Ignite Creation Date:
2025-12-24 @ 4:07 PM
Ignite Modification Date:
2025-12-25 @ 2:08 PM
Study NCT ID:
NCT03596866
Status:
COMPLETED
Last Update Posted:
2025-09-12
First Post:
2018-07-13
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study of Brigatinib Compared to Alectinib in Adults With Non-Small-Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000598580', 'term': 'brigatinib'}, {'id': 'C582670', 'term': 'alectinib'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'TrialDisclosures@takeda.com', 'phone': '+1-877-825-3327', 'title': 'Study Director', 'organization': 'Takeda'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to approximately 5 years 4 months', 'description': 'All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.', 'eventGroups': [{'id': 'EG000', 'title': 'Brigatinib', 'description': 'Participants were administered brigatinib 90 mg, tablets, orally, QD for 7 days, followed by brigatinib 180 mg, tablets, orally, QD until objective disease progression per RECIST v1.1, as assessed by the investigator, or intolerable toxicity, or up to 63.47 months.', 'otherNumAtRisk': 125, 'deathsNumAtRisk': 125, 'otherNumAffected': 122, 'seriousNumAtRisk': 125, 'deathsNumAffected': 37, 'seriousNumAffected': 38}, {'id': 'EG001', 'title': 'Alectinib', 'description': 'Participants were administered alectinib 600 mg, capsules, orally, BID until objective disease progression per RECIST version 1.1, as assessed by the investigator, or intolerable toxicity, or up to 59.83 months.', 'otherNumAtRisk': 122, 'deathsNumAtRisk': 123, 'otherNumAffected': 118, 'seriousNumAtRisk': 122, 'deathsNumAffected': 25, 'seriousNumAffected': 24}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 59}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 47}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Alpha hydroxybutyrate dehydrogenase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Amylase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 14}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 45}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 19}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 71}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 51}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 16}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Bilirubin conjugated increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 25}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 39}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Blood bilirubin unconjugated increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Blood cholesterol increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Blood creatine phosphokinase MB increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 92}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 39}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 21}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Blood insulin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Blood lactate dehydrogenase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 13}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Blood urea increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 35}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 26}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 21}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 12}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 19}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 21}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Hypercholesterolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 11}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Hypertriglyceridaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Hyperuricaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 17}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Hypoalbuminaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 12}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 6}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Lipase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 23}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 20}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 23}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Photosensitivity reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Productive cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 11}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 12}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 12}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}], 'seriousEvents': [{'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Brain neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Brain oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Breast cancer', 'notes': 'Number of participants at risk in each arm is based on the female population in this study.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Bronchoscopy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'COVID-19 pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Cardiac tamponade', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Cardiovascular somatic symptom disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Cervix carcinoma', 'notes': 'Number of participants at risk in each arm is based on the female population in this study.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Cervix carcinoma recurrent', 'notes': 'Number of participants at risk in each arm is based on the female population in this study.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Enteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Fibroadenoma of breast', 'notes': 'Number of participants at risk in each arm is based on the female population in this study.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Gastritis erosive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Hepatocellular carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Hyperpyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Hypophagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Intestinal adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Lung neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Malignant neoplasm progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Metastases to ovary', 'notes': 'Number of participants at risk in each arm is based on the female population in this study.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Multiple organ dysfunction syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Nodule', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Non-small cell lung cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Osteonecrosis of jaw', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Pelvic mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Radiation necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Spinal osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Subileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Swelling face', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression-free Survival (PFS) as Assessed by Blinded Independent Review Committee (BIRC) Per RECIST v1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brigatinib', 'description': 'Participants were administered brigatinib 90 mg, tablets, orally, QD for 7 days, followed by brigatinib 180 mg, tablets, orally, QD until objective disease progression per RECIST v1.1, as assessed by the investigator, or intolerable toxicity, or up to 63.47 months.'