Ignite Creation Date:
2025-12-24 @ 5:47 PM
Ignite Modification Date:
2026-01-05 @ 6:08 PM
Study NCT ID:
NCT03849768
Status:
UNKNOWN
Last Update Posted:
2023-01-20
First Post:
2018-11-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate Safety and Efficacy of HS-10296 as First-Line Treatment in Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000718108', 'term': 'aumolertinib'}, {'id': 'D000077156', 'term': 'Gefitinib'}], 'ancestors': [{'id': 'D011799', 'term': 'Quinazolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Alison.li@hspharm.com', 'phone': '86-21-51211850', 'title': 'Alison Li', 'organization': 'Jiangsu Hansoh Pharmaceutical Group Co., Ltd.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Serious and Other (Not Including Serious)Adverse Events (AEs) were collected from first dose of study drug up to 28days after last dose of study drug taken (up to data cut-off (15 Jan 2021)), approximately 2 years.', 'eventGroups': [{'id': 'EG000', 'title': 'HS-10296', 'description': '110mg PO once daily\n\nHS-10296: Drug: HS-10296 110 mg/55 mg + placebo The initial dose of HS-10296 110 mg once daily can be reduced to 55 mg once daily under specific circumstances. A cycle of treatment is defined as 21 days of once daily treatment. Number of Cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria.', 'otherNumAtRisk': 214, 'deathsNumAtRisk': 214, 'otherNumAffected': 211, 'seriousNumAtRisk': 214, 'deathsNumAffected': 54, 'seriousNumAffected': 47}, {'id': 'EG001', 'title': 'Gefitinib', 'description': '250mg PO once daily\n\nGefitinib: Drug: Gefitinib 250 mg + placebo The initial dose of Gefitinib 250 mg once daily cannot be reduced. A cycle of treatment is defined as 21 days of once daily treatment. Number of cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria.', 'otherNumAtRisk': 215, 'deathsNumAtRisk': 215, 'otherNumAffected': 213, 'seriousNumAtRisk': 215, 'deathsNumAffected': 69, 'seriousNumAffected': 46}], 'otherEvents': [{'term': 'Weight loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 35, 'numAffected': 35}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 18, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 34, 'numAffected': 34}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'γ-glutamyl transferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 19, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 30, 'numAffected': 30}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 76, 'numAffected': 76}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 20, 'numAffected': 20}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'QT interval prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 23, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 19, 'numAffected': 19}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 47, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 17, 'numAffected': 17}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Blood lactate dehydrogenase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 26, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Erythra', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 50, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 89, 'numAffected': 89}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 26, 'numAffected': 26}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Dental ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 22, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 21, 'numAffected': 21}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 23, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 20, 'numAffected': 20}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Emesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 26, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Upper respiratory infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 41, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 26, 'numAffected': 26}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 19, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 33, 'numAffected': 33}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hypoalbuminemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 23, 'numAffected': 23}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 43, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 21, 'numAffected': 21}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Bound bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 21, 'numAffected': 21}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Blood in urine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 16, 'numAffected': 16}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Serum creatinine increased i', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'White blood cells in urine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Weight gain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Blood urea increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Serum alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Decreased