Viewing Study NCT02437318

Home

Certify Doc

Genes

Clinical Trials

CompTox

DrugMatrix

Open Targets

Products

Support

Bugs

Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug

Ignite Creation Date: 2025-12-25 @ 4:54 AM

Ignite Modification Date: 2026-06-11 @ 7:45 AM

Study NCT ID: NCT02437318

Status: COMPLETED

Last Update Posted: 2025-02-13

First Post: 2015-04-22

Is NOT Gene Therapy: True

Has Adverse Events: True

Brief Title: Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant in Men and Postmenopausal Women With Advanced Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment.

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Denmark', 'Portugal', 'Turkey (Türkiye)', 'United Arab Emirates']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D018761', 'term': 'Multiple Endocrine Neoplasia Type 1'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D009377', 'term': 'Multiple Endocrine Neoplasia'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009378', 'term': 'Neoplasms, Multiple Primary'}, {'id': 'D009386', 'term': 'Neoplastic Syndromes, Hereditary'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077267', 'term': 'Fulvestrant'}, {'id': 'C585539', 'term': 'Alpelisib'}], 'ancestors': [{'id': 'D004958', 'term': 'Estradiol'}, {'id': 'D004963', 'term': 'Estrenes'}, {'id': 'D004962', 'term': 'Estranes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D045166', 'term': 'Estradiol Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'novartis.email@novartis.com', 'phone': '862-778-8300', 'title': 'Study Director', 'organization': 'Novartis Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e.,data from all sites) in clinical trial or disclosure of trial results in their entirety.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All-cause mortality: from randomization up to approx. 6.5 years, including post-treatment survival follow up period. Serious and Other Adverse Events: from first dose of study treatment until 30 days after last dose up to approx. 6.5 years', 'description': 'All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow (more than 30 days after last dose) are reported separately and are not considered AEs.\n\nSerious and Other Adverse Events: reported for all randomized participants who received any amount of study treatment', 'eventGroups': [{'id': 'EG000', 'title': 'Alpelisib + Fulvestrant', 'description': 'All-cause mortality from randomization until 30 days after last dose. Adverse Events from first dose until 30 days after last dose.', 'otherNumAtRisk': 284, 'deathsNumAtRisk': 284, 'otherNumAffected': 280, 'seriousNumAtRisk': 284, 'deathsNumAffected': 9, 'seriousNumAffected': 110}, {'id': 'EG001', 'title': 'Placebo + Fulvestrant', 'description': 'All-cause mortality from randomization until 30 days after last dose. Adverse Events from first dose until 30 days after last dose.', 'otherNumAtRisk': 287, 'deathsNumAtRisk': 288, 'otherNumAffected': 244, 'seriousNumAtRisk': 287, 'deathsNumAffected': 12, 'seriousNumAffected': 54}, {'id': 'EG002', 'title': 'Alpelisib + Fulvestrant (Post-treatment Survival Follow-up)', 'description': 'Deaths collected in the post- treatment survival follow-up period (starting from day 31 after last dose). No AEs were collected during this period', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 275, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 151, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Placebo + Fulvestrant (Post-treatment Survival Follow-up)', 'description': 'Deaths collected in the post- treatment survival follow-up period (starting from day 31 after last dose). No AEs were collected during this period', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 275, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 156, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 37}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 167}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 48}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 133}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 64}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 70}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 80}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 64}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 40}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 73}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 51}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Lipase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 79}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 103}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 182}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 56}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 43}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Osteonecrosis of jaw', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 38}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 32}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 58}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 54}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 101}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Lymphoedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Thrombotic microangiopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Arteriospasm coronary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Enterocolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Gallstone ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Large intestine perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Melaena', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Subileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Upper gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Adverse drug reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'General physical health deterioration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Multiple organ dysfunction syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Hepatic failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Hepatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Anaphylactic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Abdominal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Abscess jaw', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Diverticulitis intestinal haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Erysipelas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Mediastinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Peritonsillar abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Pulmonary tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Pyelonephritis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Jaw fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Postoperative wound complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Radiation proctitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Spinal compression fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Ulna fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Wrist fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Blood lactate dehydrogenase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Hepatic enzyme increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Lipase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Diabetic ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Hypercalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Hypochloraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Type 2 diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Osteitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Osteonecrosis of jaw', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Spinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Cancer pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Metastases to meninges', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Second primary malignancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Tumour pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Altered state of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Brain oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Haemorrhagic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Motor dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Spinal cord compression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Bipolar disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Ureterolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Pelvic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Bronchostenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Dermatitis acneiform', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Dermatitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Drug eruption', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Erythema multiforme', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Rash macular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Stevens-Johnson syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression-free Survival (PFS) Per Investigator Assessment in the PIK3CA Mutant Cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PIK3CA Mutant Cohort by Tumor Tissue: Alpelisib + Fulvestrant', 'description': 'Subjects with advanced breast cancer with a PIK3CA mutation (based on central testing of hotspot-mutations in tumor tissue) treated with alpelisib (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle)'}, {'id': 'OG001', 'title': 'PIK3CA Mutant Cohort by Tumor Tissue: Placebo + Fulvestrant', 'description': 'Subjects with advanced breast cancer with a PIK3CA mutation (based on central testing of hotspot-mutations in tumor tissue) treated with placebo (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle)'}], 'classes': [{'categories': [{'measurements': [{'value': '11.0', 'groupId': 'OG000', 'lowerLimit': '7.49', 'upperLimit': '14.52'}, {'value': '5.7', 'groupId': 'OG001', 'lowerLimit': '3.65', 'upperLimit': '7.36'}]}]}], 'analyses': [{'pValue': '0.00065', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.65', 'ciLowerLimit': '0.50', 'ciUpperLimit': '0.85', 'pValueComment': '(one-sided)', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Once approximately 243 PFS events in the PIK3CA mutant cohort had been observed, up to 33.3 months', 'description': 'PFS was defined as the time from the date of randomization to the date of the first documented progression or death due to any cause. PFS was assessed via a local radiology assessment according to RECIST 1.1. If a patient did not have an event, PFS was censored at the date of last adequate tumor assessment.