Ignite Creation Date:
2025-12-24 @ 6:29 PM
Ignite Modification Date:
2025-12-29 @ 2:27 AM
Study NCT ID:
NCT01923168
Status:
COMPLETED
Last Update Posted:
2018-09-14
First Post:
2013-08-13
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Letrozole With or Without BYL719 or Buparlisib, for the Neoadjuvant Treatment of Postmenopausal Women
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['France', 'South Africa']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C585539', 'term': 'Alpelisib'}, {'id': 'C571178', 'term': 'NVP-BKM120'}]}}, '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 Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).', 'description': 'Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment', 'eventGroups': [{'id': 'EG000', 'title': 'Alpelisib + Letrozole', 'description': 'Participants took alpelisib 300 mg once daily plus letrozole 2.5 mg once daily.', 'otherNumAtRisk': 130, 'deathsNumAtRisk': 130, 'otherNumAffected': 126, 'seriousNumAtRisk': 130, 'deathsNumAffected': 1, 'seriousNumAffected': 21}, {'id': 'EG001', 'title': 'Buparlisib + Letrozole', 'description': 'Participants took buparlisib 100 mg once daily or 5 days on/2 days off plus letrozole 2.5 mg once daily.', 'otherNumAtRisk': 81, 'deathsNumAtRisk': 81, 'otherNumAffected': 80, 'seriousNumAtRisk': 81, 'deathsNumAffected': 0, 'seriousNumAffected': 22}, {'id': 'EG002', 'title': 'Placebo + Letrozole', 'description': 'Participants took matching Placebo (of alpelisib 300 mg once daily/buparlisib 100 mg once daily or 5 days on/2 days off) plus Letrozole 2.5 mg once daily.', 'otherNumAtRisk': 125, 'deathsNumAtRisk': 125, 'otherNumAffected': 106, 'seriousNumAtRisk': 125, 'deathsNumAffected': 1, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 6}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 66}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 19}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 57}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 37}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 23}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 17}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 42}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Mucosal dryness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 9}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 49}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 44}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 10}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 69}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 38}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 34}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 11}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 13}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 19}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 16}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Memory impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 10}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 17}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Breast pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 10}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 7}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 9}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 58}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 31}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 10}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 31}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 8}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}], 'seriousEvents': [{'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Cardiac disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Stress cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Iritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 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125, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Hepatotoxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Hypertransaminasaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Accidental overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Post procedural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Ejection fraction decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Hypercalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Hyperuricaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Ureterolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Angioedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Skin necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pathological Complete Response (pCR) Per Investigator Assessment for Alpelisib vs. Placebo for PIK3CA Mutant Cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alpelisib + Letrozole', 'description': 'Participants took alpelisib 300 mg once daily plus letrozole 2.5 mg once daily.'}, {'id': 'OG001', 'title': 'Placebo + Letrozole', 'description': 'Participants took matching Placebo (of alpelisib 300 mg once daily/buparlisib 100 mg once daily or 5 days on/2 days off) plus Letrozole 2.5 mg once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '6.3'}, {'value': '3.0', 'groupId': 'OG001', 'lowerLimit': '0.8', 'upperLimit': '7.7'}]}]}], 'analyses': [{'pValue': '0.282', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-1.3', 'ciLowerLimit': '-4.5', 'ciUpperLimit': '1.7', 'statisticalMethod': 'Posterior mean diff. & credible interval', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Bayesian double criteria'}], 'paramType': 'NUMBER', 'timeFrame': 'After 24 weeks of treatment', 'description': 'Pathologic complete response (pCR) defined as absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes following completion of 24 weeks of treatment by local assessment (ypT0/Tis ypN0). Patients who experienced progression of disease while undergoing neoadjuvant therapy, or who did not receive surgery for any reason, or received antineoplastic treatment other than study drug(s) before surgery were considered as non-responders for the calculation of pCR rate.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '80% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) for the PIK3CA mutant cohort comprised all randomized participants who were assigned to the PIK3CA mutant cohort based on tumor tissue for the randomization.'}, {'type': 'PRIMARY', 'title': 'Pathological Complete Response (pCR) Per Investigator Assessment for Alpelisib vs. Placebo for PIK3CA Wild-type Cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alpelisib + Letrozole', 'description': 'Participants took alpelisib 300 mg once daily plus letrozole 2.5 mg once daily.'}, {'id': 'OG001', 'title': 'Placebo + Letrozole', 'description': 'Participants took matching Placebo (of alpelisib 300 mg once daily/buparlisib 100 mg once daily or 5 days on/2 days off) plus Letrozole 2.5 mg once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.8', 'groupId': 'OG000', 'lowerLimit': '0.8', 'upperLimit': '7.3'}, {'value': '1.7', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '6.4'}]}]}], 'analyses': [{'pValue': '0.697', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '1.1', 'ciLowerLimit': '-1.9', 'ciUpperLimit': '4.2', 'statisticalMethod': 'Posterior mean difference', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Posterior mean difference', 'nonInferiorityComment': 'Bayesian double criteria'}], 'paramType': 'NUMBER', 'timeFrame': 'After 24 weeks of treatment', 'description': 'Pathologic complete response (pCR) defined as absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes following completion of 24 weeks of treatment by local assessment (ypT0/Tis ypN0). Patients who experienced progression of disease while undergoing neoadjuvant therapy, or who did not receive surgery for any reason, or received antineoplastic treatment other than study drug(s) before surgery were considered as non-responders for the calculation of pCR rate.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '80% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) for the PIK3CA wild-type cohort comprised all randomized participants who were assigned to the PIK3CA wild-type cohort based on tumor tissue for the randomization.'