Ignite Creation Date:
2025-12-24 @ 3:43 PM
Ignite Modification Date:
2026-02-03 @ 10:12 AM
Study NCT ID:
NCT00678392
Status:
COMPLETED
Last Update Posted:
2019-01-09
First Post:
2008-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Axitinib (AG 013736) As Second Line Therapy For Metastatic Renal Cell Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Netherlands']}, 'conditionBrowseModule': {'meshes': [{'id': 'D007680', 'term': 'Kidney Neoplasms'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077784', 'term': 'Axitinib'}, {'id': 'D000077157', 'term': 'Sorafenib'}], 'ancestors': [{'id': 'D001549', 'term': 'Benzamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D007191', 'term': 'Indazoles'}, {'id': 'D011720', 'term': 'Pyrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010671', 'term': 'Phenylurea Compounds'}, {'id': 'D014508', 'term': 'Urea'}, {'id': 'D009536', 'term': 'Niacinamide'}, {'id': 'D009539', 'term': 'Nicotinic Acids'}, {'id': 'D000147', 'term': 'Acids, Heterocyclic'}, {'id': 'D011725', 'term': 'Pyridines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From initiation of treatment up to follow-up period (up to 3 years)', 'description': 'Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.', 'eventGroups': [{'id': 'EG000', 'title': 'Axitinib 5 mg', 'description': 'Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.', 'otherNumAtRisk': 359, 'otherNumAffected': 337, 'seriousNumAtRisk': 359, 'seriousNumAffected': 146}, {'id': 'EG001', 'title': 'Sorafenib 400 mg', 'description': 'Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.', 'otherNumAtRisk': 355, 'otherNumAffected': 346, 'seriousNumAtRisk': 355, 'seriousNumAffected': 127}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 44}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 74}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 33}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 55}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 46}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 79}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 82}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 208}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 195}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 128}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 84}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 60}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 47}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 95}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 69}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 78}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 57}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 20}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 151}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 122}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 61}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 45}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 22}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 17}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 40}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Blood thyroid stimulating hormone increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 11}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Lipase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 22}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 111}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 83}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 140}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 112}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 10}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 62}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 46}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 59}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 54}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 21}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 27}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 12}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 53}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 21}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 31}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 55}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 43}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 21}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 32}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 68}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 70}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Dysphonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 116}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 49}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 64}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 53}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Dyspnoea exertional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 11}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 19}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 18}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 21}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 122}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 42}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 39}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Palmar-plantar erythrodysaesthesia syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 100}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 183}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 48}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 109}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 156}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 107}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 6}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 8}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Splenic infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Arrhythmia supraventricular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Arteriosclerosis coronary artery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Atrioventricular block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cardiopulmonary failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Congestive cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Coronary artery insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Haemorrhage coronary artery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Mitral valve 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'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pneumonia viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pulmonary tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Femoral neck fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Neutrophil count abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hypercalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hypovolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Flank pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Polyarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Spinal column stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Spondylolisthesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Metastasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Metastatic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Neoplasm progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Renal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Tumour associated fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Aphasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Balance disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Central nervous system haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cerebral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hemiparesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Leukoencephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Loss of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Meningeal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Monoplegia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Spinal cord compression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Disorientation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Acute prerenal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Nephropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Oliguria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Benign prostatic hyperplasia', 'notes': 'This event was gender specific.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 258, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Menometrorrhagia', 'notes': 'This event was gender specific.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Vaginal polyp', 'notes': 'This event was gender specific.