Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2025-12-26 @ 2:43 AM
Study NCT ID:
NCT00606502
Status:
COMPLETED
Last Update Posted:
2021-03-05
First Post:
2008-01-22
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study of Pralatrexate vs. Erlotinib for Non-Small Cell Lung Cancer After at Least 1 Prior Platinum-based Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012907', 'term': 'Smoking'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial 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'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C418863', 'term': '10-propargyl-10-deazaaminopterin'}, {'id': 'D000069347', 'term': 'Erlotinib Hydrochloride'}, {'id': 'D014805', 'term': 'Vitamin B 12'}, {'id': 'D005492', 'term': 'Folic Acid'}], 'ancestors': [{'id': 'D011799', 'term': 'Quinazolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D045728', 'term': 'Corrinoids'}, {'id': 'D045725', 'term': 'Tetrapyrroles'}, {'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'gweems@allos.com', 'phone': '303-426-6262', 'title': 'Medical Monitor', 'organization': 'Allos Therapeutics, Inc'}, 'certainAgreement': {'otherDetails': 'Allos agreements with investigators (PIs) may vary. The PI may publish/make public data from the study after the earlier of publication by Allos or 24 months after database lock. Allos is allowed 60 days to review and comment on the communication prior to public release. Allos can request removal of confidential information (other than study results).', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The date of the CRF database cut-off for patients (no further case report form or query data entry) was 24 Jun 2010. As of the CRF data cut-off date, 3 patients, remained on therapy.'}}, 'adverseEventsModule': {'timeFrame': 'Assessed every 2 weeks while on treatment through safety follow-up visit (35 +/-5 days post-last dose) or early termination visit (at time of withdrawal).', 'description': 'Events reported for all patients who received at least one dose of Pralatrexate or Erlotinib.', 'eventGroups': [{'id': 'EG000', 'title': 'Pralatrexate', 'otherNumAtRisk': 97, 'otherNumAffected': 91, 'seriousNumAtRisk': 97, 'seriousNumAffected': 31}, {'id': 'EG001', 'title': 'Erlotinib', 'otherNumAtRisk': 101, 'otherNumAffected': 94, 'seriousNumAtRisk': 101, 'seriousNumAffected': 32}], 'otherEvents': [{'term': 'stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 62}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 32}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'dermatitis acneiform', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 28}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 21}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 9}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 16}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 22}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 17}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 19}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 10}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 12}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}], 'seriousEvents': [{'term': 'dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'acute respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'anal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'chest wall abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'pulmonary sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'multimorbidity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'sudden death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'flank pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'arterial thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'bile duct obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'hyperbilirubinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'cancer pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'renal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Survival (OS) of Patients Receiving Pralatrexate vs. Erlotinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pralatrexate'}, {'id': 'OG001', 'title': 'Erlotinib'}], 'classes': [{'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000', 'lowerLimit': '5.3', 'upperLimit': '9.0'}, {'value': '7.0', 'groupId': 'OG001', 'lowerLimit': '3.9', 'upperLimit': '7.9'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.84', 'ciLowerLimit': '0.61', 'ciUpperLimit': '1.14', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Assessed from date of randomization no less frequently than every 16 weeks for up to 2 years after randomization.', 'description': 'OS was defined as the length of time from randomization until death due to any cause. Patients who were alive at the time of the data cut-off date were censored at the last contact date.', 'unitOfMeasure': 'Months Survival', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'anticipatedPostingDate': '2012-12'}, {'type': 'SECONDARY', 'title': 'Response Rate (RR) to Treatment of Patients Receiving Pralatrexate vs. Erlotinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pralatrexate'}, {'id': 'OG001', 'title': 'Erlotinib'}], 'classes': [{'title': 'Complete + Partial Response', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Complete Response (CR)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Partial Response (PR)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Stable Disease (SD)', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}, {'title': 'Progressive Disease (PD)', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}]}, {'title': 'Disease Control (CR+PR+SD)', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}]}, {'title': 'Unable to Evaluate', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Missing (off or no treatment, not confirmed)', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Assessed every 8 weeks for the first 24 weeks, then every 16 weeks for up to 2 years or until PD or start of subsequent treatment.', 'description': 'Number of patients whose tumors responded to Pralatrexate or Erlotinib, using the Response Criteria in Solid Tumors (RECIST).