}, {'id': 'OG001', 'title': 'Alectinib', 'description': 'Participants were administered alectinib 600 mg, capsules, orally, BID until objective disease progression per RECIST v1.1, as assessed by the investigator, or intolerable toxicity, or up to 59.83 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '19.253', 'comment': 'The upper limit of 95% confidence interval (CI) was not estimable due to censoring.', 'groupId': 'OG000', 'lowerLimit': '15.671', 'upperLimit': 'NA'}, {'value': '19.187', 'comment': 'The upper limit of 95% CI was not estimable due to censoring.', 'groupId': 'OG001', 'lowerLimit': '12.879', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '=0.8672', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.968', 'ciLowerLimit': '0.658', 'ciUpperLimit': '1.424', 'pValueComment': 'P-value from a 2-sided stratified log-rank test using the stratification factors: presence of intracranial central nervous system (CNS) metastases at baseline, and best prior response to crizotinib therapy as assessed by the investigator.', 'estimateComment': 'The hazard ratio was obtained using the stratified Cox regression model with the same stratification factors.', 'statisticalMethod': '2-sided Stratified Log-rank Test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 33.8 months', 'description': 'PFS is defined as the time interval from the date of randomization until the first date at which disease progression is objectively documented via RECIST v1.1 by BIRC, or death due to any cause, whichever occurs first, in the full analysis set. PFS was censored for participants without documented disease progression or death at the last valid tumor response assessment.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all participants randomized to each regimen regardless of whether they were ALK+ by an FDA approved test (Vysis ALK Break Apart FISH Probe Kit, Ventana ALK (D5F3) CDx Assay, Foundation Medicine's FoundationOne CDx) or a local test other than FISH and immunohistochemistry, or whether they received study drug or adhered to the assigned dose."}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brigatinib', 'description': 'Participants were administered brigatinib 90 mg, tablets, orally, QD for 7 days, followed by brigatinib 180 mg, tablets, orally, QD until objective disease progression per RECIST v1.1, as assessed by the investigator, or intolerable toxicity, or up to 63.47 months.'}, {'id': 'OG001', 'title': 'Alectinib', 'description': 'Participants were administered alectinib 600 mg, capsules, orally, BID until objective disease progression per RECIST v1.1, as assessed by the investigator, or intolerable toxicity, or up to 59.83 months.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'The median and upper limit of 95% CI was not estimable due to low number of participants with events.', 'groupId': 'OG000', 'lowerLimit': '38.472', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'The median and 95% CI was not estimable due to low number of participants with events.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '=0.0713', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.592', 'ciLowerLimit': '0.956', 'ciUpperLimit': '2.652', 'pValueComment': 'P-value was based on a 2-sided stratified log-rank test using the stratification factors: presence of intracranial CNS metastases at baseline and best prior response to crizotinib therapy as assessed by the investigator.', 'estimateComment': 'The HR was obtained using the stratified Cox regression model with the same stratification factors.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 64 months', 'description': 'OS is defined as the time interval from the date of randomization until death due to any cause in the full analysis set. OS was censored on the date of last contact for those participants who are alive.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all participants randomized to each regimen regardless of whether they are ALK+ by an FDA approved test (Vysis ALK Break Apart FISH Probe Kit, Ventana ALK (D5F3) CDx Assay, Foundation Medicine's FoundationOne CDx) or a local test other than FISH and immunohistochemistry, or whether they receive study drug or adhere to the assigned dose."}, {'type': 'SECONDARY', 'title': 'PFS as Assessed by Investigator Per RECIST v1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brigatinib', 'description': 'Participants were administered brigatinib 90 mg, tablets, orally, QD for 7 days, followed by brigatinib 180 mg, tablets, orally, QD until objective disease progression per RECIST v1.1, as assessed by the investigator, or intolerable toxicity, or up to 63.47 months.'}, {'id': 'OG001', 'title': 'Alectinib', 'description': 'Participants were administered alectinib 600 mg, capsules, orally, BID until objective disease progression per RECIST v1.1, as assessed by the investigator, or intolerable toxicity, or up to 59.83 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.789', 'groupId': 'OG000', 'lowerLimit': '10.940', 'upperLimit': '19.417'}, {'value': '16.591', 'groupId': 'OG001', 'lowerLimit': '13.602', 'upperLimit': '27.565'}]}]}], 'analyses': [{'pValue': '=0.2501', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.232', 'ciLowerLimit': '0.862', 'ciUpperLimit': '1.761', 'pValueComment': 'P-value was based on a 2-sided stratified log-rank test using the stratification factors: presence of intracranial CNS metastases at baseline and best prior response to crizotinib therapy as assessed by the investigator.', 'estimateComment': 'The HR was obtained using the stratified Cox regression model with the same stratification factors.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 33.8 months', 'description': 'PFS is defined as the time interval from the date of randomization until the first date at which disease progression is objectively documented via RECIST v1.1 by investigator, or death due to any cause, whichever occurs first, in the full analysis set. PFS was censored for participants without documented disease progression or death at the last valid tumor response assessment.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all participants randomized to each regimen regardless of whether they are ALK+ by an FDA approved test (Vysis ALK Break Apart FISH Probe Kit, Ventana ALK (D5F3) CDx Assay, Foundation Medicine's FoundationOne CDx) or a local test other than FISH and immunohistochemistry, or whether they receive study drug or adhere to the assigned dose."}, {'type': 'SECONDARY', 'title': 'Objective Response Rate (ORR) as Assessed by BIRC and Investigator Per RECIST v1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brigatinib', 'description': 'Participants were administered brigatinib 90 mg, tablets, orally, QD for 7 days, followed by brigatinib 180 mg, tablets, orally, QD until objective disease progression per RECIST v1.1, as assessed by the investigator, or intolerable toxicity, or up to 63.47 months.'