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Dyspnoea exertional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Haemothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Lung disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pleurisy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pneumothorax spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pulmonary haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Erythema multiforme', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Palmar-plantar erythrodysaesthesia syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pustular psoriasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pain management', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Vertebroplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Accelerated hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Jugular vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Subclavian vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Gastrointestinal anastomotic leak', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Lumbar vertebral fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Radiation pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Soft tissue injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Spinal compression fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Blood lactate dehydrogenase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'C-reactive protein increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hepatic enzyme increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression-Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '362', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Axitinib 5 mg', 'description': 'Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.'}, {'id': 'OG001', 'title': 'Sorafenib 400 mg', 'description': 'Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000', 'lowerLimit': '6.3', 'upperLimit': '8.6'}, {'value': '4.7', 'groupId': 'OG001', 'lowerLimit': '4.6', 'upperLimit': '5.6'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.665', 'ciLowerLimit': '0.544', 'ciUpperLimit': '0.812', 'pValueComment': 'P-value was obtained from 1-sided log rank test, stratified by eastern cooperative oncology group (ECOG) and prior treatment. One-sided log-rank test at 0.025 level of significance was used to compare PFS between the 2 treatment arms.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'From initiation of treatment up to follow-up period (up to 3 years)', 'description': 'PFS was defined as the time in months from start of study treatment to the first documentation of objective tumor progression of disease (PD) or to death due to any cause, whichever occurs first. PD was assessed by response evaluation criteria in solid tumors (RECIST) version 1.0. PD: \\>=20 percent (%) increase in the sum of the longest dimensions (LD) of the target lesions taking as a reference the smallest sum of the LD recorded since the start of treatment or unequivocal progression in non-target lesions or the appearance of 1 or more new lesions. Occurrence of a pleural effusion or ascites was also considered PD if demonstrated by cytological investigation and it was not previously documented. New bone lesions not previously documented were considered PD if confirmed by computed tomography/magnetic resonance imaging or X-ray.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '362', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Axitinib 5 mg', 'description': 'Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.'}, {'id': 'OG001', 'title': 'Sorafenib 400 mg', 'description': 'Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.1', 'groupId': 'OG000', 'lowerLimit': '16.7', 'upperLimit': '23.4'}, {'value': '19.2', 'groupId': 'OG001', 'lowerLimit': '17.5', 'upperLimit': '22.3'}]}]}], 'analyses': [{'pValue': '0.3744', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.969', 'ciLowerLimit': '0.800', 'ciUpperLimit': '1.174', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value was obtained from a 1-sided log-rank test of treatment stratified by ECOG performance status and prior treatment.'}], 'paramType': 'MEDIAN', 'timeFrame': 'From initiation of treatment up to follow-up period (up to 3 years)', 'description': 'OS was defined as the duration from start of study treatment to date of death due to any cause. OS was calculated as (months) = (date of death minus the date of first dose of study medication plus 1) divided by 30.4. For participants who were alive, overall survival was censored on last date the participants were known to be alive.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized.'}, {'type': 'SECONDARY', 'title': 'Objective Response Rate (ORR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '362', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Axitinib 5 mg', 'description': 'Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.'}, {'id': 'OG001', 'title': 'Sorafenib 400 mg', 'description': 'Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '19.4', 'groupId': 'OG000', 'lowerLimit': '15.4', 'upperLimit': '23.9'}, {'value': '9.4', 'groupId': 'OG001', 'lowerLimit': '6.6', 'upperLimit': '12.9'}]}]}], 'analyses': [{'pValue': '0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.056', 'ciLowerLimit': '1.408', 'ciUpperLimit': '3.003', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value was obtained from a 1-sided Cochran-Mantel-Haenszel test of treatment stratified by ECOG performance status and prior treatment.'}], 'paramType': 'NUMBER', 'timeFrame': 'From initiation of treatment up to follow-up period (up to 3 years)', 'description': 'ORR = percentage of participants with confirmed complete response (CR) or confirmed partial response (PR) according to RECIST version 1.0 recorded from first dose of study treatment until PD or death due to any cause. CR: disappearance of all target, non target lesions and no appearance of new lesions, documented on 2 occasions separated by at least 4 weeks. PR: at least 30 % decrease in sum of LD of target lesions taking as reference baseline sum of LD, without progression of non target lesions, no appearance of new lesions. PD: \\>=20% increase in sum of LD of the target lesions taking as a reference smallest sum of LD recorded since the start of treatment or unequivocal progression in non-target lesions or appearance of 1 or more new lesions. Occurrence of pleural effusion or ascites if demonstrated by cytological investigation, not previously documented. New bone lesions not previously documented if confirmed by computed tomography/magnetic resonance imaging or X-ray.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized.'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '362', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Axitinib 5 mg', 'description': 'Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.'}, {'id': 'OG001', 'title': 'Sorafenib 400 mg', 'description': 'Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.0', 'comment': 'The upper limit of 95 percent confidence interval was not reached at the time of data cut-off.', 'groupId': 'OG000', 'lowerLimit': '7.4', 'upperLimit': 'NA'}, {'value': '10.6', 'groupId': 'OG001', 'lowerLimit': '8.8', 'upperLimit': '11.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From initiation of treatment up to follow-up period (up to 3 years)', 'description': 'DR: time from first documentation of objective tumor response (CR or PR), that was subsequently confirmed, to the first documentation of PD or to death due to any cause, whichever occurred first as per RECIST version 1.0, a) CR: disappearance of all target, non target lesions and no appearance of new lesions, documented on 2 occasions separated by at least 4 weeks, b) PR: at least 30 % decrease in sum of LD of target lesions taking as reference baseline sum of LD, without progression of non target lesions, no appearance of new lesions, c) PD: \\>=20% increase in sum of LD of the target lesions taking as a reference smallest sum of LD recorded since the start of treatment or unequivocal progression in non-target lesions or appearance of 1 or more new lesions. Occurrence of pleural effusion or ascites if demonstrated by cytological investigation, not previously documented. New bone lesions not previously documented if confirmed by computed tomography/magnetic resonance imaging or X-ray.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '359', 'groupId': 'OG000'}, {'value': '355', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Axitinib 5 mg', 'description': 'Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.'}, {'id': 'OG001', 'title': 'Sorafenib 400 mg', 'description': 'Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.'}], 'classes': [{'title': 'AEs', 'categories': [{'measurements': [{'value': '96.1', 'groupId': 'OG000'}, {'value': '98.0', 'groupId': 'OG001'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '40.7', 'groupId': 'OG000'}, {'value': '35.8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From initiation of treatment up to follow-up period (up to 3 years)', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life- threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious AEs.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Adverse Events (AEs) by Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '359', 'groupId': 'OG000'}, {'value': '355', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Axitinib 5 mg', 'description': 'Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.'}, {'id': 'OG001', 'title': 'Sorafenib 400 mg', 'description': 'Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.'