\n\nThe PFS distribution was estimated using Kaplan-Meier methodology. Progression was defined as at least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects with a PIK3CA mutation (based on central testing of hotspot-mutations in tumor tissue) who were randomized to study treatment'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS) in the PIK3CA Mutant Cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PIK3CA Mutant Cohort by Tumor Tissue: Alpelisib + Fulvestrant', 'description': 'Subjects with advanced breast cancer with a PIK3CA mutation (based on central testing of hotspot-mutations in tumor tissue) treated with alpelisib (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle)'}, {'id': 'OG001', 'title': 'PIK3CA Mutant Cohort by Tumor Tissue: Placebo + Fulvestrant', 'description': 'Subjects with advanced breast cancer with a PIK3CA mutation (based on central testing of hotspot-mutations in tumor tissue) treated with placebo (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle)'}], 'classes': [{'categories': [{'measurements': [{'value': '39.3', 'groupId': 'OG000', 'lowerLimit': '34.10', 'upperLimit': '44.85'}, {'value': '31.4', 'groupId': 'OG001', 'lowerLimit': '26.78', 'upperLimit': '41.30'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Once approximately 178 deaths in the PIK3CA mutant cohort had been observed, up to 55.7 months', 'description': 'OS was defined as the time from date of randomization to date of death due to any cause. If a patient was not known to have died, survival was censored at the date of last known date patient alive.\n\nThe OS distribution was estimated using Kaplan-Meier methodology.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects with a PIK3CA mutation (based on central testing of hotspot-mutations in tumor tissue) who were randomized to study treatment'}, {'type': 'SECONDARY', 'title': 'PFS Per Investigator Assessment in the PIK3CA Non-mutant Cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PIK3CA Non-mutant Cohort by Tumor Tissue: Alpelisib + Fulvestrant', 'description': 'Subjects with advanced breast cancer without a PIK3CA mutation (based on central testing of hotspot-mutations in tumor tissue) treated with alpelisib (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle)'}, {'id': 'OG001', 'title': 'PIK3CA Non-mutant Cohort by Tumor Tissue: Placebo + Fulvestrant', 'description': 'Subjects with advanced breast cancer without a PIK3CA mutation (based on central testing of hotspot-mutations in tumor tissue) treated with placebo (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle)'}], 'classes': [{'categories': [{'measurements': [{'value': '7.43', 'groupId': 'OG000', 'lowerLimit': '5.55', 'upperLimit': '10.84'}, {'value': '7.23', 'groupId': 'OG001', 'lowerLimit': '5.06', 'upperLimit': '9.17'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 56.4 months', 'description': 'PFS was defined as the time from the date of randomization to the date of the first documented progression or death due to any cause. PFS was assessed via a local radiology assessment according to RECIST 1.1. If a patient did not have an event, PFS was censored at the date of last adequate tumor assessment.\n\nThe PFS distribution was estimated using Kaplan-Meier methodology. Progression was defined as at least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects without a PIK3CA mutation (based on central testing of hotspot-mutations in tumor tissue) who were randomized to study treatment'}, {'type': 'SECONDARY', 'title': 'OS in the PIK3CA Non-mutant Cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PIK3CA Non-mutant Cohort by Tumor Tissue: Alpelisib + Fulvestrant', 'description': 'Subjects with advanced breast cancer without a PIK3CA mutation (based on central testing of hotspot-mutations in tumor tissue) treated with alpelisib (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle)'}, {'id': 'OG001', 'title': 'PIK3CA Non-mutant Cohort by Tumor Tissue: Placebo + Fulvestrant', 'description': 'Subjects with advanced breast cancer without a PIK3CA mutation (based on central testing of hotspot-mutations in tumor tissue) treated with placebo (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle)'}], 'classes': [{'categories': [{'measurements': [{'value': '37.29', 'groupId': 'OG000', 'lowerLimit': '27.89', 'upperLimit': '45.47'}, {'value': '34.30', 'groupId': 'OG001', 'lowerLimit': '26.81', 'upperLimit': '39.03'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 56.4 months', 'description': 'OS was defined as the time from date of randomization to date of death due to any cause. If a patient was not known to have died, survival was censored at the date of last known date patient alive.\n\nThe OS distribution was estimated using Kaplan-Meier methodology.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects without a PIK3CA mutation (based on central testing of hotspot-mutations in tumor tissue) who were randomized to study treatment'}, {'type': 'SECONDARY', 'title': 'Overall Response Rate (ORR) Per Investigator Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}, {'value': '115', 'groupId': 'OG002'}, {'value': '116', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PIK3CA Mutant Cohort by Tumor Tissue: Alpelisib + Fulvestrant', 'description': 'Subjects with advanced breast cancer with a PIK3CA mutation (based on central testing of hotspot-mutations in tumor tissue) treated with alpelisib (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle)'}, {'id': 'OG001', 'title': 'PIK3CA Mutant Cohort by Tumor Tissue: Placebo + Fulvestrant', 'description': 'Subjects with advanced breast cancer with a PIK3CA mutation (based on central testing of hotspot-mutations in tumor tissue) treated with placebo (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle)'}, {'id': 'OG002', 'title': 'PIK3CA Non-mutant Cohort by Tumor Tissue: Alpelisib + Fulvestrant', 'description': 'Subjects with advanced breast cancer without a PIK3CA mutation (based on central testing of hotspot-mutations in tumor tissue) treated with alpelisib (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle)'}, {'id': 'OG003', 'title': 'PIK3CA Non-mutant Cohort by Tumor Tissue: Placebo + Fulvestrant', 'description': 'Subjects with advanced breast cancer without a PIK3CA mutation (based on central testing of hotspot-mutations in tumor tissue) treated with placebo (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle)'}], 'classes': [{'categories': [{'measurements': [{'value': '26.6', 'groupId': 'OG000', 'lowerLimit': '20.1', 'upperLimit': '34.0'}, {'value': '13.4', 'groupId': 'OG001', 'lowerLimit': '8.7', 'upperLimit': '19.4'}, {'value': '20.9', 'groupId': 'OG002', 'lowerLimit': '13.9', 'upperLimit': '29.4'}, {'value': '12.9', 'groupId': 'OG003', 'lowerLimit': '7.4', 'upperLimit': '20.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 56.4 months', 'description': "ORR was defined as the percentage of patients with best overall response of complete response (CR) or partial response (PR) based on local investigator's assessment according to RECIST 1.1.\n\nCR: Disappearance of all non-nodal target and non-target lesions. In addition, any pathological lymph nodes assigned as target and non-target lesions must have a reduction in short axis to \\< 10 mm.\n\nPR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who were randomized to study treatment.'}, {'type': 'SECONDARY', 'title': 'Clinical Benefit Rate (CBR) Per Investigator Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}, {'value': '115', 'groupId': 'OG002'}, {'value': '116', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PIK3CA Mutant Cohort by Tumor Tissue: Alpelisib + Fulvestrant', 'description': 'Subjects with advanced breast cancer with a PIK3CA mutation (based on central testing of hotspot-mutations in tumor tissue) treated with alpelisib (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle)'}, {'id': 'OG001', 'title': 'PIK3CA Mutant Cohort by Tumor Tissue: Placebo + Fulvestrant', 'description': 'Subjects with advanced breast cancer with a PIK3CA mutation (based on central testing of hotspot-mutations in tumor tissue) treated with placebo (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle)'}, {'id': 'OG002', 'title': 'PIK3CA Non-mutant Cohort by Tumor Tissue: Alpelisib + Fulvestrant', 'description': 'Subjects with advanced breast cancer without a PIK3CA mutation (based on central testing of hotspot-mutations in tumor tissue) treated with alpelisib (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle)'}, {'id': 'OG003', 'title': 'PIK3CA Non-mutant Cohort by Tumor Tissue: Placebo + Fulvestrant', 'description': 'Subjects with advanced breast cancer without a PIK3CA mutation (based on central testing of hotspot-mutations in tumor tissue) treated with placebo (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle)'}], 'classes': [{'categories': [{'measurements': [{'value': '61.5', 'groupId': 'OG000', 'lowerLimit': '53.8', 'upperLimit': '68.9'}, {'value': '44.8', 'groupId': 'OG001', 'lowerLimit': '37.2', 'upperLimit': '52.5'}, {'value': '53.9', 'groupId': 'OG002', 'lowerLimit': '44.4', 'upperLimit': '63.2'}, {'value': '49.1', 'groupId': 'OG003', 'lowerLimit': '39.7', 'upperLimit': '58.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 56.4 months', 'description': 'Clinical benefit rate was defined as the percentage of patients with a best overall response of CR or PR or stable disease (SD) or Non-CR/Non-PD lasting more than 24 weeks based on local investigator assessment according to RECIST 1.1.\n\nCR: Disappearance of all non-nodal target and non-target lesions. In addition, any pathological lymph nodes assigned as target and non-target lesions must have a reduction in short axis to \\< 10 mm.\n\nPR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.\n\nSD: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who were randomized to study treatment.'