Ignite Creation Date:
2025-12-24 @ 7:09 PM
Ignite Modification Date:
2025-12-29 @ 3:21 AM
Study NCT ID:
NCT00871403
Status:
COMPLETED
Last Update Posted:
2013-06-20
First Post:
2009-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Pazopanib and Pemetrexed in Advanced Non-small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Belgium', 'France', 'Germany', 'Italy', 'Netherlands', 'Spain']}, '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': 'C516667', 'term': 'pazopanib'}, {'id': 'D000068437', 'term': 'Pemetrexed'}, {'id': 'D002945', 'term': 'Cisplatin'}], 'ancestors': [{'id': 'D006147', 'term': 'Guanine'}, {'id': 'D007042', 'term': 'Hypoxanthines'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005971', 'term': 'Glutamates'}, {'id': 'D024342', 'term': 'Amino Acids, Acidic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000600', 'term': 'Amino Acids, Dicarboxylic'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '866-435-7343', 'title': 'GSK Response Center', 'organization': 'GlaxoSmithKline'}, 'certainAgreement': {'otherDetails': 'GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Efficacy data were only summarized for the pazopanib (pazo.) 800 mg + pemetrexed (peme.) 500 mg/m\\^2 and the cisplatin 75 mg/m\\^2 + peme. 500 mg/m\\^2 arms due to the small sample size/short treatment duration in the pazo. 600 mg + peme. 500 mg/m\\^2 arm.'}}, 'adverseEventsModule': {'description': 'Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.', 'eventGroups': [{'id': 'EG000', 'title': 'Pazopanib 600 mg Plus Pemetrexed 500 mg/m^2', 'description': 'Oral pazopanib 600 milligrams (mg) once daily plus intravenous pemetrexed 500 mg/meters squared (m\\^2) once every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase.', 'otherNumAtRisk': 8, 'otherNumAffected': 7, 'seriousNumAtRisk': 8, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Pazopanib 800 mg Plus Pemetrexed 500 mg/m^2', 'description': 'Oral pazopanib 800 mg once daily plus intravenous (IV) pemetrexed 500 mg/ m\\^2 once every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase. If participants experienced no disease progression, unacceptable toxicities, or death during the Combination Treatment Phase, they continued on pazopanib 800 mg monotherapy until disease progression, unacceptable toxicities, or death.', 'otherNumAtRisk': 61, 'otherNumAffected': 59, 'seriousNumAtRisk': 61, 'seriousNumAffected': 34}, {'id': 'EG002', 'title': 'Cisplatin 75 mg/m^2 Plus Pemetrexed 500 mg/m^2', 'description': 'IV cisplatin 75 mg/m\\^2 plus intravenous pemetrexed 500 mg/m\\^2 once daily every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase. Until Protocol Amendment 2, upon disease progression participants had the opportunity to receive pazopanib 800 mg monotherapy if the investigator considered it an appropriate treatment option after considering alternative options for second-line treatment.', 'otherNumAtRisk': 34, 'otherNumAffected': 32, 'seriousNumAtRisk': 34, 'seriousNumAffected': 12}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 21}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 36}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 9}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 8}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 7}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 10}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Thrombocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pruritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hair colour changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Palmar-plantar erythrodysaesthesia syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Night sweats', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Blood lactate dehydrogenase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Creatinine renal clearance decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Transaminases increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 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'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Necrotising fascitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumonitis chemical', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Prostatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Spinal cord compression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Tumour embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vasculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression-free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pazopanib 800 mg Plus Pemetrexed 500 mg/m^2', 'description': 'Oral pazopanib 800 mg once daily plus intravenous (IV) pemetrexed 500 mg/ m\\^2 once every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase. If participants experienced no disease progression, unacceptable toxicities, or death during the Combination Treatment Phase, they continued on pazopanib 800 mg monotherapy until disease progression, unacceptable toxicities, or death.'