECONDARY', 'title': 'Overall Survival in Patients With Chemotherapy-free Interval < 90 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lurbinectedin/Doxorubicin', 'description': 'Doxorubicin: 40.0 mg/m2 i.v. on Day 1 through peripheral or central lines (according to local label), followed by, Lurbinectedin: 2.0 mg/m2 i.v. as a 1-hour infusion on Day 1 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines. A minimum volume of 100 mL diluted in 5% glucose or 0.9% sodium chloride solution for infusion, had to be used for administration through a central venous catheter; if a peripheral venous catheter was used, the minimum volume was 250 mL.\n\nThe combination was to be administered for up to a maximum of ten cycles.'}, {'id': 'OG001', 'title': 'Topotecan or Cyclophosphamide/Doxorubicin/Vincristine', 'description': "If the patient was randomized to the Control Arm, the assigned treatment was based on the reported Investigator's preference between topotecan and CAV, until the first of these options had reached 55% of the target patient enrollment in this arm. Once this had occurred, patients in the Control Arm were to receive the other option.\n\nTopotecan: i.v. daily on Days 1-5 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines (according to local label) at the following doses:\n\n* 1.50 mg/m2 daily, for patients with calculated CrCL ≥60 mL/min.\n* 1.25 mg/m2 daily, for patients with calculated CrCL between 40 and 59 mL/min.\n* 0.75 mg/m2 daily, for patients with calculated CrCL between 30 and 39 mL/min.\n\nor\n\nCAV: i.v. on Day 1 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines at the following doses:\n\n* Cyclophosphamide: 1000 mg/m2,\n* Doxorubicin: 45.0 mg/m2,\n* Vincristine: 2.0 mg FD. The triple combination was to be administered for up to a maximum of ten cycles"}], 'classes': [{'categories': [{'measurements': [{'value': '5.7', 'groupId': 'OG000', 'lowerLimit': '4.1', 'upperLimit': '6.7'}, {'value': '5.3', 'groupId': 'OG001', 'lowerLimit': '4.2', 'upperLimit': '6.1'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.122', 'ciLowerLimit': '0.840', 'ciUpperLimit': '1.500', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Every three months up to death or study termination, a period of approximately 3.5 years', 'description': 'Overall survival (OS) will be calculated from the date of randomization to the date of death (death event) or last contact(in this case, survival will be censored on that date).', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'A preplanned exploratory efficacy subgroup analysis was focused on patients had chemotherapy-free interval \\<90 days after first-line chemotherapy'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival in Patients With Chemotherapy-free Interval <90 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lurbinectedin/Doxorubicin', 'description': 'Doxorubicin: 40.0 mg/m2 i.v. on Day 1 through peripheral or central lines (according to local label), followed by, Lurbinectedin: 2.0 mg/m2 i.v. as a 1-hour infusion on Day 1 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines. A minimum volume of 100 mL diluted in 5% glucose or 0.9% sodium chloride solution for infusion, had to be used for administration through a central venous catheter; if a peripheral venous catheter was used, the minimum volume was 250 mL.\n\nThe combination was to be administered for up to a maximum of ten cycles.'}, {'id': 'OG001', 'title': 'Topotecan or Cyclophosphamide/Doxorubicin/Vincristine', 'description': "If the patient was randomized to the Control Arm, the assigned treatment was based on the reported Investigator's preference between topotecan and CAV, until the first of these options had reached 55% of the target patient enrollment in this arm. Once this had occurred, patients in the Control Arm were to receive the other option.\n\nTopotecan: i.v. daily on Days 1-5 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines (according to local label) at the following doses:\n\n* 1.50 mg/m2 daily, for patients with calculated CrCL ≥60 mL/min.\n* 1.25 mg/m2 daily, for patients with calculated CrCL between 40 and 59 mL/min.\n* 0.75 mg/m2 daily, for patients with calculated CrCL between 30 and 39 mL/min.\n\nor\n\nCAV: i.v. on Day 1 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines at the following doses:\n\n* Cyclophosphamide: 1000 mg/m2,\n* Doxorubicin: 45.0 mg/m2,\n* Vincristine: 2.0 mg FD. The triple combination was to be administered for up to a maximum of ten cycles"}], 'classes': [{'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.4', 'upperLimit': '2.7'}, {'value': '2.8', 'groupId': 'OG001', 'lowerLimit': '2.5', 'upperLimit': '3.0'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.306', 'ciLowerLimit': '0.955', 'ciUpperLimit': '1.786', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Every six weeks up to progression disease, a period of approximately 3.5 years', 'description': 'Progression-free survival (PFS) is defined as the time from the date of randomization to the date of documented progression per RECIST v.1.1 or death (regardless of the cause of death). If the patient receives further antitumor therapy or is lost to follow-up before PD, PFS will be censored at the date of last tumor assessment before the date of subsequent antitumor therapy.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'A preplanned exploratory efficacy subgroup analysis was focused on patients had chemotherapy-free interval \\<90 days after first-line chemotherapy'}, {'type': 'SECONDARY', 'title': 'Best Antitumor Response in Patients With Chemotherapy-free Interval <90 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lurbinectedin/Doxorubicin', 'description': 'Doxorubicin: 40.0 mg/m2 i.v. on Day 1 through peripheral or central lines (according to local label), followed by, Lurbinectedin: 2.0 mg/m2 i.v. as a 1-hour infusion on Day 1 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines. A minimum volume of 100 mL diluted in 5% glucose or 0.9% sodium chloride solution for infusion, had to be used for administration through a central venous catheter; if a peripheral venous catheter was used, the minimum volume was 250 mL.\n\nThe combination was to be administered for up to a maximum of ten cycles.'}, {'id': 'OG001', 'title': 'Topotecan or Cyclophosphamide/Doxorubicin/Vincristine', 'description': "If the patient was randomized to the Control Arm, the assigned treatment was based on the reported Investigator's preference between topotecan and CAV, until the first of these options had reached 55% of the target patient enrollment in this arm. Once this had occurred, patients in the Control Arm were to receive the other option.\n\nTopotecan: i.v. daily on Days 1-5 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines (according to local label) at the following doses:\n\n* 1.50 mg/m2 daily, for patients with calculated CrCL ≥60 mL/min.\n* 1.25 mg/m2 daily, for patients with calculated CrCL between 40 and 59 mL/min.\n* 0.75 mg/m2 daily, for patients with calculated CrCL between 30 and 39 mL/min.\n\nor\n\nCAV: i.v. on Day 1 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines at the following doses:\n\n* Cyclophosphamide: 1000 mg/m2,\n* Doxorubicin: 45.0 mg/m2,\n* Vincristine: 2.0 mg FD. The triple combination was to be administered for up to a maximum of ten cycles"}], 'classes': [{'categories': [{'title': 'Partial response', 'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}, {'title': 'Stable disease', 'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}, {'title': 'Progression disease', 'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}, {'title': 'Unknown', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Every three months up to death or study termination, a period of approximately 3.5 years', 'description': 'Best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1.\n\nCR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'A preplanned exploratory efficacy subgroup analysis was focused on patients had chemotherapy-free interval \\<90 days after first-line chemotherapy'}, {'type': 'SECONDARY', 'title': 'Overall Response Rate in Patients With Chemotherapy-free Interval <90 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lurbinectedin/Doxorubicin', 'description': 'Doxorubicin: 40.0 mg/m2 i.v. on Day 1 through peripheral or central lines (according to local label), followed by, Lurbinectedin: 2.0 mg/m2 i.v. as a 1-hour infusion on Day 1 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines. A minimum volume of 100 mL diluted in 5% glucose or 0.9% sodium chloride solution for infusion, had to be used for administration through a central venous catheter; if a peripheral venous catheter was used, the minimum volume was 250 mL.\n\nThe combination was to be administered for up to a maximum of ten cycles.'}, {'id': 'OG001', 'title': 'Topotecan or Cyclophosphamide/Doxorubicin/Vincristine', 'description': "If the patient was randomized to the Control Arm, the assigned treatment was based on the reported Investigator's preference between topotecan and CAV, until the first of these options had reached 55% of the target patient enrollment in this arm. Once this had occurred, patients in the Control Arm were to receive the other option.\n\nTopotecan: i.v. daily on Days 1-5 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines (according to local label) at the following doses:\n\n* 1.50 mg/m2 daily, for patients with calculated CrCL ≥60 mL/min.\n* 1.25 mg/m2 daily, for patients with calculated CrCL between 40 and 59 mL/min.