}, {'id': 'OG001', 'title': 'Alectinib', 'description': 'Participants were administered alectinib 600 mg, capsules, orally, BID until objective disease progression per RECIST v1.1, as assessed by the investigator, or intolerable toxicity, or up to 59.83 months.'}], 'classes': [{'title': 'BIRC Assessed', 'categories': [{'measurements': [{'value': '52.0', 'groupId': 'OG000', 'lowerLimit': '42.9', 'upperLimit': '61.0'}, {'value': '61.0', 'groupId': 'OG001', 'lowerLimit': '51.8', 'upperLimit': '69.6'}]}]}, {'title': 'Investigator Assessed', 'categories': [{'measurements': [{'value': '40.8', 'groupId': 'OG000', 'lowerLimit': '32.1', 'upperLimit': '49.9'}, {'value': '56.1', 'groupId': 'OG001', 'lowerLimit': '46.9', 'upperLimit': '65.0'}]}]}], 'analyses': [{'pValue': '=0.1555', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.7', 'ciLowerLimit': '0.42', 'ciUpperLimit': '1.15', 'pValueComment': 'P-value was from a Cochran-Mantel-Haenszel test stratified by the stratification factors: presence of intracranial CNS metastases at baseline and best prior response to crizotinib therapy as assessed by the investigator.', 'estimateComment': 'Odds ratio stratified by the stratification factors: presence of intracranial CNS metastases at baseline and best prior response to crizotinib therapy as assessed by the investigator.', 'groupDescription': 'BIRC Assessed', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '=0.0169', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.55', 'ciLowerLimit': '0.33', 'ciUpperLimit': '0.90', 'pValueComment': 'P-value was from a Cochran-Mantel-Haenszel test stratified by the stratification factors: presence of intracranial CNS metastases at baseline and best prior response to crizotinib therapy as assessed by the investigator.', 'estimateComment': 'Odds ratio stratified by the stratification factors: presence of intracranial CNS metastases at baseline and best prior response to crizotinib therapy as assessed by the investigator.', 'groupDescription': 'Investigator Assessed', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 33.8 months', 'description': 'ORR is defined as the percentage of the participants who are confirmed to have achieved complete response (CR) or partial response (PR), using RECIST v1.1 after the initiation of study treatment. Percentages were rounded off to the nearest single decimal place.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all participants randomized to each regimen regardless of whether they are ALK+ by an FDA approved test (Vysis ALK Break Apart FISH Probe Kit, Ventana ALK (D5F3) CDx Assay, Foundation Medicine's FoundationOne CDx) or a local test other than FISH and immunohistochemistry, or whether they receive study drug or adhere to the assigned dose."}, {'type': 'SECONDARY', 'title': 'Duration of Response (DOR) as Assessed by BIRC and Investigator Per RECIST v1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brigatinib', 'description': 'Participants were administered brigatinib 90 mg, tablets, orally, QD for 7 days, followed by brigatinib 180 mg, tablets, orally, QD until objective disease progression per RECIST v1.1, as assessed by the investigator, or intolerable toxicity, or up to 63.47 months.'}, {'id': 'OG001', 'title': 'Alectinib', 'description': 'Participants were administered alectinib 600 mg, capsules, orally, BID until objective disease progression per RECIST v1.1, as assessed by the investigator, or intolerable toxicity, or up to 59.83 months.'}], 'classes': [{'title': 'BIRC Assessed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.544', 'comment': 'The upper limit of 95% CI was not estimable due to low number of participants with events.', 'groupId': 'OG000', 'lowerLimit': '14.784', 'upperLimit': 'NA'}, {'value': '20.205', 'comment': 'The upper limit of 95% CI was not estimable due to low number of participants with events.', 'groupId': 'OG001', 'lowerLimit': '12.649', 'upperLimit': 'NA'}]}]}, {'title': 'Investigator Assessed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.511', 'groupId': 'OG000', 'lowerLimit': '11.335', 'upperLimit': '23.031'}, {'value': '19.614', 'comment': 'The upper limit of 95% CI was not estimable due to low number of participants with events.', 'groupId': 'OG001', 'lowerLimit': '14.226', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 33.8 months', 'description': 'DOR is defined as the time interval from the time that the measurement criteria are first met for CR or PR (whichever is first recorded) until the first date that the progressive disease (PD) is objectively documented or death, as assessed by the investigator and BIRC, using RECIST v1.1. Participants who did not progress or died, were censored at the last tumor assessment date prior to receiving subsequent anticancer therapy.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "FAS=all participants randomized to each regimen regardless of whether they are ALK+ by an FDA approved test (Vysis ALK Break Apart FISH Probe Kit, Ventana ALK (D5F3) CDx Assay, Foundation Medicine's FoundationOne CDx) or a local test other than FISH and immunohistochemistry, or whether they receive study drug or adhere to the assigned dose. N=number of participants with data available for analysis. n=number of participants with data available for analysis at specified categories."}, {'type': 'SECONDARY', 'title': 'Time to Response as Assessed by Investigator and BIRC Per RECIST v1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brigatinib', 'description': 'Participants were administered brigatinib 90 mg, tablets, orally, QD for 7 days, followed by brigatinib 180 mg, tablets, orally, QD until objective disease progression per RECIST v1.1, as assessed by the investigator, or intolerable toxicity, or up to 63.47 months.'}, {'id': 'OG001', 'title': 'Alectinib', 'description': 'Participants were administered alectinib 600 mg, capsules, orally, BID until objective disease progression per RECIST v1.1, as assessed by the investigator, or intolerable toxicity, or up to 59.83 months.'}], 'classes': [{'title': 'BIRC Assessed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.873', 'groupId': 'OG000', 'lowerLimit': '1.64', 'upperLimit': '16.49'}, {'value': '1.840', 'groupId': 'OG001', 'lowerLimit': '1.41', 'upperLimit': '16.56'}]}]}, {'title': 'Investigator Assessed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.873', 'groupId': 'OG000', 'lowerLimit': '1.61', 'upperLimit': '14.00'}, {'value': '1.873', 'groupId': 'OG001', 'lowerLimit': '1.41', 'upperLimit': '10.87'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 33.8 months', 'description': 'Time to response is defined as the time interval from randomization until the initial observation of CR or PR, as assessed by the investigator and BIRC, using RECIST v1.1. Time to response will be summarized using descriptive statistics in participants with confirmed objective response.