}], 'classes': [{'title': 'Grade 1', 'categories': [{'measurements': [{'value': '3.9', 'groupId': 'OG000'}, {'value': '3.1', 'groupId': 'OG001'}]}]}, {'title': 'Grade 2', 'categories': [{'measurements': [{'value': '20.1', 'groupId': 'OG000'}, {'value': '21.7', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3', 'categories': [{'measurements': [{'value': '47.6', 'groupId': 'OG000'}, {'value': '52.4', 'groupId': 'OG001'}]}]}, {'title': 'Grade 4', 'categories': [{'measurements': [{'value': '10.6', 'groupId': 'OG000'}, {'value': '11.5', 'groupId': 'OG001'}]}]}, {'title': 'Grade 5', 'categories': [{'measurements': [{'value': '13.9', 'groupId': 'OG000'}, {'value': '9.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From initiation of treatment up to follow-up period (up to 3 years)', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Severity of the AEs was graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Grade 1= mild; Grade 2= moderate; Grade 3= severe; Grade 4= life-threatening or disabling; Grade 5= death related to AE.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '359', 'groupId': 'OG000'}, {'value': '355', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Axitinib 5 mg', 'description': 'Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.'}, {'id': 'OG001', 'title': 'Sorafenib 400 mg', 'description': 'Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.'}], 'classes': [{'title': 'AEs', 'categories': [{'measurements': [{'value': '92.2', 'groupId': 'OG000'}, {'value': '95.2', 'groupId': 'OG001'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '15.3', 'groupId': 'OG000'}, {'value': '13.8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From initiation of treatment up to follow-up period (up to 3 years)', 'description': 'An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life -threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both serious and non -serious AEs.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinically Significant Laboratory Abnormalities: Hematology', 'denoms': [{'units': 'Participants', 'counts': [{'value': '359', 'groupId': 'OG000'}, {'value': '355', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Axitinib 5 mg', 'description': 'Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.'}, {'id': 'OG001', 'title': 'Sorafenib 400 mg', 'description': 'Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.'}], 'classes': [{'title': 'Hemoglobin: Grade 1 (n =320, 316)', 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}]}, {'title': 'Hemoglobin: Grade 2 (n =320, 316)', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}]}, {'title': 'Hemoglobin: Grade 3 (n =320, 316)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Hemoglobin: Grade 4 (n =320, 316)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Lymphocytes: Grade 1 (n =317, 309)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Lymphocytes: Grade 2 (n =317, 309)', 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}]}, {'title': 'Lymphocytes: Grade 3 (n =317, 309)', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Lymphocytes: Grade 4 (n =317, 309)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Neutrophils: Grade 1 (n =316, 308)', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Neutrophils: Grade 2 (n =316, 308)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Neutrophils: Grade 3 (n =316, 308)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Neutrophils: Grade 4 (n =316, 308)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Platelets: Grade 1 (n =312, 310)', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}]}, {'title': 'Platelets: Grade 2 (n =312, 310)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Platelets: Grade 3 (n =312, 310)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Platelets: Grade 4 (n =312, 310)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'White Blood Cells: Grade 1 (n =320, 315)', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}]}, {'title': 'White Blood Cells: Grade 2 (n =320, 315)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'White Blood Cells: Grade 3 (n =320, 315)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'White Blood Cells: Grade 4 (n =320, 315)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From initiation of treatment up to follow-up period (up to 3 years)', 'description': 'Hematology laboratory test included hemoglobin, platelet count, white blood cells count, neutrophils and lymphocytes. Abnormalities were assessed by CTCAE Grade Version 2 for severity: Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received. Here, "n" signifies number of participants available for specified categories for each arm respectively.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinically Significant Laboratory Abnormalities: Biochemistry', 'denoms': [{'units': 'Participants', 'counts': [{'value': '359', 'groupId': 'OG000'}, {'value': '355', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Axitinib 5 mg', 'description': 'Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.'}, {'id': 'OG001', 'title': 'Sorafenib 400 mg', 'description': 'Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.'}], 'classes': [{'title': 'Alanine aminotransferase: Grade 1 (n =331, 313)', 'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}]}, {'title': 'Alanine aminotransferase: Grade 2 (n =331, 313)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Alanine aminotransferase: Grade 3 (n =331, 313)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Alanine aminotransferase: Grade 4 (n =331, 313)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Alkaline phosphatase: Grade 1 (n =336, 319)', 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}]}, {'title': 'Alkaline phosphatase: Grade 2 (n =336, 319)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Alkaline phosphatase: Grade 3 (n =336, 319)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Alkaline phosphatase: Grade 4 (n =336, 319)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Amylase: Grade 1 (n =338, 319)', 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}]}, {'title': 'Amylase: Grade 2 (n =338, 319)', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'Amylase: Grade 3 (n =338, 319)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Amylase: Grade 4 (n =338, 319)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Aspartate aminotransferase: Grade 1 (n =331, 311)', 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}]}, {'title': 'Aspartate aminotransferase: Grade 2 (n =331, 311)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Aspartate aminotransferase: Grade 3 (n =331, 311)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Aspartate aminotransferase: Grade 4 (n =331, 311)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Bicarbonate: Grade 1 (n =314, 291)', 'categories': [{'measurements': [{'value': '127', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}]}, {'title': 'Bicarbonate: Grade 2 (n =314, 291)', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Bicarbonate: Grade 3 (n =314, 291)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Bicarbonate: Grade 4 (n =314, 291)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Bilirubin: Grade 1 (n =336, 318)', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Bilirubin: Grade 2 (n =336, 318)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Bilirubin: Grade 3 (n =336, 318)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Bilirubin: Grade 4 (n =336, 318)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine: Grade 1 (n =336, 318)', 'categories': [{'measurements': [{'value': '155', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine: Grade 2 (n =336, 318)', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine: Grade 3 (n =336, 318)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine: Grade 4 (n =336, 318)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hypercalcemia: Grade 1 (n =336, 319)', 'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': 'Hypercalcemia: Grade 2 (n =336, 319)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Hypercalcemia: Grade 3 (n =336, 319)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hypercalcemia: Grade 4 (n =336, 319)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hyperglycemia: Grade 1 (n =336, 319)', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}, {'title': 'Hyperglycemia: Grade 2 (n =336, 319)', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}, {'title': 'Hyperglycemia: Grade 3 (n =336, 319)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Hyperglycemia: Grade 4 (n =336, 319)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hyperkalemia: Grade 1 (n =333, 314)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hyperkalemia: Grade 2 (n =333, 314)', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': 'Hyperkalemia: Grade 3 (n =333, 314)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Hyperkalemia: Grade 4 (n =333, 314)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hypernatremia: Grade 1 (n =338, 319)', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}, {'title': 'Hypernatremia: Grade 2 (n =338, 319)', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Hypernatremia: Grade 3 (n =338, 