\n* 0.75 mg/m2 daily, for patients with calculated CrCL between 30 and 39 mL/min.\n\nor\n\nCAV: i.v. on Day 1 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines at the following doses:\n\n* Cyclophosphamide: 1000 mg/m2,\n* Doxorubicin: 45.0 mg/m2,\n* Vincristine: 2.0 mg FD. The triple combination was to be administered for up to a maximum of ten cycles"}], 'classes': [{'categories': [{'measurements': [{'value': '20.2', 'groupId': 'OG000', 'lowerLimit': '12.8', 'upperLimit': '29.5'}, {'value': '18.8', 'groupId': 'OG001', 'lowerLimit': '11.7', 'upperLimit': '27.8'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.915', 'ciLowerLimit': '0.455', 'ciUpperLimit': '1.843', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Every three months up to death or study termination, a period of approximately 3.5 years', 'description': 'Overall response rate is defined as the proportion of patients who have a partial or complete response in the best antitumor response. The best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1.\n\nCR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'A preplanned exploratory efficacy subgroup analysis was focused on patients had chemotherapy-free interval \\<90 days after first-line chemotherapy'}, {'type': 'SECONDARY', 'title': 'Duration of Response in Patients With Chemotherapy-free Interval <90 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lurbinectedin/Doxorubicin', 'description': 'Doxorubicin: 40.0 mg/m2 i.v. on Day 1 through peripheral or central lines (according to local label), followed by, Lurbinectedin: 2.0 mg/m2 i.v. as a 1-hour infusion on Day 1 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines. A minimum volume of 100 mL diluted in 5% glucose or 0.9% sodium chloride solution for infusion, had to be used for administration through a central venous catheter; if a peripheral venous catheter was used, the minimum volume was 250 mL.\n\nThe combination was to be administered for up to a maximum of ten cycles.'}, {'id': 'OG001', 'title': 'Topotecan or Cyclophosphamide/Doxorubicin/Vincristine', 'description': "If the patient was randomized to the Control Arm, the assigned treatment was based on the reported Investigator's preference between topotecan and CAV, until the first of these options had reached 55% of the target patient enrollment in this arm. Once this had occurred, patients in the Control Arm were to receive the other option.\n\nTopotecan: i.v. daily on Days 1-5 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines (according to local label) at the following doses:\n\n* 1.50 mg/m2 daily, for patients with calculated CrCL ≥60 mL/min.\n* 1.25 mg/m2 daily, for patients with calculated CrCL between 40 and 59 mL/min.\n* 0.75 mg/m2 daily, for patients with calculated CrCL between 30 and 39 mL/min.\n\nor\n\nCAV: i.v. on Day 1 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines at the following doses:\n\n* Cyclophosphamide: 1000 mg/m2,\n* Doxorubicin: 45.0 mg/m2,\n* Vincristine: 2.0 mg FD. The triple combination was to be administered for up to a maximum of ten cycles"}], 'classes': [{'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000', 'lowerLimit': '1.4', 'upperLimit': '4.5'}, {'value': '2.8', 'groupId': 'OG001', 'lowerLimit': '1.4', 'upperLimit': '4.1'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.092', 'ciLowerLimit': '0.506', 'ciUpperLimit': '2.360', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Every three months up to death or study termination, a period of approximately 3.5 years', 'description': 'Duration of Response is defined as the time that patients who have a partial or complete response in the best antitumor response. The best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1.\n\nCR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who have a partial or complete response in the best antitumor response. A preplanned exploratory efficacy subgroup analysis was focused on patients had chemotherapy-free interval \\<90 days after first-line chemotherapy.'}, {'type': 'SECONDARY', 'title': 'Overall Survival in Patients Without Central Nervous System Involvement at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '261', 'groupId': 'OG000'}, {'value': '257', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lurbinectedin/Doxorubicin', 'description': 'Doxorubicin: 40.0 mg/m2 i.v. on Day 1 through peripheral or central lines (according to local label), followed by, Lurbinectedin: 2.0 mg/m2 i.v. as a 1-hour infusion on Day 1 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines. A minimum volume of 100 mL diluted in 5% glucose or 0.9% sodium chloride solution for infusion, had to be used for administration through a central venous catheter; if a peripheral venous catheter was used, the minimum volume was 250 mL.\n\nThe combination was to be administered for up to a maximum of ten cycles.'}, {'id': 'OG001', 'title': 'Topotecan or Cyclophosphamide/Doxorubicin/Vincristine', 'description': "If the patient was randomized to the Control Arm, the assigned treatment was based on the reported Investigator's preference between topotecan and CAV, until the first of these options had reached 55% of the target patient enrollment in this arm. Once this had occurred, patients in the Control Arm were to receive the other option.\n\nTopotecan: i.v. daily on Days 1-5 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines (according to local label) at the following doses:\n\n* 1.50 mg/m2 daily, for patients with calculated CrCL ≥60 mL/min.\n* 1.25 mg/m2 daily, for patients with calculated CrCL between 40 and 59 mL/min.\n* 0.75 mg/m2 daily, for patients with calculated CrCL between 30 and 39 mL/min.\n\nor\n\nCAV: i.v. on Day 1 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines at the following doses:\n\n* Cyclophosphamide: 1000 mg/m2,\n* Doxorubicin: 45.0 mg/m2,\n* Vincristine: 2.0 mg FD. The triple combination was to be administered for up to a maximum of ten cycles"}], 'classes': [{'categories': [{'measurements': [{'value': '9.1', 'groupId': 'OG000', 'lowerLimit': '8.1', 'upperLimit': '10.2'}, {'value': '7.7', 'groupId': 'OG001', 'lowerLimit': '6.7', 'upperLimit': '8.6'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.923', 'ciLowerLimit': '0.765', 'ciUpperLimit': '1.113', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Every three months up to death or study termination, a period of approximately 3.5 years', 'description': 'Overall survival (OS) will be calculated from the date of randomization to the date of death (death event) or last contact(in this case, survival will be censored on that date).', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'A preplanned exploratory efficacy subgroup analysis was focused on patients without Central Nervous System Involvement at Baseline'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival in Patients Without Central Nervous System Involvement at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '261', 'groupId': 'OG000'}, {'value': '257', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lurbinectedin/Doxorubicin', 'description': 'Doxorubicin: 40.0 mg/m2 i.v. on Day 1 through peripheral or central lines (according to local label), followed by, Lurbinectedin: 2.0 mg/m2 i.v. as a 1-hour infusion on Day 1 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines. A minimum volume of 100 mL diluted in 5% glucose or 0.9% sodium chloride solution for infusion, had to be used for administration through a central venous catheter; if a peripheral venous catheter was used, the minimum volume was 250 mL.\n\nThe combination was to be administered for up to a maximum of ten cycles.'}, {'id': 'OG001', 'title': 'Topotecan or Cyclophosphamide/Doxorubicin/Vincristine', 'description': "If the patient was randomized to the Control Arm, the assigned treatment was based on the reported Investigator's preference between topotecan and CAV, until the first of these options had reached 55% of the target patient enrollment in this arm. Once this had occurred, patients in the Control Arm were to receive the other option.\n\nTopotecan: i.v. daily on Days 1-5 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines (according to local label) at the following doses:\n\n* 1.50 mg/m2 daily, for patients with calculated CrCL ≥60 mL/min.\n* 1.25 mg/m2 daily, for patients with calculated CrCL between 40 and 59 mL/min.\n* 0.75 mg/m2 daily, for patients with calculated CrCL between 30 and 39 mL/min.\n\nor\n\nCAV: i.v. on Day 1 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines at the following doses:\n\n* Cyclophosphamide: 1000 mg/m2,\n* Doxorubicin: 45.0 mg/m2,\n* Vincristine: 2.0 mg FD. The triple combination was to be administered for up to a maximum of ten cycles"}], 'classes': [{'categories': [{'measurements': [{'value': '4.2', 'groupId': 'OG000', 'lowerLimit': '3.7', 'upperLimit': '4.8'}, {'value': '4.1', 'groupId': 'OG001', 'lowerLimit': '3.1', 'upperLimit': '4.3'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.788', 'ciLowerLimit': '0.645', 'ciUpperLimit': '0.961', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Every six weeks up to progression disease, a period of approximately 3.5 years', 'description': 'Progression-free survival (PFS) is defined as the time from the date of randomization to the date of documented progression per RECIST v.1.1 or death (regardless of the cause of death). If the patient receives further antitumor therapy or is lost to follow-up before PD, PFS will be censored at the date of last tumor assessment before the date of subsequent antitumor therapy.