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Based on all treated patients with measurable disease at baseline. Patients who were declared unevaluable for response were considered nonresponders and were included in the calculation of response rate. Patients were unevaluable if they were off-treatment prior to first response assessment, never received treatment or had unconfirmed responses.'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival (PFS) of Patients Receiving Pralatrexate vs. Erlotinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pralatrexate'}, {'id': 'OG001', 'title': 'Erlotinib'}], 'classes': [{'categories': [{'measurements': [{'value': '3.4', 'groupId': 'OG000', 'lowerLimit': '2.1', 'upperLimit': '4.7'}, {'value': '2.8', 'groupId': 'OG001', 'lowerLimit': '2.1', 'upperLimit': '3.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Assessed every 8 weeks for the first 24 weeks, then every 16 weeks for up to 2 years or until PD or start of subsequent treatment.', 'description': 'PFS was calculated as the number of days from randomization to the date of radiological evidence of PD or death due to any cause.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who were alive without a disease response assessment of PD as of the data cut-off date were censored at the last disease assessment date or the date of randomization, whichever was later. Patients with no response assessments after baseline were censored at date of randomization resulting in a duration of PFS of 1 day.'}, {'type': 'SECONDARY', 'title': 'Adverse Events of Patients Receiving Pralatrexate vs. Erlotinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pralatrexate'}, {'id': 'OG001', 'title': 'Erlotinib'}], 'classes': [{'title': 'At least one AE', 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 AEs', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Grade 4 AEs', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'At least one SAE', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Assessed every 2 weeks while on treatment through safety follow-up visit (35 +/-5 days post-last dose) or early termination visit (at time of withdrawal).', 'unitOfMeasure': 'Treated Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Adverse Events (AEs) and Serious AEs (SAEs) are presented regardless of causality for patients who received at least one dose of Pralatrexate or Erlotinib. Events were graded by the investigator using the NCI CTCAE Scale (version 3.0) which provides a grading scale for each AE term.\n\nGrade 3 = Severe\n\nGrade 4 = Life-threatening or disabling'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pralatrexate', 'description': '190 or 230 mg/m2 starting dose with increases or decreases to 150 to 270 mg/m2 per protocol, administered as an IV push over 3-5 minutes on days 1 and 15 of a 4-week cycle (ie, every 2 weeks)'}, {'id': 'FG001', 'title': 'Erlotinib', 'description': '150 mg tablet taken orally daily'}], 'periods': [{'title': 'Randomization', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '100'}, {'groupId': 'FG001', 'numSubjects': '101'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '97'}, {'groupId': 'FG001', 'numSubjects': '101'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Randomized but not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Treatment', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '97'}, {'groupId': 'FG001', 'numSubjects': '101'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '97'}, {'groupId': 'FG001', 'numSubjects': '98'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Treatment ongoing at time of data cutoff', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'Patients were enrolled between January 2008 and June 2009 across 43 study sites in 6 countries.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}, {'value': '101', 'groupId': 'BG001'}, {'value': '201', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Pralatrexate'}, {'id': 'BG001', 'title': 'Erlotinib'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Between 18 and 65 years', 'categories': [{'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}]}]}, {'title': '>=65 years', 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.0', 'spread': '9.0', 'groupId': 'BG000'}, {'value': '62.0', 'spread': '9.1', 'groupId': 'BG001'}, {'value': '63.0', 'spread': '9.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '137', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}]}, {'title': 'Czech Republic', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}]}, {'title': 'Hungary', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}, {'title': 'India', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}, {'title': 'Brazil', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}, {'title': 'Argentina', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 201}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2010-06-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-08', 'studyFirstSubmitDate': '2008-01-22', 'resultsFirstSubmitDate': '2010-12-22', 'studyFirstSubmitQcDate': '2008-02-01', 'lastUpdatePostDateStruct': {'date': '2021-03-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2010-12-22', 'studyFirstPostDateStruct': {'date': '2008-02-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-01-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival (OS) of Patients Receiving Pralatrexate vs. Erlotinib', 'timeFrame': 'Assessed from date of randomization no less frequently than every 16 weeks for up to 2 years after randomization.', 'description': 'OS was defined as the length of time from randomization until death due to any cause. Patients who were alive at the time of the data cut-off date were censored at the last contact date.'