319)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Hypernatremia: Grade 4 (n =338, 319)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Hypoalbuminemia: Grade 1 (n =337, 319)', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}, {'title': 'Hypoalbuminemia: Grade 2 (n =337, 319)', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}, {'title': 'Hypoalbuminemia: Grade 3 (n =337, 319)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Hypoalbuminemia: Grade 4 (n =337, 319)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hypocalcemia: Grade 1 (n =336, 319)', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}]}, {'title': 'Hypocalcemia: Grade 2 (n =336, 319)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Hypocalcemia: Grade 3 (n =336, 319)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Hypocalcemia: Grade 4 (n =336, 319)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Hypoglycemia: Grade 1 (n =336, 319)', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Hypoglycemia: Grade 2 (n =336, 319)', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Hypoglycemia: Grade 3 (n =336, 319)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Hypoglycemia: Grade 4 (n =336, 319)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hypokalemia: Grade 1 (n =333, 314)', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'Hypokalemia: Grade 2 (n =333, 314)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hypokalemia: Grade 3 (n =333, 314)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Hypokalemia: Grade 4 (n =333, 314)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hyponatremia: Grade 1 (n =338, 319)', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}, {'title': 'Hyponatremia: Grade 2 (n =338, 319)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hyponatremia: Grade 3 (n =338, 319)', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Hyponatremia: Grade 4 (n =338, 319)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Hypophosphatemia: Grade 1 (n =336, 318)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Hypophosphatemia: Grade 2 (n =336, 318)', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}]}, {'title': 'Hypophosphatemia: Grade 3 (n =336, 318)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}]}, {'title': 'Hypophosphatemia: Grade 4 (n =336, 318)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Lipase: Grade 1 (n =338, 319)', 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}]}, {'title': 'Lipase: Grade 2 (n =338, 319)', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}, {'title': 'Lipase: Grade 3 (n =338, 319)', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}, {'title': 'Lipase: Grade 4 (n =338, 319)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From initiation of treatment up to follow-up period (up to 3 years)', 'description': 'Biochemistry laboratory test included parameters: alanine aminotransferase, alkaline phosphatase, amylase, aspartate aminotransferase, bicarbonate, bilirubin, creatinine, hypercalcemia, hyperglycemia, hyperkalemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypoglycemia, hypokalemia, hyponatremia, hypophosphatemia and lipase. Abnormalities were assessed by CTCAE Grade Version 2 for severity: Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received. Here, "n" signifies number of participants available for specified categories for each arm respectively.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinically Significant Laboratory Abnormalities: Urinalysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '359', 'groupId': 'OG000'}, {'value': '355', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Axitinib 5 mg', 'description': 'Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.'}, {'id': 'OG001', 'title': 'Sorafenib 400 mg', 'description': 'Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.'}], 'classes': [{'title': 'Urine blood/ hemoglobin: Grade 1 (n =304, 272)', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}, {'title': 'Urine blood/ hemoglobin: Grade 2 (n =304, 272)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Urine blood/ hemoglobin: Grade 3 (n =304, 272)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Urine blood/ hemoglobin: Grade 4 (n =304, 272)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Urine glucose: Grade 1 (n =322, 286)', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Urine glucose: Grade 2 (n =322, 286)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Urine glucose: Grade 3 (n =322, 286)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Urine glucose: Grade 4 (n =322, 286)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Urine protein: Grade 1 (n =326, 289)', 'categories': [{'measurements': [{'value': '105', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}]}, {'title': 'Urine protein: Grade 2 (n =326, 289)', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}, {'title': 'Urine protein: Grade 3 (n =326, 289)', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'Urine protein: Grade 4 (n =326, 289)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From initiation of treatment up to follow-up period (up to 3 years)', 'description': 'Urinalysis included urine blood/ hemoglobin, glucose and protein. Abnormalities were assessed by CTCAE Grade Version 2 for severity: Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received. Here, "n" signifies number of participants available for specified categories for each arm respectively.'}, {'type': 'SECONDARY', 'title': 'Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '362', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Axitinib 5 mg', 'description': 'Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.'}, {'id': 'OG001', 'title': 'Sorafenib 400 mg', 'description': 'Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.'}], 'classes': [{'title': 'Baseline (n =346, 342)', 'categories': [{'measurements': [{'value': '43.199', 'spread': '8.416', 'groupId': 'OG000'}, {'value': '43.339', 'spread': '8.162', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 2/Day1 (n =319, 296)', 'categories': [{'measurements': [{'value': '42.351', 'spread': '8.305', 'groupId': 'OG000'}, {'value': '41.668', 'spread': '7.696', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 3/Day1 (n =279, 246)', 'categories': [{'measurements': [{'value': '42.590', 'spread': '7.729', 'groupId': 'OG000'}, {'value': '42.424', 'spread': '7.888', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 4/Day1 (n =257, 221)', 'categories': [{'measurements': [{'value': '42.791', 'spread': '8.180', 'groupId': 'OG000'}, {'value': '43.424', 'spread': '7.345', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 5/Day1 (n =238, 203)', 'categories': [{'measurements': [{'value': '42.968', 'spread': '8.152', 'groupId': 'OG000'}, {'value': '42.907', 'spread': '7.255', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 6/Day1 (n =213, 179)', 'categories': [{'measurements': [{'value': '42.949', 'spread': '7.842', 'groupId': 'OG000'}, {'value': '43.057', 'spread': '7.724', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 7/Day1 (n =206, 158)', 'categories': [{'measurements': [{'value': '42.747', 'spread': '7.621', 'groupId': 'OG000'}, {'value': '43.578', 'spread': '7.621', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 8/Day1 (n =177, 136)', 'categories': [{'measurements': [{'value': '43.580', 'spread': '7.578', 'groupId': 'OG000'}, {'value': '44.074', 'spread': '7.757', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 9/Day1 (n =163, 118)', 'categories': [{'measurements': [{'value': '43.191', 'spread': '8.300', 'groupId': 'OG000'}, {'value': '44.518', 'spread': '6.511', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 10/Day1 (n =146, 96)', 'categories': [{'measurements': [{'value': '43.312', 'spread': '8.564', 'groupId': 'OG000'}, {'value': '44.771', 'spread': '7.155', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 11/Day1 (n =122, 85)', 'categories': [{'measurements': [{'value': '44.119', 'spread': '8.306', 'groupId': 'OG000'}, {'value': '44.438', 'spread': '7.388', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 12/Day1 (n =110, 70)', 'categories': [{'measurements': [{'value': '44.517', 'spread': '8.212', 'groupId': 'OG000'}, {'value': '44.357', 'spread': '7.247', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 13/Day1 (n =92, 58)', 'categories': [{'measurements': [{'value': '44.492', 'spread': '7.972', 'groupId': 'OG000'}, {'value': '45.261', 'spread': '7.840', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 14/Day1 (n =81, 54)', 'categories': [{'measurements': [{'value': '44.485', 'spread': '8.204', 'groupId': 'OG000'}, {'value': '44.898', 'spread': '7.495', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 15/Day1 (n =61, 38)', 'categories': [{'measurements': [{'value': '45.291', 'spread': '7.095', 'groupId': 'OG000'}, {'value': '45.053', 'spread': '6.682', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 16/Day1 (n =52, 34)', 'categories': [{'measurements': [{'value': '45.217', 'spread': '7.656', 'groupId': 'OG000'}, {'value': '44.445', 'spread': '7.160', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 17/Day1 (n =47, 28)', 'categories': [{'measurements': [{'value': '45.242', 'spread': '7.344', 