Ignite Creation Date:
2025-12-25 @ 12:30 AM
Ignite Modification Date:
2026-02-23 @ 4:55 AM
Study NCT ID:
NCT00243867
Status:
COMPLETED
Last Update Posted:
2025-08-01
First Post:
2005-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Taxoprexin Plus Carboplatin Treatment for Advanced Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C528070', 'term': 'docosahexaenoyl-paclitaxel'}, {'id': 'D004281', 'term': 'Docosahexaenoic Acids'}, {'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D017239', 'term': 'Paclitaxel'}], 'ancestors': [{'id': 'D015525', 'term': 'Fatty Acids, Omega-3'}, {'id': 'D004042', 'term': 'Dietary Fats, Unsaturated'}, {'id': 'D004041', 'term': 'Dietary Fats'}, {'id': 'D005223', 'term': 'Fats'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D005395', 'term': 'Fish Oils'}, {'id': 'D009821', 'term': 'Oils'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'HRathfon@americanregent.com', 'phone': '631-772-3555', 'title': 'Manager Medical Writing', 'organization': 'American Regent Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Day of initial treatment with study drug until 30 days after last treatment, up to 12 months', 'description': "An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.\n\nThe Safety Set was the population used to evaluate adverse events.", 'eventGroups': [{'id': 'EG000', 'title': 'Taxoprexin® and Carboplatin', 'description': 'Taxoprexin® 400 mg/m² intravenously weekly for 5 weeks\n\nCarboplatin was given at an Area Under the Curve (AUC) = 4 mg\\*min/mL on Week 1 and Week 4, Taxoprexin and carboplatin were given up to 3 treatment cycles.\n\nTaxoprexin: Administered by intravenous infusion over 1 hour infusion\n\nCarboplatin: Administered by intravenous infusion over 30 minutes. Dosing was based on the Calvert formula: carboplatin dose (mg) = (Target AUC) x (glomerular filtration rate \\[GFR\\] + 25).', 'otherNumAtRisk': 256, 'deathsNumAtRisk': 256, 'otherNumAffected': 235, 'seriousNumAtRisk': 256, 'deathsNumAffected': 198, 'seriousNumAffected': 70}, {'id': 'EG001', 'title': 'Paclitaxel and Carboplatin', 'description': 'Paclitaxel 225 mg/m² intravenously followed immediately by carboplatin AUC = 6 mg\\*min/mL. Paclitaxel and carboplatin were given up to 6 treatment cycles.\n\nCarboplatin: Administered by intravenous infusion over 30 minutes. Dosing was based on the Calvert formula: carboplatin dose (mg) = (Target AUC) x (glomerular filtration rate \\[GFR\\] + 25).\n\nPaclitaxel: Administered by intravenous infusion over 3 hour infusion', 'otherNumAtRisk': 251, 'deathsNumAtRisk': 251, 'otherNumAffected': 239, 'seriousNumAtRisk': 251, 'deathsNumAffected': 196, 'seriousNumAffected': 91}], 'otherEvents': [{'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 101, 'numAffected': 101}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 92, 'numAffected': 92}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Edema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 36, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 32, 'numAffected': 32}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 29, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 54, 'numAffected': 54}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 21, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 23, 'numAffected': 23}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 91, 'numAffected': 91}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 94, 'numAffected': 94}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 63, 'numAffected': 63}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 69, 'numAffected': 69}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 37, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 46, 'numAffected': 46}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 31, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 42, 'numAffected': 42}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 18, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Dyspenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 56, 'numAffected': 56}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 58, 'numAffected': 58}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 37, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 40, 'numAffected': 40}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Hemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 29, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 29, 'numAffected': 29}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 25, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 19, 