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'A preplanned exploratory efficacy subgroup analysis was focused on patients without Central Nervous System Involvement at Baseline'}, {'type': 'SECONDARY', 'title': 'Best Antitumor Response in Patients Without Central Nervous System Involvement at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '261', 'groupId': 'OG000'}, {'value': '257', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lurbinectedin/Doxorubicin', 'description': 'Doxorubicin: 40.0 mg/m2 i.v. on Day 1 through peripheral or central lines (according to local label), followed by, Lurbinectedin: 2.0 mg/m2 i.v. as a 1-hour infusion on Day 1 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines. A minimum volume of 100 mL diluted in 5% glucose or 0.9% sodium chloride solution for infusion, had to be used for administration through a central venous catheter; if a peripheral venous catheter was used, the minimum volume was 250 mL.\n\nThe combination was to be administered for up to a maximum of ten cycles.'}, {'id': 'OG001', 'title': 'Topotecan or Cyclophosphamide/Doxorubicin/Vincristine', 'description': "If the patient was randomized to the Control Arm, the assigned treatment was based on the reported Investigator's preference between topotecan and CAV, until the first of these options had reached 55% of the target patient enrollment in this arm. Once this had occurred, patients in the Control Arm were to receive the other option.\n\nTopotecan: i.v. daily on Days 1-5 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines (according to local label) at the following doses:\n\n* 1.50 mg/m2 daily, for patients with calculated CrCL ≥60 mL/min.\n* 1.25 mg/m2 daily, for patients with calculated CrCL between 40 and 59 mL/min.\n* 0.75 mg/m2 daily, for patients with calculated CrCL between 30 and 39 mL/min.\n\nor\n\nCAV: i.v. on Day 1 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines at the following doses:\n\n* Cyclophosphamide: 1000 mg/m2,\n* Doxorubicin: 45.0 mg/m2,\n* Vincristine: 2.0 mg FD. The triple combination was to be administered for up to a maximum of ten cycles"}], 'classes': [{'categories': [{'title': 'Complete response', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Partial response', 'measurements': [{'value': '79', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}, {'title': 'Stable disease', 'measurements': [{'value': '101', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}, {'title': 'Progression disease', 'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}, {'title': 'Unknown', 'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Every three months up to death or study termination, a period of approximately 3.5 years', 'description': 'Best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1.\n\nCR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'A preplanned exploratory efficacy subgroup analysis was focused on patients without Central Nervous System Involvement at Baseline'}, {'type': 'SECONDARY', 'title': 'Overall Response Rate in Patients Without Central Nervous System Involvement at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '261', 'groupId': 'OG000'}, {'value': '257', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lurbinectedin/Doxorubicin', 'description': 'Doxorubicin: 40.0 mg/m2 i.v. on Day 1 through peripheral or central lines (according to local label), followed by, Lurbinectedin: 2.0 mg/m2 i.v. as a 1-hour infusion on Day 1 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines. A minimum volume of 100 mL diluted in 5% glucose or 0.9% sodium chloride solution for infusion, had to be used for administration through a central venous catheter; if a peripheral venous catheter was used, the minimum volume was 250 mL.\n\nThe combination was to be administered for up to a maximum of ten cycles.'}, {'id': 'OG001', 'title': 'Topotecan or Cyclophosphamide/Doxorubicin/Vincristine', 'description': "If the patient was randomized to the Control Arm, the assigned treatment was based on the reported Investigator's preference between topotecan and CAV, until the first of these options had reached 55% of the target patient enrollment in this arm. Once this had occurred, patients in the Control Arm were to receive the other option.\n\nTopotecan: i.v. daily on Days 1-5 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines (according to local label) at the following doses:\n\n* 1.50 mg/m2 daily, for patients with calculated CrCL ≥60 mL/min.\n* 1.25 mg/m2 daily, for patients with calculated CrCL between 40 and 59 mL/min.\n* 0.75 mg/m2 daily, for patients with calculated CrCL between 30 and 39 mL/min.\n\nor\n\nCAV: i.v. on Day 1 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines at the following doses:\n\n* Cyclophosphamide: 1000 mg/m2,\n* Doxorubicin: 45.0 mg/m2,\n* Vincristine: 2.0 mg FD. The triple combination was to be administered for up to a maximum of ten cycles"}], 'classes': [{'categories': [{'measurements': [{'value': '33.0', 'groupId': 'OG000', 'lowerLimit': '27.3', 'upperLimit': '39.0'}, {'value': '30.7', 'groupId': 'OG001', 'lowerLimit': '25.2', 'upperLimit': '36.8'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.903', 'ciLowerLimit': '0.624', 'ciUpperLimit': '1.307', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Every three months up to death or study termination, a period of approximately 3.5 years', 'description': 'Overall response rate is defined as the proportion of patients who have a partial or complete response in the best antitumor response. The best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1.\n\nCR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'A preplanned exploratory efficacy subgroup analysis was focused on patients without Central Nervous System Involvement at Baseline'}, {'type': 'SECONDARY', 'title': 'Duration of Response in Patients Without Central Nervous System Involvement at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lurbinectedin/Doxorubicin', 'description': 'Doxorubicin: 40.0 mg/m2 i.v. on Day 1 through peripheral or central lines (according to local label), followed by, Lurbinectedin: 2.0 mg/m2 i.v. as a 1-hour infusion on Day 1 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines. A minimum volume of 100 mL diluted in 5% glucose or 0.9% sodium chloride solution for infusion, had to be used for administration through a central venous catheter; if a peripheral venous catheter was used, the minimum volume was 250 mL.\n\nThe combination was to be administered for up to a maximum of ten cycles.'}, {'id': 'OG001', 'title': 'Topotecan or Cyclophosphamide/Doxorubicin/Vincristine', 'description': "If the patient was randomized to the Control Arm, the assigned treatment was based on the reported Investigator's preference between topotecan and CAV, until the first of these options had reached 55% of the target patient enrollment in this arm. Once this had occurred, patients in the Control Arm were to receive the other option.\n\nTopotecan: i.v. daily on Days 1-5 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines (according to local label) at the following doses:\n\n* 1.50 mg/m2 daily, for patients with calculated CrCL ≥60 mL/min.\n* 1.25 mg/m2 daily, for patients with calculated CrCL between 40 and 59 mL/min.\n* 0.75 mg/m2 daily, for patients with calculated CrCL between 30 and 39 mL/min.\n\nor\n\nCAV: i.v. on Day 1 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines at the following doses:\n\n* Cyclophosphamide: 1000 mg/m2,\n* Doxorubicin: 45.0 mg/m2,\n* Vincristine: 2.0 mg FD. The triple combination was to be administered for up to a maximum of ten cycles"}], 'classes': [{'categories': [{'measurements': [{'value': '5.7', 'groupId': 'OG000', 'lowerLimit': '4.1', 'upperLimit': '7.3'}, {'value': '4.0', 'groupId': 'OG001', 'lowerLimit': '3.0', 'upperLimit': '4.9'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.560', 'ciLowerLimit': '0.392', 'ciUpperLimit': '0.799', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Every three months up to death or study termination, a period of approximately 3.5 years', 'description': 'Duration of Response is defined as the time that patients who have a partial or complete response in the best antitumor response. The best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1.\n\nCR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who have a partial or complete response in the best antitumor response. A preplanned exploratory efficacy subgroup analysis was focused on patients without Central Nervous System Involvement at Baseline'}, {'type': 'SECONDARY', 'title': 'Overall Survival in Patients With Central Nervous System Involvement at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lurbinectedin/Doxorubicin', 'description': 'Doxorubicin: 40.0 mg/m2 i.v. on Day 1 through peripheral or central lines (according to local label), followed by, Lurbinectedin: 2.0 mg/m2 i.v. as a 1-hour infusion on Day 1 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines. A minimum volume of 100 mL diluted in 5% glucose or 0.9% sodium chloride solution for infusion, had to be used for administration through a central venous catheter; if a peripheral venous catheter was used, the minimum volume was 250 mL.\n\nThe combination was to be administered for up to a maximum of ten cycles.'