}, {'type': 'PRIMARY', 'title': 'Objective Response Rate Per Investigator Assessment According to RECIST 1.1 for Alpelisib vs. Placebo - PIK3CA Mutant Cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alpelisib + Letrozole', 'description': 'Participants took alpelisib 300 mg once daily plus letrozole 2.5 mg once daily.'}, {'id': 'OG001', 'title': 'Placebo + Letrozole', 'description': 'Participants took matching Placebo (of alpelisib 300 mg once daily/buparlisib 100 mg once daily or 5 days on/2 days off) plus Letrozole 2.5 mg once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '43.3', 'groupId': 'OG000', 'lowerLimit': '34.6', 'upperLimit': '52.4'}, {'value': '44.8', 'groupId': 'OG001', 'lowerLimit': '36.5', 'upperLimit': '53.3'}]}]}], 'analyses': [{'pValue': '0.435', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-1.4', 'ciLowerLimit': '-12.5', 'ciUpperLimit': '9.7', 'statisticalMethod': 'Posterior mean diff. & credible interval', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Bayesian double criteria'}], 'paramType': 'NUMBER', 'timeFrame': 'After 24 weeks of treatment', 'description': "Objective Response Rate (ORR) defined as the proportion of patients with a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) based on local investigator's assessment according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST) 1.1.\n\nBOR was assessed per MRI or Ultrasound and defined as per RECIST 1.1 as CR for a disappearance of all non-nodal target lesions (TL)/non-target lesions (NTL) and a reduction in short axis to \\< 10 mm of any pathological lymph nodes assigned as TL/NTL and no new lesion; as PR if not qualifying for CR but with a decrease from baseline ≥ 30% in the sum of diameter of all TL, no progression of NTL and no new lesion.", 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '80% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) for the PIK3CA mutant cohort comprised all randomized participants who were assigned to the PIK3CA mutant cohort based on tumor tissue for the randomization.'}, {'type': 'PRIMARY', 'title': 'Objective Response Rate According to RECIST 1.1 Per Investigator Assessment for Alpelisib vs. Placebo - PIK3CA Wild-type Cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alpelisib + Letrozole', 'description': 'Participants took alpelisib 300 mg once daily plus letrozole 2.5 mg once daily.'}, {'id': 'OG001', 'title': 'Placebo + Letrozole', 'description': 'Participants took matching Placebo (of alpelisib 300 mg once daily/buparlisib 100 mg once daily or 5 days on/2 days off) plus Letrozole 2.5 mg once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '63.4', 'groupId': 'OG000', 'lowerLimit': '55.1', 'upperLimit': '71.0'}, {'value': '61.0', 'groupId': 'OG001', 'lowerLimit': '51.8', 'upperLimit': '69.6'}]}]}], 'analyses': [{'pValue': '0.611', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '2.4', 'ciLowerLimit': '-8.4', 'ciUpperLimit': '13.2', 'statisticalMethod': 'Posterior mean diff. & credible interval', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Bayesian double criteria'}], 'paramType': 'NUMBER', 'timeFrame': 'After 24 weeks of treatment', 'description': "Objective Response Rate (ORR) defined as the proportion of patients with a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) based on local investigator's assessment according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST) 1.1.\n\nBOR was assessed per MRI or Ultrasound and defined as per RECIST 1.1 as CR for a disappearance of all non-nodal target lesions (TL)/non-target lesions (NTL) and a reduction in short axis to \\< 10 mm of any pathological lymph nodes assigned as TL/NTL and no new lesion; as PR if not qualifying for CR but with a decrease from baseline ≥ 30% in the sum of diameter of all TL, no progression of NTL and no new lesion.", 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '80% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) for the PIK3CA wild-type cohort comprised all randomized participants who were assigned to the PIK3CA wild-type cohort based on tumor tissue for the randomization.'}, {'type': 'SECONDARY', 'title': 'pCR and Objective Response Rate According to RECIST 1.1 Criteria Per Investigator Assessment for Alpelisib vs. Placebo in PIK3CA Mutant Cohort Based on ctDNA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alpelisib + Letrozole', 'description': 'Participants took alpelisib 300 mg once daily plus letrozole 2.5 mg once daily.'}, {'id': 'OG001', 'title': 'Placebo + Letrozole', 'description': 'Participants took matching Placebo (of alpelisib 300 mg once daily/buparlisib 100 mg once daily or 5 days on/2 days off) plus Letrozole 2.5 mg once daily.'}], 'timeFrame': 'After 24 weeks of treatment', 'description': 'pCR and Objective response rate according to RECIST 1.1 per investigator assessment after 24 weeks of treatment', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS comprised all randomized participants. This analysis was to be done in patients with PIK3CA mutation based on Circulating tumor DNA (ctDNA). Data could not be reported as the ctDNA analysis was not done after the primary endpoint was negative.'}, {'type': 'SECONDARY', 'title': 'pCR and Objective Response Rate According to RECIST 1.1 Criteria Per Investigator Assessment for Alpelisib vs. Placebo in PIK3CA Wild-type Cohort Based on ctDNA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alpelisib + Letrozole', 'description': 'Participants took alpelisib 300 mg once daily plus letrozole 2.5 mg once daily.'}, {'id': 'OG001', 'title': 'Placebo + Letrozole', 'description': 'Participants took matching Placebo (of alpelisib 300 mg once daily/buparlisib 100 mg once daily or 5 days on/2 days off) plus Letrozole 2.5 mg once daily.'}], 'timeFrame': 'After 24 weeks of treatment', 'description': 'pCR and Objective response rate according to RECIST 1.1 per investigator assessment after 24 weeks of treatment', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) comprised all randomized participants in the study. This analysis was to be done in PIK3CA wild-type patients based on Circulating tumor DNA (ctDNA). Data could not be reported in this table as the ctDNA analysis was not done after the primary endpoint was negative.'}, {'type': 'SECONDARY', 'title': 'Rate of Breast Conserving Surgery for Alpelisib vs. Placebo - PIK3CA Mutant Cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alpelisib + Letrozole', 'description': 'Participants took alpelisib 300 mg once daily plus letrozole 2.5 mg once daily.'}, {'id': 'OG001', 'title': 'Placebo + Letrozole', 'description': 'Participants took matching Placebo (of alpelisib 300 mg once daily/buparlisib 100 mg once daily or 5 days on/2 days off) plus Letrozole 2.5 mg once daily.'}], 'classes': [{'title': 'Breast conserving surgery', 'categories': [{'measurements': [{'value': '56.7', 'groupId': 'OG000', 'lowerLimit': '47.6', 'upperLimit': '65.4'}, {'value': '50.7', 'groupId': 'OG001', 'lowerLimit': '42.2', 'upperLimit': '59.2'}]}]}, {'title': 'No Surgery', 'categories': [{'measurements': [{'value': '15.0', 'groupId': 'OG000', 'lowerLimit': '9.3', 'upperLimit': '22.6'}, {'value': '9.0', 'groupId': 'OG001', 'lowerLimit': '4.8', 'upperLimit': '15.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'After 24 weeks of treatment', 'description': 'Breast conserving surgery is defined for participants who underwent surgery and did not have a mastectomy. The row "no surgery" provides the number of patients who did not undergo surgery at all for various reasons.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '80% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) for the PIK3CA mutant cohort comprised all randomized participants who were assigned to the PIK3CA mutant cohort based on tumor tissue for the randomization. PIK3CA mutation is based on tumor tissue.'}, {'type': 'SECONDARY', 'title': 'Rate of Breast Conserving Surgery for Alpelisib vs. Placebo - PIK3CA Wild-type Cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alpelisib + Letrozole', 'description': 'Participants took alpelisib 300 mg once daily plus letrozole 2.5 mg once daily.'}, {'id': 'OG001', 'title': 'Placebo + Letrozole', 'description': 'Participants took matching Placebo (of alpelisib 300 mg once daily/buparlisib 100 mg once daily or 5 days on/2 days off) plus Letrozole 2.5 mg once daily.'