'numAffected': 19}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 23, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 54, 'numAffected': 54}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 18, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 63, 'numAffected': 63}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 20, 'numAffected': 20}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 23, 'numAffected': 23}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 27, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 22, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 49, 'numAffected': 49}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 18, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 17, 'numAffected': 17}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 30, 'numAffected': 30}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Chest wall pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 22, 'numAffected': 22}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 17, 'numAffected': 17}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 24, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 124, 'numAffected': 124}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 17, 'numAffected': 17}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 38, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 49, 'numAffected': 49}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 29, 'numAffected': 29}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 28, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 32, 'numAffected': 32}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 20, 'numAffected': 20}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 19, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 33, 'numAffected': 33}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}], 'seriousEvents': [{'term': 'Respiratory, thoracic, and mediastinal disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 21, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 18, 'numAffected': 18}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Dyspenea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Pulmonary hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'General disorders and administration site conditions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 19, 'numAffected': 19}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Disease progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Infections and infestations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 21, 'numAffected': 21}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Cardiac disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Gastrointestinal disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Metabolism and nutrition disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Nervous system disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Vascular disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Musculoskeletal and connective tissue disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Psychiatric disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '258', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Taxoprexin® and Carboplatin', 'description': 'Taxoprexin® 400 mg/m² intravenously weekly for 5 weeks\n\nCarboplatin was given at an Area Under the Curve (AUC) = 4 mg\\*min/mL on Week 1 and Week 4, Taxoprexin and carboplatin were given up to 3 treatment cycles.\n\nTaxoprexin: Administered by intravenous infusion over 1 hour infusion\n\nCarboplatin: Administered by intravenous infusion over 30 minutes. Dosing was based on the Calvert formula: carboplatin dose (mg) = (Target AUC) x (glomerular filtration rate \\[GFR\\] + 25).'}, {'id': 'OG001', 'title': 'Paclitaxel and Carboplatin', 'description': 'Paclitaxel 225 mg/m² intravenously followed immediately by carboplatin AUC = 6 mg\\*min/mL. Paclitaxel and carboplatin were given up to 6 treatment cycles.\n\nCarboplatin: Administered by intravenous infusion over 30 minutes. Dosing was based on the Calvert formula: carboplatin dose (mg) = (Target AUC) x (glomerular filtration rate \\[GFR\\] + 25).\n\nPaclitaxel: Administered by intravenous infusion over 3 hour infusion'}], 'classes': [{'categories': [{'measurements': [{'value': '8.31', 'groupId': 'OG000', 'lowerLimit': '7.0', 'upperLimit': '9.89'}, {'value': '8.51', 'groupId': 'OG001', 'lowerLimit': '7.82', 'upperLimit': '9.69'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 12 months', 'description': 'Overall survival was defined as the time from the day of randomization and ends at death of the participant. Participants were followed every 2 months, whether on or off study, for survival information. Participants alive at the time of termination of the study were considered censored.