}, {'id': 'OG001', 'title': 'Topotecan or Cyclophosphamide/Doxorubicin/Vincristine', 'description': "If the patient was randomized to the Control Arm, the assigned treatment was based on the reported Investigator's preference between topotecan and CAV, until the first of these options had reached 55% of the target patient enrollment in this arm. Once this had occurred, patients in the Control Arm were to receive the other option.\n\nTopotecan: i.v. daily on Days 1-5 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines (according to local label) at the following doses:\n\n* 1.50 mg/m2 daily, for patients with calculated CrCL ≥60 mL/min.\n* 1.25 mg/m2 daily, for patients with calculated CrCL between 40 and 59 mL/min.\n* 0.75 mg/m2 daily, for patients with calculated CrCL between 30 and 39 mL/min.\n\nor\n\nCAV: i.v. on Day 1 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines at the following doses:\n\n* Cyclophosphamide: 1000 mg/m2,\n* Doxorubicin: 45.0 mg/m2,\n* Vincristine: 2.0 mg FD. The triple combination was to be administered for up to a maximum of ten cycles"}], 'classes': [{'categories': [{'measurements': [{'value': '4.6', 'groupId': 'OG000', 'lowerLimit': '3.1', 'upperLimit': '6.1'}, {'value': '6.6', 'groupId': 'OG001', 'lowerLimit': '4.0', 'upperLimit': '8.8'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.291', 'ciLowerLimit': '0.838', 'ciUpperLimit': '1.990', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Every three months up to death or study termination, a period of approximately 3.5 years', 'description': 'Overall survival (OS) will be calculated from the date of randomization to the date of death (death event) or last contact(in this case, survival will be censored on that date).', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'A preplanned exploratory efficacy subgroup analysis was focused on patients with Central Nervous System Involvement at Baseline'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival in Patients With Central Nervous System Involvement at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lurbinectedin/Doxorubicin', 'description': 'Doxorubicin: 40.0 mg/m2 i.v. on Day 1 through peripheral or central lines (according to local label), followed by, Lurbinectedin: 2.0 mg/m2 i.v. as a 1-hour infusion on Day 1 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines. A minimum volume of 100 mL diluted in 5% glucose or 0.9% sodium chloride solution for infusion, had to be used for administration through a central venous catheter; if a peripheral venous catheter was used, the minimum volume was 250 mL.\n\nThe combination was to be administered for up to a maximum of ten cycles.'}, {'id': 'OG001', 'title': 'Topotecan or Cyclophosphamide/Doxorubicin/Vincristine', 'description': "If the patient was randomized to the Control Arm, the assigned treatment was based on the reported Investigator's preference between topotecan and CAV, until the first of these options had reached 55% of the target patient enrollment in this arm. Once this had occurred, patients in the Control Arm were to receive the other option.\n\nTopotecan: i.v. daily on Days 1-5 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines (according to local label) at the following doses:\n\n* 1.50 mg/m2 daily, for patients with calculated CrCL ≥60 mL/min.\n* 1.25 mg/m2 daily, for patients with calculated CrCL between 40 and 59 mL/min.\n* 0.75 mg/m2 daily, for patients with calculated CrCL between 30 and 39 mL/min.\n\nor\n\nCAV: i.v. on Day 1 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines at the following doses:\n\n* Cyclophosphamide: 1000 mg/m2,\n* Doxorubicin: 45.0 mg/m2,\n* Vincristine: 2.0 mg FD. The triple combination was to be administered for up to a maximum of ten cycles"}], 'classes': [{'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000', 'lowerLimit': '1.4', 'upperLimit': '2.7'}, {'value': '2.8', 'groupId': 'OG001', 'lowerLimit': '1.4', 'upperLimit': '3.8'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.290', 'ciLowerLimit': '0.824', 'ciUpperLimit': '2.019', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Every six weeks up to progression disease, a period of approximately 3.5 years', 'description': 'Progression-free survival (PFS) is defined as the time from the date of randomization to the date of documented progression per RECIST v.1.1 or death (regardless of the cause of death). If the patient receives further antitumor therapy or is lost to follow-up before PD, PFS will be censored at the date of last tumor assessment before the date of subsequent antitumor therapy.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'A preplanned exploratory efficacy subgroup analysis was focused on patients with Central Nervous System Involvement at Baseline'}, {'type': 'SECONDARY', 'title': 'Best Antitumor Response in Patients With Central Nervous System Involvement at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lurbinectedin/Doxorubicin', 'description': 'Doxorubicin: 40.0 mg/m2 i.v. on Day 1 through peripheral or central lines (according to local label), followed by, Lurbinectedin: 2.0 mg/m2 i.v. as a 1-hour infusion on Day 1 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines. A minimum volume of 100 mL diluted in 5% glucose or 0.9% sodium chloride solution for infusion, had to be used for administration through a central venous catheter; if a peripheral venous catheter was used, the minimum volume was 250 mL.\n\nThe combination was to be administered for up to a maximum of ten cycles.'}, {'id': 'OG001', 'title': 'Topotecan or Cyclophosphamide/Doxorubicin/Vincristine', 'description': "If the patient was randomized to the Control Arm, the assigned treatment was based on the reported Investigator's preference between topotecan and CAV, until the first of these options had reached 55% of the target patient enrollment in this arm. Once this had occurred, patients in the Control Arm were to receive the other option.\n\nTopotecan: i.v. daily on Days 1-5 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines (according to local label) at the following doses:\n\n* 1.50 mg/m2 daily, for patients with calculated CrCL ≥60 mL/min.\n* 1.25 mg/m2 daily, for patients with calculated CrCL between 40 and 59 mL/min.\n* 0.75 mg/m2 daily, for patients with calculated CrCL between 30 and 39 mL/min.\n\nor\n\nCAV: i.v. on Day 1 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines at the following doses:\n\n* Cyclophosphamide: 1000 mg/m2,\n* Doxorubicin: 45.0 mg/m2,\n* Vincristine: 2.0 mg FD. The triple combination was to be administered for up to a maximum of ten cycles"}], 'classes': [{'categories': [{'title': 'Complete response', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Partial response', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}, {'title': 'Stable disease', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}, {'title': 'Progression disease', 'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}, {'title': 'Unknown', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Every three months up to death or study termination, a period of approximately 3.5 years', 'description': 'Best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1.\n\nCR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'A preplanned exploratory efficacy subgroup analysis was focused on patients with Central Nervous System Involvement at Baseline'}, {'type': 'SECONDARY', 'title': 'Overall Response Rate in Patients With Central Nervous System Involvement at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lurbinectedin/Doxorubicin', 'description': 'Doxorubicin: 40.0 mg/m2 i.v. on Day 1 through peripheral or central lines (according to local label), followed by, Lurbinectedin: 2.0 mg/m2 i.v. as a 1-hour infusion on Day 1 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines. A minimum volume of 100 mL diluted in 5% glucose or 0.9% sodium chloride solution for infusion, had to be used for administration through a central venous catheter; if a peripheral venous catheter was used, the minimum volume was 250 mL.\n\nThe combination was to be administered for up to a maximum of ten cycles.'}, {'id': 'OG001', 'title': 'Topotecan or Cyclophosphamide/Doxorubicin/Vincristine', 'description': "If the patient was randomized to the Control Arm, the assigned treatment was based on the reported Investigator's preference between topotecan and CAV, until the first of these options had reached 55% of the target patient enrollment in this arm. Once this had occurred, patients in the Control Arm were to receive the other option.\n\nTopotecan: i.v. daily on Days 1-5 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines (according to local label) at the following doses:\n\n* 1.50 mg/m2 daily, for patients with calculated CrCL ≥60 mL/min.\n* 1.25 mg/m2 daily, for patients with calculated CrCL between 40 and 59 mL/min.\n* 0.75 mg/m2 daily, for patients with calculated CrCL between 30 and 39 mL/min.\n\nor\n\nCAV: i.v. on Day 1 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines at the following doses:\n\n* Cyclophosphamide: 1000 mg/m2,\n* Doxorubicin: 45.0 mg/m2,\n* Vincristine: 2.0 mg FD. The triple combination was to be administered for up to a maximum of ten cycles"}], 'classes': [{'categories': [{'measurements': [{'value': '23.9', 'groupId': 'OG000', 'lowerLimit': '12.6', 'upperLimit': '38.8'}, {'value': '24.5', 'groupId': 'OG001', 'lowerLimit': '13.3', 'upperLimit': '38.9'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.032', 'ciLowerLimit': '0.403', 'ciUpperLimit': '2.641', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Every three months up to death or study termination, a period of approximately 3.5 years', 'description': 'Overall response rate is defined as the proportion of patients who have a partial or complete response in the best antitumor response. The best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1.