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "FAS=all participants randomized to each regimen regardless of whether they are ALK+ by an FDA approved test (Vysis ALK Break Apart FISH Probe Kit, Ventana ALK (D5F3) CDx Assay, Foundation Medicine's FoundationOne CDx) or a local test other than FISH and immunohistochemistry, or whether they receive study drug or adhere to the assigned dose. N=number of participants with data available for analysis. n=number of participants with data available for analysis at specified categories."}, {'type': 'SECONDARY', 'title': 'Confirmed Intracranial Objective Response Rate (iORR) as Assessed by BIRC Per Modified RECIST v1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brigatinib', 'description': 'Participants were administered brigatinib 90 mg, tablets, orally, QD for 7 days, followed by brigatinib 180 mg, tablets, orally, QD until objective disease progression per RECIST v1.1, as assessed by the investigator, or intolerable toxicity, or up to 63.47 months.'}, {'id': 'OG001', 'title': 'Alectinib', 'description': 'Participants were administered alectinib 600 mg, capsules, orally, BID until objective disease progression per RECIST v1.1, as assessed by the investigator, or intolerable toxicity, or up to 59.83 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '73.3', 'groupId': 'OG000', 'lowerLimit': '54.1', 'upperLimit': '87.7'}, {'value': '67.7', 'groupId': 'OG001', 'lowerLimit': '48.6', 'upperLimit': '83.3'}]}]}], 'analyses': [{'pValue': '=0.6246', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.31', 'ciLowerLimit': '0.44', 'ciUpperLimit': '3.84', 'pValueComment': 'P-value was from a Cochran-Mantel-Haenszel test stratified by best prior response to crizotinib therapy as assessed by the investigator at randomization per IXRS.', 'estimateComment': 'Odds ratio was stratified by best prior response to crizotinib therapy as assessed by the investigator at randomization per IXRS.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 33.8 months', 'description': 'Confirmed iORR, as assessed by the BIRC, is defined as the percentage of the participants who have achieved CR or PR in the central nervous system (CNS) per a modification RECIST v1.1 after the initiation of study treatment in participants with CNS metastases at baseline. Percentages were rounded off to the nearest single decimal place.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Measurable iCNS disease population included all participants in the full analysis population determined by the BIRC to have had at least 1 measurable iCNS tumor lesion.'}, {'type': 'SECONDARY', 'title': 'Intracranial Duration of Response (iDOR) as Assessed by the BIRC Per Modified RECIST v1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brigatinib', 'description': 'Participants were administered brigatinib 90 mg, tablets, orally, QD for 7 days, followed by brigatinib 180 mg, tablets, orally, QD until objective disease progression per RECIST v1.1, as assessed by the investigator, or intolerable toxicity, or up to 63.47 months.'}, {'id': 'OG001', 'title': 'Alectinib', 'description': 'Participants were administered alectinib 600 mg, capsules, orally, BID until objective disease progression per RECIST v1.1, as assessed by the investigator, or intolerable toxicity, or up to 59.83 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.413', 'comment': 'The upper limit of 95% CI was not estimable due to low number of participants with events.', 'groupId': 'OG000', 'lowerLimit': '7.425', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'The median and upper limit of 95% CI were not estimable due to low number of participants with events.', 'groupId': 'OG001', 'lowerLimit': '5.552', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 33.8 months', 'description': 'iDOR, as assessed by the BIRC per modified RECIST v1.1, is defined as the time interval from the time that the measurement criteria are first met for CR or PR in the CNS (whichever is first recorded) until the first date that the PD in the CNS is objectively documented or death. Participants who did not progress or died, were censored at the last iCNS tumor assessment date prior to receiving subsequent anticancer therapy.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Measurable iCNS disease population included all participants in the full analysis population determined by the BIRC to have had at least 1 measurable iCNS tumor lesion. Overall number analyzed is the number of participants with data available for analysis.'}, {'type': 'SECONDARY', 'title': 'Cumulative Incidence of Intracranial Disease Progression (iPD) as Assessed by BIRC Per Modified RECIST v1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brigatinib', 'description': 'Participants were administered brigatinib 90 mg, tablets, orally, QD for 7 days, followed by brigatinib 180 mg, tablets, orally, QD until objective disease progression per RECIST v1.1, as assessed by the investigator, or intolerable toxicity, or up to 63.47 months.'}, {'id': 'OG001', 'title': 'Alectinib', 'description': 'Participants were administered alectinib 600 mg, capsules, orally, BID until objective disease progression per RECIST v1.1, as assessed by the investigator, or intolerable toxicity, or up to 59.83 months.'}], 'classes': [{'title': '6 months', 'categories': [{'measurements': [{'value': '0.115', 'groupId': 'OG000', 'lowerLimit': '0.064', 'upperLimit': '0.182'}, {'value': '0.076', 'groupId': 'OG001', 'lowerLimit': '0.037', 'upperLimit': '0.133'}]}]}, {'title': '12 months', 'categories': [{'measurements': [{'value': '0.218', 'groupId': 'OG000', 'lowerLimit': '0.144', 'upperLimit': '0.302'}, {'value': '0.171', 'groupId': 'OG001', 'lowerLimit': '0.107', 'upperLimit': '0.247'}]}]}, {'title': '18 months', 'categories': [{'measurements': [{'value': '0.305', 'groupId': 'OG000', 'lowerLimit': '0.211', 'upperLimit': '0.404'}, {'value': '0.209', 'groupId': 'OG001', 'lowerLimit': '0.135', 'upperLimit': '0.293'}]}]}, {'title': '24 months', 'categories': [{'measurements': [{'value': '0.388', 'groupId': 'OG000', 'lowerLimit': '0.274', 'upperLimit': '0.500'}, {'value': '0.248', 'groupId': 'OG001', 'lowerLimit': '0.161', 'upperLimit': '0.344'}]}]}], 'analyses': [{'pValue': '=0.0778', 'groupIds': ['OG000', 'OG001'], 'pValueComment': "P-value from a 2-sided stratified Gray's test using the stratification factors (at randomization per IxRS): presence of intracranial CNS metastases at baseline, and best prior response to crizotinib therapy as assessed by the investigator.", 'statisticalMethod': "Gray's Test", 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'P-value is for the event type: Intracranial Disease Progression without Prior Systemic Progression or Death.'}], 'paramType': 'NUMBER', 'timeFrame': '6, 12, 18 and 24 months', 'description': "Time to iPD as assessed by the BIRC,is defined as time interval from date of randomization until first date at which iPD is objectively documented via a modification of RECIST v1.1 without prior systemic progression (PD) or death. Time to iPD was analyzed within a competing risk framework (with systemic progression and death as the competing risks) by estimating the cumulative incidence function (CIF) within each arm. The CIF is a function of time, and indicates the probability of an event (e.g. iPD without prior PD or death) occurring by the specified time. The estimated CIFs were analyzed using Grey's Test and the estimated probability of CIFs is reported at pre-specified landmark times (6, 12, 18 and 24 months).", 'unitOfMeasure': 'probability', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all participants randomized to each regimen regardless of whether they are ALK+ by an FDA approved test (Vysis ALK Break Apart FISH Probe Kit, Ventana ALK (D5F3) CDx Assay, Foundation Medicine's FoundationOne CDx) or a local test other than FISH and immunohistochemistry, or whether they receive study drug or adhere to the assigned dose."