}], 'classes': [{'title': 'Breast conserving surgery', 'categories': [{'measurements': [{'value': '50.7', 'groupId': 'OG000', 'lowerLimit': '42.5', 'upperLimit': '58.9'}, {'value': '62.7', 'groupId': 'OG001', 'lowerLimit': '53.6', 'upperLimit': '71.2'}]}]}, {'title': 'No Surgery', 'categories': [{'measurements': [{'value': '18.3', 'groupId': 'OG000', 'lowerLimit': '12.5', 'upperLimit': '25.6'}, {'value': '8.5', 'groupId': 'OG001', 'lowerLimit': '4.5', 'upperLimit': '15.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'After 24 weeks of treatment', 'description': 'Breast conserving surgery is defined as the percentage of participants with no mastectomy following completion of 24 weeks of treatment. Breast conserving surgery is defined for participants who underwent surgery and did not have a mastectomy. The row "no surgery" provides the number of patients who did not undergo surgery at all for various reasons.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '80% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) for the PIK3CA wild-type cohort comprised all randomized participants who were assigned to the PIK3CA wild-type cohort based on tumor tissue for the randomization. PIK3CA mutation is based on tumor tissue.'}, {'type': 'SECONDARY', 'title': 'Association Between pCR and Changes in Ki67 From Baseline for Alpelisib vs. Placebo - PIK3CA Mutant Cohort: Responders as Per pCR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alpelisib + Letrozole', 'description': 'Participants took alpelisib 300 mg once daily plus letrozole 2.5 mg once daily.'}, {'id': 'OG001', 'title': 'Placebo + Letrozole', 'description': 'Participants took matching Placebo (of alpelisib 300 mg once daily/buparlisib 100 mg once daily or 5 days on/2 days off) plus Letrozole 2.5 mg once daily.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '5'}, {'value': '11.0', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '17'}]}]}, {'title': 'C1D15: % change from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-80.0', 'groupId': 'OG000', 'lowerLimit': '-80', 'upperLimit': '-80'}, {'value': '80.0', 'groupId': 'OG001', 'lowerLimit': '80', 'upperLimit': '80'}]}]}, {'title': 'EOT % change from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Cycle 1 Day 15 (each cycle is 28 days) and surgery (End of Treatment (EOT) expected after 24 weeks of treatment)', 'description': 'Association Between pCR and Changes in Ki67 From Baseline for Alpelisib vs. Placebo - PIK3CA Mutant Cohort: Responders as Per pCR', 'unitOfMeasure': 'Percentage of positive cells', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS for the PIK3CA mutant cohort comprised all randomized participants who were assigned to the PIK3CA mutant cohort based on tumor tissue for the randomization. Only responders as per pCR were considered for this analysis. No patient had data reported at end of trial (EOT), hence the percent change from baseline at EOT could not be reported.'}, {'type': 'SECONDARY', 'title': 'Association Between pCR and Changes in Ki67 From Baseline for Alpelisib vs. Placebo - PIK3CA Mutant Cohort: Non-responders as Per pCR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alpelisib + Letrozole', 'description': 'Participants took alpelisib 300 mg once daily plus letrozole 2.5 mg once daily.'}, {'id': 'OG001', 'title': 'Placebo + Letrozole', 'description': 'Participants took matching Placebo (of alpelisib 300 mg once daily/buparlisib 100 mg once daily or 5 days on/2 days off) plus Letrozole 2.5 mg once daily.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '82'}, {'value': '13.0', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '89'}]}]}, {'title': 'C1D15 % change from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-62.5', 'groupId': 'OG000', 'lowerLimit': '-97', 'upperLimit': '467'}, {'value': '-60.0', 'groupId': 'OG001', 'lowerLimit': '-96', 'upperLimit': '733'}]}]}, {'title': 'EOT % change from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-51.2', 'groupId': 'OG000', 'lowerLimit': '-94', 'upperLimit': '400'}, {'value': '-60.0', 'groupId': 'OG001', 'lowerLimit': '-97', 'upperLimit': '223'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Cycle 1 Day 15 (each cycle is 28 days ) and surgery (End of Treatment (EOT) expected after 24 weeks of treatment)', 'description': 'Association Between pCR and Changes in Ki67 From Baseline for Alpelisib vs. Placebo - PIK3CA Mutant Cohort: Non-responders as Per pCR.', 'unitOfMeasure': 'Percentage of positive cells', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) for the PIK3CA mutant cohort comprised all randomized participants who were assigned to the PIK3CA mutant cohort based on tumor tissue for the randomization. Only non-responders as per pCR are considered for this analysis.'}, {'type': 'SECONDARY', 'title': 'Association Between pCR and Changes in Ki67 From Baseline for Alpelisib vs. Placebo - PIK3CA Wild-type Cohort: Responders as Per pCR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alpelisib + Letrozole', 'description': 'Participants took alpelisib 300 mg once daily plus letrozole 2.5 mg once daily.'}, {'id': 'OG001', 'title': 'Placebo + Letrozole', 'description': 'Participants took matching Placebo (of alpelisib 300 mg once daily/buparlisib 100 mg once daily or 5 days on/2 days off) plus Letrozole 2.5 mg once daily.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.5', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '30'}, {'value': '20.0', 'groupId': 'OG001', 'lowerLimit': '20', 'upperLimit': '20'}]}]}, {'title': 'C1D15: % change from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-80.0', 'groupId': 'OG000', 'lowerLimit': '-80', 'upperLimit': '-80'}]}]}, {'title': 'EOT % change from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-45.0', 'groupId': 'OG000', 'lowerLimit': '-90', 'upperLimit': '0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Cycle 1 Day 15 (each cycle is 28 days) and surgery (End of Treatment (EOT) expected after 24 weeks of treatment)', 'description': 'Association between pCR and changes in Ki67 from baseline for alpelisib vs. placebo - PIK3CA wild-type cohort: responders as per pCR', 'unitOfMeasure': 'Percentage of positive cells', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS for PIK3CA wild-type cohort comprised all rand. Parts. assigned to PIK3CA wild-type cohort based on tumor tissue for rand. Only responders as per pCR were considered for this analysis. No patient had data reported at C1D15 \\& EOT for Placebo, hence percent change from baseline could not be reported.'}, {'type': 'SECONDARY', 'title': 'Association Between pCR and Changes in Ki67 From Baseline for Alpelisib vs. Placebo - PIK3CA Wild-type Cohort: Non-responders as Per pCR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alpelisib + Letrozole', 'description': 'Participants took alpelisib 300 mg once daily plus letrozole 2.5 mg once daily.'}, {'id': 'OG001', 'title': 'Placebo + Letrozole', 'description': 'Participants took matching Placebo (of alpelisib 300 mg once daily/buparlisib 100 mg once daily or 5 days on/2 days off) plus Letrozole 2.5 mg once daily.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.0', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '60'}, {'value': '18.0', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '85'}]}]}, {'title': 'C1D15 % change from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-60.0', 'groupId': 'OG000', 'lowerLimit': '-97', 'upperLimit': '220'}, {'value': '-52.0', 'groupId': 'OG001', 'lowerLimit': '-93', 'upperLimit': '50'}]}]}, {'title': 'EOT % change from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-60.0', 'groupId': 'OG000', 'lowerLimit': '-90', 'upperLimit': '190'}, {'value': '-71.1', 'groupId': 'OG001', 'lowerLimit': '-100', 'upperLimit': '250'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Cycle 1 Day 15 (each cycle is 28 days) and surgery (End of Treatment (EOT) expected after 24 weeks of treatment)', 'description': 'Association between pCR and changes in Ki67 from baseline for alpelisib vs. placebo - PIK3CA wild-type cohort: non-responders as per pCR', 'unitOfMeasure': 'Percentage of positive cells', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) for the PIK3CA wild-type cohort comprised all randomized participants who were assigned to the PIK3CA wild-type cohort based on tumor tissue for the randomization. Only non-responders as per pCR are considered for this analysis.'