\n\nCR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'A preplanned exploratory efficacy subgroup analysis was focused on patients with Central Nervous System Involvement at Baseline'}, {'type': 'SECONDARY', 'title': 'Duration of Response in Patients With Central Nervous System Involvement at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lurbinectedin/Doxorubicin', 'description': 'Doxorubicin: 40.0 mg/m2 i.v. on Day 1 through peripheral or central lines (according to local label), followed by, Lurbinectedin: 2.0 mg/m2 i.v. as a 1-hour infusion on Day 1 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines. A minimum volume of 100 mL diluted in 5% glucose or 0.9% sodium chloride solution for infusion, had to be used for administration through a central venous catheter; if a peripheral venous catheter was used, the minimum volume was 250 mL.\n\nThe combination was to be administered for up to a maximum of ten cycles.'}, {'id': 'OG001', 'title': 'Topotecan or Cyclophosphamide/Doxorubicin/Vincristine', 'description': "If the patient was randomized to the Control Arm, the assigned treatment was based on the reported Investigator's preference between topotecan and CAV, until the first of these options had reached 55% of the target patient enrollment in this arm. Once this had occurred, patients in the Control Arm were to receive the other option.\n\nTopotecan: i.v. daily on Days 1-5 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines (according to local label) at the following doses:\n\n* 1.50 mg/m2 daily, for patients with calculated CrCL ≥60 mL/min.\n* 1.25 mg/m2 daily, for patients with calculated CrCL between 40 and 59 mL/min.\n* 0.75 mg/m2 daily, for patients with calculated CrCL between 30 and 39 mL/min.\n\nor\n\nCAV: i.v. on Day 1 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines at the following doses:\n\n* Cyclophosphamide: 1000 mg/m2,\n* Doxorubicin: 45.0 mg/m2,\n* Vincristine: 2.0 mg FD. The triple combination was to be administered for up to a maximum of ten cycles"}], 'classes': [{'categories': [{'measurements': [{'value': '1.5', 'comment': 'Not reached', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': 'NA'}, {'value': '2.7', 'groupId': 'OG001', 'lowerLimit': '1.3', 'upperLimit': '4.0'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.013', 'ciLowerLimit': '0.373', 'ciUpperLimit': '2.750', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Every three months up to death or study termination, a period of approximately 3.5 years', 'description': 'Duration of Response is defined as the time that patients who have a partial or complete response in the best antitumor response. The best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1.\n\nCR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who have a partial or complete response in the best antitumor response. A preplanned exploratory efficacy subgroup analysis was focused on patients with Central Nervous System Involvement at Baseline'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lurbinectedin/Doxorubicin', 'description': 'Doxorubicin: 40.0 mg/m2 i.v. on Day 1 through peripheral or central lines (according to local label), followed by, Lurbinectedin: 2.0 mg/m2 i.v. as a 1-hour infusion on Day 1 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines. A minimum volume of 100 mL diluted in 5% glucose or 0.9% sodium chloride solution for infusion, had to be used for administration through a central venous catheter; if a peripheral venous catheter was used, the minimum volume was 250 mL.\n\nThe combination was to be administered for up to a maximum of ten cycles.'}, {'id': 'FG001', 'title': 'Topotecan or Cyclophosphamide/Doxorubicin/Vincristine', 'description': "If the patient was randomized to the Control Arm, the assigned treatment was based on the reported Investigator's preference between topotecan and Cyclophosphamide, Doxorubicin and Vincristine (CAV), until the first of these options had reached 55% of the target patient enrollment in this arm. Once this had occurred, patients in the Control Arm were to receive the other option.\n\nTopotecan: i.v. daily on Days 1-5 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines (according to local label) at the following doses:\n\n* 1.50 mg/m2 daily, for patients with calculated Creatinine Clearance (CrCL) ≥60 mL/min.\n* 1.25 mg/m2 daily, for patients with calculated CrCL between 40 and 59 mL/min.\n* 0.75 mg/m2 daily, for patients with calculated CrCL between 30 and 39 mL/min.\n\nor\n\nCAV: i.v. on Day 1 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines at the following doses:\n\n* Cyclophosphamide: 1000 mg/m2,\n* Doxorubicin: 45.0 mg/m2,\n* Vincristine: 2.0 mg flat dose. The triple combination was to be administered for up to a maximum of ten cycles"}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '307'}, {'groupId': 'FG001', 'numSubjects': '306'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '307'}, {'groupId': 'FG001', 'numSubjects': '306'}]}], 'dropWithdraws': [{'type': 'Randomized but not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'Progressive disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '213'}, {'groupId': 'FG001', 'numSubjects': '152'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'Study drug-related adverse event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '41'}]}, {'type': 'Non study drug-related adverse event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Symptomatic deterioration', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'End of study due to events required for OS analysis according to study protocol had been reached', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': "Sponsor's decision after incorrect treatment at site", 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Screening failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Symptomatic deterioration, progression disease, and a decision by the Investigator', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'The first randomization took place on 30 August 2016 and the first study treatment was administered on 25 October 2016. The cutoff date for results presented in this Clinical Study Report was 24 February 2020.\n\nA total of 919 patients were screened; 613 of these 919 patients were randomized at a 1:1 ratio to receive any of the study treatments at 135 investigational sites from 20 countries.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '307', 'groupId': 'BG000'}, {'value': '306', 'groupId': 'BG001'}, {'value': '613', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Lurbinectedin/Doxorubicin', 'description': 'Doxorubicin: 40.0 mg/m2 i.v. on Day 1 through peripheral or central lines (according to local label), followed by, Lurbinectedin: 2.0 mg/m2 i.v. as a 1-hour infusion on Day 1 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines. A minimum volume of 100 mL diluted in 5% glucose or 0.9% sodium chloride solution for infusion, had to be used for administration through a central venous catheter; if a peripheral venous catheter was used, the minimum volume was 250 mL.\n\nThe combination was to be administered for up to a maximum of ten cycles.'}, {'id': 'BG001', 'title': 'Topotecan or Cyclophosphamide/Doxorubicin/Vincristine', 'description': "If the patient was randomized to the Control Arm, the assigned treatment was based on the reported Investigator's preference between topotecan and CAV, until the first of these options had reached 55% of the target patient enrollment in this arm. Once this had occurred, patients in the Control Arm were to receive the other option.\n\nTopotecan: i.v. daily on Days 1-5 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines (according to local label) at the following doses:\n\n* 1.50 mg/m2 daily, for patients with calculated CrCL ≥60 mL/min.\n* 1.25 mg/m2 daily, for patients with calculated CrCL between 40 and 59 mL/min.\n* 0.75 mg/m2 daily, for patients with calculated CrCL between 30 and 39 mL/min.