}, {'type': 'SECONDARY', 'title': 'Time to Definitive Deterioration of Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Score From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}, {'value': '115', 'groupId': 'OG002'}, {'value': '116', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PIK3CA Mutant Cohort by Tumor Tissue: Alpelisib + Fulvestrant', 'description': 'Subjects with advanced breast cancer with a PIK3CA mutation (based on central testing of hotspot-mutations in tumor tissue) treated with alpelisib (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle)'}, {'id': 'OG001', 'title': 'PIK3CA Mutant Cohort by Tumor Tissue: Placebo + Fulvestrant', 'description': 'Subjects with advanced breast cancer with a PIK3CA mutation (based on central testing of hotspot-mutations in tumor tissue) treated with placebo (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle)'}, {'id': 'OG002', 'title': 'PIK3CA Non-mutant Cohort by Tumor Tissue: Alpelisib + Fulvestrant', 'description': 'Subjects with advanced breast cancer without a PIK3CA mutation (based on central testing of hotspot-mutations in tumor tissue) treated with alpelisib (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle)'}, {'id': 'OG003', 'title': 'PIK3CA Non-mutant Cohort by Tumor Tissue: Placebo + Fulvestrant', 'description': 'Subjects with advanced breast cancer without a PIK3CA mutation (based on central testing of hotspot-mutations in tumor tissue) treated with placebo (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle)'}], 'classes': [{'categories': [{'measurements': [{'value': '34.07', 'comment': 'NA: Not estimable due to the insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': '26.32', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'NA: Not estimable due to the insufficient number of participants with events', 'groupId': 'OG001', 'lowerLimit': '22.11', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'NA: Not estimable due to the insufficient number of participants with events', 'groupId': 'OG002', 'lowerLimit': '13.83', 'upperLimit': 'NA'}, {'value': '40.44', 'groupId': 'OG003', 'lowerLimit': '18.46', 'upperLimit': '47.21'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From baseline up to 56.4 months', 'description': 'ECOG PS categorized patients based on their ability to perform daily activities and self-care, with scores ranging from 0 to 5. A score of 0 indicated no restrictions in activity, while higher scores indicated increasing limitations. Time to definitive deterioration of ECOG PS by one score was defined as the time from the date of randomization to the date of the event, defined as experiencing at least one score lower than the baseline. A deterioration was considered definitive if no improvements in the ECOG PS were observed at a subsequent time. The Kaplan-Meier method was used to estimate the distribution. Patients receiving any further therapy prior to definitive worsening were censored at their date of last assessment prior to start of therapy. Patients that had not worsened at the data cutoff point were censored at the date of last assessment.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who were randomized to study treatment'}, {'type': 'SECONDARY', 'title': "Time to 10% Deterioration in the Global Health Status (GHS) /Quality of Life (QOL) Scale Score of the European Organization for Research and Treatment of Cancer's Core Quality of Life Questionnaire (EORTC QLQ-C30)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}, {'value': '115', 'groupId': 'OG002'}, {'value': '116', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PIK3CA Mutant Cohort by Tumor Tissue: Alpelisib + Fulvestrant', 'description': 'Subjects with advanced breast cancer with a PIK3CA mutation (based on central testing of hotspot-mutations in tumor tissue) treated with alpelisib (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle)'}, {'id': 'OG001', 'title': 'PIK3CA Mutant Cohort by Tumor Tissue: Placebo + Fulvestrant', 'description': 'Subjects with advanced breast cancer with a PIK3CA mutation (based on central testing of hotspot-mutations in tumor tissue) treated with placebo (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle)'}, {'id': 'OG002', 'title': 'PIK3CA Non-mutant Cohort by Tumor Tissue: Alpelisib + Fulvestrant', 'description': 'Subjects with advanced breast cancer without a PIK3CA mutation (based on central testing of hotspot-mutations in tumor tissue) treated with alpelisib (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle)'}, {'id': 'OG003', 'title': 'PIK3CA Non-mutant Cohort by Tumor Tissue: Placebo + Fulvestrant', 'description': 'Subjects with advanced breast cancer without a PIK3CA mutation (based on central testing of hotspot-mutations in tumor tissue) treated with placebo (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle)'}], 'classes': [{'categories': [{'measurements': [{'value': '18.14', 'groupId': 'OG000', 'lowerLimit': '14.55', 'upperLimit': '28.68'}, {'value': '19.98', 'groupId': 'OG001', 'lowerLimit': '11.50', 'upperLimit': '25.59'}, {'value': '7.39', 'comment': 'NA: not estimable due to the insufficient number of participants with events', 'groupId': 'OG002', 'lowerLimit': '5.62', 'upperLimit': 'NA'}, {'value': '9.23', 'groupId': 'OG003', 'lowerLimit': '3.94', 'upperLimit': '13.17'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From baseline up to 55.7 months', 'description': 'The EORTC QLQ-C30 is a questionnaire that includes 5 functional scales, 3 symptom scales, 1 GHS/QoL scale, and 6 single items. GHS/QoL scale score ranges between 0 and 100. A high score for GHS/QoL represents better functioning or QoL.The time to definitive 10% deterioration was defined as the time from the date of randomization to the date of event, which was defined as at least 10% relative to baseline worsening of the GHS/QoL score (without further improvement above the threshold) or death due to any cause. The Kaplan-Meier method was used to estimate the distribution. If a patient had not had an event, time to deterioration was censored at the date of the last adequate QoL evaluation.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who were randomized to study treatment'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the GHS/QOL Scale Score of the EORTC QLQ-C30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}, {'value': '92', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PIK3CA Mutant Cohort by Tumor Tissue: Alpelisib + Fulvestrant', 'description': 'Subjects with advanced breast cancer with a PIK3CA mutation (based on central testing of hotspot-mutations in tumor tissue) treated with alpelisib (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle)'}, {'id': 'OG001', 'title': 'PIK3CA Mutant Cohort by Tumor Tissue: Placebo + Fulvestrant', 'description': 'Subjects with advanced breast cancer with a PIK3CA mutation (based on central testing of hotspot-mutations in tumor tissue) treated with placebo (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle)'}, {'id': 'OG002', 'title': 'PIK3CA Non-mutant Cohort by Tumor Tissue: Alpelisib + Fulvestrant', 'description': 'Subjects with advanced breast cancer without a PIK3CA mutation (based on central testing of hotspot-mutations in tumor tissue) treated with alpelisib (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle)'}, {'id': 'OG003', 'title': 'PIK3CA Non-mutant Cohort by Tumor Tissue: Placebo + Fulvestrant', 'description': 'Subjects with advanced breast cancer without a PIK3CA mutation (based on central testing of hotspot-mutations in tumor tissue) treated with placebo (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle)'}], 'classes': [{'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}, {'value': '92', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2.477', 'spread': '2.286', 'groupId': 'OG000'}, {'value': '-0.369', 'spread': '2.324', 'groupId': 'OG001'}, {'value': '1.524', 'spread': '2.578', 'groupId': 'OG002'}, {'value': '2.698', 'spread': '2.601', 'groupId': 'OG003'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}, {'value': '66', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.796', 'spread': '2.349', 'groupId': 'OG000'}, {'value': '-2.685', 'spread': '2.455', 'groupId': 'OG001'}, {'value': '2.866', 'spread': '2.809', 'groupId': 'OG002'}, {'value': '1.700', 'spread': '2.835', 'groupId': 'OG003'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-3.010', 'spread': '2.415', 'groupId': 'OG000'}, {'value': '-0.337', 'spread': '2.587', 'groupId': 'OG001'}, {'value': '1.383', 'spread': '3.087', 'groupId': 'OG002'}, {'value': '4.909', 'spread': '3.385', 'groupId': 'OG003'}]}]}, {'title': 'Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2.802', 'spread': '2.519', 'groupId': 'OG000'}, {'value': '-0.891', 'spread': '2.646', 'groupId': 'OG001'}, {'value': '1.063', 'spread': '3.420', 'groupId': 'OG002'}, {'value': '4.345', 'spread': '3.731', 'groupId': 'OG003'}]}]}, {'title': 'Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2.815', 'spread': '2.581', 'groupId': 'OG000'}, {'value': '-1.854', 'spread': '2.739', 'groupId': 'OG001'}, {'value': '13.232', 'spread': '4.783', 'groupId': 'OG002'}, {'value': '4.923', 'spread': '4.003', 'groupId': 'OG003'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-3.635', 'spread': '2.621', 'groupId': 'OG000'}, {'value': '-1.460', 'spread': '2.853', 'groupId': 'OG001'}]}]}, {'title': 'Week 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.617', 'spread': '2.701', 'groupId': 'OG000'}, {'value': '0.248', 'spread': '2.935', 'groupId': 'OG001'}]}]}, {'title': 'Week 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.937', 'spread': '2.835', 'groupId': 'OG000'}, {'value': '-1.979', 'spread': '2.984', 'groupId': 'OG001'}]}]}, {'title': 'Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2.525', 'spread': '2.823', 'groupId': 'OG000'}, {'value': '-1.526', 'spread': '3.098', 'groupId': 'OG001'}]}]}, {'title': 'Week 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.135', 'spread': '2.958', 'groupId': 'OG000'}, {'value': '-1.495', 'spread': '3.143', 'groupId': 'OG001'}]}]}, {'title': 'Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-3.869', 'spread': '3.054', 'groupId': 'OG000'}, {'value': '-3.581', 'spread': '3.423', 'groupId': 'OG001'}]}]}, {'title': 'Week 108', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2.158', 'spread': '3.328', 'groupId': 'OG000'}, {'value': '-2.068', 'spread': '3.609', 'groupId': 'OG001'}]}]}, {'title': 'Week 120', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2.928', 'spread': '3.251', 'groupId': 'OG000'}, {'value': '-2.593', 'spread': '3.868', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, every 8 weeks after randomization during the first 18 months and thereafter every 12 weeks, up to 120 weeks.', 'description': 'The EORTC QLQ-C30 is a questionnaire that includes 5 functional scales, 3 symptom scales, 1 GHS/QoL scale, and 6 single items. GHS/QoL scale score ranges between 0 and 100. A high score for GHS/QoL represents better functioning or QoL.The change from baseline in the GHS/QoL score was assessed. A positive change from baseline indicated improvement.