lymphocyte count', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Increased Serum creatine phosphokinase MB', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 20, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Gastroesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 20, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hypocalcemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 19, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'hyperuricemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 19, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hypertriglyceridemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'weak', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 17, 'numAffected': 17}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Sinus bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 18, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 18, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 19, 'numAffected': 19}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 18, 'numAffected': 18}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Physical pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'High blood pressure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'seriousEvents': [{'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Paronychia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Skin infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hepatic function abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Drug-induced liver injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Liver function injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Spontaneous pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pulmonary artery thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pulmonary edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Increased alanine aminotransferase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Increased aspartate aminotransferase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Increased aminotransferases', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Decreased white blood cell count', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Decreased neutrophil count', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Intracranial hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cerebral hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hypoglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cerebral thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Acute cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Coronary atherosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cardiorespiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Ureteral stones', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Impairment of renal function', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Difficulty urinating', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Humeral fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Complications of hepatobiliary surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pathological fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Sudden cardiac death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hypoproteinemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Upper gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Completed suicide', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Venous thrombosis of extremities', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Thrombophlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Liver cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Rhegmatogenous retinal detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '215', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HS-10296', 'description': '110mg PO once daily\n\nHS-10296: Drug: HS-10296 110 mg/55 mg + placebo The initial dose of HS-10296 110 mg once daily can be reduced to 55 mg once daily under specific circumstances. A cycle of treatment is defined as 21 days of once daily treatment. Number of Cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria.'}, {'id': 'OG001', 'title': 'Gefitinib', 'description': '250mg PO once daily\n\nGefitinib: Drug: Gefitinib 250 mg + placebo The initial dose of Gefitinib 250 mg once daily cannot be reduced. A cycle of treatment is defined as 21 days of once daily treatment. Number of cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria.'}], 'classes': [{'categories': [{'measurements': [{'value': '19.3', 'groupId': 'OG000', 'lowerLimit': '17.8', 'upperLimit': '20.8'}, {'value': '9.9', 'groupId': 'OG001', 'lowerLimit': '8.3', 'upperLimit': '12.