\n\nor\n\nCAV: i.v. on Day 1 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines at the following doses:\n\n* Cyclophosphamide: 1000 mg/m2,\n* Doxorubicin: 45.0 mg/m2,\n* Vincristine: 2.0 mg flat dose. The triple combination was to be administered for up to a maximum of ten cycles"}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.0', 'groupId': 'BG000', 'lowerLimit': '19', 'upperLimit': '83'}, {'value': '63.0', 'groupId': 'BG001', 'lowerLimit': '37', 'upperLimit': '82'}, {'value': '63', 'groupId': 'BG002', 'lowerLimit': '19', 'upperLimit': '83'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Age, Customized', 'classes': [{'categories': [{'title': '18-49 years', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}, {'title': '50-65 years', 'measurements': [{'value': '161', 'groupId': 'BG000'}, {'value': '166', 'groupId': 'BG001'}, {'value': '327', 'groupId': 'BG002'}]}, {'title': '>65 years', 'measurements': [{'value': '130', 'groupId': 'BG000'}, {'value': '127', 'groupId': 'BG001'}, {'value': '257', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '131', 'groupId': 'BG000'}, {'value': '133', 'groupId': 'BG001'}, {'value': '264', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '176', 'groupId': 'BG000'}, {'value': '173', 'groupId': 'BG001'}, {'value': '349', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'White', 'measurements': [{'value': '266', 'groupId': 'BG000'}, {'value': '265', 'groupId': 'BG001'}, {'value': '531', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Not available', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Argentina', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Romania', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}]}, {'title': 'Hungary', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}]}, {'title': 'Czechia', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}, {'title': 'Portugal', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '125', 'groupId': 'BG002'}]}]}, {'title': 'Greece', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}, {'title': 'Lebanon', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}, {'title': 'Austria', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'Netherlands', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}, {'title': 'Belgium', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}, {'title': 'Brazil', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}]}, {'title': 'Bulgaria', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '73.0', 'groupId': 'BG000', 'lowerLimit': '40', 'upperLimit': '143'}, {'value': '74.0', 'groupId': 'BG001', 'lowerLimit': '38', 'upperLimit': '158'}, {'value': '73.4', 'groupId': 'BG002', 'lowerLimit': '37.9', 'upperLimit': '158'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Kg', 'dispersionType': 'FULL_RANGE'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '168', 'groupId': 'BG000', 'lowerLimit': '145', 'upperLimit': '196'}, {'value': '168', 'groupId': 'BG001', 'lowerLimit': '146', 'upperLimit': '191'}, {'value': '168', 'groupId': 'BG002', 'lowerLimit': '145', 'upperLimit': '196'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'cm', 'dispersionType': 'FULL_RANGE'}, {'title': 'Body surface area', 'classes': [{'categories': [{'measurements': [{'value': '1.8', 'groupId': 'BG000', 'lowerLimit': '1.4', 'upperLimit': '2.5'}, {'value': '1.8', 'groupId': 'BG001', 'lowerLimit': '1.3', 'upperLimit': '2.8'}, {'value': '1.8', 'groupId': 'BG002', 'lowerLimit': '1.3', 'upperLimit': '2.8'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'm^2', 'dispersionType': 'FULL_RANGE'}, {'title': 'Body mass index', 'classes': [{'categories': [{'measurements': [{'value': '25.9', 'groupId': 'BG000', 'lowerLimit': '15.3', 'upperLimit': '51.2'}, {'value': '26.0', 'groupId': 'BG001', 'lowerLimit': '14.8', 'upperLimit': '43.8'}, {'value': '25.9', 'groupId': 'BG002', 'lowerLimit': '14.8', 'upperLimit': '51.2'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Kg/m^2', 'dispersionType': 'FULL_RANGE'}, {'title': 'Eastern Cooperative Oncology Group Performance Status', 'classes': [{'categories': [{'title': 'PS 0', 'measurements': [{'value': '95', 'groupId': 'BG000'}, {'value': '95', 'groupId': 'BG001'}, {'value': '190', 'groupId': 'BG002'}]}, {'title': 'PS 1', 'measurements': [{'value': '197', 'groupId': 'BG000'}, {'value': '204', 'groupId': 'BG001'}, {'value': '401', 'groupId': 'BG002'}]}, {'title': 'PS 2', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Eastern Cooperative Oncology Group Performance Status (ECOG PS) 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': 'Smoking status', 'classes': [{'categories': [{'title': 'Former', 'measurements': [{'value': '197', 'groupId': 'BG000'}, {'value': '199', 'groupId': 'BG001'}, {'value': '396', 'groupId': 'BG002'}]}, {'title': 'Current', 'measurements': [{'value': '91', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '180', 'groupId': 'BG002'}]}, {'title': 'Never', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Time from first diagnosis to randomization', 'classes': [{'categories': [{'measurements': [{'value': '9.3', 'groupId': 'BG000', 'lowerLimit': '2.5', 'upperLimit': '55.5'}, {'value': '9.1', 'groupId': 'BG001', 'lowerLimit': '2.3', 'upperLimit': '42.3'}, {'value': '9.2', 'groupId': 'BG002', 'lowerLimit': '2.5', 'upperLimit': '55.5'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'months', 'dispersionType': 'FULL_RANGE'}, {'title': 'Disease stage', 'classes': [{'categories': [{'title': 'Limited', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}, {'title': 'Extensive', 'measurements': [{'value': '282', 'groupId': 'BG000'}, {'value': '278', 'groupId': 'BG001'}, {'value': '560', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Limited stage. Limited stage means that the cancer is only in 1 part of the chest and radiation therapy could be a treatment option.\n\nExtensive stage. Extensive stage is used to describe SCLC that has spread to other parts of the body such as the opposite lung, bone, brain, or bone marrow.', 'unitOfMeasure': 'Participants'}, {'title': 'Number of sites involved', 'classes': [{'categories': [{'title': '<3 sites', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}, {'title': '≥3 sites', 'measurements': [{'value': '269', 'groupId': 'BG000'}, {'value': '275', 'groupId': 'BG001'}, {'value': '544', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of sites involved', 'classes': [{'categories': [{'measurements': [{'value': '4.0', 'groupId': 'BG000', 'lowerLimit': '1', 'upperLimit': '10'}, {'value': '4.0', 'groupId': 'BG001', 'lowerLimit': '2', 'upperLimit': '11'}, {'value': '4.0', 'groupId': 'BG002', 'lowerLimit': '1', 'upperLimit': '11'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'sites', 'dispersionType': 'FULL_RANGE'}, {'title': 'Bulky disease', 'classes': [{'categories': [{'measurements': [{'value': '144', 'groupId': 'BG000'}, {'value': '127', 'groupId': 'BG001'}, {'value': '271', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Bulky disease defined as one lesion ≥50 mm', 'unitOfMeasure': 'Participants'}, {'title': 'Central Nervous System involvement', 'classes': [{'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Paraneoplastic syndrome', 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Prior radiotherapy', 'classes': [{'categories': [{'measurements': [{'value': '237', 'groupId': 'BG000'}, {'value': '236', 'groupId': 'BG001'}, {'value': '473', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Prior surgery', 'classes': [{'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Lines of anticancer therapy', 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'groupId': 'BG000', 'lowerLimit': '1', 'upperLimit': '2'}, {'value': '1.0', 'groupId': 'BG001', 'lowerLimit': '1', 'upperLimit': '2'}, {'value': '1.0', 'groupId': 'BG002', 'lowerLimit': '1', 'upperLimit': '2'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'lines of therapies', 'dispersionType': 'FULL_RANGE'}, {'title': 'Best response to last prior chemotherapy', 'classes': [{'categories': [{'title': 'Complete response', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}, {'title': 'Partial response', 'measurements': [{'value': '192', 'groupId': 'BG000'}, {'value': '191', 'groupId': 'BG001'}, {'value': '383', 'groupId': 'BG002'}]}, {'title': 'Stable disease', 'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '134', 'groupId': 'BG002'}]}, {'title': 'Progressive disease', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}, {'title': 'Unknown', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Complete response (CR): disappearance of all lesions; Partial response (PR): ≥10% decrease in target lesion size or ≥15% decrease in tumor density; Disease progression (PD): ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; Stable disease (SD): none of the CR, PR, or PD criteria met; Unknown (UK)', 'unitOfMeasure': 'Participants'}, {'title': 'Prior immunotherapy against PD-1 or PD-L1', 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'PD-1, programmed cell death protein-1; PD-L1, programmed death ligand-1', 'unitOfMeasure': 'Participants'}, {'title': 'Time-to-progression to prior chemotherapy', 'classes': [{'categories': [{'measurements': [{'value': '7.4', 'groupId': 'BG000', 'lowerLimit': '0.8', 'upperLimit': '40.2'}, {'value': '7.4', 'groupId': 'BG001', 'lowerLimit': '1.6', 'upperLimit': '33.7'}, {'value': '7.4', 'groupId': 'BG002', 'lowerLimit': '0.8', 'upperLimit': '40.2'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'months', 'dispersionType': 'FULL_RANGE'}, {'title': 'Time from last prior progressive disease to randomization', 'classes': [{'categories': [{'measurements': [{'value': '25.0', 'groupId': 'BG000', 'lowerLimit': '3', 'upperLimit': '621'}, {'value': '25.5', 'groupId': 'BG001', 'lowerLimit': '1', 'upperLimit': '327'}, {'value': '25.0', 'groupId': 'BG002', 'lowerLimit': '1.0', 'upperLimit': '621'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'days', 'dispersionType': 'FULL_RANGE'}, {'title': 'Time from end date of last prior chemotherapy to randomization', 'classes': [{'categories': [{'measurements': [{'value': '157.0', 'groupId': 'BG000', 'lowerLimit': '28.0', 'upperLimit': '1545.0'}, {'value': '153.0', 'groupId': 'BG001', 'lowerLimit': '29.0', 'upperLimit': '1151.0'}, {'value': '155', 'groupId': 'BG002', 'lowerLimit': '28', 'upperLimit': '1545'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'days', 'dispersionType': 'FULL_RANGE'}, {'title': 'Chemotherapy-free interval', 'classes': [{'categories': [{'measurements': [{'value': '115.0', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '1094'}, {'value': '120.5', 'groupId': 'BG001', 'lowerLimit': '13', 'upperLimit': '960'}, {'value': '120', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '1094'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'days', 'dispersionType': 