}], 'secondaryOutcomes': [{'measure': 'Response Rate (RR) to Treatment of Patients Receiving Pralatrexate vs. Erlotinib', 'timeFrame': 'Assessed every 8 weeks for the first 24 weeks, then every 16 weeks for up to 2 years or until PD or start of subsequent treatment.', 'description': 'Number of patients whose tumors responded to Pralatrexate or Erlotinib, using the Response Criteria in Solid Tumors (RECIST).'}, {'measure': 'Progression-free Survival (PFS) of Patients Receiving Pralatrexate vs. Erlotinib', 'timeFrame': 'Assessed every 8 weeks for the first 24 weeks, then every 16 weeks for up to 2 years or until PD or start of subsequent treatment.', 'description': 'PFS was calculated as the number of days from randomization to the date of radiological evidence of PD or death due to any cause.'}, {'measure': 'Adverse Events of Patients Receiving Pralatrexate vs. Erlotinib', 'timeFrame': 'Assessed every 2 weeks while on treatment through safety follow-up visit (35 +/-5 days post-last dose) or early termination visit (at time of withdrawal).'}]}, 'conditionsModule': {'keywords': ['Stage IIIB/IV non-small cell lung cancer', 'Non-small cell lung cancer', 'NSCLC', 'Lung Cancer', 'Pralatrexate', 'Erlotinib', 'Tarceva', 'PDX', 'Smoking', 'Smoker'], 'conditions': ['Non-small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this clinical study is to determine the effectiveness (ability to provide beneficial treatment of the disease) and safety of pralatrexate compared to erlotinib when given to non-small cell lung cancer (NSCLC) patients who are current or former cigarette smokers and who have received at least 1 prior treatment with a platinum drug (cisplatin or carboplatin)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed Stage IIIB/ IV non-small cell lung cancer (NSCLC).\n* Relapsed after treatment with 1 or 2 prior chemotherapy regimens, including at least 1 platinum-based treatment. Patients may have received pemetrexed as 1 of the prior therapies. Patients may not have received investigational therapy as their only prior therapy.\n* Recovered from the toxic effects of prior therapy.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Smoked ≥ 100 cigarettes in their lifetime, whether a former or current cigarette smoker.\n* Adequate blood, liver and kidney function as defined by laboratory values.\n* Received 1-1.25 mg daily oral folic acid for at least 7 days prior to randomization and 1 mg intramuscular injection of vitamin B12 within 10 weeks prior to randomization.\n* Women of childbearing potential must use medically acceptable birth control and have a negative serum pregnancy test within 14 days prior to randomization. Patients who are postmenopausal for at least 1 year (\\> 12 months since last menses) or are surgically sterilized do not require this test.\n* Men who are not surgically sterile must use medically safe and effective birth control from the time of study randomization, and agree to continue practicing until at least 90 days after the last administration of study treatment.\n* Accessible for repeat dosing and follow-up.\n* Give written informed consent.\n\nExclusion Criteria:\n\n* Active concurrent primary malignancy (except non-melanoma skin cancer or in situ carcinoma of the cervix). If there is a history of prior malignancy, the patient must be disease-free for ≥ 5 years. Patients with other prior malignancies less than 5 years before study entry may still be enrolled if they have received treatment resulting in complete resolution of the cancer and currently have no evidence of active or recurrent disease.\n* Use of investigational drugs, biologics, or devices within 4 weeks prior to randomization.\n* Previous exposure to pralatrexate or erlotinib.\n* Women who are pregnant or breastfeeding.\n* Congestive Heart Failure Class III/IV according to New York Heart Association (NYHA) Functional Classification.\n* Uncontrolled hypertension.\n* Human immunodeficiency virus (HIV)-positive diagnosis with a CD4 count of \\<100 mm3 or detectable viral load within the past 3 months, and is receiving combination anti-retroviral therapy.\n* Symptomatic central nervous system metastases or lesions for which treatment is required.\n* Major surgery within 2 weeks of study randomization.\n* Receipt of any conventional systemic chemotherapy within 4 weeks (6 weeks for nitrosoureas, mitomycin C), or radiation therapy (RT) within 2 weeks, prior to randomization.\n* Active infection or any serious underlying medical condition, which would impair the ability of the patient to receive protocol treatment.\n* Dementia or significantly altered mental status that would prohibit the understanding and giving of informed consent or limit study compliance.'