'groupId': 'OG000'}, {'value': '44.438', 'spread': '7.683', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 18/Day1 (n =36, 22)', 'categories': [{'measurements': [{'value': '44.861', 'spread': '7.769', 'groupId': 'OG000'}, {'value': '44.182', 'spread': '7.228', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 19/Day1 (n =29, 14)', 'categories': [{'measurements': [{'value': '45.379', 'spread': '6.662', 'groupId': 'OG000'}, {'value': '45.026', 'spread': '7.705', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 20/Day1 (n =20, 12)', 'categories': [{'measurements': [{'value': '47.050', 'spread': '5.375', 'groupId': 'OG000'}, {'value': '44.780', 'spread': '6.689', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 21/Day1 (n =15, 7)', 'categories': [{'measurements': [{'value': '45.850', 'spread': '5.209', 'groupId': 'OG000'}, {'value': '44.494', 'spread': '6.153', 'groupId': 'OG001'}]}]}, {'title': 'End of treatment (n=163, 191)', 'categories': [{'measurements': [{'value': '38.328', 'spread': '9.472', 'groupId': 'OG000'}, {'value': '38.457', 'spread': '8.787', 'groupId': 'OG001'}]}]}, {'title': 'Follow up (n =80, 110)', 'categories': [{'measurements': [{'value': '41.919', 'spread': '8.318', 'groupId': 'OG000'}, {'value': '40.028', 'spread': '9.048', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Predose on Cycle 1 Day 1) , Day 1 of each cycle until Cycle 21, End of treatment (Day 670) and Follow-up visit (Day 698)', 'description': 'FKSI was used to assess quality of life (QoL) for those diagnosed with renal cell cancer and consisted of 15 items (lack of energy, side effects, pain, losing weight, bone pain, fatigue, enjoying life, short of breath, worsened condition, appetite, coughing, bothered by fevers, ability to work, hematuria and sleep). Each of the 15 items was answered on a 5-point Likert-type scale ranging from 0 to 4 (0= not at all, 1= a little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI score = sum of the 15 item scores; total range: 0 - 60; 0 (no symptoms) to 60 (very much); higher scores indicate greater presence of symptoms.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized. Here, "n" signifies those participants who were evaluable for the specified time points.'}, {'type': 'SECONDARY', 'title': 'Functional Assessment of Cancer Therapy Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '362', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Axitinib 5 mg', 'description': 'Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.'}, {'id': 'OG001', 'title': 'Sorafenib 400 mg', 'description': 'Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.'}], 'classes': [{'title': 'Baseline (n =346, 341)', 'categories': [{'measurements': [{'value': '28.874', 'spread': '5.187', 'groupId': 'OG000'}, {'value': '28.975', 'spread': '5.193', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 2/Day1 (n =319, 295)', 'categories': [{'measurements': [{'value': '28.211', 'spread': '4.920', 'groupId': 'OG000'}, {'value': '28.399', 'spread': '5.064', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 3/Day1 (n =279, 244)', 'categories': [{'measurements': [{'value': '28.640', 'spread': '4.837', 'groupId': 'OG000'}, {'value': '28.640', 'spread': '4.868', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 4/Day1 (n =257, 220)', 'categories': [{'measurements': [{'value': '28.822', 'spread': '4.952', 'groupId': 'OG000'}, {'value': '29.130', 'spread': '4.322', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 5/Day1 (n =238, 202)', 'categories': [{'measurements': [{'value': '28.869', 'spread': '4.880', 'groupId': 'OG000'}, {'value': '29.007', 'spread': '4.379', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 6/Day1 (n =213, 178)', 'categories': [{'measurements': [{'value': '29.159', 'spread': '4.462', 'groupId': 'OG000'}, {'value': '29.098', 'spread': '4.697', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 7/Day1 (n =206, 157)', 'categories': [{'measurements': [{'value': '29.042', 'spread': '4.581', 'groupId': 'OG000'}, {'value': '29.361', 'spread': '4.558', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 8/Day1 (n =177, 135)', 'categories': [{'measurements': [{'value': '29.520', 'spread': '4.346', 'groupId': 'OG000'}, {'value': '29.619', 'spread': '4.386', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 9/Day1 (n =163, 117)', 'categories': [{'measurements': [{'value': '29.194', 'spread': '4.937', 'groupId': 'OG000'}, {'value': '29.884', 'spread': '3.838', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 10/Day1 (n =146, 96)', 'categories': [{'measurements': [{'value': '29.343', 'spread': '4.907', 'groupId': 'OG000'}, {'value': '29.604', 'spread': '3.959', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 11/Day1 (n =122, 85)', 'categories': [{'measurements': [{'value': '29.762', 'spread': '4.943', 'groupId': 'OG000'}, {'value': '29.366', 'spread': '4.404', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 12/Day1 (n =110, 70)', 'categories': [{'measurements': [{'value': '29.764', 'spread': '4.507', 'groupId': 'OG000'}, {'value': '29.257', 'spread': '4.299', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 13/Day1 (n =92, 58)', 'categories': [{'measurements': [{'value': '29.594', 'spread': '4.205', 'groupId': 'OG000'}, {'value': '29.666', 'spread': '4.710', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 14/Day1 (n =81, 54)', 'categories': [{'measurements': [{'value': '29.711', 'spread': '4.313', 'groupId': 'OG000'}, {'value': '29.820', 'spread': '4.333', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 15/Day1 (n =61, 38)', 'categories': [{'measurements': [{'value': '30.324', 'spread': '3.582', 'groupId': 'OG000'}, {'value': '29.500', 'spread': '3.454', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 16/Day1 (n =52, 34)', 'categories': [{'measurements': [{'value': '30.430', 'spread': '3.443', 'groupId': 'OG000'}, {'value': '29.474', 'spread': '4.146', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 17/Day1 (n =47, 28)', 'categories': [{'measurements': [{'value': '30.551', 'spread': '3.331', 'groupId': 'OG000'}, {'value': '28.737', 'spread': '4.930', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 18/Day1 (n =36, 22)', 'categories': [{'measurements': [{'value': '30.194', 'spread': '3.992', 'groupId': 'OG000'}, {'value': '29.045', 'spread': '4.520', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 19/Day1 (n =29, 14)', 'categories': [{'measurements': [{'value': '30.130', 'spread': '3.636', 'groupId': 'OG000'}, {'value': '29.286', 'spread': '4.795', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 20/Day1 (n =20, 12)', 'categories': [{'measurements': [{'value': '31.300', 'spread': '2.736', 'groupId': 'OG000'}, {'value': '29.250', 'spread': '4.025', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 21/Day1 (n =15, 7)', 'categories': [{'measurements': [{'value': '31.067', 'spread': '3.173', 'groupId': 'OG000'}, {'value': '30.143', 'spread': '4.100', 'groupId': 'OG001'}]}]}, {'title': 'End of Treatment (n =163, 191)', 'categories': [{'measurements': [{'value': '26.288', 'spread': '5.806', 'groupId': 'OG000'}, {'value': '26.517', 'spread': '5.614', 'groupId': 'OG001'}]}]}, {'title': 'Follow up (n =80, 110)', 'categories': [{'measurements': [{'value': '28.263', 'spread': '4.802', 'groupId': 'OG000'}, {'value': '27.516', 'spread': '5.577', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Predose on Cycle 1 Day 1) , Day 1 of each cycle until Cycle 21, End of treatment (Day 670) and Follow-up visit (Day 698)', 'description': 'FKSI-DRS was used to assess quality of life for those diagnosed with renal cell cancer and consisted of 9 items (lack of energy, pain, losing weight, bone pain, fatigue, short of breath, coughing, bothered by fevers, and hematuria). Each of the 9 items was answered on a 5-point Likert-type scale ranging from 0 to 4 (0= not at all, 1= a little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI-DRS score = sum of the 9 item scores; total range: 0 - 36; 0 (no symptoms) to 36 (very much); higher scores indicate greater presence of symptoms.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized. Here, "n" signifies those participants who were evaluable for the specified time points.'}, {'type': 'SECONDARY', 'title': 'Euro Quality of Life Questionnaire- 5 Dimension (EQ-5D): Health State Profile Utility Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '362', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Axitinib 5 mg', 'description': 'Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.'}, {'id': 'OG001', 'title': 'Sorafenib 400 mg', 'description': 'Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.'