'FULL_RANGE'}, {'title': 'Chemotherapy-free interval', 'classes': [{'categories': [{'title': '<90 days', 'measurements': [{'value': '99', 'groupId': 'BG000'}, {'value': '101', 'groupId': 'BG001'}, {'value': '200', 'groupId': 'BG002'}]}, {'title': '90-179 days', 'measurements': [{'value': '115', 'groupId': 'BG000'}, {'value': '116', 'groupId': 'BG001'}, {'value': '231', 'groupId': 'BG002'}]}, {'title': '≥180 days', 'measurements': [{'value': '93', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '182', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-05-03', 'size': 1425541, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-04-26T04:52', 'hasProtocol': True}, {'date': '2020-09-04', 'size': 2706100, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-07-09T07:09', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 613}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2020-02-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-29', 'studyFirstSubmitDate': '2015-09-24', 'resultsFirstSubmitDate': '2021-08-06', 'studyFirstSubmitQcDate': '2015-10-01', 'lastUpdatePostDateStruct': {'date': '2021-10-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-09-29', 'studyFirstPostDateStruct': {'date': '2015-10-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-10-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': 'Every three months up to death or study termination, a period of approximately 3.5 years', 'description': 'Overall survival (OS) will be calculated from the date of randomization to the date of death (death event) or last contact(in this case, survival will be censored on that date).'}], 'secondaryOutcomes': [{'measure': "Difference in Overall Survival Between Lurbinectedin/Doxorubicin (DOX) and CAV in Patients With CAV as Best Investigator's Choice: Overall Survival Rate at 12 Months", 'timeFrame': 'At 12 months', 'description': 'Overall survival (OS) will be calculated from the date of randomization to the date of death (death event) or last contact(in this case, survival will be censored on that date).'}, {'measure': "Difference in Overall Survival Between Lurbinectedin/DOX and CAV in Patients With CAV as Best Investigator's Choice: Overall Survival Rate at 18 Months", 'timeFrame': 'At 18 months', 'description': 'Overall survival (OS) will be calculated from the date of randomization to the date of death (death event) or last contact(in this case, survival will be censored on that date).'}, {'measure': "Difference in Overall Survival Between Lurbinectedin/DOX and CAV in Patients With CAV as Best Investigator's Choice: Overall Survival Rate at 24 Months", 'timeFrame': 'At 24 months', 'description': 'Overall survival (OS) will be calculated from the date of randomization to the date of death (death event) or last contact(in this case, survival will be censored on that date).'}, {'measure': 'Progression-free Survival (PFS) by Independent Review Committee', 'timeFrame': 'Every six weeks up to progression disease, a period of approximately 3.5 years', 'description': 'Progression-free survival (PFS) is defined as the time from the date of randomization to the date of documented progression per RECIST v.1.1 or death (regardless of the cause of death). If the patient receives further antitumor therapy or is lost to follow-up before PD, PFS will be censored at the date of last tumor assessment before the date of subsequent antitumor therapy.'}, {'measure': 'Progression-free Survival Rate at 6 Months by Independent Review Committee', 'timeFrame': 'At 6 months', 'description': 'Progression-free survival (PFS) is defined as the time from the date of randomization to the date of documented progression per RECIST v.1.1 or death (regardless of the cause of death). If the patient receives further antitumor therapy or is lost to follow-up before PD, PFS will be censored at the date of last tumor assessment before the date of subsequent antitumor therapy.'}, {'measure': 'Progression-free Survival Rate at 12 Months by Independent Review Committee', 'timeFrame': 'at 12 months', 'description': 'Progression-free survival (PFS) is defined as the time from the date of randomization to the date of documented progression per RECIST v.1.1 or death (regardless of the cause of death). If the patient receives further antitumor therapy or is lost to follow-up before PD, PFS will be censored at the date of last tumor assessment before the date of subsequent antitumor therapy.'}, {'measure': 'Best Antitumor Response by Independent Review Committee', 'timeFrame': 'Every three months up to death or study termination, a period of approximately 3.5 years', 'description': 'Best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1.\n\nCR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown'}, {'measure': 'Overall Response Rate by Independent Review Committee', 'timeFrame': 'Every three months up to death or study termination, a period of approximately 3.5 years', 'description': 'Overall response rate is defined as the proportion of patients who have a partial or complete response in the best antitumor response. The best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1.\n\nCR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown'}, {'measure': 'Duration of Response by Independent Review Committee', 'timeFrame': 'Every three months up to death or study termination, a period of approximately 3.5 years', 'description': 'Duration of Response is defined as the time that patients who have a partial or complete response in the best antitumor response. The best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1.\n\nCR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown'}, {'measure': 'Overall Survival in Patients With Chemotherapy-free Interval ≥ 90 Days', 'timeFrame': 'Every three months up to death or study termination, a period of approximately 3.5 years', 'description': 'Overall survival (OS) will be calculated from the date of randomization to the date of death (death event) or last contact(in this case, survival will be censored on that date).'}, {'measure': 'Progression-free Survival in Patients With Chemotherapy-free Interval ≥90 Days', 'timeFrame': 'Every six weeks up to progression disease, a period of approximately 3.5 years', 'description': 'Progression-free survival (PFS) is defined as the time from the date of randomization to the date of documented progression per RECIST v.1.1 or death (regardless of the cause of death). If the patient receives further antitumor therapy or is lost to follow-up before PD, PFS will be censored at the date of last tumor assessment before the date of subsequent antitumor therapy.'}, {'measure': 'Best Antitumor Response in Patients With Chemotherapy-free Interval ≥ 90 Days', 'timeFrame': 'Every three months up to death or study termination, a period of approximately 3.5 years', 'description': 'Best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1.\n\nCR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown'}, {'measure': 'Overall Response Rate in Patients With Chemotherapy-free Interval ≥ 90 Days', 'timeFrame': 'Every three months up to death or study termination, a period of approximately 3.5 years', 'description': 'Overall response rate is defined as the proportion of patients who have a partial or complete response in the best antitumor response. The best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1.\n\nCR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown'}, {'measure': 'Duration of Response in Patients With Chemotherapy-free Interval ≥ 90 Days', 'timeFrame': 'Every three months up to death or study termination, a period of approximately 3.5 years', 'description': 'Duration of Response is defined as the time that patients who have a partial or complete response in the best antitumor response. The best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1.\n\nCR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown'}, {'measure': 'Overall Survival in Patients With Chemotherapy-free Interval < 90 Days', 'timeFrame': 'Every three months up to death or study termination, a period of approximately 3.5 years', 'description': 'Overall survival (OS) will be calculated from the date of randomization to the date of death (death event) or last contact(in this case, survival will be censored on that date).'}, {'measure': 'Progression-free Survival in Patients With Chemotherapy-free Interval <90 Days', 'timeFrame': 'Every six weeks up to progression disease, a period of approximately 3.5 years', 'description': 'Progression-free survival (PFS) is defined as the time from the date of randomization to the date of documented progression per RECIST v.1.1 or death (regardless of the cause of death). If the patient receives further antitumor therapy or is lost to follow-up before PD, PFS will be censored at the date of last tumor assessment before the date of subsequent antitumor therapy.'}, {'measure': 'Best Antitumor Response in Patients With Chemotherapy-free Interval <90 Days', 'timeFrame': 'Every three months up to death or study termination, a period of approximately 3.5 years', 'description': 'Best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1.\n\nCR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown'}, {'measure': 'Overall Response Rate in Patients With Chemotherapy-free Interval <90 Days', 'timeFrame': 'Every three months up to death or study termination, a period of approximately 3.5 years', 'description': 'Overall response rate is defined as the proportion of patients who have a partial or complete response in the best antitumor response. The best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1.