}, {'type': 'SECONDARY', 'title': 'Preoperative Endocrine Prognostic Index (PEPI) Response as Per Central Assessment for Alpelisib vs. Placebo - PIK3CA Mutant Cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alpelisib + Letrozole', 'description': 'Participants took alpelisib 300 mg once daily plus letrozole 2.5 mg once daily.'}, {'id': 'OG001', 'title': 'Placebo + Letrozole', 'description': 'Participants took matching Placebo (of alpelisib 300 mg once daily/buparlisib 100 mg once daily or 5 days on/2 days off) plus Letrozole 2.5 mg once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At the time of surgery (expected after 24 weeks of treatment)', 'description': 'Preoperative endocrine prognostic index (PEPI) response as per central assessment for alpelisib vs. placebo - PIK3CA mutant cohort. The total PEPI score assigned to each patient is the sum of the risk points derived from the pT stage, pN stage, Ki67 level, and ER status of the surgical specimen (Ellis et al, Contemp Clin Trials 2008). The PEPI score ranges from 0 to to 12, and a higher score means a worse outcome. PEPI response is defined as a PEPI score of 0.', 'unitOfMeasure': 'Number of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) for the PIK3CA mutant cohort comprised all randomized participants who were assigned to the PIK3CA mutant cohort based on tumor tissue for the randomization.'}, {'type': 'SECONDARY', 'title': 'Preoperative Endocrine Prognostic Index (PEPI) Response as Per Central Assessment for Alpelisib vs. Placebo - PIK3CA Wild-type Cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alpelisib + Letrozole', 'description': 'Participants took alpelisib 300 mg once daily plus letrozole 2.5 mg once daily.'}, {'id': 'OG001', 'title': 'Placebo + Letrozole', 'description': 'Participants took matching Placebo (of alpelisib 300 mg once daily/buparlisib 100 mg once daily or 5 days on/2 days off) plus Letrozole 2.5 mg once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At the time of surgery (expected after 24 weeks of treatment)', 'description': 'Preoperative endocrine prognostic index (PEPI) response as per central assessment for alpelisib vs. placebo - PIK3CA wild-type cohort. The total PEPI score assigned to each patient is the sum of the risk points derived from the pT stage, pN stage, Ki67 level, and ER status of the surgical specimen (Ellis et al, Contemp Clin Trials 2008). The PEPI score ranges from 0 to to 12, and a higher score means a worse outcome. PEPI response is defined as a PEPI score of 0.', 'unitOfMeasure': 'Number of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) for the PIK3CA wild-type cohort comprised all randomized participants who were assigned to the PIK3CA wild-type cohort based on tumor tissue for the randomization.'}, {'type': 'SECONDARY', 'title': 'Alpelisib PK Parameters: AUC0-24, AUClast at Cycle 1 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Alpelisib + Letrozole', 'description': 'Participants took alpelisib 300 mg once daily plus letrozole 2.5 mg once daily.'}], 'classes': [{'title': 'AUC0-24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '30800', 'spread': '20.6', 'groupId': 'OG000'}]}]}, {'title': 'AUClast', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '27300', 'spread': '68.6', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0, 0.5, 1, 3, 6, 9 and 24 hours post-dose at Cycle 1 Day 1 (each cycle is 28 days)', 'description': 'Summary of primary PK parameters for alpelisib plasma concentration', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The BYL FPAS included participants who received at least 1 dose of alpelisib, had at least 1 evaluable post-treatment alpelisib concentration, received adequate doses of alpelisib and letrozole prior to full PK assessment, did not vomit within 4 hours of alpelisib or letrozole dosing on the day of full PK and had an evaluable full PK profile.'}, {'type': 'SECONDARY', 'title': 'Alpelisib PK Parameter: Cmax at Cycle 1 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Alpelisib + Letrozole', 'description': 'Participants took alpelisib 300 mg once daily plus letrozole 2.5 mg once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '3160', 'spread': '25.3', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 1 (each cycle is 28 days)', 'description': 'Summary of primary PK parameters for alpelisib plasma concentration', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The BYL FPAS included participants who received at least 1 dose of alpelisib, had at least 1 evaluable post-treatment alpelisib concentration, received adequate doses of alpelisib and letrozole prior to full PK assessment, did not vomit within 4 hours of alpelisib or letrozole dosing on the day of full PK and had an evaluable full PK profile.'}, {'type': 'SECONDARY', 'title': 'Alpelisib and PK Parameter: Tmax at Cycle 1 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Alpelisib + Letrozole', 'description': 'Participants took alpelisib 300 mg once daily plus letrozole 2.5 mg once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.93', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cycle 1 Day 1 (each cycle is 28 days)', 'description': 'Summary of primary PK parameters for alpelisib plasma concentration', 'unitOfMeasure': 'HR', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Alpelisib Pharmacokinetic Analysis Set (BYL PAS): The BYL PAS included all participants who received at least one dose of alpelisib and had at least one evaluable post-treatment alpelisib concentration measurement.'}, {'type': 'SECONDARY', 'title': 'Alpelisib PK Parameters: AUC0-24, AUClast at Cycle 4 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Alpelisib + Letrozole', 'description': 'Participants took alpelisib 300 mg once daily plus letrozole 2.5 mg once daily.'}], 'classes': [{'title': 'AUC0-24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '38000', 'spread': '13.2', 'groupId': 'OG000'}]}]}, {'title': 'AUClast', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '38000', 'spread': '13.1', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0, 0.5, 1, 3, 6, 9 and 24 hours post-dose at Cycle 4 Day 1 (each cycle is 28 days)', 'description': 'Summary of primary PK parameters for alpelisib plasma concentration', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The BYL FPAS included participants who received at least 1 dose of alpelisib, had at least 1 evaluable post-treatment alpelisib concentration, received adequate doses of alpelisib and letrozole prior to full PK assessment, did not vomit within 4 hours of alpelisib or letrozole dosing on the day of full PK and had an evaluable full PK profile.'}, {'type': 'SECONDARY', 'title': 'Alpelisib PK Parameter: Cmax at Cycle 4 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Alpelisib + Letrozole', 'description': 'Participants took alpelisib 300 mg once daily plus letrozole 2.5 mg once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '3260', 'spread': '26.7', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 4 Day 1 (each cycle is 28 days)', 'description': 'Summary of primary PK parameters for alpelisib plasma concentration', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Alpelisib Pharmacokinetic Analysis Set (BYL PAS): The BYL PAS included all participants who received at least one dose of alpelisib and had at least one evaluable post-treatment alpelisib concentration measurement.'}, {'type': 'SECONDARY', 'title': 'Alpelisib PK Parameter: Tmax at Cycle 4 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Alpelisib + Letrozole', 'description': 'Participants took alpelisib 300 mg once daily plus letrozole 2.5 mg once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.99', 'groupId': 'OG000', 'lowerLimit': '2.98', 'upperLimit': '3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cycle 4 Day 1 (each cycle is 28 days)', 'description': 'Summary of primary PK parameters for alpelisib plasma concentration', 'unitOfMeasure': 'hr', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Alpelisib Pharmacokinetic Analysis Set (BYL PAS): The BYL PAS included all participants who received at least one dose of alpelisib and had at least one evaluable post-treatment alpelisib concentration measurement.'