}], 'classes': [{'title': 'Baseline (n =347, 341)', 'categories': [{'measurements': [{'value': '0.732', 'spread': '0.275', 'groupId': 'OG000', 'lowerLimit': '0.275'}, {'value': '0.731', 'spread': '0.257', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 2/Day1 (n =326, 307)', 'categories': [{'measurements': [{'value': '0.716', 'spread': '0.267', 'groupId': 'OG000'}, {'value': '0.696', 'spread': '0.237', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 3/Day1 (n =287, 248)', 'categories': [{'measurements': [{'value': '0.722', 'spread': '0.243', 'groupId': 'OG000'}, {'value': '0.709', 'spread': '0.239', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 4/Day1 (n =262, 226)', 'categories': [{'measurements': [{'value': '0.730', 'spread': '0.236', 'groupId': 'OG000'}, {'value': '0.716', 'spread': '0.248', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 5/Day1 (n =244, 207)', 'categories': [{'measurements': [{'value': '0.730', 'spread': '0.237', 'groupId': 'OG000'}, {'value': '0.711', 'spread': '0.243', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 6/Day1 (n =221, 178)', 'categories': [{'measurements': [{'value': '0.734', 'spread': '0.230', 'groupId': 'OG000'}, {'value': '0.704', 'spread': '0.246', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 7/Day1 (n =213, 163)', 'categories': [{'measurements': [{'value': '0.718', 'spread': '0.267', 'groupId': 'OG000'}, {'value': '0.728', 'spread': '0.228', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 8/Day1 (n =181, 136)', 'categories': [{'measurements': [{'value': '0.756', 'spread': '0.236', 'groupId': 'OG000'}, {'value': '0.702', 'spread': '0.259', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 9/Day1 (n =169, 120)', 'categories': [{'measurements': [{'value': '0.760', 'spread': '0.227', 'groupId': 'OG000'}, {'value': '0.730', 'spread': '0.229', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 10/Day1 (n =151, 98)', 'categories': [{'measurements': [{'value': '0.734', 'spread': '0.243', 'groupId': 'OG000'}, {'value': '0.730', 'spread': '0.233', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 11/Day1 (n =126, 87)', 'categories': [{'measurements': [{'value': '0.764', 'spread': '0.235', 'groupId': 'OG000'}, {'value': '0.724', 'spread': '0.250', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 12/Day1 (n =110, 73)', 'categories': [{'measurements': [{'value': '0.744', 'spread': '0.244', 'groupId': 'OG000'}, {'value': '0.734', 'spread': '0.232', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 13/Day1 (n =96, 61)', 'categories': [{'measurements': [{'value': '0.760', 'spread': '0.211', 'groupId': 'OG000'}, {'value': '0.753', 'spread': '0.232', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 14/Day1 (n =80, 57)', 'categories': [{'measurements': [{'value': '0.723', 'spread': '0.239', 'groupId': 'OG000'}, {'value': '0.752', 'spread': '0.211', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 15/Day1 (n =63, 41)', 'categories': [{'measurements': [{'value': '0.730', 'spread': '0.255', 'groupId': 'OG000'}, {'value': '0.758', 'spread': '0.191', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 16/Day1 (n =54, 37)', 'categories': [{'measurements': [{'value': '0.749', 'spread': '0.220', 'groupId': 'OG000'}, {'value': '0.785', 'spread': '0.158', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 17/Day1 (n =48, 29)', 'categories': [{'measurements': [{'value': '0.779', 'spread': '0.186', 'groupId': 'OG000'}, {'value': '0.764', 'spread': '0.193', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 18/Day1 (n =37, 20)', 'categories': [{'measurements': [{'value': '0.755', 'spread': '0.204', 'groupId': 'OG000'}, {'value': '0.755', 'spread': '0.208', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 19/Day1 (n =29, 14)', 'categories': [{'measurements': [{'value': '0.734', 'spread': '0.253', 'groupId': 'OG000'}, {'value': '0.804', 'spread': '0.184', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 20/Day1 (n =21, 12)', 'categories': [{'measurements': [{'value': '0.794', 'spread': '0.220', 'groupId': 'OG000'}, {'value': '0.771', 'spread': '0.182', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 21/Day1 (n =16, 7)', 'categories': [{'measurements': [{'value': '0.700', 'spread': '0.273', 'groupId': 'OG000'}, {'value': '0.771', 'spread': '0.182', 'groupId': 'OG001'}]}]}, {'title': 'End of Treatment (n =169, 196)', 'categories': [{'measurements': [{'value': '0.608', 'spread': '0.316', 'groupId': 'OG000'}, {'value': '0.612', 'spread': '0.310', 'groupId': 'OG001'}]}]}, {'title': 'Follow up (n =76, 106)', 'categories': [{'measurements': [{'value': '0.682', 'spread': '0.294', 'groupId': 'OG000'}, {'value': '0.666', 'spread': '0.295', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Predose on Cycle 1 Day 1) , Day 1 of each cycle until Cycle 21, End of treatment (Day 670) and Follow-up visit (Day 698)', 'description': 'EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility or index score. Health state profile component assesses level of health for 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each domain was rated on a 3-point response scale (1= no problems, 2= some/moderate problems and 3= extreme problems). Scoring formula developed by EuroQol Group assigned a utility value for each domain in the profile. Score were transformed and resulted in a total score range of 0 to 1, with higher scores indicating better health.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized. Here, "n" signifies those participants who were evaluable for the specified time points.'}, {'type': 'SECONDARY', 'title': 'Euro Quality of Life Questionnaire- 5 Dimension (EQ-5D): Visual Analog Scale (VAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '362', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Axitinib 5 mg', 'description': 'Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.'}, {'id': 'OG001', 'title': 'Sorafenib 400 mg', 'description': 'Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.'}], 'classes': [{'title': 'Baseline (n =341, 339)', 'categories': [{'measurements': [{'value': '70.560', 'spread': '19.187', 'groupId': 'OG000', 'lowerLimit': '0.275'}, {'value': '70.351', 'spread': '17.403', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 2/Day1 (n =317, 302)', 'categories': [{'measurements': [{'value': '69.003', 'spread': '20.195', 'groupId': 'OG000'}, {'value': '67.606', 'spread': '18.265', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 3/Day1 (n =280, 250)', 'categories': [{'measurements': [{'value': '69.843', 'spread': '17.927', 'groupId': 'OG000'}, {'value': '69.712', 'spread': '18.429', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 4/Day1 (n =261, 224)', 'categories': [{'measurements': [{'value': '69.180', 'spread': '18.636', 'groupId': 'OG000'}, {'value': '70.759', 'spread': '17.189', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 5/Day1 (n =244, 205)', 'categories': [{'measurements': [{'value': '69.705', 'spread': '18.330', 'groupId': 'OG000'}, {'value': '71.888', 'spread': '16.999', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 6/Day1 (n =220, 178)', 'categories': [{'measurements': [{'value': '69.900', 'spread': '18.168', 'groupId': 'OG000'}, {'value': '71.365', 'spread': '17.019', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 7/Day1 (n =209, 163)', 'categories': [{'measurements': [{'value': '69.919', 'spread': '18.063', 'groupId': 'OG000'}, {'value': '72.282', 'spread': '17.521', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 8/Day1 (n =180, 139)', 'categories': [{'measurements': [{'value': '70.756', 'spread': '19.183', 'groupId': 'OG000'}, {'value': '71.475', 'spread': '18.523', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 9/Day1 (n =168, 121)', 'categories': [{'measurements': [{'value': '70.667', 'spread': '18.556', 'groupId': 'OG000'}, {'value': '73.380', 'spread': '17.473', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 10/Day1 (n =151, 98)', 'categories': [{'measurements': [{'value': '70.629', 'spread': '18.680', 'groupId': 'OG000'}, {'value': '75.102', 'spread': '14.854', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 11/Day1 (n =126, 87)', 'categories': [{'measurements': [{'value': '72.103', 'spread': '18.064', 'groupId': 'OG000'}, {'value': '74.586', 'spread': '15.161', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 12/Day1 (n =111, 73)', 'categories': [{'measurements': [{'value': '71.730', 'spread': '17.276', 'groupId': 'OG000'}, {'value': '73.959', 'spread': '15.852', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 13/Day1 (n =94, 61)', 'categories': [{'measurements': [{'value': '70.723', 'spread': '19.147', 'groupId': 'OG000'}, {'value': '75.693', 'spread': '14.571', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 14/Day1 (n =81, 58)', 'categories': [{'measurements': [{'value': '69.420', 'spread': '20.286', 'groupId': 'OG000'}, {'value': '75.362', 'spread': '15.875', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 15/Day1 (n =62, 42)', 'categories': [{'measurements': [{'value': '73.016', 'spread': '15.325', 'groupId': 'OG000'}, {'value': '75.357', 'spread': '15.368', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 16/Day1 (n =52, 37)', 'categories': [{'measurements': [{'value': '70.269', 'spread': '19.272', 'groupId': 'OG000'}, {'value': '73.676', 'spread': '15.699', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 17/Day1 (n =48, 30)', 'categories': [{'measurements': [{'value': '71.375', 'spread': '17.840', 'groupId': 'OG000'}, {'value': '73.767', 'spread': '16.298', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 18/Day1 (n =37, 23)', 'categories': [{'measurements': [{'value': '70.459', 'spread': '18.853', 'groupId': 'OG000'}, {'value': '73.870', 'spread': '16.904', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 19/Day1 (n =29, 14)', 'categories': [{'measurements': [{'value': '71.034', 'spread': '16.963', 'groupId': 'OG000'}, {'value': '70.571', 'spread': '17.956', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 20/Day1 (n =21, 12)', 'categories': [{'measurements': [{'value': '73.143', 'spread': '15.347', 'groupId': 'OG000'}, {'value': '66.917', 'spread': '17.758', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 21/Day1 (n =16, 7)', 'categories': [{'measurements': [{'value': '74.563', 'spread': '16.054', 'groupId': 'OG000'}, {'value': '64.714', 'spread': '16.183', 'groupId': 'OG001'}]}]}, {'title': 'End of Treatment (n =166, 197)', 'categories': [{'measurements': [{'value': '61.759', 'spread': '21.668', 'groupId': 'OG000'}, {'value': '61.690', 'spread': '20.973', 'groupId': 'OG001'}]}]}, {'title': 'Follow up (n =76, 109)', 'categories': [{'measurements': [{'value': '64.382', 'spread': '21.392', 'groupId': 'OG000'}, {'value': '66.037', 'spread': '19.754', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Predose on Cycle 1 Day 1) , Day 1 of each cycle until Cycle 21, End of treatment (Day 670) and Follow-up visit (Day 698)', 'description': 'EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. VAS component: participants rated their current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized. Here, "n" signifies those participants who were evaluable for the specified time points.