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From baseline, then every 6 weeks, until disease progression or discontinuation from study. From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, approximately 2 years.', 'description': 'PFS was defined as the time from the date of first dose until the date of radiological disease progression or until death due to any cause, based on the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, as assessed by investigators. Progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Objective Response Rate (ORR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '215', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HS-10296', 'description': '110mg PO once daily\n\nHS-10296: Drug: HS-10296 110 mg/55 mg + placebo The initial dose of HS-10296 110 mg once daily can be reduced to 55 mg once daily under specific circumstances. A cycle of treatment is defined as 21 days of once daily treatment. Number of Cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria.'}, {'id': 'OG001', 'title': 'Gefitinib', 'description': '250mg PO once daily\n\nGefitinib: Drug: Gefitinib 250 mg + placebo The initial dose of Gefitinib 250 mg once daily cannot be reduced. A cycle of treatment is defined as 21 days of once daily treatment. Number of cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria.'}], 'classes': [{'categories': [{'measurements': [{'value': '73.8', 'groupId': 'OG000', 'lowerLimit': '67.4', 'upperLimit': '79.6'}, {'value': '72.1', 'groupId': 'OG001', 'lowerLimit': '65.6', 'upperLimit': '78.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline, then every 6 weeks, until disease progression or discontinuation from study.（up to 24 months）', 'description': 'ORR is defined as the percentage of patients who have at least 1 response of CR or PR prior to any evidence of progression. Target lesions and assessed by CT per RECIST v1.1 (Complete Response(CR), Disappearance of all target lesions; Partial Response (PR), \\>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Assess the Anti-tumor Activity: Duration of Response (DoR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '215', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HS-10296', 'description': '110mg PO once daily\n\nHS-10296: Drug: HS-10296 110 mg/55 mg + placebo The initial dose of HS-10296 110 mg once daily can be reduced to 55 mg once daily under specific circumstances. A cycle of treatment is defined as 21 days of once daily treatment. Number of Cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria.'}, {'id': 'OG001', 'title': 'Gefitinib', 'description': '250mg PO once daily\n\nGefitinib: Drug: Gefitinib 250 mg + placebo The initial dose of Gefitinib 250 mg once daily cannot be reduced. A cycle of treatment is defined as 21 days of once daily treatment. Number of cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria.'}], 'classes': [{'categories': [{'measurements': [{'value': '18.1', 'comment': 'This outcome measure data was not available at the analysis cut-off due to insufficient number of participants with events.', 'groupId': 'OG000', 'lowerLimit': '15.2', 'upperLimit': 'NA'}, {'value': '8.3', 'groupId': 'OG001', 'lowerLimit': '6.9', 'upperLimit': '11.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From baseline, then every 6 weeks, until disease progression or discontinuation from study. (up to 24 months)', 'description': 'DoR is defined as the time from the date of first documented response until the date of documented progression or death in the absence of disease progression assessed up to 24 months.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Assess the Anti-tumor Activity: Disease Control Rate (DCR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '215', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HS-10296', 'description': '110mg PO once daily\n\nHS-10296: Drug: HS-10296 110 mg/55 mg + placebo The initial dose of HS-10296 110 mg once daily can be reduced to 55 mg once daily under specific circumstances. A cycle of treatment is defined as 21 days of once daily treatment. Number of Cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria.'}, {'id': 'OG001', 'title': 'Gefitinib', 'description': '250mg PO once daily\n\nGefitinib: Drug: Gefitinib 250 mg + placebo The initial dose of Gefitinib 250 mg once daily cannot be reduced. A cycle of treatment is defined as 21 days of once daily treatment. Number of cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria.'}], 'classes': [{'categories': [{'measurements': [{'value': '93.0', 'groupId': 'OG000', 'lowerLimit': '88.7', 'upperLimit': '96.0'}, {'value': '96.7', 'groupId': 'OG001', 'lowerLimit': '93.4', 'upperLimit': '98.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline, then every 6 weeks, until disease progression or discontinuation from study.', 'description': 'The DCR is defined as the proportion of patients with a best overall response of CR, PR, or SD assessed up to 24 months.', 'unitOfMeasure': 'percentage', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Assess the Anti-tumor Activity: Depth of Response (DepOR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '215', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HS-10296', 'description': '110mg PO once daily\n\nHS-10296: Drug: HS-10296 110 mg/55 mg + placebo The initial dose of HS-10296 110 mg once daily can be reduced to 55 mg once daily under specific circumstances. A cycle of treatment is defined as 21 days of once daily treatment. Number of Cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria.'