}, {'type': 'SECONDARY', 'title': 'Letrozole and PK Parameters: AUC0-24, AUClast at Cycle 1 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alpelisib + Letrozole', 'description': 'Participants took alpelisib 300 mg once daily plus letrozole 2.5 mg once daily.'}, {'id': 'OG001', 'title': 'Placebo + Letrozole', 'description': 'Participants took matching Placebo (of alpelisib 300 mg once daily/buparlisib 100 mg once daily or 5 days on/2 days off) plus Letrozole 2.5 mg once daily.'}], 'classes': [{'title': 'AUC0-24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '433', 'spread': '36.3', 'groupId': 'OG000'}, {'value': '427', 'spread': '28.8', 'groupId': 'OG001'}]}]}, {'title': 'AUClast', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '314', 'spread': '96.9', 'groupId': 'OG000'}, {'value': '347', 'spread': '49.6', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0, 0.5, 1, 3, 6, 9 and 24 hours post-dose at Cycle 1 Day 1 (each cycle is 28 days)', 'description': 'Summary of primary PK parameters for Letrozole plasma concentration', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The LZ FPAS included participants who received at least 1 dose of letrozole, had at least 1 evaluable post-treatment letrozole concentration, received adequate doses of letrozole prior to full PK assessment, did not vomit within 4 hours of letrozole dosing on the day of full PK and had an evaluable full PK profile.'}, {'type': 'SECONDARY', 'title': 'Letrozole PK Parameter: Cmax at Cycle 1 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alpelisib + Letrozole', 'description': 'Participants took alpelisib 300 mg once daily plus letrozole 2.5 mg once daily.'}, {'id': 'OG001', 'title': 'Placebo + Letrozole', 'description': 'Participants took matching Placebo (of alpelisib 300 mg once daily/buparlisib 100 mg once daily or 5 days on/2 days off) plus Letrozole 2.5 mg once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '30.2', 'spread': '33.2', 'groupId': 'OG000'}, {'value': '28', 'spread': '42.3', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 1 (each cycle is 28 days)', 'description': 'Summary of primary PK parameters for letrozole plasma concentration', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The LZ FPAS included participants who received at least 1 dose of letrozole, had at least 1 evaluable post-treatment letrozole concentration, received adequate doses of letrozole prior to full PK assessment, did not vomit within 4 hours of letrozole dosing on the day of full PK and had an evaluable full PK profile.'}, {'type': 'SECONDARY', 'title': 'Letrozole PK Parameter: Tmax at Cycle 1 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alpelisib + Letrozole', 'description': 'Participants took alpelisib 300 mg once daily plus letrozole 2.5 mg once daily.'}, {'id': 'OG001', 'title': 'Placebo + Letrozole', 'description': 'Participants took matching Placebo (of alpelisib 300 mg once daily/buparlisib 100 mg once daily or 5 days on/2 days off) plus Letrozole 2.5 mg once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.03', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '3'}, {'value': '2.25', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '24.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cycle 1 Day 1 (each cycle is 28 days)', 'description': 'Summary of primary PK parameters for letrozole plasma concentration', 'unitOfMeasure': 'hr', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The LZ FPAS included participants who received at least 1 dose of letrozole, had at least 1 evaluable post-treatment letrozole concentration, received adequate doses of letrozole prior to full PK assessment, did not vomit within 4 hours of letrozole dosing on the day of full PK and had an evaluable full PK profile.'}, {'type': 'SECONDARY', 'title': 'Letrozole PK Parameters: AUC0-24, AUClast at Cycle 4 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alpelisib + Letrozole', 'description': 'Participants took alpelisib 300 mg once daily plus letrozole 2.5 mg once daily.'}, {'id': 'OG001', 'title': 'Placebo + Letrozole', 'description': 'Participants took matching Placebo (of alpelisib 300 mg once daily/buparlisib 100 mg once daily or 5 days on/2 days off) plus Letrozole 2.5 mg once daily.'}], 'classes': [{'title': 'AUC0-24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1280', 'spread': '18', 'groupId': 'OG000'}, {'value': '1810', 'spread': '33.1', 'groupId': 'OG001'}]}]}, {'title': 'AUClast', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1280', 'spread': '17.9', 'groupId': 'OG000'}, {'value': '1440', 'spread': '66.7', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0, 0.5, 1, 3, 6, 9 and 24 hours post-dose at Cycle 4 Day 1 (each cycle is 28 days)', 'description': 'Summary of primary PK parameters for Letrozole plasma concentration', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Letrozole Pharmacokinetic Analysis Set (LZ PAS): The LZ PAS included all participants who received at least one dose of letrozole and had at least one evaluable post-treatment letrozole concentration measurement.'}, {'type': 'SECONDARY', 'title': 'Letrozole PK Parameter: Cmax at Cycle 4 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alpelisib + Letrozole', 'description': 'Participants took alpelisib 300 mg once daily plus letrozole 2.5 mg once daily.'}, {'id': 'OG001', 'title': 'Placebo + Letrozole', 'description': 'Participants took matching Placebo (of alpelisib 300 mg once daily/buparlisib 100 mg once daily or 5 days on/2 days off) plus Letrozole 2.5 mg once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '75.6', 'spread': '6.84', 'groupId': 'OG000'}, {'value': '103', 'spread': '30', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 4 Day 1 (each cycle is 28 days)', 'description': 'Summary of primary PK parameters for letrozole plasma concentration', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The LZ FPAS included participants who received at least 1 dose of letrozole, had at least 1 evaluable post-treatment letrozole concentration, received adequate doses of letrozole prior to full PK assessment, did not vomit within 4 hours of letrozole dosing on the day of full PK and had an evaluable full PK profile.'}, {'type': 'SECONDARY', 'title': 'Letrozole PK Parameter: Tmax at Cycle 4 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alpelisib + Letrozole', 'description': 'Participants took alpelisib 300 mg once daily plus letrozole 2.5 mg once daily.'}, {'id': 'OG001', 'title': 'Placebo + Letrozole', 'description': 'Participants took matching Placebo (of alpelisib 300 mg once daily/buparlisib 100 mg once daily or 5 days on/2 days off) plus Letrozole 2.5 mg once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '3'}, {'value': '1.17', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cycle 4 Day 1 (each cycle is 28 days)', 'description': 'Summary of primary PK parameters for letrozole plasma concentration', 'unitOfMeasure': 'hr', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The LZ FPAS included participants who received at least 1 dose of letrozole, had at least 1 evaluable post-treatment letrozole concentration, received adequate doses of letrozole prior to full PK assessment, did not vomit within 4 hours of letrozole dosing on the day of full PK and had an evaluable full PK profile.'}, {'type': 'SECONDARY', 'title': 'Buparlisib PK Parameters: AUC0-24, AUClast at Cycle 1 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Buparlisib + Letrozole', 'description': 'Participants took buparlisib 100 mg once daily or 5 days on/2 days off plus letrozole 2.5 mg once daily.'}], 'classes': [{'title': 'AUC0-24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6420', 'spread': '60', 'groupId': 'OG000'}]}]}, {'title': 'AUClast', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4820', 'spread': '123', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0, 0.5, 1, 3, 6, 9 and 24 hours post-dose at Cycle 1 Day 1 (each cycle is 28 days)', 'description': 'Summary of primary PK parameters for Buparlisib plasma concentration', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The BKM FPAS included participants who received at least 1 dose of buparlisib, had at least 1 evaluable post-treatment concentration, received adequate doses of buparlisib and letrozole prior to full PK assessment, did not vomit within 4 hours of buparlisib or letrozole dosing on the day of full PK and had an evaluable full PK profile.'