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieved an Objective Complete Response or Partial Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '258', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Taxoprexin® and Carboplatin', 'description': 'Taxoprexin® 400 mg/m² intravenously weekly for 5 weeks\n\nCarboplatin was given at an Area Under the Curve (AUC) = 4 mg\\*min/mL on Week 1 and Week 4, Taxoprexin and carboplatin were given up to 3 treatment cycles.\n\nTaxoprexin: Administered by intravenous infusion over 1 hour infusion\n\nCarboplatin: Administered by intravenous infusion over 30 minutes. Dosing was based on the Calvert formula: carboplatin dose (mg) = (Target AUC) x (glomerular filtration rate \\[GFR\\] + 25).'}, {'id': 'OG001', 'title': 'Paclitaxel and Carboplatin', 'description': 'Paclitaxel 225 mg/m² intravenously followed immediately by carboplatin AUC = 6 mg\\*min/mL. Paclitaxel and carboplatin were given up to 6 treatment cycles.\n\nCarboplatin: Administered by intravenous infusion over 30 minutes. Dosing was based on the Calvert formula: carboplatin dose (mg) = (Target AUC) x (glomerular filtration rate \\[GFR\\] + 25).\n\nPaclitaxel: Administered by intravenous infusion over 3 hour infusion'}], 'classes': [{'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Assessed every 6 weeks, up to 12 months', 'description': 'Antitumor response was defined as the percentage of participants who achieved an objective response (Complete Response or Partial Response), confirmed by repeat assessments performed no less than 4 weeks after the criteria for response were first met. Response was based on the blinded radiological review using Response Evaluation Criteria in Solid Tumors (RECIST) response guidelines, Version 1.0.\n\nA complete response was defined as a disappearance of all target lesions determined by 2 consecutive observations not less than 4 weeks apart.\n\nPartial response was defined as a 30% decrease in the sum of the longest diameters (LD) of target lesions, taking as reference the baseline sum of LD determined by 2 consecutive observations not less than 4 weeks apart.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat'}, {'type': 'SECONDARY', 'title': 'Duration of Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Taxoprexin® and Carboplatin', 'description': 'Taxoprexin® 400 mg/m² intravenously weekly for 5 weeks\n\nCarboplatin was given at an Area Under the Curve (AUC) = 4 mg\\*min/mL on Week 1 and Week 4, Taxoprexin and carboplatin were given up to 3 treatment cycles.\n\nTaxoprexin: Administered by intravenous infusion over 1 hour infusion\n\nCarboplatin: Administered by intravenous infusion over 30 minutes. Dosing was based on the Calvert formula: carboplatin dose (mg) = (Target AUC) x (glomerular filtration rate \\[GFR\\] + 25).'}, {'id': 'OG001', 'title': 'Paclitaxel and Carboplatin', 'description': 'Paclitaxel 225 mg/m² intravenously followed immediately by carboplatin AUC = 6 mg\\*min/mL. Paclitaxel and carboplatin were given up to 6 treatment cycles.\n\nCarboplatin: Administered by intravenous infusion over 30 minutes. Dosing was based on the Calvert formula: carboplatin dose (mg) = (Target AUC) x (glomerular filtration rate \\[GFR\\] + 25).\n\nPaclitaxel: Administered by intravenous infusion over 3 hour infusion'}], 'classes': [{'categories': [{'measurements': [{'value': '5.75', 'groupId': 'OG000', 'lowerLimit': '5.09', 'upperLimit': '8.54'}, {'value': '5.35', 'groupId': 'OG001', 'lowerLimit': '3.98', 'upperLimit': '6.21'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Assessed every 6 weeks, up to 12 months', 'description': 'Duration of overall response was a measurement from the time measure criteria was met for confirmed complete response or partial response (whichever was first recorded) until the first date that recurrent of progressive disease was objectively documented (taking as reference for progressive disease the smallest measurement recorded since treatment started).', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat'}, {'type': 'SECONDARY', 'title': 'Time to Progression (TTP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '258', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Taxoprexin® and Carboplatin', 'description': 'Taxoprexin® 400 mg/m² intravenously weekly for 5 weeks\n\nCarboplatin was given at an Area Under the Curve (AUC) = 4 mg\\*min/mL on Week 1 and Week 4, Taxoprexin and carboplatin were given up to 3 treatment cycles.