}, {'id': 'OG001', 'title': 'Gefitinib', 'description': '250mg PO once daily\n\nGefitinib: Drug: Gefitinib 250 mg + placebo The initial dose of Gefitinib 250 mg once daily cannot be reduced. A cycle of treatment is defined as 21 days of once daily treatment. Number of cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria.'}], 'classes': [{'categories': [{'measurements': [{'value': '-44.95', 'spread': '21.961', 'groupId': 'OG000'}, {'value': '-41.95', 'spread': '19.966', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline, then every 6 weeks, until disease progression or discontinuation from study.（up to 24 months）', 'description': 'DepOR is defined as the percentage change in tumor shrinkage, based on longest diameter or reconstructed volume, observed at the lowest point (nadir) compared with baseline.', 'unitOfMeasure': 'percentage of change from baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events (AEs)/Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '215', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HS-10296', 'description': '110mg PO once daily\n\nHS-10296: Drug: HS-10296 110 mg/55 mg + placebo The initial dose of HS-10296 110 mg once daily can be reduced to 55 mg once daily under specific circumstances. A cycle of treatment is defined as 21 days of once daily treatment. Number of Cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria.'}, {'id': 'OG001', 'title': 'Gefitinib', 'description': '250mg PO once daily\n\nGefitinib: Drug: Gefitinib 250 mg + placebo The initial dose of Gefitinib 250 mg once daily cannot be reduced. A cycle of treatment is defined as 21 days of once daily treatment. Number of cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria.'}], 'classes': [{'categories': [{'measurements': [{'value': '211', 'groupId': 'OG000'}, {'value': '213', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Continuously throughout the study until 28 days after HS-10296 discontinuation.From first dose of study drug up to 28 days after last dose of study drug taken (up to data cut-off (15 Jan 2021)),approximately 2 years.', 'description': 'Safety was assessed by AEs, which included abnormalities identified during a medical test (e.g. laboratory tests, vital signs, electrocardiogram, etc.) if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study medication or was clinically significant. A treatment-emergent AE (TEAE) was defined as an AE observed after starting administration of the study drug. AEs were considered serious (SAEs) if the AE resulted in death, was life threatening, resulted in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, resulted in congenital anomaly, or birth defect or required inpatient hospitalization or led to prolongation of hospitalization.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Dose Interruptions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '215', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HS-10296', 'description': '110mg PO once daily\n\nHS-10296: Drug: HS-10296 110 mg/55 mg + placebo The initial dose of HS-10296 110 mg once daily can be reduced to 55 mg once daily under specific circumstances. A cycle of treatment is defined as 21 days of once daily treatment. Number of Cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria.'}, {'id': 'OG001', 'title': 'Gefitinib', 'description': '250mg PO once daily\n\nGefitinib: Drug: Gefitinib 250 mg + placebo The initial dose of Gefitinib 250 mg once daily cannot be reduced. A cycle of treatment is defined as 21 days of once daily treatment. Number of cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria.'}], 'classes': [{'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From baseline, then every 6 weeks, until disease progression or discontinuation from study. (up to 24 months)', 'description': 'Participants had at least one delay in planned treatment due to treatment emergent adverse events.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Dose Reductions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '215', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HS-10296', 'description': '110mg PO once daily\n\nHS-10296: Drug: HS-10296 110 mg/55 mg + placebo The initial dose of HS-10296 110 mg once daily can be reduced to 55 mg once daily under specific circumstances. A cycle of treatment is defined as 21 days of once daily treatment. Number of Cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria.'}, {'id': 'OG001', 'title': 'Gefitinib', 'description': '250mg PO once daily\n\nGefitinib: Drug: Gefitinib 250 mg + placebo The initial dose of Gefitinib 250 mg once daily cannot be reduced. A cycle of treatment is defined as 21 days of once daily treatment. Number of cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria.'