\n\nFor each cohort, this analysis only included assessments up to the time point where there were at least 10 patients on each of the 2 treatment groups.', 'unitOfMeasure': 'Score on a Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants with baseline scores and at least one non-missing post-baseline assessment. Number analyzed refers to the number of participants with an evaluable value at the specified time point'}, {'type': 'SECONDARY', 'title': 'Trough Plasma Concentration of Alpelisib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Alpelisib + Fulvestrant', 'description': 'Subjects with advanced breast cancer with or without a PIK3CA mutation treated with alpelisib (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle)'}], 'classes': [{'title': 'Cycle 1 Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '424', 'spread': '41.1', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 1 Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '468', 'spread': '57.6', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 2 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '436', 'spread': '53.4', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 4 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '458', 'spread': '69.4', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 6 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '418', 'spread': '57.1', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 8 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '469', 'spread': '58.3', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 8 and Day 15 of Cycle 1, then Day 1 of Cycles 2, 4, 6 and 8. Cycle = 28 days', 'description': 'Pre-dose plasma concentrations of alpelisib were assessed. Only participants randomized to the alpelisib + fulvestrant arm were included in this analysis.', 'unitOfMeasure': 'nanogram (ng)/ milliliter (mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least one dose of alpelisib and provided at least one evaluable trough plasma concentration for alpelisib at the specified time points'}, {'type': 'SECONDARY', 'title': 'Trough Plasma Concentration of Fulvestrant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alpelisib + Fulvestrant', 'description': 'Subjects with advanced breast cancer with or without a PIK3CA mutation treated with alpelisib (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle)'}, {'id': 'OG001', 'title': 'Placebo + Fulvestrant', 'description': 'Subjects with advanced breast cancer with or without a PIK3CA mutation treated with placebo (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle)'}], 'classes': [{'title': 'Cycle 1 Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.8', 'spread': '43.5', 'groupId': 'OG000'}, {'value': '10.3', 'spread': '51.0', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 2 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.0', 'spread': '39.7', 'groupId': 'OG000'}, {'value': '14.7', 'spread': '41.2', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 4 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.5', 'spread': '32.2', 'groupId': 'OG000'}, {'value': '12.2', 'spread': '29.8', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 6 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.6', 'spread': '30.5', 'groupId': 'OG000'}, {'value': '14.0', 'spread': '24.2', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 8 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.5', 'spread': '35.2', 'groupId': 'OG000'}, {'value': '14.7', 'spread': '23.2', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 15 of Cycle 1, then Day 1 of Cycles 2, 4, 6 and 8. Cycle = 28 days', 'description': 'Pre-dose plasma concentrations of fulvestrant were assessed.', 'unitOfMeasure': 'nanogram (ng)/ milliliter (mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least one dose of fulvestrant and provided at least one evaluable trough plasma concentration for fulvestrant at the specified time points'}, {'type': 'SECONDARY', 'title': 'PFS Per Investigator Criteria in Subjects With PIK3CA Mutation Status Measured in ctDNA at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '181', 'groupId': 'OG002'}, {'value': '182', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PIK3CA Mutant Determined by ctDNA: Alpelisib + Fulvestrant', 'description': 'Subjects with advanced breast cancer with a PIK3CA mutation (measured in ctDNA) treated with alpelisib (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle)'}, {'id': 'OG001', 'title': 'PIK3CA Mutant Determined by ctDNA: Placebo + Fulvestrant', 'description': 'Subjects with advanced breast cancer with a PIK3CA mutation (measured in ctDNA) treated with placebo (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle)'}, {'id': 'OG002', 'title': 'PIK3CA Non-mutant Determined by ctDNA: Alpelisib + Fulvestrant', 'description': 'Subjects with advanced breast cancer without a PIK3CA mutation (measured in ctDNA) treated with alpelisib (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle)'}, {'id': 'OG003', 'title': 'PIK3CA Non-mutant Determined by ctDNA: Placebo + Fulvestrant', 'description': 'Subjects with advanced breast cancer without a PIK3CA mutation (measured in ctDNA) treated with placebo (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle)'}], 'classes': [{'categories': [{'measurements': [{'value': '10.9', 'groupId': 'OG000', 'lowerLimit': '7.03', 'upperLimit': '15.28'}, {'value': '3.7', 'groupId': 'OG001', 'lowerLimit': '2.27', 'upperLimit': '6.11'}, {'value': '9.0', 'groupId': 'OG002', 'lowerLimit': '7.23', 'upperLimit': '11.01'}, {'value': '7.4', 'groupId': 'OG003', 'lowerLimit': '5.55', 'upperLimit': '9.20'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From baseline up to 56.4 months', 'description': 'PFS was defined as the time from the date of randomization to the date of the first documented progression or death due to any cause. PFS was assessed via a local radiology assessment according to RECIST 1.1. If a patient did not have an event, PFS was censored at the date of last adequate tumor assessment. The PFS distribution was estimated using Kaplan-Meier methodology.\n\nSubjects were analyzed according to the PIK3CA mutation status (mutant or non-mutant) as identified using plasma ctDNA.\n\nProgression was defined as at least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who were randomized to study treatment with an evaluable mutation status by ctDNA at baseline'}, {'type': 'POST_HOC', 'title': 'All Collected Deaths', 'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'OG000'}, {'value': '288', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alpelisib + Fulvestrant', 'description': 'Subjects with advanced breast cancer with or without a PIK3CA mutation treated with alpelisib (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle)'}, {'id': 'OG001', 'title': 'Placebo + Fulvestrant', 'description': 'Subjects with advanced breast cancer with or without a PIK3CA mutation treated with placebo (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle)'}], 'classes': [{'title': 'Pre-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'OG000'}, {'value': '288', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'On-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'OG000'}, {'value': '287', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Post-treatment survival follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '275', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '151', 'groupId': 'OG000'}, {'value': '156', 'groupId': 'OG001'}]}]}, {'title': 'All deaths', 'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'OG000'}, {'value': '288', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '160', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Pre-treatment: Up to 35 days. On-treatment: Up to approx. 6.5 years. Post-treatment survival follow-up: Up to approx. 6.5 years', 'description': 'Pre-treatment deaths were collected from randomization to the day before first dose of study medication.\n\nOn-treatment deaths were collected from start of treatment to 30 days after last dose of study medication.\n\nPost-treatment survival follow-up deaths were collected from day 31 after last dose of study treatment to end of study.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who were randomized to study treatment.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Updated PFS Per Investigator Assessment in the PIK3CA Mutant Cohort (Longer Follow-up)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PIK3CA Mutant Cohort by Tumor Tissue: Alpelisib + Fulvestrant', 'description': 'Subjects with advanced breast cancer with a PIK3CA mutation (based on central testing of hotspot-mutations in tumor tissue) treated with alpelisib (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle)'}, {'id': 'OG001', 'title': 'PIK3CA Mutant Cohort by Tumor Tissue: Placebo + Fulvestrant', 'description': 'Subjects with advanced breast cancer with a PIK3CA mutation (based on central testing of hotspot-mutations in tumor tissue) treated with placebo (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle)'}], 'classes': [{'categories': [{'measurements': [{'value': '10.97', 'groupId': 'OG000', 'lowerLimit': '7.49', 'upperLimit': '14.52'}, {'value': '5.65', 'groupId': 'OG001', 'lowerLimit': '3.65', 'upperLimit': '7.36'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 55.7 months', 'description': 'PFS was defined as the time from the date of randomization to the date of the first documented progression or death due to any cause. PFS was assessed via a local radiology assessment according to RECIST 1.1. If a patient did not have an event, PFS was censored at the date of last adequate tumor assessment.\n\nThe PFS distribution was estimated using Kaplan-Meier methodology. This analysis was conducted at the time of the final OS analysis (when approximately 178 deaths in the PIK3CA mutant cohort had been achieved) and includes a longer follow-up time.\n\nProgression was defined as at least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects with a PIK3CA mutation who were randomized to study treatment'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Alpelisib + Fulvestrant', 'description': 'Subjects treated with alpelisib (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle)'}, {'id': 'FG001', 'title': 'Placebo + Fulvestrant', 'description': 'Subjects treated with placebo (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '284'}, {'groupId': 'FG001', 'numSubjects': '288'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '284'}, {'groupId': 'FG001', 'numSubjects': '287'}]}, {'type': 'PIK3CA Mutant Cohort by Tumor Tissue', 'comment': 'Subjects with advanced breast cancer with a PIK3CA mutation based on central testing of hotspot-mutations in tumor tissue', 'achievements': [{'groupId': 'FG000', 'numSubjects': '169'}, {'groupId': 'FG001', 'numSubjects': '172'}]}, {'type': 'PIK3CA Non-mutant Cohort by Tumor Tissue', 'comment': 'Subjects with advanced breast cancer without a PIK3CA mutation based on central testing of hotspot-mutations in tumor tissue', 'achievements': [{'groupId': 'FG000', 'numSubjects': '115'}, {'groupId': 'FG001', 'numSubjects': '116'}]}, {'type': 'PIK3CA Mutant Cohort by ctDNA', 'comment': 'Subjects with advanced breast cancer with a PIK3CA mutation measured in ctDNA', 'achievements': [{'groupId': 'FG000', 'numSubjects': '92'}, {'groupId': 'FG001', 'numSubjects': '94'}]}, {'type': 'PIK3CA Non-mutant Cohort by ctDNA', 'comment': 'Subjects with advanced breast cancer without a PIK3CA mutation measured in ctDNA', 'achievements': [{'groupId': 'FG000', 'numSubjects': '181'}, {'groupId': 'FG001', 'numSubjects': '182'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '284'}, {'groupId': 'FG001', 'numSubjects': '288'}]}], 'dropWithdraws': [{'type': 'Progressive disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '207'}, {'groupId': 'FG001', 'numSubjects': '240'}]}, {'type': 'Subject/guardian decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Protocol deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Sponsor decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were enrolled in 198 centers across 31 countries', 'preAssignmentDetails': 'One subject in the PIK3CA mutant cohort, who was randomized to the placebo + fulvestrant arm, did not receive study treatment due to a protocol deviation.