\n\nTaxoprexin: Administered by intravenous infusion over 1 hour infusion\n\nCarboplatin: Administered by intravenous infusion over 30 minutes. Dosing was based on the Calvert formula: carboplatin dose (mg) = (Target AUC) x (glomerular filtration rate \\[GFR\\] + 25).'}, {'id': 'OG001', 'title': 'Paclitaxel and Carboplatin', 'description': 'Paclitaxel 225 mg/m² intravenously followed immediately by carboplatin AUC = 6 mg\\*min/mL. Paclitaxel and carboplatin were given up to 6 treatment cycles.\n\nCarboplatin: Administered by intravenous infusion over 30 minutes. Dosing was based on the Calvert formula: carboplatin dose (mg) = (Target AUC) x (glomerular filtration rate \\[GFR\\] + 25).\n\nPaclitaxel: Administered by intravenous infusion over 3 hour infusion'}], 'classes': [{'categories': [{'measurements': [{'value': '3.02', 'groupId': 'OG000', 'lowerLimit': '2.66', 'upperLimit': '4.01'}, {'value': '4.47', 'groupId': 'OG001', 'lowerLimit': '3.04', 'upperLimit': '5.22'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 12 months', 'description': 'TTP was defined as the time from randomization to documented disease progression. Progressive disease was defined as at least a 20% increase in the sum of longest diameter (LD) of target lesions, taking as references the smallest sum LD recorded since treatment start or the appearance of 1 or more lesions.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat'}, {'type': 'SECONDARY', 'title': 'Time to Treatment Failure (TTF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '258', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Taxoprexin® and Carboplatin', 'description': 'Taxoprexin® 400 mg/m² intravenously weekly for 5 weeks\n\nCarboplatin was given at an Area Under the Curve (AUC) = 4 mg\\*min/mL on Week 1 and Week 4, Taxoprexin and carboplatin were given up to 3 treatment cycles.\n\nTaxoprexin: Administered by intravenous infusion over 1 hour infusion\n\nCarboplatin: Administered by intravenous infusion over 30 minutes. Dosing was based on the Calvert formula: carboplatin dose (mg) = (Target AUC) x (glomerular filtration rate \\[GFR\\] + 25).'}, {'id': 'OG001', 'title': 'Paclitaxel and Carboplatin', 'description': 'Paclitaxel 225 mg/m² intravenously followed immediately by carboplatin AUC = 6 mg\\*min/mL. Paclitaxel and carboplatin were given up to 6 treatment cycles.\n\nCarboplatin: Administered by intravenous infusion over 30 minutes. Dosing was based on the Calvert formula: carboplatin dose (mg) = (Target AUC) x (glomerular filtration rate \\[GFR\\] + 25).\n\nPaclitaxel: Administered by intravenous infusion over 3 hour infusion'}], 'classes': [{'categories': [{'measurements': [{'value': '2.79', 'groupId': 'OG000', 'lowerLimit': '2.10', 'upperLimit': '3.02'}, {'value': '3.25', 'groupId': 'OG001', 'lowerLimit': '2.89', 'upperLimit': '3.78'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to stopping treatment, up to 12 months', 'description': 'TTF is defined as the time from randomization to the discontinuation of protocol treatment for any reason', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Taxoprexin® and Carboplatin', 'description': 'Taxoprexin® 400 mg/m² intravenously weekly for 5 weeks\n\nCarboplatin was given at an Area Under the Curve (AUC) = 4 mg\\*min/mL on Week 1 and Week 4, Taxoprexin and carboplatin were given up to 3 treatment cycles.\n\nTaxoprexin: Administered by intravenous infusion over 1 hour infusion\n\nCarboplatin: Administered by intravenous infusion over 30 minutes. Dosing was based on the Calvert formula: carboplatin dose (mg) = (Target AUC) x (glomerular filtration rate \\[GFR\\] + 25).'}, {'id': 'FG001', 'title': 'Paclitaxel and Carboplatin', 'description': 'Paclitaxel 225 mg/m² intravenously followed immediately by carboplatin AUC = 6 mg\\*min/mL. Paclitaxel and carboplatin were given up to 6 treatment cycles.\n\nCarboplatin: Administered by intravenous infusion over 30 minutes. Dosing was based on the Calvert formula: carboplatin dose (mg) = (Target AUC) x (glomerular filtration rate \\[GFR\\] + 25).