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From baseline, then every 6 weeks, until disease progression or discontinuation from study. (up to 24 months)', 'description': 'Participants had at least one reduction in planned treatment dosage due to treatment emergent adverse events. Every participant took 2 pills of HS\n\n-10296 + 1 pill of placebo(experimental arm) or 2pills of placebo + 1pill of Gefitinib (control arm). When a dose reduction was decided by INV, the set of "2 pills of placebo" was decreased resulting in no reduction of active compound in control arm, compliance with dose modification for AEs in Gefitinib\'s label which includes interruption, discontinuation but reduction.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'HS-10296', 'description': '110mg PO once daily\n\nHS-10296: Drug: HS-10296 110 mg/55 mg + placebo The initial dose of HS-10296 110 mg once daily can be reduced to 55 mg once daily under specific circumstances. A cycle of treatment is defined as 21 days of once daily treatment. Number of Cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria.'}, {'id': 'FG001', 'title': 'Gefitinib', 'description': '250mg PO once daily\n\nGefitinib: Drug: Gefitinib 250 mg + placebo The initial dose of Gefitinib 250 mg once daily cannot be reduced. A cycle of treatment is defined as 21 days of once daily treatment. Number of cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '214'}, {'groupId': 'FG001', 'numSubjects': '215'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '121'}, {'groupId': 'FG001', 'numSubjects': '181'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '93'}, {'groupId': 'FG001', 'numSubjects': '34'}]}]}], 'recruitmentDetails': 'A total of 429 participants were randomized to at 53 study sites.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'BG000'}, {'value': '215', 'groupId': 'BG001'}, {'value': '429', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'HS-10296', 'description': '110mg PO once daily\n\nHS-10296: Drug: HS-10296 110 mg/55 mg + placebo The initial dose of HS-10296 110 mg once daily can be reduced to 55 mg once daily under specific circumstances. A cycle of treatment is defined as 21 days of once daily treatment. Number of Cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria.'}, {'id': 'BG001', 'title': 'Gefitinib', 'description': '250mg PO once daily\n\nGefitinib: Drug: Gefitinib 250 mg + placebo The initial dose of Gefitinib 250 mg once daily cannot be reduced. A cycle of treatment is defined as 21 days of once daily treatment. Number of cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '155', 'groupId': 'BG000'}, {'value': '139', 'groupId': 'BG001'}, {'value': '294', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '135', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.1', 'spread': '9.59', 'groupId': 'BG000'}, {'value': '60.6', 'spread': '9.72', 'groupId': 'BG001'}, {'value': '59.3', 'spread': '9.72', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '134', 'groupId': 'BG000'}, {'value': '135', 'groupId': 'BG001'}, {'value': '269', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '160', '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': '214', 'groupId': 'BG000'}, {'value': '215', 'groupId': 'BG001'}, {'value': '429', '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': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Smoking status', 'classes': [{'title': 'Never smoked', 'categories': [{'measurements': [{'value': '156', 'groupId': 'BG000'}, {'value': '144', 'groupId': 'BG001'}, {'value': '300', 'groupId': 'BG002'}]}]}, {'title': 'smoked', 'categories': [{'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '129', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-12-10', 'size': 1808508, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-10-11T23:10', 'hasProtocol': True}, {'date': '2020-10-21', 'size': 1162114, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-10-11T23:11', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 429}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2023-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-12-25', 'studyFirstSubmitDate': '2018-11-23', 'resultsFirstSubmitDate': '2022-09-02', 'studyFirstSubmitQcDate': '2019-02-19', 'lastUpdatePostDateStruct': {'date': '2023-01-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-12-25', 'studyFirstPostDateStruct': {'date': '2019-02-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-01-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression Free Survival (PFS)', 'timeFrame': 'From baseline, then every 6 weeks, until disease progression or discontinuation from study. From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, approximately 2 years.', 'description': 'PFS was defined as the time from the date of first dose until the date of radiological disease progression or until death due to any cause, based on the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, as assessed by investigators. Progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Objective Response Rate (ORR)', 'timeFrame': 'From baseline, then every 6 weeks, until disease progression or discontinuation from study.