}, {'type': 'SECONDARY', 'title': 'Buparlisib PK Parameter: Cmax at Cycle 1 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Buparlisib + Letrozole', 'description': 'Participants took buparlisib 100 mg once daily or 5 days on/2 days off plus letrozole 2.5 mg once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '760', 'spread': '86.7', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 1 (each cycle is 28 days)', 'description': 'Summary of primary PK parameters for buparlisib plasma concentration', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The BKM FPAS included participants who received at least 1 dose of buparlisib, had at least 1 evaluable post-treatment concentration, received adequate doses of buparlisib and letrozole prior to full PK assessment, did not vomit within 4 hours of buparlisib or letrozole dosing on the day of full PK and had an evaluable full PK profile.'}, {'type': 'SECONDARY', 'title': 'Buparlisib PK Parameter: Tmax at Cycle 1 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Buparlisib + Letrozole', 'description': 'Participants took buparlisib 100 mg once daily or 5 days on/2 days off plus letrozole 2.5 mg once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.03', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '3.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cycle 1 Day 1 (each cycle is 28 days)', 'description': 'Summary of primary PK parameters for buparlisib plasma concentration', 'unitOfMeasure': 'hr', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Buparlisib Pharmacokinetic Analysis Set (BKM PAS): The BKM PAS included all participants who received at least one dose of buparlisib and had at least one evaluable post-treatment buparlisib concentration measurement.'}, {'type': 'SECONDARY', 'title': 'Buparlisib PK Parameter: AUClast at Cycle 4 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Buparlisib + Letrozole', 'description': 'Participants took buparlisib 100 mg once daily or 5 days on/2 days off plus letrozole 2.5 mg once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '10400', 'groupId': 'OG000', 'lowerLimit': '10400', 'upperLimit': '10400'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '0, 0.5, 1, 3, 6, 9 and 24 hours post-dose at Cycle 4 Day 1 (each cycle is 28 days)', 'description': 'Summary of primary PK parameters for Buparlisib plasma concentration', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'BKM FPAS: The BKM FPAS included participants who received at least 1 dose of buparlisib, had at least 1 evaluable post-treatment concentration, received adequate doses of buparlisib and letrozole prior to full PK assessment, did not vomit within 4 hours of buparlisib or letrozole dosing on the day of full PK and had an evaluable full PK profile.'}, {'type': 'SECONDARY', 'title': 'Buparlisb PK Parameter: Cmax at Cycle 4 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Buparlisib + Letrozole', 'description': 'Participants took buparlisib 100 mg once daily or 5 days on/2 days off plus letrozole 2.5 mg once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '610', 'groupId': 'OG000', 'lowerLimit': '610', 'upperLimit': '610'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cycle 4 Day 1 (each cycle is 28 days)', 'description': 'Summary of primary PK parameters for buparlisib plasma concentration', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Buparlisib Pharmacokinetic Analysis Set (BKM PAS): The BKM PAS included all participants who received at least one dose of buparlisib and had at least one evaluable post-treatment buparlisib concentration measurement.'}, {'type': 'SECONDARY', 'title': 'Buparlisib PK Parameter: Tmax at Cycle 4 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Buparlisib + Letrozole', 'description': 'Participants took buparlisib 100 mg once daily or 5 days on/2 days off plus letrozole 2.5 mg once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cycle 4 Day 1 (each cycle is 28 days)', 'description': 'Summary of primary PK parameters for buparlisib plasma concentration', 'unitOfMeasure': 'hr', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Buparlisib Pharmacokinetic Analysis Set (BKM PAS): The BKM PAS included all participants who received at least one dose of buparlisib and had at least one evaluable post-treatment buparlisib concentration measurement.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Alpelisib + Letrozole', 'description': 'Participants took alpelisib 300 mg once daily plus letrozole 2.5 mg once daily.'}, {'id': 'FG001', 'title': 'Buparlisib + Letrozole', 'description': 'Participants took buparlisib 100 mg once daily or 5 days on/2 days off plus letrozole 2.5 mg once daily.'}, {'id': 'FG002', 'title': 'Placebo + Letrozole', 'description': 'Participants took matching Placebo (of alpelisib 300 mg once daily/buparlisib 100 mg once daily or 5 days on/2 days off) plus Letrozole 2.5 mg once daily.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '131'}, {'groupId': 'FG001', 'numSubjects': '83'}, {'groupId': 'FG002', 'numSubjects': '126'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '94'}, {'groupId': 'FG001', 'numSubjects': '44'}, {'groupId': 'FG002', 'numSubjects': '109'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '39'}, {'groupId': 'FG002', 'numSubjects': '17'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Subject/guardian decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'Progressive disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'A total of approximately 320 patients were planned to be randomized: this was based on 60 patients per arm in each cohort (PIK3CA mutant and PIK3CA wild-type) for the alpelisib+letrozole and placebo+letrozole arms, plus the estimated number of patients randomized to buparlisib+letrozole arm at the time this arm was discontinued.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '126', 'groupId': 'BG002'}, {'value': '340', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Alpelisib + Letrozole', 'description': 'Participants took alpelisib 300 mg once daily plus letrozole 2.5 mg once daily.'}, {'id': 'BG001', 'title': 'Buparlisib + Letrozole', 'description': 'Participants took buparlisib 100 mg once daily or 5 days on/2 days off plus letrozole 2.5 mg once daily.'}, {'id': 'BG002', 'title': 'Placebo + Letrozole', 'description': 'Participants took matching Placebo (of alpelisib 300 mg once daily/buparlisib 100 mg once daily or 5 days on/2 days off) plus Letrozole 2.5 mg once daily.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.3', 'spread': '8.53', 'groupId': 'BG000'}, {'value': '65.2', 'spread': '8.61', 'groupId': 'BG001'}, {'value': '63.1', 'spread': '8.31', 'groupId': 'BG002'}, {'value': '64.1', 'spread': '8.49', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '131', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '126', 'groupId': 'BG002'}, {'value': '340', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '117', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}, {'value': '290', 'groupId': 'BG003'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The Full Analysis Set (FAS) comprised all randomized subjects in the study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-02-07', 'size': 758401, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-07-04T01:30', 'hasProtocol': False}, {'date': '2016-10-18', 'size': 1898853, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-07-04T01:30', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 340}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2017-07-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-13', 'studyFirstSubmitDate': '2013-08-13', 'resultsFirstSubmitDate': '2018-07-04', 'studyFirstSubmitQcDate': '2013-08-13', 'lastUpdatePostDateStruct': {'date': '2018-09-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-08-13', 'studyFirstPostDateStruct': {'date': '2013-08-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pathological Complete Response (pCR) Per Investigator Assessment for Alpelisib vs. Placebo for PIK3CA Mutant Cohort', 'timeFrame': 'After 24 weeks of treatment', 'description': 'Pathologic complete response (pCR) defined as absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes following completion of 24 weeks of treatment by local assessment (ypT0/Tis ypN0). Patients who experienced progression of disease while undergoing neoadjuvant therapy, or who did not receive surgery for any reason, or received antineoplastic treatment other than study drug(s) before surgery were considered as non-responders for the calculation of pCR rate.'