\n\nPaclitaxel: Administered by intravenous infusion over 3 hour infusion'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '260'}, {'groupId': 'FG001', 'numSubjects': '258'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '84'}, {'groupId': 'FG001', 'numSubjects': '84'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '176'}, {'groupId': 'FG001', 'numSubjects': '174'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '115'}, {'groupId': 'FG001', 'numSubjects': '78'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Delayed treatment, omission of treatment, peripheral neuropathy, intercurrent illness', 'reasons': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '31'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'BG000'}, {'value': '258', 'groupId': 'BG001'}, {'value': '518', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Taxoprexin® and Carboplatin', 'description': 'Taxoprexin® 400 mg/m² intravenously weekly for 5 weeks\n\nCarboplatin was given at an Area Under the Curve (AUC) = 4 mg\\*min/mL on Week 1 and Week 4, Taxoprexin and carboplatin were given up to 3 treatment cycles.\n\nTaxoprexin: Administered by intravenous infusion over 1 hour infusion\n\nCarboplatin: Administered by intravenous infusion over 30 minutes. Dosing was based on the Calvert formula: carboplatin dose (mg) = (Target AUC) x (glomerular filtration rate \\[GFR\\] + 25).'}, {'id': 'BG001', 'title': 'Paclitaxel and Carboplatin', 'description': 'Paclitaxel 225 mg/m² intravenously followed immediately by carboplatin AUC = 6 mg\\*min/mL. Paclitaxel and carboplatin were given up to 6 treatment cycles.\n\nCarboplatin: Administered by intravenous infusion over 30 minutes. Dosing was based on the Calvert formula: carboplatin dose (mg) = (Target AUC) x (glomerular filtration rate \\[GFR\\] + 25).\n\nPaclitaxel: Administered by intravenous infusion over 3 hour infusion'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'BG000'}, {'value': '258', 'groupId': 'BG001'}, {'value': '518', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '63.1', 'spread': '9.35', 'groupId': 'BG000'}, {'value': '62.4', 'spread': '10.54', 'groupId': 'BG001'}, {'value': '62.8', 'spread': '9.96', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'BG000'}, {'value': '258', 'groupId': 'BG001'}, {'value': '518', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '149', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '179', 'groupId': 'BG000'}, {'value': '190', 'groupId': 'BG001'}, {'value': '369', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'BG000'}, {'value': '258', 'groupId': 'BG001'}, {'value': '518', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '249', 'groupId': 'BG000'}, {'value': '244', 'groupId': 'BG001'}, {'value': '493', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'BG000'}, {'value': '258', 'groupId': 'BG001'}, {'value': '518', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '161', 'groupId': 'BG000'}, {'value': '163', 'groupId': 'BG001'}, {'value': '324', 'groupId': 'BG002'}]}]}, {'title': 'Russia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'BG000'}, {'value': '258', 'groupId': 'BG001'}, {'value': '518', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}]}]}, {'title': 'Ukraine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'BG000'}, {'value': '258', 'groupId': 'BG001'}, {'value': '518', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Disease Stage', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'BG000'}, {'value': '258', 'groupId': 'BG001'}, {'value': '518', 'groupId': 'BG002'}]}], 'categories': [{'title': 'IIIb', 'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '110', 'groupId': 'BG002'}]}, {'title': 'IV', 'measurements': [{'value': '203', 'groupId': 'BG000'}, {'value': '205', 'groupId': 'BG001'}, {'value': '408', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'BG000'}, {'value': '257', 'groupId': 'BG001'}, {'value': '517', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '73.88', 'spread': '15.111', 'groupId': 'BG000'}, {'value': '75.46', 'spread': '17.567', 'groupId': 'BG001'}, {'value': '74.67', 'spread': '16.378', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilograms', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'One participants weight is missing'}], 'populationDescription': 'Intent to treat'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 518}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'dispFirstSubmitDate': '2017-07-27', 'completionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-15', 'studyFirstSubmitDate': '2005-10-21', 'dispFirstSubmitQcDate': '2018-01-22', 'resultsFirstSubmitDate': '2025-06-19', 'studyFirstSubmitQcDate': '2005-10-21', 'dispFirstPostDateStruct': {'date': '2018-01-26', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-07-15', 'studyFirstPostDateStruct': {'date': '2005-10-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': 'Up to 12 months', 'description': 'Overall survival was defined as the time from the day of randomization and ends at death of the participant. Participants were followed every 2 months, whether on or off study, for survival information. Participants alive at the time of termination of the study were considered censored.