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'BG000'}, {'value': '288', 'groupId': 'BG001'}, {'value': '572', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Alpelisib + Fulvestrant', 'description': 'Subjects treated with alpelisib (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle)'}, {'id': 'BG001', 'title': 'Placebo + Fulvestrant', 'description': 'Subjects treated with placebo (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.6', 'spread': '9.74', 'groupId': 'BG000'}, {'value': '63.3', 'spread': '10.26', 'groupId': 'BG001'}, {'value': '63.0', 'spread': '10.00', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '283', 'groupId': 'BG000'}, {'value': '288', 'groupId': 'BG001'}, {'value': '571', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'White', 'measurements': [{'value': '199', 'groupId': 'BG000'}, {'value': '178', 'groupId': 'BG001'}, {'value': '377', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '125', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'American Indian or Alaska', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': 'Unknown', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-02-11', 'size': 2216660, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-05-23T03:31', 'hasProtocol': True}, {'date': '2023-05-08', 'size': 1486784, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_003.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-05-23T03:31', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 572}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'dispFirstSubmitDate': '2018-07-24', 'completionDateStruct': {'date': '2023-06-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-10', 'studyFirstSubmitDate': '2015-04-22', 'dispFirstSubmitQcDate': '2018-07-24', 'resultsFirstSubmitDate': '2019-06-17', 'studyFirstSubmitQcDate': '2015-05-04', 'dispFirstPostDateStruct': {'date': '2018-07-26', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-02-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-07-22', 'studyFirstPostDateStruct': {'date': '2015-05-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-08-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Updated PFS Per Investigator Assessment in the PIK3CA Mutant Cohort (Longer Follow-up)', 'timeFrame': 'Up to 55.7 months', 'description': 'PFS was defined as the time from the date of randomization to the date of the first documented progression or death due to any cause. PFS was assessed via a local radiology assessment according to RECIST 1.1. If a patient did not have an event, PFS was censored at the date of last adequate tumor assessment.\n\nThe PFS distribution was estimated using Kaplan-Meier methodology. This analysis was conducted at the time of the final OS analysis (when approximately 178 deaths in the PIK3CA mutant cohort had been achieved) and includes a longer follow-up time.\n\nProgression was defined as at least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.'}], 'primaryOutcomes': [{'measure': 'Progression-free Survival (PFS) Per Investigator Assessment in the PIK3CA Mutant Cohort', 'timeFrame': 'Once approximately 243 PFS events in the PIK3CA mutant cohort had been observed, up to 33.3 months', 'description': 'PFS was defined as the time from the date of randomization to the date of the first documented progression or death due to any cause. PFS was assessed via a local radiology assessment according to RECIST 1.1. If a patient did not have an event, PFS was censored at the date of last adequate tumor assessment.\n\nThe PFS distribution was estimated using Kaplan-Meier methodology. Progression was defined as at least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.'}], 'secondaryOutcomes': [{'measure': 'Overall Survival (OS) in the PIK3CA Mutant Cohort', 'timeFrame': 'Once approximately 178 deaths in the PIK3CA mutant cohort had been observed, up to 55.7 months', 'description': 'OS was defined as the time from date of randomization to date of death due to any cause. If a patient was not known to have died, survival was censored at the date of last known date patient alive.\n\nThe OS distribution was estimated using Kaplan-Meier methodology.'}, {'measure': 'PFS Per Investigator Assessment in the PIK3CA Non-mutant Cohort', 'timeFrame': 'Up to 56.4 months', 'description': 'PFS was defined as the time from the date of randomization to the date of the first documented progression or death due to any cause. PFS was assessed via a local radiology assessment according to RECIST 1.1. If a patient did not have an event, PFS was censored at the date of last adequate tumor assessment.\n\nThe PFS distribution was estimated using Kaplan-Meier methodology. Progression was defined as at least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.'}, {'measure': 'OS in the PIK3CA Non-mutant Cohort', 'timeFrame': 'Up to 56.4 months', 'description': 'OS was defined as the time from date of randomization to date of death due to any cause. If a patient was not known to have died, survival was censored at the date of last known date patient alive.\n\nThe OS distribution was estimated using Kaplan-Meier methodology.'}, {'measure': 'Overall Response Rate (ORR) Per Investigator Assessment', 'timeFrame': 'Up to 56.4 months', 'description': "ORR was defined as the percentage of patients with best overall response of complete response (CR) or partial response (PR) based on local investigator's assessment according to RECIST 1.1.\n\nCR: Disappearance of all non-nodal target and non-target lesions. In addition, any pathological lymph nodes assigned as target and non-target lesions must have a reduction in short axis to \\< 10 mm.\n\nPR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters."}, {'measure': 'Clinical Benefit Rate (CBR) Per Investigator Assessment', 'timeFrame': 'Up to 56.4 months', 'description': 'Clinical benefit rate was defined as the percentage of patients with a best overall response of CR or PR or stable disease (SD) or Non-CR/Non-PD lasting more than 24 weeks based on local investigator assessment according to RECIST 1.1.\n\nCR: Disappearance of all non-nodal target and non-target lesions. In addition, any pathological lymph nodes assigned as target and non-target lesions must have a reduction in short axis to \\< 10 mm.\n\nPR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.\n\nSD: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease.'}, {'measure': 'Time to Definitive Deterioration of Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Score From Baseline', 'timeFrame': 'From baseline up to 56.4 months', 'description': 'ECOG PS categorized patients based on their ability to perform daily activities and self-care, with scores ranging from 0 to 5. A score of 0 indicated no restrictions in activity, while higher scores indicated increasing limitations. Time to definitive deterioration of ECOG PS by one score was defined as the time from the date of randomization to the date of the event, defined as experiencing at least one score lower than the baseline. A deterioration was considered definitive if no improvements in the ECOG PS were observed at a subsequent time. The Kaplan-Meier method was used to estimate the distribution. Patients receiving any further therapy prior to definitive worsening were censored at their date of last assessment prior to start of therapy. Patients that had not worsened at the data cutoff point were censored at the date of last assessment.'}, {'measure': "Time to 10% Deterioration in the Global Health Status (GHS) /Quality of Life (QOL) Scale Score of the European Organization for Research and Treatment of Cancer's Core Quality of Life Questionnaire (EORTC QLQ-C30)", 'timeFrame': 'From baseline up to 55.7 months', 'description': 'The EORTC QLQ-C30 is a questionnaire that includes 5 functional scales, 3 symptom scales, 1 GHS/QoL scale, and 6 single items. GHS/QoL scale score ranges between 0 and 100. A high score for GHS/QoL represents better functioning or QoL.The time to definitive 10% deterioration was defined as the time from the date of randomization to the date of event, which was defined as at least 10% relative to baseline worsening of the GHS/QoL score (without further improvement above the threshold) or death due to any cause. The Kaplan-Meier method was used to estimate the distribution. If a patient had not had an event, time to deterioration was censored at the date of the last adequate QoL evaluation.'}, {'measure': 'Change From Baseline in the GHS/QOL Scale Score of the EORTC QLQ-C30', 'timeFrame': 'Baseline, every 8 weeks after randomization during the first 18 months and thereafter every 12 weeks, up to 120 weeks.', 'description': 'The EORTC QLQ-C30 is a questionnaire that includes 5 functional scales, 3 symptom scales, 1 GHS/QoL scale, and 6 single items. GHS/QoL scale score ranges between 0 and 100. A high score for GHS/QoL represents better functioning or QoL.The change from baseline in the GHS/QoL score was assessed. A positive change from baseline indicated improvement.\n\nFor each cohort, this analysis only included assessments up to the time point where there were at least 10 patients on each of the 2 treatment groups.'}, {'measure': 'Trough Plasma Concentration of Alpelisib', 'timeFrame': 'Day 8 and Day 15 of Cycle 1, then Day 1 of Cycles 2, 4, 6 and 8. Cycle = 28 days', 'description': 'Pre-dose plasma concentrations of alpelisib were assessed. Only participants randomized to the alpelisib + fulvestrant arm were included in this analysis.'}, {'measure': 'Trough Plasma Concentration of Fulvestrant', 'timeFrame': 'Day 15 of Cycle 1, then Day 1 of Cycles 2, 4, 6 and 8. Cycle = 28 days', 'description': 'Pre-dose plasma concentrations of fulvestrant were assessed.'}, {'measure': 'PFS Per Investigator Criteria in Subjects With PIK3CA Mutation Status Measured in ctDNA at Baseline', 'timeFrame': 'From baseline up to 56.4 months', 'description': 'PFS was defined as the time from the date of randomization to the date of the first documented progression or death due to any cause. PFS was assessed via a local radiology assessment according to RECIST 1.1. If a patient did not have an event, PFS was censored at the date of last adequate tumor assessment. The PFS distribution was estimated using Kaplan-Meier methodology.\n\nSubjects were analyzed according to the PIK3CA mutation status (mutant or non-mutant) as identified using plasma ctDNA.\n\nProgression was defined as at least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['BYL719', 'HR+', 'HER2-negative', 'advanced breast cancer', 'alpelisib', 'fulvestrant', 'PI3K', 'Phase III', 'ER+', 'PgR+', 'men', 'postmenopausal', 'aromatase inhibitor', 'neoplasms'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '39177931', 'type': 'DERIVED', 'citation': 'Borrego MR, Lu YS, Reyes-Cosmelli F, Park YH, Yamashita T, Chiu J, Airoldi M, Turner N, Fein L, Ghaznawi F, Singh J, Pantoja K, Schnell C, Akdere M, Chia S. SGLT2 inhibition improves PI3Kalpha inhibitor-induced hyperglycemia: findings from preclinical animal models and from patients in the BYLieve and SOLAR-1 trials. Breast Cancer Res Treat. 