}, {'id': 'OG001', 'title': 'Cisplatin 75 mg/m^2 Plus Pemetrexed 500 mg/m^2', 'description': 'IV cisplatin 75 mg/m\\^2 plus intravenous pemetrexed 500 mg/m\\^2 once daily every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase. Until Protocol Amendment 2, upon disease progression participants had the opportunity to receive pazopanib 800 mg monotherapy if the investigator considered it an appropriate treatment option after considering alternative options for second-line treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000', 'lowerLimit': '17.3', 'upperLimit': '34.1'}, {'value': '22.9', 'groupId': 'OG001', 'lowerLimit': '18.4', 'upperLimit': '27.7'}]}]}], 'analyses': [{'pValue': '0.2647', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.75', 'ciLowerLimit': '0.43', 'ciUpperLimit': '1.28', 'estimateComment': 'The hazard ratios is estimated using a Pike estimator. The estimated value is the hazard ratio comparing Pazopanib 800 mg plus pemetrexed 500 mg/m\\^2 to Cisplatin 75 mg/m\\^2 plus pemetrexed 500 mg/m\\^2.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Randomization until progression or death (up to 85 weeks)', 'description': 'PFS is defined as the interval between the date of randomization (date on which the investigator evaluated the participant and first determined he/she had disease progression) and the first occurrence of progressive disease (PD) or death from any cause. Per Response Evaluation Criteria in Solid Tumors (RECIST), version 1, PD is defined as a \\>=20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of \\>=1 new lesion).', 'unitOfMeasure': 'weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: all participants randomized to receive treatment and who were analyzed based on the assigned randomized treatment and not based on actual treatment received/not received. Participants who had neither progressed nor died were censored at the date of the last adequate tumor assessment at the time of the cut-off.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pazopanib 800 mg Plus Pemetrexed 500 mg/m^2', 'description': 'Oral pazopanib 800 mg once daily plus intravenous (IV) pemetrexed 500 mg/ m\\^2 once every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase. If participants experienced no disease progression, unacceptable toxicities, or death during the Combination Treatment Phase, they continued on pazopanib 800 mg monotherapy until disease progression, unacceptable toxicities, or death.'}, {'id': 'OG001', 'title': 'Cisplatin 75 mg/m^2 Plus Pemetrexed 500 mg/m^2', 'description': 'IV cisplatin 75 mg/m\\^2 plus intravenous pemetrexed 500 mg/m\\^2 once daily every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase. Until Protocol Amendment 2, upon disease progression participants had the opportunity to receive pazopanib 800 mg monotherapy if the investigator considered it an appropriate treatment option after considering alternative options for second-line treatment.'}], 'timeFrame': 'Randomization until death (up to 85 weeks)', 'description': 'OS was determined from the date of randomization to the date of death from any cause. Participants who had not died at the time of the cut-off for the final analysis were censored at the date the participants were last known to be alive. Because enrollment in the study was halted prematurely, the ability to achieve an estimate of OS was compromised. Consequently, OS was not estimated.', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Best Overall Response, Assessed as the Number of Participants With the Indicated Tumor Response: Investigator Assessed Only', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pazopanib 800 mg Plus Pemetrexed 500 mg/m^2', 'description': 'Oral pazopanib 800 mg once daily plus intravenous (IV) pemetrexed 500 mg/ m\\^2 once every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase. If participants experienced no disease progression, unacceptable toxicities, or death during the Combination Treatment Phase, they continued on pazopanib 800 mg monotherapy until disease progression, unacceptable toxicities, or death.'}, {'id': 'OG001', 'title': 'Cisplatin 75 mg/m^2 Plus Pemetrexed 500 mg/m^2', 'description': 'IV cisplatin 75 mg/m\\^2 plus intravenous pemetrexed 500 mg/m\\^2 once daily every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase. Until Protocol Amendment 2, upon disease progression participants had the opportunity to receive pazopanib 800 mg monotherapy if the investigator considered it an appropriate treatment option after considering alternative options for second-line treatment.'