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Who Achieved an Objective Complete Response or Partial Response', 'timeFrame': 'Assessed every 6 weeks, up to 12 months', 'description': 'Antitumor response was defined as the percentage of participants who achieved an objective response (Complete Response or Partial Response), confirmed by repeat assessments performed no less than 4 weeks after the criteria for response were first met. Response was based on the blinded radiological review using Response Evaluation Criteria in Solid Tumors (RECIST) response guidelines, Version 1.0.\n\nA complete response was defined as a disappearance of all target lesions determined by 2 consecutive observations not less than 4 weeks apart.\n\nPartial response was defined as a 30% decrease in the sum of the longest diameters (LD) of target lesions, taking as reference the baseline sum of LD determined by 2 consecutive observations not less than 4 weeks apart.'}, {'measure': 'Duration of Response', 'timeFrame': 'Assessed every 6 weeks, up to 12 months', 'description': 'Duration of overall response was a measurement from the time measure criteria was met for confirmed complete response or partial response (whichever was first recorded) until the first date that recurrent of progressive disease was objectively documented (taking as reference for progressive disease the smallest measurement recorded since treatment started).'}, {'measure': 'Time to Progression (TTP)', 'timeFrame': 'Up to 12 months', 'description': 'TTP was defined as the time from randomization to documented disease progression. Progressive disease was defined as at least a 20% increase in the sum of longest diameter (LD) of target lesions, taking as references the smallest sum LD recorded since treatment start or the appearance of 1 or more lesions.'}, {'measure': 'Time to Treatment Failure (TTF)', 'timeFrame': 'Baseline to stopping treatment, up to 12 months', 'description': 'TTF is defined as the time from randomization to the discontinuation of protocol treatment for any reason'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Advanced Non-Small Cell Lung Cancer'], 'conditions': ['Non-Small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'The primary objective of this trial is to compare the survival of patients with advanced non-small cell lung cancer (NSCLC) treated with weekly Taxoprexin in combination with carboplatin to those treated with paclitaxel plus carboplatin in a prospectively randomized trial. In addition, the response rate to each regimen, response duration, time to progression and time to treatment failure will be measured. Toxicity will be evaluated and compared between the two groups.', 'detailedDescription': 'This is a randomized, multicenter, Phase III open-label study of weekly Taxoprexin® in combination with every three (3) week carboplatin compared to paclitaxel plus carboplatin every three (3) weeks, in patients with advanced non-small cell lung cancer (NSCLC) who have not received cytotoxic agents for advanced disease. Patients may have been previously treated with immunological agents. Patients will be randomized to receive Taxoprexin® at a dose of 400 mg/m2 intravenously by one (1)-hour weekly infusion, 5/6 weeks followed immediately by carboplatin AUC = 4 on weeks one (1) and four (4) as a 30 minute intravenous infusion or paclitaxel 225mg/m2 as a three (3) hour intravenous infusion followed immediately by carboplatin AUC = 6 as a 30 minute intravenous infusion, every three (3) weeks. Patients will receive Taxoprexin® and carboplatin infusions or paclitaxel and carboplatin infusions until progression of disease, intolerable toxicity, completion of six (6) treatment cycles of paclitaxel plus carboplatin or three (3) treatment cycles of Taxoprexin® plus carboplatin, refusal of continued treatment by the patient, or Investigator decision.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patients must have a histologic or cytologic diagnosis of non-small cell lung cancer. At the time of study entry, patients must have locally advanced (stage IIIb) or metastatic (stage IV) disease.\n2. Patients must have at least one site of either measurable or non-measurable disease.