}, {'type': 'SECONDARY', 'title': 'Health-Related Quality of Life (HRQOL) From European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30 v3.0) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brigatinib', 'description': 'Participants were administered brigatinib 90 mg, tablets, orally, QD for 7 days, followed by brigatinib 180 mg, tablets, orally, QD until objective disease progression per RECIST v1.1, as assessed by the investigator, or intolerable toxicity, or up to 63.47 months.'}, {'id': 'OG001', 'title': 'Alectinib', 'description': 'Participants were administered alectinib 600 mg, capsules, orally, BID until objective disease progression per RECIST v1.1, as assessed by the investigator, or intolerable toxicity, or up to 59.83 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '86.15', 'groupId': 'OG000', 'lowerLimit': '35.9', 'upperLimit': '100.0'}, {'value': '84.74', 'groupId': 'OG001', 'lowerLimit': '36.6', 'upperLimit': '100.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 33.8 months', 'description': 'EORTC QLQ-C30 incorporates 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). EORTC QLQ-C30 contains 28 questions (4-point scale where 1=Not at all \\[best\\] to 4=Very Much \\[worst\\]) and 2 questions (7-point scale where 1=Very poor \\[worst\\] to 7= Excellent \\[best\\]). Raw scores are converted into scale scores ranging from 0 to 100. For the functional scales and the global health status scale, higher scores represent better quality of life (QOL); for the symptom scales, lower scores represent better QOL.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The patient-reported outcome (PRO) analysis set included all participants with baseline and at least 1 post-baseline PRO measurement in the full analysis set. Overall number analyzed is the number of participants with data available for analysis of this outcome measure at end of treatment visit.'}, {'type': 'SECONDARY', 'title': 'HRQOL From EORTC QLQ- Lung Cancer (LC) 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brigatinib', 'description': 'Participants were administered brigatinib 90 mg, tablets, orally, QD for 7 days, followed by brigatinib 180 mg, tablets, orally, QD until objective disease progression per RECIST v1.1, as assessed by the investigator, or intolerable toxicity, or up to 63.47 months.'}, {'id': 'OG001', 'title': 'Alectinib', 'description': 'Participants were administered alectinib 600 mg, capsules, orally, BID until objective disease progression per RECIST v1.1, as assessed by the investigator, or intolerable toxicity, or up to 59.83 months.'}], 'classes': [{'title': 'End of Treatment: Dyspnoea', 'categories': [{'measurements': [{'value': '22.22', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '88.9'}, {'value': '11.11', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '88.9'}]}]}, {'title': 'End of Treatment: Coughing', 'categories': [{'measurements': [{'value': '33.33', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '100.0'}, {'value': '33.33', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '66.7'}]}]}, {'title': 'End of Treatment: Haemoptysis', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '33.3'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '66.7'}]}]}, {'title': 'End of Treatment: Sore mouth', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '100.0'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '66.7'}]}]}, {'title': 'End of Treatment: Dysphagia', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '100.0'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '66.7'}]}]}, {'title': 'End of Treatment: Peripheral neuropathy', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '66.7'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '100.0'}]}]}, {'title': 'End of Treatment: Alopecia', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '33.3'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '100.0'}]}]}, {'title': 'End of Treatment: Pain in chest', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '66.7'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '100.0'}]}]}, {'title': 'End of Treatment: Pain in arm or shoulder', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '66.7'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '100.0'}]}]}, {'title': 'End of Treatment: Pain in other parts', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '66.7'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '100.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 33.8 months', 'description': 'HRQOL scores were assessed with European Organization for Research and Treatment (EORTC), its lung cancer module QLQ-LC13. QLQ-LC13 contains 13 questions assessing lung cancer-associated symptoms (cough, hemoptysis, dyspnea, and site-specific pain), treatment-related side effects (sore mouth, dysphagia, peripheral neuropathy, and alopecia), and use of pain medication. Subscales were scored on a range of 0 to 100. Higher symptom score = greater degree of symptom severity.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The PRO analysis set included all participants with baseline and at least 1 post-baseline PRO measurement in the full analysis set. Overall number analyzed is the number of participants with data available for analysis of this outcome measure at end of treatment visit.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Brigatinib', 'description': 'Participants were administered brigatinib 90 milligrams (mg), tablets, orally, once daily (QD) for 7 days, followed by brigatinib 180 mg, tablets, orally, QD until objective disease progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), as assessed by the investigator, or intolerable toxicity, or up to 63.47 months.'}, {'id': 'FG001', 'title': 'Alectinib', 'description': 'Participants were administered alectinib 600 mg, capsules, orally, twice daily (BID) until objective disease progression per RECIST v1.1, as assessed by the investigator, or intolerable toxicity, or up to 59.83 months.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '125'}, {'groupId': 'FG001', 'numSubjects': '123'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '122'}, {'groupId': 'FG001', 'numSubjects': '117'}]}], 'dropWithdraws': [{'type': 'Site terminated by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '64'}, {'groupId': 'FG001', 'numSubjects': '65'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Missing', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Reason Not Specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '13'}]}]}], 'recruitmentDetails': 'Participants took part in the study at various investigative sites globally from 19 April 2019 to 18 September 2024.', 'preAssignmentDetails': 'Participants with anaplastic lymphoma kinase positive (ALK+) non-small-cell lung cancer (NSCLC) who had progressed on crizotinib were administered either brigatinib or alectinib in this study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'BG000'}, {'value': '123', 'groupId': 'BG001'}, {'value': '248', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Brigatinib', 'description': 'Participants were administered brigatinib 90 mg, tablets, orally, QD for 7 days, followed by brigatinib 180 mg, tablets, orally, QD until objective disease progression per RECIST v1.1, as assessed by the investigator, or intolerable toxicity, or up to 33.8 months.'