}], 'classes': [{'title': 'Complete response', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Partial response', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Stable disease', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Progressive disease', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Randomization until response or progressive disease (up to 85 weeks)', 'description': 'Tumor response was assessed by the Investigator according to the RECIST, version 1.0. A participant was defined as a responder if he/she sustained a complete response (CR; the disappearance of all target lesions) or partial response (PR; \\>=30% decrease in the sum of the longest diameter of target lesions) for at least 4 weeks at any time during randomized treatment. Stable disease is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. A participant without a post-baseline assessment of response was considered to be a non-responder; i.e., all randomized participants are included in the denominator.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Complete Response or a Partial Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pazopanib 800 mg Plus Pemetrexed 500 mg/m^2', 'description': 'Oral pazopanib 800 mg once daily plus intravenous (IV) pemetrexed 500 mg/ m\\^2 once every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase. If participants experienced no disease progression, unacceptable toxicities, or death during the Combination Treatment Phase, they continued on pazopanib 800 mg monotherapy until disease progression, unacceptable toxicities, or death.'}, {'id': 'OG001', 'title': 'Cisplatin 75 mg/m^2 Plus Pemetrexed 500 mg/m^2', 'description': 'IV cisplatin 75 mg/m\\^2 plus intravenous pemetrexed 500 mg/m\\^2 once daily every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase. Until Protocol Amendment 2, upon disease progression participants had the opportunity to receive pazopanib 800 mg monotherapy if the investigator considered it an appropriate treatment option after considering alternative options for second-line treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2113', 'groupIds': ['OG000', 'OG001'], 'paramType': 'percent difference in response', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12.0', 'ciLowerLimit': '-30.6', 'ciUpperLimit': '7.2', 'estimateComment': 'The estimated value is the percent difference in the response rate comparing Pazopanib 800 mg plus pemetrexed 500 mg/m\\^2 to Cisplatin 75 mg/m\\^2 plus pemetrexed 500 mg/m\\^2.', 'statisticalMethod': 'Binomial asymptotic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Randomization until response or progressive disease (up to 85 weeks)', 'description': 'The percentage of participants with a complete response or a partial response was evaluated.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pazopanib 600 mg Plus Pemetrexed 500 mg/m^2', 'description': 'Oral pazopanib 600 milligrams (mg) once daily plus intravenous pemetrexed 500 mg/meters squared (m\\^2) once every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase.'}, {'id': 'FG001', 'title': 'Pazopanib 800 mg Plus Pemetrexed 500 mg/m^2', 'description': 'Oral pazopanib 800 mg once daily plus intravenous (IV) pemetrexed 500 mg/ m\\^2 once every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase. If participants experienced no disease progression, unacceptable toxicities, or death during the Combination Treatment Phase, they continued on pazopanib 800 mg monotherapy until disease progression, unacceptable toxicities, or death.'}, {'id': 'FG002', 'title': 'Cisplatin 75 mg/m^2 Plus Pemetrexed 500 mg/m^2', 'description': 'IV cisplatin 75 mg/m\\^2 plus intravenous pemetrexed 500 mg/m\\^2 once daily every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase. Until Protocol Amendment 2, upon disease progression participants had the opportunity to receive pazopanib 800 mg monotherapy if the investigator considered it an appropriate treatment option after considering alternative options for second-line treatment.'}], 'periods': [{'title': 'Combination Treatment Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '62'}, {'groupId': 'FG002', 'numSubjects': '35'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'No particiapants completed Combination Treatement.', 'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'These participants completed combination treatment', 'groupId': 'FG001', 'numSubjects': '13'}, {'comment': 'These participants completed combination treatment', 'groupId': 'FG002', 'numSubjects': '23'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '49'}, {'groupId': 'FG002', 'numSubjects': '12'}]}], 'dropWithdraws': [{'type': 'Randomized but Not Treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Treatment Stopped; Protocol Amendment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Disease Progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}]}]}, {'title': 'Monotherapy Treatment Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Disease Progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Per protocol, the study had 2 treatment arms: Arm 1, investigational (pazopanib+pemetrexed); and Arm 2, standard of care (cisplatin+pemetrexed). Protocol amendment 1 lowered the pazopanib starting dose (SD) for new Arm 1 participants from 800 to 600 milligrams. For clarity, safety/demography data for these different SDs are presented separately.