（up to 24 months）', 'description': 'ORR is defined as the percentage of patients who have at least 1 response of CR or PR prior to any evidence of progression. Target lesions and assessed by CT per RECIST v1.1 (Complete Response(CR), Disappearance of all target lesions; Partial Response (PR), \\>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.).'}, {'measure': 'Assess the Anti-tumor Activity: Duration of Response (DoR)', 'timeFrame': 'From baseline, then every 6 weeks, until disease progression or discontinuation from study. (up to 24 months)', 'description': 'DoR is defined as the time from the date of first documented response until the date of documented progression or death in the absence of disease progression assessed up to 24 months.'}, {'measure': 'Assess the Anti-tumor Activity: Disease Control Rate (DCR)', 'timeFrame': 'From baseline, then every 6 weeks, until disease progression or discontinuation from study.', 'description': 'The DCR is defined as the proportion of patients with a best overall response of CR, PR, or SD assessed up to 24 months.'}, {'measure': 'Assess the Anti-tumor Activity: Depth of Response (DepOR)', 'timeFrame': 'From baseline, then every 6 weeks, until disease progression or discontinuation from study.（up to 24 months）', 'description': 'DepOR is defined as the percentage change in tumor shrinkage, based on longest diameter or reconstructed volume, observed at the lowest point (nadir) compared with baseline.'}, {'measure': 'Number of Participants With Adverse Events (AEs)/Serious Adverse Events (SAEs)', 'timeFrame': 'Continuously throughout the study until 28 days after HS-10296 discontinuation.From first dose of study drug up to 28 days after last dose of study drug taken (up to data cut-off (15 Jan 2021)),approximately 2 years.', 'description': 'Safety was assessed by AEs, which included abnormalities identified during a medical test (e.g. laboratory tests, vital signs, electrocardiogram, etc.) if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study medication or was clinically significant. A treatment-emergent AE (TEAE) was defined as an AE observed after starting administration of the study drug. AEs were considered serious (SAEs) if the AE resulted in death, was life threatening, resulted in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, resulted in congenital anomaly, or birth defect or required inpatient hospitalization or led to prolongation of hospitalization.'}, {'measure': 'Number of Participants With Dose Interruptions', 'timeFrame': 'From baseline, then every 6 weeks, until disease progression or discontinuation from study. (up to 24 months)', 'description': 'Participants had at least one delay in planned treatment due to treatment emergent adverse events.'}, {'measure': 'Number of Participants With Dose Reductions', 'timeFrame': 'From baseline, then every 6 weeks, until disease progression or discontinuation from study. (up to 24 months)', 'description': 'Participants had at least one reduction in planned treatment dosage due to treatment emergent adverse events. Every participant took 2 pills of HS\n\n-10296 + 1 pill of placebo(experimental arm) or 2pills of placebo + 1pill of Gefitinib (control arm). When a dose reduction was decided by INV, the set of "2 pills of placebo" was decreased resulting in no reduction of active compound in control arm, compliance with dose modification for AEs in Gefitinib\'s label which includes interruption, discontinuation but reduction.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non Small Cell Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '39016053', 'type': 'DERIVED', 'citation': 'Lu S, Dong X, Jian H, Chen J, Chen G, Sun Y, Ji Y, Wang Z, Shi J, Lu J, Chen S, Lv D, Zhang G, Liu C, Li J, Yu X, Lin Z, Yu Z, Wang Z, Cui J, Xu X, Fang J, Feng J, Xu Z, Ma R, Hu J, Yang N, Zhou X, Wu X, Hu C, Zhang Z, Lu Y, Hu Y, Jiang L, Wang Q, Guo R, Zhou J, Li B, Hu C, Tong W, Zhang H, Ma L, Chen Y, Jie Z, Yao Y, Zhang L, Weng J, Li W, Xiong J, Ye X, Duan J, Yang H, Sun M, Wei H, Wei J, Zhang Z, Wu Q. Central nervous system efficacy of aumolertinib versus gefitinib in patients with untreated, EGFR-mutated, advanced non-small cell lung cancer: data from a randomized phase III trial (AENEAS). Cancer Commun (Lond). 2024 Sep;44(9):1005-1017. doi: 10.1002/cac2.12594. Epub 2024 Jul 17.'}, {'pmid': '35580297', 'type': 'DERIVED', 'citation': 'Lu S, Dong X, Jian H, Chen J, Chen G, Sun Y, Ji Y, Wang Z, Shi J, Lu J, Chen S, Lv D, Zhang G, Liu C, Li J, Yu X, Lin Z, Yu Z, Wang Z, Cui J, Xu X, Fang J, Feng J, Xu Z, Ma R, Hu J, Yang N, Zhou X, Wu X, Hu C, Zhang Z, Lu Y, Hu Y, Jiang L, Wang Q, Guo R, Zhou J, Li B, Hu C, Tong W, Zhang H, Ma L, Chen Y, Jie Z, Yao Y, Zhang L, Jie W, Li W, Xiong J, Ye X, Duan J, Yang H, Sun M, Sun C, Wei H, Li C, Ali SM, Miller VA, Wu Q. AENEAS: A Randomized Phase III Trial of Aumolertinib Versus Gefitinib as First-Line Therapy for Locally Advanced or MetastaticNon-Small-Cell Lung Cancer With EGFR Exon 19 Deletion or L858R Mutations. J Clin Oncol. 