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Axitinib 5 mg', 'description': 'Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.'}, {'id': 'FG001', 'title': 'Sorafenib 400 mg', 'description': 'Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '361'}, {'groupId': 'FG001', 'numSubjects': '362'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '359'}, {'groupId': 'FG001', 'numSubjects': '355'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '361'}, {'groupId': 'FG001', 'numSubjects': '362'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '280'}, {'groupId': 'FG001', 'numSubjects': '269'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'Objective Progression or Relapse', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': "Sponsor's Decision", 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Randomized But Not Treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '53'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'BG000'}, {'value': '362', 'groupId': 'BG001'}, {'value': '723', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Axitinib 5 mg', 'description': 'Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.'}, {'id': 'BG001', 'title': 'Sorafenib 400 mg', 'description': 'Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Less than (<) 65 years', 'categories': [{'measurements': [{'value': '238', 'groupId': 'BG000'}, {'value': '238', 'groupId': 'BG001'}, {'value': '476', 'groupId': 'BG002'}]}]}, {'title': 'Greater than or equal to (>=) 65 years', 'categories': [{'measurements': [{'value': '123', 'groupId': 'BG000'}, {'value': '124', 'groupId': 'BG001'}, {'value': '247', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '96', 'groupId': 'BG000'}, {'value': '104', 'groupId': 'BG001'}, {'value': '200', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '265', 'groupId': 'BG000'}, {'value': '258', 'groupId': 'BG001'}, {'value': '523', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full analysis set (FAS) included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or receive a different drug from that to which they were randomized.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 723}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'dispFirstSubmitDate': '2010-10-02', 'completionDateStruct': {'date': '2016-02-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-20', 'studyFirstSubmitDate': '2008-05-12', 'dispFirstSubmitQcDate': '2010-10-02', 'resultsFirstSubmitDate': '2012-02-25', 'studyFirstSubmitQcDate': '2008-05-12', 'dispFirstPostDateStruct': {'date': '2010-10-05', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2019-01-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2012-02-25', 'studyFirstPostDateStruct': {'date': '2008-05-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-03-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-Free Survival (PFS)', 'timeFrame': 'From initiation of treatment up to follow-up period (up to 3 years)', 'description': 'PFS was defined as the time in months from start of study treatment to the first documentation of objective tumor progression of disease (PD) or to death due to any cause, whichever occurs first. PD was assessed by response evaluation criteria in solid tumors (RECIST) version 1.0. PD: \\>=20 percent (%) increase in the sum of the longest dimensions (LD) of the target lesions taking as a reference the smallest sum of the LD recorded since the start of treatment or unequivocal progression in non-target lesions or the appearance of 1 or more new lesions. Occurrence of a pleural effusion or ascites was also considered PD if demonstrated by cytological investigation and it was not previously documented. New bone lesions not previously documented were considered PD if confirmed by computed tomography/magnetic resonance imaging or X-ray.'}], 'secondaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': 'From initiation of treatment up to follow-up period (up to 3 years)', 'description': 'OS was defined as the duration from start of study treatment to date of death due to any cause. OS was calculated as (months) = (date of death minus the date of first dose of study medication plus 1) divided by 30.4. For participants who were alive, overall survival was censored on last date the participants were known to be alive.'}, {'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'From initiation of treatment up to follow-up period (up to 3 years)', 'description': 'ORR = percentage of participants with confirmed complete response (CR) or confirmed partial response (PR) according to RECIST version 1.0 recorded from first dose of study treatment until PD or death due to any cause. CR: disappearance of all target, non target lesions and no appearance of new lesions, documented on 2 occasions separated by at least 4 weeks. PR: at least 30 % decrease in sum of LD of target lesions taking as reference baseline sum of LD, without progression of non target lesions, no appearance of new lesions. PD: \\>=20% increase in sum of LD of the target lesions taking as a reference smallest sum of LD recorded since the start of treatment or unequivocal progression in non-target lesions or appearance of 1 or more new lesions. Occurrence of pleural effusion or ascites if demonstrated by cytological investigation, not previously documented. New bone lesions not previously documented if confirmed by computed tomography/magnetic resonance imaging or X-ray.'}, {'measure': 'Duration of Response (DR)', 'timeFrame': 'From initiation of treatment up to follow-up period (up to 3 years)', 'description': 'DR: time from first documentation of objective tumor response (CR or PR), that was subsequently confirmed, to the first documentation of PD or to death due to any cause, whichever occurred first as per RECIST version 1.0, a) CR: disappearance of all target, non target lesions and no appearance of new lesions, documented on 2 occasions separated by at least 4 weeks, b) PR: at least 30 % decrease in sum of LD of target lesions taking as reference baseline sum of LD, without progression of non target lesions, no appearance of new lesions, c) PD: \\>=20% increase in sum of LD of the target lesions taking as a reference smallest sum of LD recorded since the start of treatment or unequivocal progression in non-target lesions or appearance of 1 or more new lesions. Occurrence of pleural effusion or ascites if demonstrated by cytological investigation, not previously documented. New bone lesions not previously documented if confirmed by computed tomography/magnetic resonance imaging or X-ray.'}, {'measure': 'Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'From initiation of treatment up to follow-up period (up to 3 years)', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life- threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious AEs.'}, {'measure': 'Percentage of Participants With Adverse Events (AEs) by Severity', 'timeFrame': 'From initiation of treatment up to follow-up period (up to 3 years)', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Severity of the AEs was graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Grade 1= mild; Grade 2= moderate; Grade 3= severe; Grade 4= life-threatening or disabling; Grade 5= death related to AE.'}, {'measure': 'Percentage of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'From initiation of treatment up to follow-up period (up to 3 years)', 'description': 'An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life -threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both serious and non -serious AEs.'}, {'measure': 'Number of Participants With Clinically Significant Laboratory Abnormalities: Hematology', 'timeFrame': 'From initiation of treatment up to follow-up period (up to 3 years)', 'description': 'Hematology laboratory test included hemoglobin, platelet count, white blood cells count, neutrophils and lymphocytes. Abnormalities were assessed by CTCAE Grade Version 2 for severity: Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling.'