}, {'measure': 'Pathological Complete Response (pCR) Per Investigator Assessment for Alpelisib vs. Placebo for PIK3CA Wild-type Cohort', 'timeFrame': 'After 24 weeks of treatment', 'description': 'Pathologic complete response (pCR) defined as absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes following completion of 24 weeks of treatment by local assessment (ypT0/Tis ypN0). Patients who experienced progression of disease while undergoing neoadjuvant therapy, or who did not receive surgery for any reason, or received antineoplastic treatment other than study drug(s) before surgery were considered as non-responders for the calculation of pCR rate.'}, {'measure': 'Objective Response Rate Per Investigator Assessment According to RECIST 1.1 for Alpelisib vs. Placebo - PIK3CA Mutant Cohort', 'timeFrame': 'After 24 weeks of treatment', 'description': "Objective Response Rate (ORR) defined as the proportion of patients with a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) based on local investigator's assessment according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST) 1.1.\n\nBOR was assessed per MRI or Ultrasound and defined as per RECIST 1.1 as CR for a disappearance of all non-nodal target lesions (TL)/non-target lesions (NTL) and a reduction in short axis to \\< 10 mm of any pathological lymph nodes assigned as TL/NTL and no new lesion; as PR if not qualifying for CR but with a decrease from baseline ≥ 30% in the sum of diameter of all TL, no progression of NTL and no new lesion."}, {'measure': 'Objective Response Rate According to RECIST 1.1 Per Investigator Assessment for Alpelisib vs. Placebo - PIK3CA Wild-type Cohort', 'timeFrame': 'After 24 weeks of treatment', 'description': "Objective Response Rate (ORR) defined as the proportion of patients with a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) based on local investigator's assessment according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST) 1.1.\n\nBOR was assessed per MRI or Ultrasound and defined as per RECIST 1.1 as CR for a disappearance of all non-nodal target lesions (TL)/non-target lesions (NTL) and a reduction in short axis to \\< 10 mm of any pathological lymph nodes assigned as TL/NTL and no new lesion; as PR if not qualifying for CR but with a decrease from baseline ≥ 30% in the sum of diameter of all TL, no progression of NTL and no new lesion."}], 'secondaryOutcomes': [{'measure': 'pCR and Objective Response Rate According to RECIST 1.1 Criteria Per Investigator Assessment for Alpelisib vs. Placebo in PIK3CA Mutant Cohort Based on ctDNA', 'timeFrame': 'After 24 weeks of treatment', 'description': 'pCR and Objective response rate according to RECIST 1.1 per investigator assessment after 24 weeks of treatment'}, {'measure': 'pCR and Objective Response Rate According to RECIST 1.1 Criteria Per Investigator Assessment for Alpelisib vs. Placebo in PIK3CA Wild-type Cohort Based on ctDNA', 'timeFrame': 'After 24 weeks of treatment', 'description': 'pCR and Objective response rate according to RECIST 1.1 per investigator assessment after 24 weeks of treatment'}, {'measure': 'Rate of Breast Conserving Surgery for Alpelisib vs. Placebo - PIK3CA Mutant Cohort', 'timeFrame': 'After 24 weeks of treatment', 'description': 'Breast conserving surgery is defined for participants who underwent surgery and did not have a mastectomy. The row "no surgery" provides the number of patients who did not undergo surgery at all for various reasons.'}, {'measure': 'Rate of Breast Conserving Surgery for Alpelisib vs. Placebo - PIK3CA Wild-type Cohort', 'timeFrame': 'After 24 weeks of treatment', 'description': 'Breast conserving surgery is defined as the percentage of participants with no mastectomy following completion of 24 weeks of treatment. Breast conserving surgery is defined for participants who underwent surgery and did not have a mastectomy. The row "no surgery" provides the number of patients who did not undergo surgery at all for various reasons.'}, {'measure': 'Association Between pCR and Changes in Ki67 From Baseline for Alpelisib vs. Placebo - PIK3CA Mutant Cohort: Responders as Per pCR', 'timeFrame': 'Baseline, Cycle 1 Day 15 (each cycle is 28 days) and surgery (End of Treatment (EOT) expected after 24 weeks of treatment)', 'description': 'Association Between pCR and Changes in Ki67 From Baseline for Alpelisib vs. Placebo - PIK3CA Mutant Cohort: Responders as Per pCR'}, {'measure': 'Association Between pCR and Changes in Ki67 From Baseline for Alpelisib vs. Placebo - PIK3CA Mutant Cohort: Non-responders as Per pCR', 'timeFrame': 'Baseline, Cycle 1 Day 15 (each cycle is 28 days ) and surgery (End of Treatment (EOT) expected after 24 weeks of treatment)', 'description': 'Association Between pCR and Changes in Ki67 From Baseline for Alpelisib vs. Placebo - PIK3CA Mutant Cohort: Non-responders as Per pCR.'}, {'measure': 'Association Between pCR and Changes in Ki67 From Baseline for Alpelisib vs. Placebo - PIK3CA Wild-type Cohort: Responders as Per pCR', 'timeFrame': 'Baseline, Cycle 1 Day 15 (each cycle is 28 days) and surgery (End of Treatment (EOT) expected after 24 weeks of treatment)', 'description': 'Association between pCR and changes in Ki67 from baseline for alpelisib vs. placebo - PIK3CA wild-type cohort: responders as per pCR'}, {'measure': 'Association Between pCR and Changes in Ki67 From Baseline for Alpelisib vs. Placebo - PIK3CA Wild-type Cohort: Non-responders as Per pCR', 'timeFrame': 'Baseline, Cycle 1 Day 15 (each cycle is 28 days) and surgery (End of Treatment (EOT) expected after 24 weeks of treatment)', 'description': 'Association between pCR and changes in Ki67 from baseline for alpelisib vs. placebo - PIK3CA wild-type cohort: non-responders as per pCR'}, {'measure': 'Preoperative Endocrine Prognostic Index (PEPI) Response as Per Central Assessment for Alpelisib vs. Placebo - PIK3CA Mutant Cohort', 'timeFrame': 'At the time of surgery (expected after 24 weeks of treatment)', 'description': 'Preoperative endocrine prognostic index (PEPI) response as per central assessment for alpelisib vs. placebo - PIK3CA mutant cohort. The total PEPI score assigned to each patient is the sum of the risk points derived from the pT stage, pN stage, Ki67 level, and ER status of the surgical specimen (Ellis et al, Contemp Clin Trials 2008). The PEPI score ranges from 0 to to 12, and a higher score means a worse outcome. PEPI response is defined as a PEPI score of 0.'}, {'measure': 'Preoperative Endocrine Prognostic Index (PEPI) Response as Per Central Assessment for Alpelisib vs. Placebo - PIK3CA Wild-type Cohort', 'timeFrame': 'At the time of surgery (expected after 24 weeks of treatment)', 'description': 'Preoperative endocrine prognostic index (PEPI) response as per central assessment for alpelisib vs. placebo - PIK3CA wild-type cohort. The total PEPI score assigned to each patient is the sum of the risk points derived from the pT stage, pN stage, Ki67 level, and ER status of the surgical specimen (Ellis et al, Contemp Clin Trials 2008). The PEPI score ranges from 0 to to 12, and a higher score means a worse outcome. PEPI response is defined as a PEPI score of 0.'