\n3. Patients must not have received prior systemic chemotherapy for metastatic disease. Prior adjuvant systemic chemotherapy is allowed. At least six (6) months must have elapsed since any prior adjuvant systemic chemotherapy.\n4. At least 6 weeks (42 days) since any prior immunotherapy, cytokine, biologic, vaccine or other non chemotherapy anticancer systemic therapies, unless patients have progressed during or after such therapy.\n5. At least 4 weeks (28 days) since any prior radiotherapy to \\> 25% of the bone marrow.\n6. Patients must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2.\n7. Patients must be at least 18 years of age.\n8. Patients must have adequate hepatic and renal function.\n9. Patients must have adequate bone marrow function.\n10. Life expectancy of at least 3 months.\n11. Patients must sign an informed consent form indicating that they are aware of the investigational nature of this study and in keeping with the policies of their institution.\n\nExclusion Criteria:\n\n1. Patients who have received prior systemic chemotherapy in the adjuvant setting with a treatment-free interval of less than six (6) months.\n2. Patients who have a past or current history of neoplasms other than the entry diagnosis, except for curatively treated non-melanoma skin cancer or carcinoma in situ of the cervix and except for other cancers treated for cure and with a disease-free survival greater than 5 years.\n3. Patients with symptomatic brain metastasis(es).\n4. Women who are pregnant or nursing and men or women who are not practicing an acceptable method of birth control. Women may not breast-feed while on this study.\n5. Patients with current active infections requiring anti-infectious treatment (e.g., antibiotics, antivirals, or antifungals).\n6. Patients with current peripheral neuropathy of any etiology that is greater than grade 1.\n7. Patients with unstable or serious concurrent medical conditions.\n8. Patients with a known hypersensitivity to Cremophor.\n9. Patients with Gilbert's syndrome.\n10. Patients must not have had major surgery within the past 14 days.\n11. Patients must not receive any concurrent chemotherapy, radiotherapy, or immunotherapy while on study.\n12. No known HIV disease or infection.\n13. Patients receiving ketoconazole, erythromycin, verapamil, diazepam, quinidine, or diltiazem."}, 'identificationModule': {'nctId': 'NCT00243867', 'briefTitle': 'Taxoprexin Plus Carboplatin Treatment for Advanced Lung Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'American Regent, Inc.'}, 'officialTitle': 'A Phase III, Randomized, Study of Weekly Taxoprexin Plus Carboplatin Versus Paclitaxel Plus Carboplatin as First Line Chemotherapy in Patients With Advanced Non-Small Cell Lung Cancer', 'orgStudyIdInfo': {'id': 'P01-04-20'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Taxoprexin® and carboplatin', 'description': 'Taxoprexin® 400 mg/m² intravenously weekly for 5 weeks\n\nCarboplatin was given at an Area Under the Curve (AUC) = 4 mg\\*min/mL on Week 1 and Week 4, Taxoprexin and carboplatin were given up to 3 treatment cycles.', 'interventionNames': ['Drug: Taxoprexin', 'Drug: Carboplatin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Paclitaxel and carboplatin', 'description': 'Paclitaxel 225 mg/m² intravenously followed immediately by carboplatin AUC = 6 mg\\*min/mL. Paclitaxel and carboplatin were given up to 6 treatment cycles.', 'interventionNames': ['Drug: Carboplatin', 'Drug: Paclitaxel']}], 'interventions': [{'name': 'Taxoprexin', 'type': 'DRUG', 'otherNames': ['Docosahexaenoic acid (DHA)-paclitaxel'], 'description': 'Administered by intravenous infusion over 1 hour infusion', 'armGroupLabels': ['Taxoprexin® and carboplatin']}, {'name': 'Carboplatin', 'type': 'DRUG', 'otherNames': ['Paraplatin'], 'description': 'Administered by intravenous infusion over 30 minutes. Dosing was based on the Calvert formula: carboplatin dose (mg) = (Target AUC) x (glomerular filtration rate (GFR) + 25).', 'armGroupLabels': ['Paclitaxel and carboplatin', 'Taxoprexin® and carboplatin']}, {'name': 'Paclitaxel', 'type': 'DRUG', 'otherNames': ['Taxol'], 'description': 'Administered by intravenous infusion over 3 hour infusion', 'armGroupLabels': ['Paclitaxel and carboplatin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75201', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'US Oncology', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Mark A Falone, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'American Regent, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'American Regent, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}