2022 Sep 20;40(27):3162-3171. doi: 10.1200/JCO.21.02641. Epub 2022 May 17.'}]}, 'descriptionModule': {'briefSummary': 'This is a randomized, controlled, double-blind, multicenter, phase III clinical study.', 'detailedDescription': 'This is a randomized, controlled, double-blind, multicenter, phase III clinical trial, evaluating the efficacy and safety of HS-10296 compared to gefitinib in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor sensitizing mutations (EGFRm+) who have not received systemic therapy. Patients are randomly assigned to an HS-10296 treatment group or a gefitinib treatment group at a ratio of 1:1 and receive a once-daily oral dose of HS-10296 or gefitinib, in order to compare the efficacy and safety of the two different treatment regimens.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria: Inclusion Criteria:\n\nAny patient who meets all of the following inclusion criteria will qualify for entry into the study:\n\n1. Provision of informed consent prior to any study specific procedures, sampling and analyses.\n2. Male or female, age at least 18 years.\n3. Pathologically confirmed locally advanced or metastatic NSCLC (e.g. this may occur systemic recurrence after prior surgery for early stage disease or patients may be newly diagnosed with stage IIIB/IV disease). Patients must be treatment-naïve for locally advanced or metastatic NSCLC. Prior adjuvant and neo-adjuvant therapy is permitted (chemotherapy, radiotherapy, investigational agents) provided all other entry criteria are satisfied.\n4. The tumour harbours one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R), either or in combination with other EGFR mutations assessed by central testing using tumour tissue sample or blood sample.\n5. A WHO performance status equal to 0-1 with no deterioration over the previous 2 weeks and a minimum life expectancy of 12 weeks.\n6. At least 1 lesion that has not previously been irradiated, that has not been chosen for biopsy during the study screening period, and that can be accurately measured at Baseline as ≥ 10 mm in the longest diameter (except lymph nodes, which must have short axis ≥ 15mm) with computerized tomography (CT) or magnetic resonance imaging (MRI), whichever is suitable for accurately repeated measurements. If only one measurable lesion exists, it is acceptable to be used (as a target lesion) as long as it has not been previously irradiated and baseline tumour assessment scans are done at least 14days afar the screening biopsy is performed.\n7. Females should be using adequate contraceptive measures throughout the study; should not be breastfeeding at the time of screening, during the study and until 3 months after completion of the study; and must have a negative pregnancy test prior to start of dosing if of childbearing potential or must have evidence of non-childbearing potential by fulfilling 1 of the following criteria at Screening:\n\n 1. Postmenopausal defined as age more than 50 years and amenorrheic for at least 12 months following cessation of all exogenous hormonal treatments.\n 2. Women under 50 years old would be considered postmenopausal if they have been amenorrheic for 12 months or more, following cessation of exogenous hormonal treatments, and with luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels in the postmenopausal range for the laboratory.\n 3. Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy, but not by tubal ligation.\n8. Male patients should be willing to use barrier contraception (i.e., condoms).\n9. For inclusion in study, patient must provide a written informed consent.\n\n \\-\n\nExclusion Criteria: Exclusion Criteria:\n\nAny patient who meets any of the following exclusion criteria will not qualify for entry into the study:\n\n1. Treatment with any of the following:\n\n 1. Prior treatment with systemic anti-cancer therapy for locally advancer or metastatic NSCLC including chemotherapy, biologic therapy, immunotherapy, or any investigational drug.\n 2. Prior treatment with an EGFR TKI.\n 3. Major surgery (excluding placement of vascular access) within 4 weeks of the first dose of study drug.\n 4. Radiotherapy with a limited field of radiation for palliation within 4 week of the first dose of study drug, with the exception of patients receiving radiation to \\> 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of study drug.\n 5. Medications that are predominantly CYP3A4 strong inhibitors or inducers or sensitive substrates of CYP3A4 with a narrow therapeutic range within 7 days of the first dose of study drug.\n2. Any concurrent and/or other active malignancy that has required treatment within 2 years of first dose of study drug.\n3. Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 at the time of starting study treatment, with the exception of alopecia and Grade 2, prior platinum-therapy related neuropathy.