}, 'identificationModule': {'nctId': 'NCT00606502', 'briefTitle': 'Study of Pralatrexate vs. Erlotinib for Non-Small Cell Lung Cancer After at Least 1 Prior Platinum-based Treatment', 'organization': {'class': 'INDUSTRY', 'fullName': 'Spectrum Pharmaceuticals, Inc'}, 'officialTitle': 'A Randomized, Phase 2b, Multi-center Study of Pralatrexate Versus Erlotinib in Patients With Stage IIIB/IV Non-small Cell Lung Cancer After Failure of at Least 1 Prior Platinum-based Treatment', 'orgStudyIdInfo': {'id': 'PDX-012'}, 'secondaryIdInfos': [{'id': '2007-004673-26', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pralatrexate', 'description': 'Intravenous (IV) push administration over 3-5 minutes into a patent IV line containing normal saline (0.9% sodium chloride).', 'interventionNames': ['Drug: Pralatrexate', 'Dietary Supplement: Vitamin B12', 'Dietary Supplement: Folic Acid']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Erlotinib', 'description': '150 mg orally in tablet form\n\nAdministered daily 1 hour before or 2 hours after ingestion of food until criteria for discontinuation per the protocol are met.', 'interventionNames': ['Drug: Erlotinib', 'Dietary Supplement: Vitamin B12', 'Dietary Supplement: Folic Acid']}], 'interventions': [{'name': 'Pralatrexate', 'type': 'DRUG', 'otherNames': ['FOLOTYN', 'PDX', '(RS)-10-propargyl-10-deazaaminopterin'], 'description': 'Intravenous (IV) push administration over 3-5 minutes into a patent IV line containing normal saline (0.9% sodium chloride).\n\nInitial dose: 230 mg/m2, increased to 270 mg/m2 if patient does not have specific adverse events (AEs) as per the protocol after receipt of 2 consecutive doses 2 weeks apart. Reductions allowed in 40 mg/m2 decrements to 190 mg/m2 per the protocol defined dose modifications.\n\nProtocol amended dose: 190 mg/m2, then 230 mg/m2 if patient does not have specific AEs per the protocol after receipt of 2 consecutive doses 2 weeks apart. Reductions allowed in 40 mg/2 decrements to 150 mg/m2 per the protocol defined dose modifications.\n\nAdministered on days 1 and 15 of a 4-week cycle (every 2 weeks) until criteria for discontinuation per the protocol are met.', 'armGroupLabels': ['Pralatrexate']}, {'name': 'Erlotinib', 'type': 'DRUG', 'otherNames': ['Tarceva®', 'Erlotinib hydrochloride'], 'description': '150 mg orally in tablet form\n\nAdministered daily 1 hour before or 2 hours after ingestion of food until criteria for discontinuation per the protocol are met.', 'armGroupLabels': ['Erlotinib']}, {'name': 'Vitamin B12', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Cyanocobalamin'], 'description': '1 mg intramuscular injection\n\nAdministered within 10 weeks of randomization, every 8-10 weeks throughout the study and for at least 30 days after last dose of study treatment.', 'armGroupLabels': ['Erlotinib', 'Pralatrexate']}, {'name': 'Folic Acid', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Vitamin B9', 'Folate', 'Folacin'], 'description': '1-1.25 mg orally\n\nAdministered daily for at least 7 days prior to randomization, throughout the study and for at least 30 days after last dose of study treatment.', 'armGroupLabels': ['Erlotinib', 'Pralatrexate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93309', 'city': 'Bakersfield', 'state': 'California', 'country': 'United States', 'facility': 'Comprehensive Blood and Cancer Center', 'geoPoint': {'lat': 35.37329, 'lon': -119.01871}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Sharp Memorial Hospital', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '34952', 'city': 'Port Saint Lucie', 'state': 'Florida', 'country': 'United States', 'facility': 'Hematology Oncology Associates of the Treasure Coast', 'geoPoint': {'lat': 27.29393, 'lon': -80.35033}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University Feinberg School of Medicine', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '66205', 'city': 'Westwood', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Cancer Center', 'geoPoint': {'lat': 39.04056, 'lon': -94.6169}}, {'zip': '59405', 'city': 'Great Falls', 'state': 'Montana', 'country': 'United States', 'facility': 'Donald Berdeaux', 'geoPoint': {'lat': 47.50024, 'lon': -111.30081}}, {'zip': '07922', 'city': 'Berkeley Heights', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Summit Medical Group', 'geoPoint': {'lat': 40.68343, 'lon': -74.44265}}, {'zip': '08060', 'city': 'Mount Holly', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Hematology and Oncology Associates South Jersey', 'geoPoint': {'lat': 39.99289, 'lon': -74.78766}}, {'zip': '12110', 'city': 'Latham', 'state': 'New York', 'country': 'United States', 'facility': 'New York Oncology Hematology-Oncology Associates, P.C.', 'geoPoint': {'lat': 42.74702, 'lon': -73.75901}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan-Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '28562', 'city': 'New Bern', 'state': 'North Carolina', 'country': 'United States', 'facility': 'New Bern Cancer Care', 'geoPoint': {'lat': 35.10849, 'lon': -77.04411}}, {'zip': '45042', 'city': 'Middletown', 'state': 'Ohio', 'country': 'United States', 'facility': 'Signal Point Clinical Research Center', 'geoPoint': {'lat': 39.51506, 'lon': -84.39828}}, {'zip': '37920', 'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Baptist Regional Cancer Center', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Cancer Therapy and Research Center', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '98201', 'city': 'Everett', 'state': 'Washington', 'country': 'United States', 'facility': 'Providence Everett Medical Center', 'geoPoint': {'lat': 47.97898, 'lon': -122.20208}}, {'zip': 'B8000FJI', 'city': 'Bahía Blanca', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Policlinica Privada - 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