}, {'id': 'BG001', 'title': 'Alectinib', 'description': 'Participants were administered alectinib 600 mg, capsules, orally, BID until objective disease progression per RECIST version 1.1, as assessed by the investigator, or intolerable toxicity, or up to 33.8 months.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.0', 'spread': '12.17', 'groupId': 'BG000'}, {'value': '52.9', 'spread': '13.53', 'groupId': 'BG001'}, {'value': '53', 'spread': '12.84', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '135', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '113', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '116', 'groupId': 'BG000'}, {'value': '106', 'groupId': 'BG001'}, {'value': '222', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '140', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': "Full Analysis Set(FAS) included all participants randomized to each regimen regardless of whether they were ALK+ by an Food and Drug Administration(FDA) approved test (Vysis ALK Break Apart fluorescence in situ hybridization(FISH) Probe Kit, Ventana ALK (D5F3) Companion Diagnostics (CDx) Assay, Foundation Medicine's FoundationOne CDx) or a local test other than FISH and immunohistochemistry, or whether they received study drug or adhered to the assigned dose."}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-03-08', 'size': 1336958, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-01-29T01:17', 'hasProtocol': True}, {'date': '2021-06-16', 'size': 1177381, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-01-29T01:17', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 248}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2024-09-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-11', 'studyFirstSubmitDate': '2018-07-13', 'resultsFirstSubmitDate': '2025-01-29', 'studyFirstSubmitQcDate': '2018-07-13', 'lastUpdatePostDateStruct': {'date': '2025-09-12', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-01-29', 'studyFirstPostDateStruct': {'date': '2018-07-24', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free Survival (PFS) as Assessed by Blinded Independent Review Committee (BIRC) Per RECIST v1.1', 'timeFrame': 'Up to 33.8 months', 'description': 'PFS is defined as the time interval from the date of randomization until the first date at which disease progression is objectively documented via RECIST v1.1 by BIRC, or death due to any cause, whichever occurs first, in the full analysis set. PFS was censored for participants without documented disease progression or death at the last valid tumor response assessment.'}], 'secondaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': 'Up to 64 months', 'description': 'OS is defined as the time interval from the date of randomization until death due to any cause in the full analysis set. OS was censored on the date of last contact for those participants who are alive.'}, {'measure': 'PFS as Assessed by Investigator Per RECIST v1.1', 'timeFrame': 'Up to 33.8 months', 'description': 'PFS is defined as the time interval from the date of randomization until the first date at which disease progression is objectively documented via RECIST v1.1 by investigator, or death due to any cause, whichever occurs first, in the full analysis set. PFS was censored for participants without documented disease progression or death at the last valid tumor response assessment.'}, {'measure': 'Objective Response Rate (ORR) as Assessed by BIRC and Investigator Per RECIST v1.1', 'timeFrame': 'Up to 33.8 months', 'description': 'ORR is defined as the percentage of the participants who are confirmed to have achieved complete response (CR) or partial response (PR), using RECIST v1.1 after the initiation of study treatment. Percentages were rounded off to the nearest single decimal place.'}, {'measure': 'Duration of Response (DOR) as Assessed by BIRC and Investigator Per RECIST v1.1', 'timeFrame': 'Up to 33.8 months', 'description': 'DOR is defined as the time interval from the time that the measurement criteria are first met for CR or PR (whichever is first recorded) until the first date that the progressive disease (PD) is objectively documented or death, as assessed by the investigator and BIRC, using RECIST v1.1. Participants who did not progress or died, were censored at the last tumor assessment date prior to receiving subsequent anticancer therapy.'}, {'measure': 'Time to Response as Assessed by Investigator and BIRC Per RECIST v1.1', 'timeFrame': 'Up to 33.8 months', 'description': 'Time to response is defined as the time interval from randomization until the initial observation of CR or PR, as assessed by the investigator and BIRC, using RECIST v1.1. Time to response will be summarized using descriptive statistics in participants with confirmed objective response.'}, {'measure': 'Confirmed Intracranial Objective Response Rate (iORR) as Assessed by BIRC Per Modified RECIST v1.1', 'timeFrame': 'Up to 33.8 months', 'description': 'Confirmed iORR, as assessed by the BIRC, is defined as the percentage of the participants who have achieved CR or PR in the central nervous system (CNS) per a modification RECIST v1.1 after the initiation of study treatment in participants with CNS metastases at baseline. Percentages were rounded off to the nearest single decimal place.'}, {'measure': 'Intracranial Duration of Response (iDOR) as Assessed by the BIRC Per Modified RECIST v1.1', 'timeFrame': 'Up to 33.8 months', 'description': 'iDOR, as assessed by the BIRC per modified RECIST v1.1, is defined as the time interval from the time that the measurement criteria are first met for CR or PR in the CNS (whichever is first recorded) until the first date that the PD in the CNS is objectively documented or death. Participants who did not progress or died, were censored at the last iCNS tumor assessment date prior to receiving subsequent anticancer therapy.'}, {'measure': 'Cumulative Incidence of Intracranial Disease Progression (iPD) as Assessed by BIRC Per Modified RECIST v1.1', 'timeFrame': '6, 12, 18 and 24 months', 'description': "Time to iPD as assessed by the BIRC,is defined as time interval from date of randomization until first date at which iPD is objectively documented via a modification of RECIST v1.1 without prior systemic progression (PD) or death. Time to iPD was analyzed within a competing risk framework (with systemic progression and death as the competing risks) by estimating the cumulative incidence function (CIF) within each arm. The CIF is a function of time, and indicates the probability of an event (e.g. iPD without prior PD or death) occurring by the specified time. The estimated CIFs were analyzed using Grey's Test and the estimated probability of CIFs is reported at pre-specified landmark times (6, 12, 18 and 24 months)."