}, {'measure': 'Number of Participants With Clinically Significant Laboratory Abnormalities: Biochemistry', 'timeFrame': 'From initiation of treatment up to follow-up period (up to 3 years)', 'description': 'Biochemistry laboratory test included parameters: alanine aminotransferase, alkaline phosphatase, amylase, aspartate aminotransferase, bicarbonate, bilirubin, creatinine, hypercalcemia, hyperglycemia, hyperkalemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypoglycemia, hypokalemia, hyponatremia, hypophosphatemia and lipase. Abnormalities were assessed by CTCAE Grade Version 2 for severity: Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling.'}, {'measure': 'Number of Participants With Clinically Significant Laboratory Abnormalities: Urinalysis', 'timeFrame': 'From initiation of treatment up to follow-up period (up to 3 years)', 'description': 'Urinalysis included urine blood/ hemoglobin, glucose and protein. Abnormalities were assessed by CTCAE Grade Version 2 for severity: Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling.'}, {'measure': 'Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15) Score', 'timeFrame': 'Baseline (Predose on Cycle 1 Day 1) , Day 1 of each cycle until Cycle 21, End of treatment (Day 670) and Follow-up visit (Day 698)', 'description': 'FKSI was used to assess quality of life (QoL) for those diagnosed with renal cell cancer and consisted of 15 items (lack of energy, side effects, pain, losing weight, bone pain, fatigue, enjoying life, short of breath, worsened condition, appetite, coughing, bothered by fevers, ability to work, hematuria and sleep). Each of the 15 items was answered on a 5-point Likert-type scale ranging from 0 to 4 (0= not at all, 1= a little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI score = sum of the 15 item scores; total range: 0 - 60; 0 (no symptoms) to 60 (very much); higher scores indicate greater presence of symptoms.'}, {'measure': 'Functional Assessment of Cancer Therapy Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Score', 'timeFrame': 'Baseline (Predose on Cycle 1 Day 1) , Day 1 of each cycle until Cycle 21, End of treatment (Day 670) and Follow-up visit (Day 698)', 'description': 'FKSI-DRS was used to assess quality of life for those diagnosed with renal cell cancer and consisted of 9 items (lack of energy, pain, losing weight, bone pain, fatigue, short of breath, coughing, bothered by fevers, and hematuria). Each of the 9 items was answered on a 5-point Likert-type scale ranging from 0 to 4 (0= not at all, 1= a little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI-DRS score = sum of the 9 item scores; total range: 0 - 36; 0 (no symptoms) to 36 (very much); higher scores indicate greater presence of symptoms.'}, {'measure': 'Euro Quality of Life Questionnaire- 5 Dimension (EQ-5D): Health State Profile Utility Score', 'timeFrame': 'Baseline (Predose on Cycle 1 Day 1) , Day 1 of each cycle until Cycle 21, End of treatment (Day 670) and Follow-up visit (Day 698)', 'description': 'EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility or index score. Health state profile component assesses level of health for 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each domain was rated on a 3-point response scale (1= no problems, 2= some/moderate problems and 3= extreme problems). Scoring formula developed by EuroQol Group assigned a utility value for each domain in the profile. Score were transformed and resulted in a total score range of 0 to 1, with higher scores indicating better health.'}, {'measure': 'Euro Quality of Life Questionnaire- 5 Dimension (EQ-5D): Visual Analog Scale (VAS)', 'timeFrame': 'Baseline (Predose on Cycle 1 Day 1) , Day 1 of each cycle until Cycle 21, End of treatment (Day 670) and Follow-up visit (Day 698)', 'description': 'EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. VAS component: participants rated their current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Axitinib in Second Line Treatment of Patients With Metastatic Renal Cell Cancer'], 'conditions': ['Kidney Neoplasms']}, 'referencesModule': {'references': [{'pmid': '37526095', 'type': 'DERIVED', 'citation': 'Rini BI, Atkins MB, Choueiri TK, Teresi RE, Rosbrook B, Thakur M, Hutson TE. Plain language summary looking at how long side effects last after treatment with axitinib is stopped in people with advanced renal cell carcinoma. Future Oncol. 2023 Dec;19(40):2623-2629. doi: 10.2217/fon-2023-0233. Epub 2023 Aug 1.'}, {'pmid': '32363929', 'type': 'DERIVED', 'citation': 'Murphy DA, Rini BI, Escudier B, Motzer RJ, Wang P, Li S, Williams JA, Tarazi JC, Martini JF. Angiogenic and immunomodulatory biomarkers in axitinib-treated patients with advanced renal cell carcinoma. Future Oncol. 2020 Jun;16(17):1199-1210. doi: 10.2217/fon-2020-0212. Epub 2020 May 4.'}, {'pmid': '31072748', 'type': 'DERIVED', 'citation': 'Bracarda S, Bamias A, Casper J, Negrier S, Sella A, Staehler M, Tarazi J, Felici A, Rosbrook B, Jardinaud-Lopez M, Escudier B. Is Axitinib Still a Valid Option for mRCC in the Second-Line Setting? Prognostic Factor Analyses From the AXIS Trial. Clin Genitourin Cancer. 2019 Jun;17(3):e689-e703. doi: 10.1016/j.clgc.2019.03.017. Epub 2019 Apr 1.'}, {'pmid': '28410911', 'type': 'DERIVED', 'citation': 'de Velasco G, McKay RR, Lin X, Moreira RB, Simantov R, Choueiri TK. Comprehensive Analysis of Survival Outcomes in Non-Clear Cell Renal Cell Carcinoma Patients Treated in Clinical Trials. Clin Genitourin Cancer. 2017 Dec;15(6):652-660.e1. doi: 10.1016/j.clgc.2017.03.004. Epub 2017 Mar 21.'}, {'pmid': '27238653', 'type': 'DERIVED', 'citation': 'Grunwald V, Lin X, Kalanovic D, Simantov R. Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma. Eur Urol. 2016 Dec;70(6):1006-1015. doi: 10.1016/j.eururo.2016.05.010. Epub 2016 May 26.'}, {'pmid': '25577718', 'type': 'DERIVED', 'citation': 'Grunwald V, McKay RR, Krajewski KM, Kalanovic D, Lin X, Perkins JJ, Simantov R, Choueiri TK. Depth of remission is a prognostic factor for survival in patients with metastatic renal cell carcinoma. Eur Urol. 2015 May;67(5):952-8. doi: 10.1016/j.eururo.2014.12.036. Epub 2015 Jan 7.'}, {'pmid': '24823696', 'type': 'DERIVED', 'citation': 'Escudier B, Michaelson MD, Motzer RJ, Hutson TE, Clark JI, Lim HY, Porfiri E, Zalewski P, Kannourakis G, Staehler M, Tarazi J, Rosbrook B, Cisar L, Hariharan S, Kim S, Rini BI. Axitinib versus sorafenib in advanced renal cell carcinoma: subanalyses by prior therapy from a randomised phase III trial. Br J Cancer. 2014 Jun 10;110(12):2821-8. doi: 10.1038/bjc.2014.244. Epub 2014 May 13.'}, {'pmid': '23630366', 'type': 'DERIVED', 'citation': 'Ueda T, Uemura H, Tomita Y, Tsukamoto T, Kanayama H, Shinohara N, Tarazi J, Chen C, Kim S, Ozono S, Naito S, Akaza H. Efficacy and safety of axitinib versus sorafenib in metastatic renal cell carcinoma: subgroup analysis of Japanese patients from the global randomized Phase 3 AXIS trial. Jpn J Clin Oncol. 2013 Jun;43(6):616-28. doi: 10.1093/jjco/hyt054. Epub 2013 Apr 28.'}, {'pmid': '23598172', 'type': 'DERIVED', 'citation': 'Motzer RJ, Escudier B, Tomczak P, Hutson TE, Michaelson MD, Negrier S, Oudard S, Gore ME, Tarazi J, Hariharan S, Chen C, Rosbrook B, Kim S, Rini BI. Axitinib versus sorafenib as second-line treatment for advanced renal cell carcinoma: overall survival analysis and updated results from a randomised phase 3 trial. Lancet Oncol. 2013 May;14(6):552-62. doi: 10.1016/S1470-2045(13)70093-7. Epub 2013 Apr 16.'}, {'pmid': '23579211', 'type': 'DERIVED', 'citation': 'Cella D, Escudier B, Rini B, Chen C, Bhattacharyya H, Tarazi J, Rosbrook B, Kim S, Motzer R. Patient-reported outcomes for axitinib vs sorafenib in metastatic renal cell carcinoma: phase III (AXIS) trial. Br J Cancer. 2013 Apr 30;108(8):1571-8. doi: 10.1038/bjc.2013.145. Epub 2013 Apr 11.'}, {'pmid': '22056247', 'type': 'DERIVED', 'citation': 'Rini BI, Escudier B, Tomczak P, Kaprin A, Szczylik C, Hutson TE, Michaelson MD, Gorbunova VA, Gore ME, Rusakov IG, Negrier S, Ou YC, Castellano D, Lim HY, Uemura H, Tarazi J, Cella D, Chen C, Rosbrook B, Kim S, Motzer RJ. Comparative effectiveness of axitinib versus sorafenib in advanced renal cell carcinoma (AXIS): a randomised phase 3 trial. Lancet. 2011 Dec 3;378(9807):1931-9. doi: 10.1016/S0140-6736(11)61613-9. Epub 2011 Nov 4.'}]}, 'descriptionModule': {'briefSummary': 'The study is designed to demonstrate that axitinib (AG-013736) is superior to sorafenib in delaying tumor progression in patients with metastatic renal cell cancer after failure of one first line regimen.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or cytologically confirmed renal cell cancer with a component of clear cell subtype, with metastasis\n* Evidence of measurable disease\n* Must have failed one prior systemic first-line regimen for metastatic renal cell cancer\n\nExclusion Criteria:\n\n* Prior treatment for metastatic renal cell cancer with more that one systemic first line therapy\n* Major surgery less than 4 weeks or radiation less than 2 weeks of starting study drug'}, 'identificationModule': {'nctId': 'NCT00678392', 'briefTitle': 'Axitinib (AG 013736) As Second 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