2024 Nov;208(1):111-121. doi: 10.1007/s10549-024-07405-8. Epub 2024 Aug 23.'}, {'pmid': '38439079', 'type': 'DERIVED', 'citation': 'Rodon J, Demanse D, Rugo HS, Burris HA, Simo R, Farooki A, Wellons MF, Andre F, Hu H, Vuina D, Quadt C, Juric D. A risk analysis of alpelisib-induced hyperglycemia in patients with advanced solid tumors and breast cancer. Breast Cancer Res. 2024 Mar 4;26(1):36. doi: 10.1186/s13058-024-01773-1.'}, {'pmid': '33780274', 'type': 'DERIVED', 'citation': 'Ciruelos EM, Rugo HS, Mayer IA, Levy C, Forget F, Delgado Mingorance JI, Safra T, Masuda N, Park YH, Juric D, Conte P, Campone M, Loibl S, Iwata H, Zhou X, Park J, Ridolfi A, Lorenzo I, Andre F. Patient-Reported Outcomes in Patients With PIK3CA-Mutated Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer From SOLAR-1. J Clin Oncol. 2021 Jun 20;39(18):2005-2015. doi: 10.1200/JCO.20.01139. Epub 2021 Mar 29.'}, {'pmid': '33246021', 'type': 'DERIVED', 'citation': 'Andre F, Ciruelos EM, Juric D, Loibl S, Campone M, Mayer IA, Rubovszky G, Yamashita T, Kaufman B, Lu YS, Inoue K, Papai Z, Takahashi M, Ghaznawi F, Mills D, Kaper M, Miller M, Conte PF, Iwata H, Rugo HS. Alpelisib plus fulvestrant for PIK3CA-mutated, hormone receptor-positive, human epidermal growth factor receptor-2-negative advanced breast cancer: final overall survival results from SOLAR-1. Ann Oncol. 2021 Feb;32(2):208-217. doi: 10.1016/j.annonc.2020.11.011. Epub 2020 Nov 25.'}, {'pmid': '32416251', 'type': 'DERIVED', 'citation': 'Rugo HS, Andre F, Yamashita T, Cerda H, Toledano I, Stemmer SM, Jurado JC, Juric D, Mayer I, Ciruelos EM, Iwata H, Conte P, Campone M, Wilke C, Mills D, Lteif A, Miller M, Gaudenzi F, Loibl S. Time course and management of key adverse events during the randomized phase III SOLAR-1 study of PI3K inhibitor alpelisib plus fulvestrant in patients with HR-positive advanced breast cancer. Ann Oncol. 2020 Aug;31(8):1001-1010. doi: 10.1016/j.annonc.2020.05.001. Epub 2020 May 13.'}, {'pmid': '31091374', 'type': 'DERIVED', 'citation': 'Andre F, Ciruelos E, Rubovszky G, Campone M, Loibl S, Rugo HS, Iwata H, Conte P, Mayer IA, Kaufman B, Yamashita T, Lu YS, Inoue K, Takahashi M, Papai Z, Longin AS, Mills D, Wilke C, Hirawat S, Juric D; SOLAR-1 Study Group. Alpelisib for PIK3CA-Mutated, Hormone Receptor-Positive Advanced Breast Cancer. N Engl J Med. 2019 May 16;380(20):1929-1940. doi: 10.1056/NEJMoa1813904.'}]}, 'descriptionModule': {'briefSummary': 'To determine whether treatment with alpelisib plus fulvestrant prolonged progression-free survival (PFS) compared to fulvestrant and placebo in men and postmenopausal women with hormone receptor positive (HR+), human epidermal growth factor receptor-2 (HER2)-negative advanced breast cancer, who received prior treatment with an aromatase Inhibitor (AI) either as (neo)adjuvant or for advanced disease.', 'detailedDescription': "This was a randomized, double-blind, placebo-controlled, international multicenter Phase III study that evaluated the efficacy and safety of treatment with alpelisib plus fulvestrant versus placebo plus fulvestrant in men and postmenopausal women with HR-positive, HER2-negative advanced breast cancer which had progressed on or after AI treatment.\n\nSubjects were allocated to either the PIK3CA mutant or PIK3CA non-mutant cohort, based on central testing of hotspot-mutations in tumor tissue. Subjects with unknown results were not eligible. Within each cohort, subjects were randomized in a 1:1 ratio to receive either alpelisib 300 mg orally once daily (q.d.), in combination with fulvestrant 500 mg intramuscular (i.m.) on Days 1 and 15 of Cycle 1 and Day 1 of a 28-day cycle thereafter, or placebo daily in combination with fulvestrant 500 mg following the same treatment regimen.\n\nSubjects were treated until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason. All subjects who discontinued study treatment were followed for safety, until 30 days after last study treatment administration, except in the case of death, loss to follow-up, or withdrawal of consent.\n\nSubjects who discontinued study treatment for reasons other than disease progression or withdrawal of consent, were followed until disease progression, death, withdrawal of consent, loss to follow-up, or subject/guardian decision (post-treatment efficacy follow-up).\n\nFinally, all subjects were followed for survival after discontinuation of study treatment and tumor evaluations until the subject's death, loss to follow-up, or withdrawal of consent for survival follow-up (post-treatment survival follow-up)"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* If female, the patient was postmenopausal.\n* The patient had identified PIK3CA status.\n* Patients could be:\n* Relapsed with documented evidence of progression while on (neo)adjuvant endocrine therapy or within 12 months from completion of (neo)adjuvant endocrine therapy with no treatment for metastatic disease.\n* Relapsed with documented evidence of progression more than 12 months from completion of (neo)adjuvant endocrine therapy and then subsequently progressed with documented evidence of progression while on or after only one line of endocrine therapy for metastatic disease.\n* Newly diagnosed with advanced breast cancer, then relapsed with documented evidence of progression while on or after only one line of endocrine therapy.\n* The patient had recurrence or progression of the disease during or after AI therapy (i.e., letrozole, anastrozole, exemestane).\n* The patient had a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive breast cancer by a local laboratory and had HER2 negative breast cancer.\n* The patient had either measurable disease per RECIST 1.1 criteria or at least one predominantly lytic bone lesion present.\n* The patient had adequate bone marrow function.\n\nExclusion Criteria:\n\n* The patient had symptomatic visceral disease or any disease burden that made the patient ineligible for endocrine therapy per the investigator's best judgment.\n* The patient had received prior treatment with chemotherapy (except for neoadjuvant/adjuvant chemotherapy), fulvestrant, any PI3K, mTOR, or AKT inhibitor (pre-treatment with CDK4/6 inhibitors was allowed).\n* The patient had inflammatory breast cancer at screening.\n* Patients had Child pugh score B or C.\n* Patients had an established diagnosis of diabetes mellitus type I or uncontrolled type II.\n* The patient had Eastern Cooperative Oncology Group (ECOG) performance status 2 or more.\n* The patient had CNS involvement unless he/she was at least 4 weeks from prior therapy completion to starting the study treatment and had a stable CNS tumor at the time of screening and was not receiving steroids and/or enzyme-inducing antiepileptic medications for brain metastases.\n* The patient had participated in a prior investigational study within 30 days prior to enrollment or within 5 half-lives of the investigational product, whichever was longer.\n* The patient had a history of acute pancreatitis within 1 year of screening or a past medical history of chronic pancreatitis.\n* The patient relapsed with documented evidence of progression more than 12 months from completion of (neo)adjuvant endocrine therapy with no treatment for metastatic disease."}, 'identificationModule': {'nctId': 'NCT02437318', 'acronym': 'SOLAR-1', 'briefTitle': 'Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant in Men and Postmenopausal Women With Advanced Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Phase III Randomized Double-blind, Placebo Controlled Study of Alpelisib in Combination With Fulvestrant for Men and Postmenopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment', 'orgStudyIdInfo': {'id': 'CBYL719C2301'}, 'secondaryIdInfos': [{'id': '2015-000340-42', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fulvestrant + alpelisib', 'description': 'Subjects treated with alpelisib (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle)', 'interventionNames': ['Drug: Fulvestrant', 'Drug: Alpelisib']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Fulvestrant + placebo', 'description': 'Subjects were treated with placebo (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle)', 'interventionNames': ['Drug: Fulvestrant', 'Drug: Placebo']}], 'interventions': [{'name': 'Fulvestrant', 'type': 'DRUG', 'description': '500 mg of fulvestrant administered via intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle', 'armGroupLabels': ['Fulvestrant + alpelisib', 'Fulvestrant + placebo']}, {'name': 'Alpelisib', 'type': 'DRUG', 'otherNames': ['BYL719'], 'description': '300 mg of alpelisib tablets for oral use administered once daily', 'armGroupLabels': ['Fulvestrant + alpelisib']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '300 mg of placebo tablets for oral use administered once daily', 'armGroupLabels': ['Fulvestrant + placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85224', 'city': 'Chandler', 'state': 'Arizona', 'country': 'United States', 'facility': 'Ironwood Cancer and Research Centers', 'geoPoint': {'lat': 33.30616, 'lon': -111.84125}}, {'zip': '85259', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic Arizona', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '72703', 'city': 'Fayetteville', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Highlands Oncology Group', 'geoPoint': {'lat': 36.06258, 'lon': -94.15743}}, {'zip': '90211', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Beverly Hills Cancer Center', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '91010 3000', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope National Medical Center', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Scripps Green Hospital', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '92120', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanent Southern Californi', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '33901', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Cancer Specialists', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '33705', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Cancer Specialists-North', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush University Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60201', 'city': 'Evanston', 'state': 'Illinois', 'country': 'United States', 'facility': 'NorthShore University Health System', 'geoPoint': {'lat': 42.04114, 'lon': -87.69006}}, {'zip': '60540', 'city': 'Naperville', 'state': 'Illinois', 'country': 'United States', 'facility': 'Edward Cancer Center', 'geoPoint': {'lat': 41.78586, 'lon': -88.14729}}, {'zip': '46815', 'city': 'Fort Wayne', 'state': 'Indiana', 'country': 'United States', 'facility': 'Fort Wayne Medical Oncology Hematology Inc', 'geoPoint': {'lat': 41.1306, 'lon': -85.12886}}, {'zip': '66606-169', 'city': 'Topeka', 'state': 'Kansas', 'country': 'United States', 'facility': 'St Francis Health Comprehensive Cancer Center', 'geoPoint': {'lat': 39.04833, 