}, {'measure': 'Alpelisib PK Parameters: AUC0-24, AUClast at Cycle 1 Day 1', 'timeFrame': '0, 0.5, 1, 3, 6, 9 and 24 hours post-dose at Cycle 1 Day 1 (each cycle is 28 days)', 'description': 'Summary of primary PK parameters for alpelisib plasma concentration'}, {'measure': 'Alpelisib PK Parameter: Cmax at Cycle 1 Day 1', 'timeFrame': 'Cycle 1 Day 1 (each cycle is 28 days)', 'description': 'Summary of primary PK parameters for alpelisib plasma concentration'}, {'measure': 'Alpelisib and PK Parameter: Tmax at Cycle 1 Day 1', 'timeFrame': 'Cycle 1 Day 1 (each cycle is 28 days)', 'description': 'Summary of primary PK parameters for alpelisib plasma concentration'}, {'measure': 'Alpelisib PK Parameters: AUC0-24, AUClast at Cycle 4 Day 1', 'timeFrame': '0, 0.5, 1, 3, 6, 9 and 24 hours post-dose at Cycle 4 Day 1 (each cycle is 28 days)', 'description': 'Summary of primary PK parameters for alpelisib plasma concentration'}, {'measure': 'Alpelisib PK Parameter: Cmax at Cycle 4 Day 1', 'timeFrame': 'Cycle 4 Day 1 (each cycle is 28 days)', 'description': 'Summary of primary PK parameters for alpelisib plasma concentration'}, {'measure': 'Alpelisib PK Parameter: Tmax at Cycle 4 Day 1', 'timeFrame': 'Cycle 4 Day 1 (each cycle is 28 days)', 'description': 'Summary of primary PK parameters for alpelisib plasma concentration'}, {'measure': 'Letrozole and PK Parameters: AUC0-24, AUClast at Cycle 1 Day 1', 'timeFrame': '0, 0.5, 1, 3, 6, 9 and 24 hours post-dose at Cycle 1 Day 1 (each cycle is 28 days)', 'description': 'Summary of primary PK parameters for Letrozole plasma concentration'}, {'measure': 'Letrozole PK Parameter: Cmax at Cycle 1 Day 1', 'timeFrame': 'Cycle 1 Day 1 (each cycle is 28 days)', 'description': 'Summary of primary PK parameters for letrozole plasma concentration'}, {'measure': 'Letrozole PK Parameter: Tmax at Cycle 1 Day 1', 'timeFrame': 'Cycle 1 Day 1 (each cycle is 28 days)', 'description': 'Summary of primary PK parameters for letrozole plasma concentration'}, {'measure': 'Letrozole PK Parameters: AUC0-24, AUClast at Cycle 4 Day 1', 'timeFrame': '0, 0.5, 1, 3, 6, 9 and 24 hours post-dose at Cycle 4 Day 1 (each cycle is 28 days)', 'description': 'Summary of primary PK parameters for Letrozole plasma concentration'}, {'measure': 'Letrozole PK Parameter: Cmax at Cycle 4 Day 1', 'timeFrame': 'Cycle 4 Day 1 (each cycle is 28 days)', 'description': 'Summary of primary PK parameters for letrozole plasma concentration'}, {'measure': 'Letrozole PK Parameter: Tmax at Cycle 4 Day 1', 'timeFrame': 'Cycle 4 Day 1 (each cycle is 28 days)', 'description': 'Summary of primary PK parameters for letrozole plasma concentration'}, {'measure': 'Buparlisib PK Parameters: AUC0-24, AUClast at Cycle 1 Day 1', 'timeFrame': '0, 0.5, 1, 3, 6, 9 and 24 hours post-dose at Cycle 1 Day 1 (each cycle is 28 days)', 'description': 'Summary of primary PK parameters for Buparlisib plasma concentration'}, {'measure': 'Buparlisib PK Parameter: Cmax at Cycle 1 Day 1', 'timeFrame': 'Cycle 1 Day 1 (each cycle is 28 days)', 'description': 'Summary of primary PK parameters for buparlisib plasma concentration'}, {'measure': 'Buparlisib PK Parameter: Tmax at Cycle 1 Day 1', 'timeFrame': 'Cycle 1 Day 1 (each cycle is 28 days)', 'description': 'Summary of primary PK parameters for buparlisib plasma concentration'}, {'measure': 'Buparlisib PK Parameter: AUClast at Cycle 4 Day 1', 'timeFrame': '0, 0.5, 1, 3, 6, 9 and 24 hours post-dose at Cycle 4 Day 1 (each cycle is 28 days)', 'description': 'Summary of primary PK parameters for Buparlisib plasma concentration'}, {'measure': 'Buparlisb PK Parameter: Cmax at Cycle 4 Day 1', 'timeFrame': 'Cycle 4 Day 1 (each cycle is 28 days)', 'description': 'Summary of primary PK parameters for buparlisib plasma concentration'}, {'measure': 'Buparlisib PK Parameter: Tmax at Cycle 4 Day 1', 'timeFrame': 'Cycle 4 Day 1 (each cycle is 28 days)', 'description': 'Summary of primary PK parameters for buparlisib plasma concentration'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['BYL719', 'alpelisib', 'Breast Cancer', 'BKM120', 'buparlisib', 'Pathological Complete Response', 'neoadjuvant', 'hormone receptor-positive', 'HER2 negative', 'Objective Response Rate'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '30723140', 'type': 'DERIVED', 'citation': 'Mayer IA, Prat A, Egle D, Blau S, Fidalgo JAP, Gnant M, Fasching PA, Colleoni M, Wolff AC, Winer EP, Singer CF, Hurvitz S, Estevez LG, van Dam PA, Kummel S, Mundhenke C, Holmes F, Babbar N, Charbonnier L, Diaz-Padilla I, Vogl FD, Sellami D, Arteaga CL. A Phase II Randomized Study of Neoadjuvant Letrozole Plus Alpelisib for Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Breast Cancer (NEO-ORB). Clin Cancer Res. 2019 May 15;25(10):2975-2987. doi: 10.1158/1078-0432.CCR-18-3160. Epub 2019 Feb 5.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study was to determine whether treatment with a PI3K inhibitor plus letrozole led to an increase in pathologic clinical response and Objective Response Rate compared to treatment with placebo plus letrozole in patients with Breast cancer.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patient is an adult, female ≥ 18 years old at the time of informed consent\n2. Patient has a histologically and/or cytologically confirmed diagnosis of breast cancer\n3. Patient is postmenopausal.\n4. Patient has T1c-T3, any N, M0, operable breast cancer\n5. Patients must have measurable disease\n6. Patient has diagnostic biopsy available for the analysis of PIK3CA mutation and Ki67 level.\n7. Patient has estrogen-receptor and/or progesterone positive breast cancer as per local laboratory testing\n8. Patient has HER2 negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0 or 1+ as per local laboratory testing\n\nExclusion Criteria:\n\n1. Patient has locally recurrent or metastatic disease\n2. Patient has received any systemic therapy (e.g. chemotherapy, targeted therapy, immunotherapy) or radiotherapy for current breast cancer disease before randomization.\n3. Patient with type 1 diabetes mellitus or not adequately controlled type 2 diabetes mellitus\n4. History of acute pancreatitis within 1 year of study entry\n5. Uncontrolled hypertension'}, 'identificationModule': {'nctId': 'NCT01923168', 'briefTitle': 'Study of Letrozole With or Without BYL719 or Buparlisib, for the Neoadjuvant Treatment of Postmenopausal Women', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Phase II Randomized, Double-blind Placebo Controlled, Study of Letrozole With or Without BYL719 or Buparlisib, for the Neoadjuvant Treatment of Postmenopausal Women With Hormone Receptor-positive HER2-negative Breast Cancer', 'orgStudyIdInfo': {'id': 'CBYL719A2201'}, 'secondaryIdInfos': [{'id': '2013-001862-41', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Alpelisib + Letrozole', 'description': 'Participants took alpelisib 300 mg once daily plus letrozole 2.5 mg once daily.', 'interventionNames': ['Drug: alpelisib']}, {'type': 'EXPERIMENTAL', 'label': 'Buparlisib + Letrozole', 'description': 'Participants took buparlisib 100 mg once daily or 5 days on/2 days off plus letrozole 2.5 mg once daily.', 'interventionNames': ['Drug: buparlisib']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo + Letrozole', 'description': 'Participants took matching Placebo (of alpelisib 300 mg once daily/buparlisib 100 mg once daily or 5 days on/2 days off) plus Letrozole 2.5 mg once daily.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'alpelisib', 'type': 'DRUG', 'otherNames': ['BYL719'], 'description': 'BYL719 + Letrozole', 'armGroupLabels': ['Alpelisib + Letrozole']}, {'name': 'buparlisib', 'type': 'DRUG', 'otherNames': ['BKM120'], 'description': 'BKM120 + Letrozole', 'armGroupLabels': ['Buparlisib + Letrozole']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['BYL719 Placebo, BKM120 Placebo'], 'description': 'Placebo (of BYL719 or BKM120) + Letrozole', 'armGroupLabels': ['Placebo + Letrozole']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294-0006', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham/ Kirklin Clinic Univ AL - PI', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '72703', 'city': 'Fayetteville', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Highlands Oncology Group', 'geoPoint': {'lat': 36.06258, 'lon': -94.15743}}, {'zip': '90017', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Los Angeles Hematology/Oncology Medical Group Onc Dept.', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of California at Los Angeles UCLA SC', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Francisco BYL719A2201 - SC', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University School of Medicine/Winship Cancer Institute SC', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '21202', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Mercy Medical Center Medical Oncology & Hematology', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21231', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Sidney Kimmel Comprehensive Cancer Center/Johns Hopkins Med. Johns Hopkins Med. 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