}, {'measure': 'Health-Related Quality of Life (HRQOL) From European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30 v3.0) Score', 'timeFrame': 'Up to 33.8 months', 'description': 'EORTC QLQ-C30 incorporates 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). EORTC QLQ-C30 contains 28 questions (4-point scale where 1=Not at all \\[best\\] to 4=Very Much \\[worst\\]) and 2 questions (7-point scale where 1=Very poor \\[worst\\] to 7= Excellent \\[best\\]). Raw scores are converted into scale scores ranging from 0 to 100. For the functional scales and the global health status scale, higher scores represent better quality of life (QOL); for the symptom scales, lower scores represent better QOL.'}, {'measure': 'HRQOL From EORTC QLQ- Lung Cancer (LC) 13', 'timeFrame': 'Up to 33.8 months', 'description': 'HRQOL scores were assessed with European Organization for Research and Treatment (EORTC), its lung cancer module QLQ-LC13. QLQ-LC13 contains 13 questions assessing lung cancer-associated symptoms (cough, hemoptysis, dyspnea, and site-specific pain), treatment-related side effects (sore mouth, dysphagia, peripheral neuropathy, and alopecia), and use of pain medication. Subscales were scored on a range of 0 to 100. Higher symptom score = greater degree of symptom severity.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Drug Therapy'], 'conditions': ['ALK+ Advanced NSCLC']}, 'referencesModule': {'references': [{'pmid': '37574132', 'type': 'DERIVED', 'citation': 'Yang JC, Liu G, Lu S, He J, Burotto M, Ahn MJ, Kim DW, Liu X, Zhao Y, Vincent S, Yin J, Ma X, Lin HM, Popat S. Brigatinib Versus Alectinib in ALK-Positive NSCLC After Disease Progression on Crizotinib: Results of Phase 3 ALTA-3 Trial. J Thorac Oncol. 2023 Dec;18(12):1743-1755. doi: 10.1016/j.jtho.2023.08.010. Epub 2023 Aug 12.'}, {'pmid': '34423676', 'type': 'DERIVED', 'citation': 'Popat S, Liu G, Lu S, Song G, Ma X, Yang JC. Brigatinib vs alectinib in crizotinib-resistant advanced anaplastic lymphoma kinase-positive non-small-cell lung cancer (ALTA-3). Future Oncol. 2021 Nov;17(32):4237-4247. doi: 10.2217/fon-2021-0608. Epub 2021 Aug 23.'}], 'seeAlsoLinks': [{'url': 'https://clinicaltrials.takeda.com/study-detail/5f6b601c4db2bf003ab493af', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Brigatinib is a medicine that binds to the surface of tumor cells in some cancers and delivers a dose of chemotherapy directly to the tumor. In this study, participants will be people with non-small-cell lung cancer (NSCLC for short). The main aim of the study is to learn if brigatinib stops the tumors from growing, or if the tumors have shrunk or disappeared, compared to a medicine called alectinib.\n\nAt the first visit, the study doctor will check who can take part. Participants who can take part will be picked for 1 of 2 treatments by chance:\n\n* Brigatinib tablets\n* Alectinib capsules\n\nAll participants will take brigatinib or alectinib at about the same time every day. They will continue with treatment throughout the study unless their cancer gets worse, they have side effects from the treatment, they leave the study for certain reasons, or the study is stopped.\n\nAfter stopping treatment, participants will visit the study clinic for a check-up 30 days later.', 'detailedDescription': 'The drug being tested in this study is called brigatinib. Brigatinib has been demonstrated to benefit people with anaplastic lymphoma kinase-positive (ALK+) NSCLC.\n\nThe comparator drug is called alectinib. Alectinib has been demonstrated to benefit people with ALK+ NSCLC. Both drugs belong to a class of drugs called anaplastic lymphoma kinase (ALK) inhibitors. Both drugs are taken by mouth. Both drugs are approved by the United States Food and Drug Administration (US FDA).\n\nThe study will enroll approximately 246 participants. Participants will be randomly assigned (by chance, like flipping a coin) in 1:1 ratio to one of the two treatment groups:\n\n* Brigatinib\n* Alectinib\n\nAll participants will be asked to take brigatinib or alectinib at the same time each day throughout the study. For each participant eligible to continue in the study and to facilitate the remaining participants from Brigatinib-2002 (NCT03535740) to have continued treatment access, the study extension phase may be initiated for participants to continue receiving their randomized study treatment (i.e., brigatinib or alectinib) until they meet at least one of the treatment discontinuation criteria.\n\nThis multi-center trial will be conducted in the United States, Argentina, Austria, Canada, Chile, China, Croatia, France, Germany, Greece, Hong Kong, Italy, Mexico, Romania, Russia, South Korea, Spain, Sweden, Taiwan, and Thailand. The overall time to participate in this study is 5 years. Participants will make multiple visits to the clinic, and 30 days after last dose of study drug for a follow-up assessment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\n2. Have histologically or cytologically confirmed stage IIIB (locally advanced or recurrent) or stage IV NSCLC.\n3. Must meet one of the following criteria:\n\n * Have documentation of ALK rearrangement by a positive result from the Vysis ALK Break-Apart fluorescence in situ hybridization (FISH) Probe Kit or the Ventana ALK (D5F3) CDx Assay or Foundation Medicine's FoundationOne CDx.\n * Have documented ALK rearrangement by a different test and be able to provide tumor sample to the central laboratory. (Note: central laboratory ALK rearrangement testing results are not required to be obtained before randomization).\n4. Had PD while on crizotinib, as assessed by the investigator or treating physician except for participants previously participating in the Brigatinib-2002 study (Note: crizotinib does not need to be the last therapy a participant received. The participant may have received chemotherapy as his/her last therapy).\n5. Treatment with crizotinib for at least 4 weeks before progression except for participants previously participating in the Brigatinib-2002 study.\n6. Have had no other ALK inhibitor other than crizotinib except for participants previously participating in the Brigatinib-2002 study.\n7. Have had no more than 2 prior regimens of systemic anticancer therapy (other than crizotinib) in the locally advanced or metastatic setting. Note: a systemic anticancer therapy regimen will be counted if it is administered for at least 1 complete cycle. A new anticancer agent used as maintenance therapy will be counted as a new regimen. Neoadjuvant or adjuvant systemic anticancer therapy will be counted as a prior regimen if disease progression/recurrence occurred within 12 months upon completion of this neoadjuvant or adjuvant therapy. (Systemic therapy followed by maintenance therapy will be considered as one regimen if the maintenance therapy consists of a drug or drugs that were used in the regimen that immediately preceded maintenance).