'lon': -95.67804}}, {'zip': '21202', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Mercy Medical Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '01805', 'city': 'Burlington', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Lahey Clinic', 'geoPoint': {'lat': 42.50482, 'lon': -71.19561}}, {'zip': '48867', 'city': 'Owosso', 'state': 'Michigan', 'country': 'United States', 'facility': 'Detroit Clinical Research Center', 'geoPoint': {'lat': 42.9978, 'lon': -84.17664}}, {'zip': '64111', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'St Lukes Cancer Institute', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '59102', 'city': 'Billings', 'state': 'Montana', 'country': 'United States', 'facility': 'St Vincent Frontier Cancer Center', 'geoPoint': {'lat': 45.78329, 'lon': -108.50069}}, {'zip': '08903', 'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Rutgers Cancer Institute of New Jersey', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Hospitals of Cleveland Seidman Cancer Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '97330', 'city': 'Corvallis', 'state': 'Oregon', 'country': 'United States', 'facility': 'Good Samaritan Regional Medical Center', 'geoPoint': {'lat': 44.56457, 'lon': -123.26204}}, {'zip': '17604', 'city': 'Lancaster', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Lancaster General Hospital', 'geoPoint': {'lat': 40.03788, 'lon': -76.30551}}, {'zip': '29615', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Prisma Health Upstate', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '57105', 'city': 'Sioux Falls', 'state': 'South Dakota', 'country': 'United States', 'facility': 'Avera Cancer', 'geoPoint': {'lat': 43.54369, 'lon': -96.72796}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'SCRI Oncology Partners', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Oncology PA Dallas Presbyterian Hospital', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '79902', 'city': 'El Paso', 'state': 'Texas', 'country': 'United States', 'facility': 'El Paso Texas Oncology', 'geoPoint': {'lat': 31.75872, 'lon': -106.48693}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Mays Cancer Ctr Uthsa Mdacc', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '75702', 'city': 'Tyler', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Oncology Northeast Texas', 'geoPoint': {'lat': 32.35126, 'lon': -95.30106}}, {'zip': '22031', 'city': 'Fairfax', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Cancer Specialists', 'geoPoint': {'lat': 38.84622, 'lon': -77.30637}}, {'zip': '98801', 'city': 'Wenatchee', 'state': 'Washington', 'country': 'United States', 'facility': 'Wenatchee Valley Medical Center', 'geoPoint': {'lat': 47.42346, 'lon': -120.31035}}, {'zip': 'B1884BBF', 'city': 'Berazategui', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': -34.76531, 'lon': -58.21278}}, {'zip': 'C1125ABD', 'city': 'CABA', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Novartis Investigative Site'}, {'zip': '8500', 'city': 'Rio Negro', 'state': 'Viedma', 'country': 'Argentina', 'facility': 'Novartis Investigative Site'}, {'zip': '5300', 'city': 'La Rioja', 'country': 'Argentina', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': -29.41328, 'lon': -66.85637}}, {'zip': '2076', 'city': 'Wahroonga', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': -33.71816, 'lon': 151.11561}}, {'zip': '4102', 'city': 'Wooloongabba', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Novartis Investigative Site'}, {'zip': '5112', 'city': 'Elizabeth Vale', 'state': 'South Australia', 'country': 'Australia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': -34.74857, 'lon': 138.66819}}, {'zip': '3000', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '4010', 'city': 'Linz', 'country': 'Austria', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}, {'zip': '1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '9100', 'city': 'Sint-Niklaas', 'state': 'Oost Vlaanderen', 'country': 'Belgium', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.16509, 'lon': 4.1437}}, {'zip': '1000', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '1090', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '2650', 'city': 'Edegem', 'country': 'Belgium', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.15662, 'lon': 4.44504}}, {'zip': '6800', 'city': 'Libramont', 'country': 'Belgium', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 49.91741, 'lon': 5.37318}}, {'zip': '1340', 'city': 'Ottignies', 'country': 'Belgium', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 50.66535, 'lon': 4.56679}}, {'zip': '4800', 'city': 'Verviers', 'country': 'Belgium', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 50.58907, 'lon': 5.86241}}, {'zip': '59075 740', 'city': 'Natal', 'state': 'Rio Grande do Norte', 'country': 'Brazil', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': -5.795, 'lon': -35.20944}}, {'zip': '95900-000', 'city': 'Lajeado', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': -29.46694, 'lon': -51.96139}}, {'zip': '04014-002', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '15090 000', 'city': 'São José do Rio Preto', 'country': 'Brazil', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': -20.81972, 'lon': -49.37944}}, {'zip': '01236 030', 'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '4004', 'city': 'Plovdiv', 'country': 'Bulgaria', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 42.15387, 'lon': 24.75001}}, {'zip': '1756', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '9002', 'city': 'Varna', 'country': 'Bulgaria', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 43.21912, 'lon': 27.91024}}, {'zip': '9010', 'city': 'Varna', 'country': 'Bulgaria', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 43.21912, 'lon': 27.91024}}, {'zip': 'T2N 4N2', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'N1R 3G2', 'city': 'Cambridge', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 43.3601, 'lon': -80.31269}}, {'zip': 'K1H 8L6', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'M5B 1W8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'G1S 4L8', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': '4810469', 'city': 'Temuco', 'state': 'Región de la Araucanía', 'country': 'Chile', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': -38.73628, 'lon': -72.59738}}, {'zip': '8420383', 'city': 'Santiago', 'country': 'Chile', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'zip': '2520612', 'city': 'Viña del Mar', 'country': 'Chile', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': -33.02457, 'lon': -71.55183}}, {'zip': '140 46', 'city': 'Prague', 'state': 'Czech Republic', 'country': 'Czechia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '762 75', 'city': 'Zlín', 'state': 'Czech Republic', 'country': 'Czechia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 49.22645, 'lon': 17.67065}}, {'zip': '500 05', 'city': 'Hradec Králové', 'state': 'CZE', 'country': 'Czechia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 50.20923, 'lon': 15.83277}}, {'zip': '180 00', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '13915', 'city': 'Marseille', 'state': 'Bouches Du Rhone', 'country': 'France', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '49055', 'city': 'Angers', 'country': 'France', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '84082', 'city': 'Avignon', 'country': 'France', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 43.94834, 'lon': 4.80892}}, {'zip': '14021', 'city': 'Caen', 'country': 'France', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '63011', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '94010', 'city': 'Créteil', 'country': 'France', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'zip': '85925', 'city': 'La Roche-sur-Yon', 'country': 'France', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 46.66974, 'lon': -1.42757}}, {'zip': '78150', 'city': 'Le Chesnay', 'country': 'France', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 48.8222, 'lon': 2.12213}}, {'zip': '92309', 'city': 'Levallois-Perret', 'country': 'France', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 48.89389, 'lon': 2.28864}}, {'zip': '69373', 'city': 'Lyon 08', 'country': 'France', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 45.73626, 'lon': 4.86866}}, {'zip': '34070', 'city': 'Montpellier', 'country': 'France', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '30029', 'city': 'Nîmes', 'country': 'France', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'zip': '76038', 'city': 'Rouen', 'country': 'France', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '44805', 'city': 'Saint-Herblain', 'country': 'France', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 47.21154, 'lon': -1.651}}, {'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '94800', 'city': 'Villejuif', 'country': 'France', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}, {'zip': '23563', 'city': 'Lübeck', 'state': 'Schleswig-Holstein', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 53.86893, 'lon': 10.68729}}, {'zip': '63739', 'city': 'Aschaffenburg', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 49.97704, 'lon': 9.15214}}, {'zip': '60389', 'city': 'Frankfurt', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'zip': '88045', 'city': 'Friedrichshafen', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 47.65689, 'lon': 9.47554}}, {'zip': '30625', 'city': 'Hanover', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': '66421', 'city': 'Homburg', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 49.32637, 'lon': 7.33867}}, {'zip': '24105', 'city': 'Kiel', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}, {'zip': '04277', 'city': 'Leipzig', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '55131', 'city': 'Mainz', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'zip': '14467', 'city': 'Potsdam', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 52.39886, 'lon': 13.06566}}, {'zip': '45657', 'city': 'Recklinghausen', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.61379, 'lon': 7.19738}}, {'zip': '18059', 'city': 'Rostock', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 54.0887, 'lon': 12.14049}}, {'zip': '89081', 'city': 'Ulm', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 48.39841, 'lon': 9.99155}}, {'zip': '42551', 'city': 'Velbert', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.33537, 'lon': 7.04348}}, {'zip': '564 29', 'city': 'Thessaloniki', 'state': 'GR', 'country': 'Greece', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'zip': '11528', 'city': 'Athens', 'country': 'Greece', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '18547', 'city': 'Athens', 'country': 'Greece', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Pokfulam', 'country': 'Hong Kong', 'facility': 'Novartis Investigative Site'}, {'zip': '1134', 'city': 'Budapest', 'state': 'Pest County', 'country': 'Hungary', 'facility': 'Novartis Investigative Site'}, {'zip': 'H 