\n\nCR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown'}, {'measure': 'Duration of Response in Patients With Chemotherapy-free Interval <90 Days', 'timeFrame': 'Every three months up to death or study termination, a period of approximately 3.5 years', 'description': 'Duration of Response is defined as the time that patients who have a partial or complete response in the best antitumor response. The best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1.\n\nCR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown'}, {'measure': 'Overall Survival in Patients Without Central Nervous System Involvement at Baseline', 'timeFrame': 'Every three months up to death or study termination, a period of approximately 3.5 years', 'description': 'Overall survival (OS) will be calculated from the date of randomization to the date of death (death event) or last contact(in this case, survival will be censored on that date).'}, {'measure': 'Progression-free Survival in Patients Without Central Nervous System Involvement at Baseline', 'timeFrame': 'Every six weeks up to progression disease, a period of approximately 3.5 years', 'description': 'Progression-free survival (PFS) is defined as the time from the date of randomization to the date of documented progression per RECIST v.1.1 or death (regardless of the cause of death). If the patient receives further antitumor therapy or is lost to follow-up before PD, PFS will be censored at the date of last tumor assessment before the date of subsequent antitumor therapy.'}, {'measure': 'Best Antitumor Response in Patients Without Central Nervous System Involvement at Baseline', 'timeFrame': 'Every three months up to death or study termination, a period of approximately 3.5 years', 'description': 'Best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1.\n\nCR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown'}, {'measure': 'Overall Response Rate in Patients Without Central Nervous System Involvement at Baseline', 'timeFrame': 'Every three months up to death or study termination, a period of approximately 3.5 years', 'description': 'Overall response rate is defined as the proportion of patients who have a partial or complete response in the best antitumor response. The best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1.\n\nCR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown'}, {'measure': 'Duration of Response in Patients Without Central Nervous System Involvement at Baseline', 'timeFrame': 'Every three months up to death or study termination, a period of approximately 3.5 years', 'description': 'Duration of Response is defined as the time that patients who have a partial or complete response in the best antitumor response. The best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1.\n\nCR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown'}, {'measure': 'Overall Survival in Patients With Central Nervous System Involvement at Baseline', 'timeFrame': 'Every three months up to death or study termination, a period of approximately 3.5 years', 'description': 'Overall survival (OS) will be calculated from the date of randomization to the date of death (death event) or last contact(in this case, survival will be censored on that date).'}, {'measure': 'Progression-free Survival in Patients With Central Nervous System Involvement at Baseline', 'timeFrame': 'Every six weeks up to progression disease, a period of approximately 3.5 years', 'description': 'Progression-free survival (PFS) is defined as the time from the date of randomization to the date of documented progression per RECIST v.1.1 or death (regardless of the cause of death). If the patient receives further antitumor therapy or is lost to follow-up before PD, PFS will be censored at the date of last tumor assessment before the date of subsequent antitumor therapy.'}, {'measure': 'Best Antitumor Response in Patients With Central Nervous System Involvement at Baseline', 'timeFrame': 'Every three months up to death or study termination, a period of approximately 3.5 years', 'description': 'Best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1.\n\nCR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown'}, {'measure': 'Overall Response Rate in Patients With Central Nervous System Involvement at Baseline', 'timeFrame': 'Every three months up to death or study termination, a period of approximately 3.5 years', 'description': 'Overall response rate is defined as the proportion of patients who have a partial or complete response in the best antitumor response. The best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1.\n\nCR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown'}, {'measure': 'Duration of Response in Patients With Central Nervous System Involvement at Baseline', 'timeFrame': 'Every three months up to death or study termination, a period of approximately 3.5 years', 'description': 'Duration of Response is defined as the time that patients who have a partial or complete response in the best antitumor response. The best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1.\n\nCR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown'}]}, 'conditionsModule': {'conditions': ['Small-cell Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '36252599', 'type': 'DERIVED', 'citation': "Aix SP, Ciuleanu TE, Navarro A, Cousin S, Bonanno L, Smit EF, Chiappori A, Olmedo ME, Horvath I, Grohe C, Farago AF, Lopez-Vilarino JA, Cullell-Young M, Nieto A, Vasco N, Gomez J, Kahatt C, Zeaiter A, Carcereny E, Roubec J, Syrigos K, Lo G, Barneto I, Pope A, Sanchez A, Kattan J, Zarogoulidis K, Waller CF, Bischoff H, Juan-Vidal O, Reinmuth N, Domine M, Paz-Ares L. Combination lurbinectedin and doxorubicin versus physician's choice of chemotherapy in patients with relapsed small-cell lung cancer (ATLANTIS): a multicentre, randomised, open-label, phase 3 trial. Lancet Respir Med. 2023 Jan;11(1):74-86. doi: 10.1016/S2213-2600(22)00309-5. Epub 2022 Oct 14."}]}, 'descriptionModule': {'briefSummary': 'Phase III randomized clinical trial of lurbinectedin (PM01183)/doxorubicin (DOX) versus cyclophosphamide (CTX), doxorubicin (DOX) and vincristine (VCR) (CAV) or topotecan as treatment in patients with small-cell lung cancer (SCLC) who failed one prior platinum-containing line.', 'detailedDescription': "Multicenter, open-label, randomized, controlled phase III clinical trial to evaluate and compare the activity and safety of an experimental arm consisting of PM01183/DOX combination followed by PM01183 alone, if applicable vs. best Investigator's choice between CAV or topotecan as a control arm, in SCLC patients who failed one prior platinum-containing line but no more than one prior chemotherapy-containing line."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Voluntary written informed consent\n2. Adult patients ≥ 18 years\n3. Histologically or cytologically confirmed diagnosis of limited or extensive stage SCLC which failed one prior platinum-containing regimen and with a chemotherapy-free interval (CTFI, time from the last dose of first-line chemotherapy to the occurrence of progressive disease) ≥ 30 days. Small-cell carcinoma of unknown primary site with or without neuroendocrine features confirmed in histology test(s) performed on metastatic lesion(s) are eligible, if Ki-67/MIB-1 is expressed in \\>50% of tumor cells.\n4. Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤ 2.\n5. Adequate hematological, renal, metabolic and hepatic function within 7-10 days prior to randomization\n6. At least three weeks since last prior anticancer treatment and adequate recovery from prior treatment toxicity\n7. Prior radiotherapy (RT): At least four weeks since completion of whole-brain irradiation, at least two weeks since completion of prophylactic cranial irradiation, and to any other site.\n8. Evidence of non-childbearing status for women of childbearing potential (WOCBP). WOCBP must agree to use a highly effective contraceptive measure up to six weeks after treatment discontinuation. Fertile male patients with WOCBP partners should use condoms during treatment and for four months following the last investigational medicinal product dose.\n\nExclusion Criteria:\n\n1. More than one prior chemotherapy-containing line(re-challenge with the same initial regimen is not allowed)\n2. Patients who never received platinum-containing regimen for Small-cell Lung Cancer (SCLC)\n3. Prior treatment with PM01183, topotecan or anthracyclines.\n4. Limited-stage patients who are candidates for local or regional therapy\n5. Impending need for palliative RT or surgery for pathological fractures and/or for medullary compression within four weeks prior to randomization.\n6. Symptomatic or progressing or steroid requiring Central Nervous System (CNS) involvement disease at least four weeks prior to randomization\n7. Concomitant diseases/conditions:\n\n Angina, myocardial infarction, congestive heart failure or clinically significant valvular heart disease, arrhythmia, immunodeficiency (including known HIV seropositive), ongoing or treatment-requiring chronic liver disease, active infection, oxygen requirement within two weeks prior to randomization, diffuse interstitial lung disease (ILD) or pulmonary fibrosis, second invasive malignancy treated with chemotherapy and/or radiotherapy, invasive fungal infections requiring systemic treatment within 12 weeks of randomization.\n8. 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