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '106', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Pazopanib 600 mg Plus Pemetrexed 500 mg/m^2', 'description': 'Oral pazopanib 600 milligrams (mg) once daily plus intravenous pemetrexed 500 mg/meters squared (m\\^2) once every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase.'}, {'id': 'BG001', 'title': 'Pazopanib 800 mg Plus Pemetrexed 500 mg/m^2', 'description': 'Oral pazopanib 800 mg once daily plus intravenous (IV) pemetrexed 500 mg/ m\\^2 once every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase. If participants experienced no disease progression, unacceptable toxicities, or death during the Combination Treatment Phase, they continued on pazopanib 800 mg monotherapy until disease progression, unacceptable toxicities, or death.'}, {'id': 'BG002', 'title': 'Cisplatin 75 mg/m^2 Plus Pemetrexed 500 mg/m^2', 'description': 'IV cisplatin 75 mg/m\\^2 plus intravenous pemetrexed 500 mg/m\\^2 once daily every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase. Until Protocol Amendment 2, upon disease progression participants had the opportunity to receive pazopanib 800 mg monotherapy if the investigator considered it an appropriate treatment option after considering alternative options for second-line treatment.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.4', 'spread': '14.32', 'groupId': 'BG000'}, {'value': '60.8', 'spread': '8.27', 'groupId': 'BG001'}, {'value': '61.8', 'spread': '9.35', 'groupId': 'BG002'}, {'value': '61.1', 'spread': '9.16', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '69', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'African American/African Heritage', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'Asian - Central/South Asian Heritage', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'White - Arabic/North African Heritage', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}, {'title': 'White - White/Caucasian/European Heritage', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '100', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 107}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-12', 'studyFirstSubmitDate': '2009-03-26', 'resultsFirstSubmitDate': '2012-01-26', 'studyFirstSubmitQcDate': '2009-03-26', 'lastUpdatePostDateStruct': {'date': '2013-06-20', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-01-26', 'studyFirstPostDateStruct': {'date': '2009-03-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-02-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free Survival (PFS)', 'timeFrame': 'Randomization until progression or death (up to 85 weeks)', 'description': 'PFS is defined as the interval between the date of randomization (date on which the investigator evaluated the participant and first determined he/she had disease progression) and the first occurrence of progressive disease (PD) or death from any cause. Per Response Evaluation Criteria in Solid Tumors (RECIST), version 1, PD is defined as a \\>=20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of \\>=1 new lesion).'}], 'secondaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': 'Randomization until death (up to 85 weeks)', 'description': 'OS was determined from the date of randomization to the date of death from any cause. Participants who had not died at the time of the cut-off for the final analysis were censored at the date the participants were last known to be alive. Because enrollment in the study was halted prematurely, the ability to achieve an estimate of OS was compromised. Consequently, OS was not estimated.'}, {'measure': 'Best Overall Response, Assessed as the Number of Participants With the Indicated Tumor Response: Investigator Assessed Only', 'timeFrame': 'Randomization until response or progressive disease (up to 85 weeks)', 'description': 'Tumor response was assessed by the Investigator according to the RECIST, version 1.0. A participant was defined as a responder if he/she sustained a complete response (CR; the disappearance of all target lesions) or partial response (PR; \\>=30% decrease in the sum of the longest diameter of target lesions) for at least 4 weeks at any time during randomized treatment. Stable disease is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started.'}, {'measure': 'Percentage of Participants With a Complete Response or a Partial Response', 'timeFrame': 'Randomization until response or progressive disease (up to 85 weeks)', 'description': 'The percentage of participants with a complete response or a partial response was evaluated.