\n4. Spinal cord compression or brain metastases unless asymptomatic, stable, and not requiring steroids for at least 2 weeks prior to start of study treatment.\n5. Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension or active bleeding diatheses, which, in the Investigator's opinion, makes it undesirable for the patient to participate in the trial OR which would jeopardize compliance with the protocol such as active infection. Screening for chronic conditions is not required.\n6. Refractory nausea, vomiting, or chronic gastrointestinal diseases, inability to swallow the study drug, or previous significant bowel resection that would preclude adequate absorption of HS 10296.\n7. Any of the following cardiac criteria:\n\n 1. Mean resting corrected QT interval (QTc) \\> 470 ms obtained from 3 electrocardiograms (ECGs), using the screening clinic's ECG machine and Fridericia's formula for QT interval correction (QTcF).\n 2. Any clinically important abnormalities in rhythm, conduction, or morphology of the resting ECG (e.g., complete left bundle branch block, third-degree heart block, second-degree heart block, PR interval \\> 250 ms).\n 3. Any factors that increase the risk of QTc prolongation or risk of arrhythmic events, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval.\n 4. Left ventricular ejection fraction (LVEF) ≤ 40%.\n8. Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis that required steroid treatment, or any evidence of clinically active interstitial lung disease.\n9. Inadequate bone marrow reserve or organ function, as demonstrated by any of the following laboratory values:\n\n 1. Absolute neutrophil count (ANC) \\<1.5×109 / L\n 2. Platelet count \\<100×109 / L\n 3. Hemoglobin \\<90 g/L（\\<9 g/dL）\n 4. Alanine aminotransferase \\> 2.5 × upper limit of normal (ULN) if no demonstrable liver metastases or \\> 5 × ULN in the presence of liver metastases.\n 5. Aspartate aminotransferase (AST) \\> 2.5 × ULN if no demonstrable liver metastases or \\> 5 × ULN in the presence of liver metastases.\n 6. Total bilirubin (TBL) \\> 1.5 × ULN if no liver metastases or \\> 3 × ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinemia) or liver metastases.\n 7. Creatinine \\> 1.5 × ULN concurrent with creatinine clearance \\< 50 mL/min (measured or calculated by the Cockcroft-Gault equation); confirmation of creatinine clearance is only required when creatinine is \\> 1.5 × ULN.\n10. Women who are breastfeeding or have a positive urine or serum pregnancy test at the Screening Visit.\n11. History of hypersensitivity to any active or inactive ingredient of HS 10296 or to drugs with a similar chemical structure or class to HS 10296.\n12. Judgment by the Investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements.\n13. Any severe and uncontrolled ocular disease that may, in the ophthalmologist's opinion, present a specific risk to the patient's safety.\n14. Any disease or condition that, in the opinion of the Investigator, would compromise the safety of the patient or interfere with study assessments.\n\n \\-"}, 'identificationModule': {'nctId': 'NCT03849768', 'briefTitle': 'A Study to Evaluate Safety and Efficacy of HS-10296 as First-Line Treatment in Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jiangsu Hansoh Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Phase III Randomized, Controlled, Double-Blind, Multicenter Clinical Trial to Evaluate the Efficacy and Safety of HS-10296 Versus Gefitinib as First-Line Therapy for Locally Advanced or Metastatic NSCLC With EGFR Sensitizing Mutations', 'orgStudyIdInfo': {'id': 'HS-10296-03-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HS-10296', 'description': '110mg PO once daily', 'interventionNames': ['Drug: HS-10296']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Gefitinib', 'description': '250mg PO once daily', 'interventionNames': ['Drug: Gefitinib']}], 'interventions': [{'name': 'HS-10296', 'type': 'DRUG', 'otherNames': ['Investigational Product'], 'description': 'Drug: HS-10296 110 mg/55 mg + placebo The initial dose of HS-10296 110 mg once daily can be reduced to 55 mg once daily under specific circumstances. A cycle of treatment is defined as 21 days of once daily treatment. Number of Cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria.', 'armGroupLabels': ['HS-10296']}, {'name': 'Gefitinib', 'type': 'DRUG', 'otherNames': ['Comparator Product'], 'description': 'Drug: Gefitinib 250 mg + placebo The initial dose of Gefitinib 250 mg once daily cannot be reduced. A cycle of treatment is defined as 21 days of once daily treatment. Number of cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria.', 'armGroupLabels': ['Gefitinib']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'facility': 'Beijing Cancer Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Maniam Ajit, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Pacific Cancer Medical Center, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jiangsu Hansoh Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}