1122', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '4400', 'city': 'Nyíregyháza', 'country': 'Hungary', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 47.95539, 'lon': 21.71671}}, {'zip': '7100', 'city': 'Szekszárd', 'country': 'Hungary', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 46.34723, 'lon': 18.71189}}, {'zip': '520002', 'city': 'Vijayawada', 'state': 'Andhra Pradesh', 'country': 'India', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 16.50745, 'lon': 80.6466}}, {'zip': '440010', 'city': 'Nagpur', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 21.14631, 'lon': 79.08491}}, {'zip': '400 012', 'city': 'Mumbai', 'country': 'India', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 19.07283, 'lon': 72.88261}}, {'zip': '8457108', 'city': 'Beersheba', 'country': 'Israel', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 31.25181, 'lon': 34.7913}}, {'zip': '3109601', 'city': 'Haifa', 'country': 'Israel', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'zip': '4941492', 'city': 'Petah Tikva', 'country': 'Israel', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}, {'zip': '52621', 'city': 'Ramat Gan', 'country': 'Israel', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 32.08227, 'lon': 34.81065}}, {'zip': '6423906', 'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}, {'zip': '60126', 'city': 'Ancona', 'state': 'AN', 'country': 'Italy', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 43.60717, 'lon': 13.5103}}, {'zip': '66100', 'city': 'Chieti', 'state': 'CH', 'country': 'Italy', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 42.34827, 'lon': 14.16494}}, {'zip': '47014', 'city': 'Meldola', 'state': 'FC', 'country': 'Italy', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 44.12775, 'lon': 12.0626}}, {'zip': '20133', 'city': 'Milan', 'state': 'MI', 'country': 'Italy', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '90127', 'city': 'Palermo', 'state': 'PA', 'country': 'Italy', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 38.1166, 'lon': 13.3636}}, {'zip': '35100', 'city': 'Padua', 'state': 'PD', 'country': 'Italy', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}, {'zip': '56025', 'city': 'Pontedera', 'state': 'PI', 'country': 'Italy', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 43.66141, 'lon': 10.63067}}, {'zip': '33081', 'city': 'Aviano', 'state': 'PN', 'country': 'Italy', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 46.07056, 'lon': 12.59472}}, {'zip': '85028', 'city': 'Rionero in Vulture', 'state': 'PZ', 'country': 'Italy', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 40.92328, 'lon': 15.6711}}, {'zip': '00168', 'city': 'Roma', 'state': 'RM', 'country': 'Italy', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '17100', 'city': 'Savona', 'state': 'SV', 'country': 'Italy', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 44.30905, 'lon': 8.47715}}, {'zip': '10126', 'city': 'Torino', 'state': 'TO', 'country': 'Italy', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}, {'zip': '37024', 'city': 'Negrar', 'state': 'VR', 'country': 'Italy', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 45.52918, 'lon': 10.93899}}, {'zip': '07100', 'city': 'Sassari', 'country': 'Italy', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 40.72586, 'lon': 8.55552}}, {'zip': '464 8681', 'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'zip': '791-0280', 'city': 'Matsuyama', 'state': 'Ehime', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 33.83916, 'lon': 132.76574}}, {'zip': '371 8511', 'city': 'Maebashi', 'state': 'Gunma', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 36.4, 'lon': 139.08333}}, {'zip': '003-0804', 'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '673-8558', 'city': 'Akashi', 'state': 'Hyōgo', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 34.65524, 'lon': 135.00687}}, {'zip': '259-1193', 'city': 'Isehara', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.39932, 'lon': 139.31019}}, {'zip': '241-8515', 'city': 'Yokohama', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}, {'zip': '540-0006', 'city': 'Osaka', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '541-8567', 'city': 'Osaka', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '362-0806', 'city': 'Kitaadachi-gun', 'state': 'Saitama', 'country': 'Japan', 'facility': 'Novartis Investigative Site'}, {'zip': '104 8560', 'city': 'Chuo Ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Novartis Investigative Site'}, {'zip': '105-8470', 'city': 'Minato Ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Novartis Investigative Site'}, {'zip': '892-0833', 'city': 'Kagoshima', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 31.56667, 'lon': 130.55}}, {'zip': '860-8556', 'city': 'Kumamoto', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 32.80589, 'lon': 130.69181}}, {'zip': '10999', 'city': 'Beirut', 'country': 'Lebanon', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 33.89332, 'lon': 35.50157}}, {'zip': '166830', 'city': 'El Achrafiyé', 'country': 'Lebanon', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 33.88533, 'lon': 35.51961}}, {'zip': '652', 'city': 'Saida', 'country': 'Lebanon', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 33.55751, 'lon': 35.37148}}, {'zip': '64320', 'city': 'Monterrey', 'state': 'Nuevo León', 'country': 'Mexico', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 25.68435, 'lon': -100.31721}}, {'zip': '78200', 'city': 'San Luis Potosí City', 'country': 'Mexico', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 22.15234, 'lon': -100.97135}}, {'zip': '5801', 'city': 'Venray', 'state': 'CE', 'country': 'Netherlands', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.525, 'lon': 5.975}}, {'zip': '4535 PA', 'city': 'Terneuzen', 'country': 'Netherlands', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.33583, 'lon': 3.82778}}, {'zip': '41', 'city': 'San Borja', 'state': 'Lima region', 'country': 'Peru', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': -12.09841, 'lon': -77.01107}}, {'zip': '34', 'city': 'Surquillo', 'state': 'Lima region', 'country': 'Peru', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': -12.11993, 'lon': -77.01147}}, {'zip': 'LIMA 27', 'city': 'Lima', 'country': 'Peru', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': -12.04318, 'lon': -77.02824}}, {'zip': '407280', 'city': 'Floreşti', 'state': 'Cluj', 'country': 'Romania', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 46.74574, 'lon': 23.49375}}, {'zip': '200347', 'city': 'Craiova', 'state': 'Dolj', 'country': 'Romania', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 44.31667, 'lon': 23.8}}, {'zip': '700483', 'city': 'Iași', 'country': 'Romania', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 47.16667, 'lon': 27.6}}, {'zip': '163045', 'city': 'Arkhangelsk', 'country': 'Russia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 64.5461, 'lon': 40.55183}}, {'zip': '390011', 'city': 'Ryazan', 'country': 'Russia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 54.62696, 'lon': 39.70415}}, {'zip': '197758', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '13620', 'city': 'Bundang Gu', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Novartis Investigative Site'}, {'zip': '10408', 'city': 'Gyeonggi-do', 'state': 'Korea', 'country': 'South Korea', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 37.58944, 'lon': 126.76917}}, {'zip': '03080', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '03722', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '05505', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '06351', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '41013', 'city': 'Seville', 'state': 'Andalusia', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '07120', 'city': 'Palma de Mallorca', 'state': 'Balearic Islands', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 39.56939, 'lon': 2.65024}}, {'zip': '11407', 'city': 'Jerez de la Frontera', 'state': 'Cadiz', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 36.68645, 'lon': -6.13606}}, {'zip': '08916', 'city': 'Badalona', 'state': 'Catalonia', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 41.45004, 'lon': 2.24741}}, {'zip': '08024', 'city': 'Barcelona', 'state': 'Catalonia', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '06080', 'city': 'Badajoz', 'state': 'Extremadura', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 38.87789, 'lon': -6.97061}}, {'zip': '10003', 'city': 'Cáceres', 'state': 'Extremadura', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 39.47649, 'lon': -6.37224}}, {'zip': '15706', 'city': 'Santiago de Compostela', 'state': 'Galicia', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 42.88052, 'lon': -8.54569}}, {'zip': '28223', 'city': 'Pozuelo de Alarcón', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 40.43293, 'lon': -3.81338}}, {'zip': '30120', 'city': 'El Palmar', 'state': 'Murcia', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 37.93939, 'lon': -1.16095}}, {'zip': '38320', 'city': 'San Cristóbal de La Laguna', 'state': 'Santa Cruz De Tenerife', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 28.4853, 'lon': -16.32014}}, {'zip': '03010', 'city': 'Alicante', 'state': 'Valencia', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 38.34517, 'lon': -0.48149}}, {'zip': '12002', 'city': 'Castellon', 'state': 'Valencia', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 39.98567, 'lon': -0.04935}}, {'zip': '46010', 'city': 'Valencia', 'state': 'Valencia', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '28034', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28040', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28041', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28046', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28050', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': 'SE-801 87', 'city': 'Gävle', 'country': 'Sweden', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 60.67452, 'lon': 17.14174}}, {'zip': '70185', 'city': 'Örebro', 'country': 'Sweden', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 59.27412, 'lon': 15.2066}}, {'zip': '721 89', 'city': 'Västerås', 'country': 'Sweden', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 59.61617, 'lon': 16.55276}}, {'zip': '10002', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '11217', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '10330', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'zip': '10700', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'zip': 'LE1 5WW', 'city': 'Leicester', 'country': 'United Kingdom', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 52.6386, 'lon': -1.13169}}, {'zip': 'SE1 9RT', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'PL6 8DH', 'city': 'Plymouth', 'country': 'United Kingdom', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 50.37153, 'lon': -4.14305}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.\n\nThis trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}