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['GW786034', 'pazopanib', 'pemetrexed', 'cisplatin', 'non-small cell lung cancer', 'NSCLC'], 'conditions': ['Lung Cancer, Non-Small Cell']}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to determine whether the combination of pazopanib and pemetrexed is safe and effective in the treatment of advanced non-small cell lung cancer (NSCLC).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Written informed consent\n* At least 18 years old\n* Histologically- or cytologically-confirmed diagnosis of predominantly nonsquamous cell Stage IIIBwet (with confirmed malignant pleural effusion) or Stage IV NSCLC\n* No prior systemic first-line therapy for advanced NSCLC\n* Measurable disease\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Life expectancy of at least 12 weeks\n* Able to swallow and retain oral medication\n* Adequate organ system function (hematological, hepatic, and renal)\n* Non-childbearing potential (i.e., physiologically incapable of becoming pregnant) OR childbearing potential, and agrees to use adequate contraception. A male with a female partner of childbearing potential is eligible if he uses a barrier method of contraception or abstinence during the study\n\nExclusion Criteria:\n\n* Active malignancy or any malignancy in the 3 years prior to first dose of study drug other than NSCLC\n* Central nervous system (CNS) metastases or leptomeningeal carcinomatosis, except for asymptomatic, previously treated CNS metastases\n* Clinically significant gastrointestinal abnormalities\n* Prolongation of corrected QT interval (QTc) \\> 480 msecs\n* History of any one or more cardiovascular conditions within the past 6 months prior to randomization\n* Poorly controlled hypertension\n* History of cerebrovascular accident (including transient ischemic attacks), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months\n* Major surgery or trauma within 28 days or any non-healing wound, fracture, or ulcer\n* Evidence of active bleeding or bleeding diathesis\n* Recent hemoptysis\n* Endobronchial lesions and/or lesions infiltrating major pulmonary vessels\n* Serious and/or unstable pre-existing medical (e.g., uncontrolled infection), psychiatric, or other condition that could interfere with subject's safety, provision of informed consent, or compliance to study procedures\n* Use of any prohibited medication\n* Use of an investigational agent within 28 days or 5 half-lives, whichever is longer, prior to the first dose of study drug\n* Ongoing toxicity from prior anti-cancer therapy that is \\>Grade 1 and/or that is progressing in severity except alopecia\n* Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib, pemetrexed, and/or cisplatin\n* Inability to interrupt aspirin or other non-steroidal anti-inflammatory drugs during the study\n* Inability or unwillingness to take folic acid, vitamin B12 supplementation, or dexamethasone\n* Clinically significant third-space fluid collections (e.g., ascites or pleural effusions) that cannot be controlled by drainage or other procedures prior to study start\n* Recent or concurrent yellow fever vaccination"}, 'identificationModule': {'nctId': 'NCT00871403', 'briefTitle': 'Study of Pazopanib and Pemetrexed in Advanced Non-small Cell Lung Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'An Open-label, Multicentre, Randomised Phase II Study of Pazopanib in Combination With Pemetrexed in First-line Treatment of Subjects With Predominantly Non-squamous Cell Stage IIIBwet/IV Non-small Cell Lung Cancer', 'orgStudyIdInfo': {'id': '111128'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'description': 'Investigational treatment (pazopanib and pemetrexed)', 'interventionNames': ['Drug: pazopanib and pemetrexed']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 2', 'description': 'Standard treatment (pemetrexed and cisplatin)', 'interventionNames': ['Drug: pemetrexed and cisplatin']}], 'interventions': [{'name': 'pazopanib and pemetrexed', 'type': 'DRUG', 'description': 'oral pazopanib 600 mg once daily and pemetrexed intravenous (IV) 500mg/m\\^2 once every 3 weeks, then pazopanib 800 mg once daily', 'armGroupLabels': ['Arm 1']}, {'name': 'pemetrexed and cisplatin', 'type': 'DRUG', 'description': 'pemetrexed IV 500 mg/m\\^2 and cisplatin IV 75 mg/m\\^2 once every 3 weeks', 'armGroupLabels': ['Arm 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2730', 'city': 'Herlev', 'country': 'Denmark', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 55.72366, 'lon': 12.43998}}, {'zip': 'SM2 5PT', 'city': 'Sutton', 'state': 'Surrey', 'country': 'United Kingdom', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 51.35, 'lon': -0.2}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}