\n8. Have at least 1 measurable (that is, target) lesion per RECIST v1.1.\n9. Have recovered from toxicities related to prior anticancer therapy to national cancer institute common terminology criteria for adverse events (NCI CTCAE) version 4.03 grade less than or equal to (\\<=)1. (Note: treatment-related alopecia or peripheral neuropathy that are grade greater than (\\>) 1 are allowed, if deemed irreversible).\n10. Have adequate organ function, at the time of initial screening, except for participants previously participating in the Brigatinib-2002 study as determined by:\n\n * Total bilirubin \\<=1.5 times the upper limit of normal (ULN).\n * Estimated glomerular filtration rate greater than equal to (\\>=) 30 milliliter per minute (mL/min)/1.73 square meter \\[m\\^2\\], using the modification of diet in renal disease equation.\n * Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) \\<=2.5\\*ULN; \\<=5\\*ULN is acceptable if liver metastases are present.\n * Serum lipase \\<=1.5\\*ULN.\n * Platelet count \\>=75\\*10\\^9 per liter \\[/L\\].\n * Hemoglobin \\>=9 gram per deciliter (g/dL).\n * Absolute neutrophil count \\>=1.5\\*10\\^9 / L.\n11. Suitable venous access for study-required blood sampling (that is, including pharmacokinetic \\[PK\\] and laboratory safety tests).\n\nExclusion Criteria:\n\n1. Had participated in the control (crizotinib) arm of Study AP26113-13-301 (ALTA 1L) \\[NCT02737501\\].\n2. Had received crizotinib within 7 days before randomization.\n3. Have a history or presence at baseline of pulmonary interstitial disease, drug related pneumonitis, or radiation pneumonitis.\n4. Have uncontrolled hypertension. Participants with hypertension should be under treatment for control of blood pressure upon study entry.\n5. Had received systemic treatment with strong cytochrome P-450 (CYP) 3A inhibitors, moderate CYP3A inhibitors, strong CYP3A inducers, or moderate CYP3A inducers within 14 days before randomization.\n6. Treatment with any investigational systemic anticancer agents within 14 days or 5 half-lives, whichever is longer, before randomization.\n7. Have been diagnosed with another primary malignancy other than NSCLC, except for adequately treated nonmelanoma skin cancer or cervical cancer in situ; definitively treated nonmetastatic prostate cancer; or participants with another primary malignancy who are definitively relapse-free with at least 3 years elapsed since the diagnosis of the other primary malignancy.\n8. Had received chemotherapy or radiation therapy within 14 days before randomization except for stereotactic radiosurgery (SRS) or stereotactic body radiation therapy.\n9. Had received antineoplastic monoclonal antibodies within 30 days of randomization.\n10. Had major surgery within 30 days of randomization. Minor surgical procedures, such as catheter placement or minimally invasive biopsies, are allowed.\n11. Have symptomatic CNS metastases (parenchymal or leptomeningeal) at screening (participants with asymptomatic brain metastases or participants who have stable symptoms and did not require an increased dose of corticosteroids to control symptoms within 7 days before randomization will be enrolled). Note: If a participant has worsening neurological symptoms or signs due to CNS metastasis, the participant needs to complete local therapy and be neurologically stable (with no requirement for an increasing dose of corticosteroids or use of anticonvulsants) for 7 days before randomization.\n12. Have current spinal cord compression (symptomatic or asymptomatic and detected by radiographic imaging). Participants with leptomeningeal disease and without cord compression are allowed.\n13. Have significant, uncontrolled, or active cardiovascular disease, specifically including, but not restricted to the following:\n\n * Myocardial infarction within 6 months before randomization.\n * Unstable angina within 6 months before randomization.\n * New York Heart Association Class III or IV heart failure within 6 months before randomization.\n * History of clinically significant atrial arrhythmia (including clinically significant bradyarrhythmia), as determined by the treating physician.\n * Any history of clinically significant ventricular arrhythmia.\n14. Had cerebrovascular accident or transient ischemic attack within 6 months before first dose of study drug.\n15. Have malabsorption syndrome or other gastrointestinal illness or condition that could affect oral absorption of the study drug.\n16. Have an ongoing or active infection, including but not limited to, the requirement for intravenous antibiotics.\n17. Have a known history of human immunodeficiency virus (HIV) infection. Testing is not required in the absence of history.\n18. Known hepatitis B surface antigen-positive, or known or suspected active hepatitis C infection. Testing is not required in the absence of history.\n19. Any serious medical condition or psychiatric illness that could, in the investigator's opinion, potentially compromise participant safety or interfere with the completion of treatment according to this protocol.\n20. Have a known or suspected hypersensitivity to brigatinib or alectinib or their excipients.\n21. Life-threatening illness unrelated to cancer.\n22. Female participants who are lactating and breastfeeding.\n23. Admission or evidence of illicit drug use, drug abuse, or alcohol abuse."}, 'identificationModule': {'nctId': 'NCT03596866', 'acronym': 'ALTA-3', 'briefTitle': 'A Study of Brigatinib Compared to Alectinib in Adults With Non-Small-Cell Lung Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'A Phase 3 Randomized Open-label Study of Brigatinib (ALUNBRIG®) Versus Alectinib (ALECENSA®) in Advanced Anaplastic Lymphoma Kinase-Positive Non-Small-Cell Lung Cancer Patients Who Have Progressed on Crizotinib (XALKORI®)', 'orgStudyIdInfo': {'id': 'Brigatinib-3001'}, 'secondaryIdInfos': [{'id': '2018-001957-29', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Brigatinib', 'description': 'Participants were administered brigatinib 90 milligrams (mg), tablets, orally, once daily (QD) for 7 days, followed by brigatinib 180 mg, tablets, orally, QD until objective disease progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), as assessed by the investigator, or intolerable toxicity, or up to 63.47 months.', 'interventionNames': ['Drug: Brigatinib']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Alectinib', 'description': 'Participants were administered alectinib 600 mg, capsules, orally, twice daily (BID) until objective disease progression per RECIST v1.1, as assessed by the investigator, or intolerable toxicity, or up to 59.83 months.', 'interventionNames': ['Drug: Alectinib']}], 'interventions': [{'name': 'Brigatinib', 'type': 'DRUG', 'otherNames': ['Alunbrig'], 'description': 'Brigatinib Tablets.', 'armGroupLabels': ['Brigatinib']}, {'name': 'Alectinib', 'type': 'DRUG', 'otherNames': ['Alecensa'], 'description': 'Alectinib Capsules.', 'armGroupLabels': ['Alectinib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90602', 'city': 'Whittier', 'state': 'California', 'country': 'United States', 'facility': 'The Oncology Institute of Hope and Innovation', 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