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

Ignite Creation Date: 2025-12-24 @ 10:39 PM

Ignite Modification Date: 2026-02-11 @ 5:56 PM

Study NCT ID: NCT00395135

Status: COMPLETED

Last Update Posted: 2019-10-02

First Post: 2006-10-31

Is NOT Gene Therapy: True

Has Adverse Events: True

Brief Title: BLOOM: Behavioral Modification and Lorcaserin for Overweight and Obesity Management

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D015431', 'term': 'Weight Loss'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C506658', 'term': 'lorcaserin'}, {'id': 'C494814', 'term': 'BID protein, human'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'esi_medinfo@eisai.com', 'phone': '+1-888-274-2378', 'title': 'Eisai Medical Information', 'organization': 'Eisai Inc.'}, 'certainAgreement': {'otherDetails': 'Publication of study results are only allowed with prior written consent from Arena Pharmaceuticals, Inc.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.', 'eventGroups': [{'id': 'EG000', 'title': 'Year 1 - Lorcaserin 10 mg BID', 'description': 'lorcaserin 10 mg BID tablets', 'otherNumAtRisk': 1593, 'otherNumAffected': 1324, 'seriousNumAtRisk': 1593, 'seriousNumAffected': 38}, {'id': 'EG001', 'title': 'Year 1 - Matching Placebo BID', 'description': 'matching placebo tablets', 'otherNumAtRisk': 1584, 'otherNumAffected': 1203, 'seriousNumAtRisk': 1584, 'seriousNumAffected': 37}, {'id': 'EG002', 'title': 'Year 2 - Lorc 10 mg BID (Yr 1) / Lorc 10 mg BID (Yr 2)', 'description': 'lorcaserin 10 mg BID tablets', 'otherNumAtRisk': 573, 'otherNumAffected': 450, 'seriousNumAtRisk': 573, 'seriousNumAffected': 15}, {'id': 'EG003', 'title': 'Year 2 - Lorc 10 mg BID (Yr 1) / Matching Placebo (Yr 2)', 'description': 'lorcaserin 10 mg BID tablets, matching placebo tablets', 'otherNumAtRisk': 283, 'otherNumAffected': 210, 'seriousNumAtRisk': 283, 'seriousNumAffected': 6}, {'id': 'EG004', 'title': 'Year 2 - Placebo (Yr 1) / Placebo (Yr 2)', 'description': 'matching placebo tablets', 'otherNumAtRisk': 697, 'otherNumAffected': 515, 'seriousNumAtRisk': 697, 'seriousNumAffected': 24}], 'otherEvents': [{'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1593, 'numEvents': 79, 'numAffected': 70}, {'groupId': 'EG001', 'numAtRisk': 1584, 'numEvents': 87, 'numAffected': 75}, {'groupId': 'EG002', 'numAtRisk': 573, 'numEvents': 44, 'numAffected': 38}, {'groupId': 'EG003', 'numAtRisk': 283, 'numEvents': 18, 'numAffected': 17}, {'groupId': 'EG004', 'numAtRisk': 697, 'numEvents': 51, 'numAffected': 43}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1593, 'numEvents': 114, 'numAffected': 99}, {'groupId': 'EG001', 'numAtRisk': 1584, 'numEvents': 93, 'numAffected': 89}, {'groupId': 'EG002', 'numAtRisk': 573, 'numEvents': 39, 'numAffected': 34}, {'groupId': 'EG003', 'numAtRisk': 283, 'numEvents': 19, 'numAffected': 16}, {'groupId': 'EG004', 'numAtRisk': 697, 'numEvents': 33, 'numAffected': 30}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1593, 'numEvents': 116, 'numAffected': 106}, {'groupId': 'EG001', 'numAtRisk': 1584, 'numEvents': 72, 'numAffected': 64}, {'groupId': 'EG002', 'numAtRisk': 573, 'numEvents': 16, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 283, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 697, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1593, 'numEvents': 118, 'numAffected': 109}, {'groupId': 'EG001', 'numAtRisk': 1584, 'numEvents': 100, 'numAffected': 85}, {'groupId': 'EG002', 'numAtRisk': 573, 'numEvents': 38, 'numAffected': 34}, {'groupId': 'EG003', 'numAtRisk': 283, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 697, 'numEvents': 31, 'numAffected': 30}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1593, 'numEvents': 149, 'numAffected': 130}, {'groupId': 'EG001', 'numAtRisk': 1584, 'numEvents': 69, 'numAffected': 60}, {'groupId': 'EG002', 'numAtRisk': 573, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 283, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 697, 'numEvents': 17, 'numAffected': 17}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1593, 'numEvents': 84, 'numAffected': 83}, {'groupId': 'EG001', 'numAtRisk': 1584, 'numEvents': 37, 'numAffected': 37}, {'groupId': 'EG002', 'numAtRisk': 573, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 283, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 697, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1593, 'numEvents': 108, 'numAffected': 95}, {'groupId': 'EG001', 'numAtRisk': 1584, 'numEvents': 51, 'numAffected': 48}, {'groupId': 'EG002', 'numAtRisk': 573, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 283, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 697, 'numEvents': 17, 'numAffected': 16}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1593, 'numEvents': 87, 'numAffected': 79}, {'groupId': 'EG001', 'numAtRisk': 1584, 'numEvents': 67, 'numAffected': 64}, {'groupId': 'EG002', 'numAtRisk': 573, 'numEvents': 18, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 283, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG004', 'numAtRisk': 697, 'numEvents': 25, 'numAffected': 21}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1593, 'numEvents': 388, 'numAffected': 287}, {'groupId': 'EG001', 'numAtRisk': 1584, 'numEvents': 211, 'numAffected': 175}, {'groupId': 'EG002', 'numAtRisk': 573, 'numEvents': 49, 'numAffected': 41}, {'groupId': 'EG003', 'numAtRisk': 283, 'numEvents': 25, 'numAffected': 18}, {'groupId': 'EG004', 'numAtRisk': 697, 'numEvents': 42, 'numAffected': 30}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1593, 'numEvents': 81, 'numAffected': 73}, {'groupId': 'EG001', 'numAtRisk': 1584, 'numEvents': 72, 'numAffected': 69}, {'groupId': 'EG002', 'numAtRisk': 573, 'numEvents': 39, 'numAffected': 38}, {'groupId': 'EG003', 'numAtRisk': 283, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG004', 'numAtRisk': 697, 'numEvents': 44, 'numAffected': 42}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1593, 'numEvents': 249, 'numAffected': 213}, {'groupId': 'EG001', 'numAtRisk': 1584, 'numEvents': 223, 'numAffected': 190}, {'groupId': 'EG002', 'numAtRisk': 573, 'numEvents': 114, 'numAffected': 94}, {'groupId': 'EG003', 'numAtRisk': 283, 'numEvents': 45, 'numAffected': 39}, {'groupId': 'EG004', 'numAtRisk': 697, 'numEvents': 103, 'numAffected': 88}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1593, 'numEvents': 141, 'numAffected': 119}, {'groupId': 'EG001', 'numAtRisk': 1584, 'numEvents': 90, 'numAffected': 85}, {'groupId': 'EG002', 'numAtRisk': 573, 'numEvents': 20, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 283, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 697, 'numEvents': 32, 'numAffected': 29}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1593, 'numEvents': 139, 'numAffected': 114}, {'groupId': 'EG001', 'numAtRisk': 1584, 'numEvents': 152, 'numAffected': 130}, {'groupId': 'EG002', 'numAtRisk': 573, 'numEvents': 62, 'numAffected': 49}, {'groupId': 'EG003', 'numAtRisk': 283, 'numEvents': 33, 'numAffected': 30}, {'groupId': 'EG004', 'numAtRisk': 697, 'numEvents': 59, 'numAffected': 48}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1593, 'numEvents': 280, 'numAffected': 235}, {'groupId': 'EG001', 'numAtRisk': 1584, 'numEvents': 216, 'numAffected': 189}, {'groupId': 'EG002', 'numAtRisk': 573, 'numEvents': 100, 'numAffected': 83}, {'groupId': 'EG003', 'numAtRisk': 283, 'numEvents': 41, 'numAffected': 31}, {'groupId': 'EG004', 'numAtRisk': 697, 'numEvents': 131, 'numAffected': 112}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1593, 'numEvents': 132, 'numAffected': 106}, {'groupId': 'EG001', 'numAtRisk': 1584, 'numEvents': 112, 'numAffected': 96}, {'groupId': 'EG002', 'numAtRisk': 573, 'numEvents': 48, 'numAffected': 41}, {'groupId': 'EG003', 'numAtRisk': 283, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG004', 'numAtRisk': 697, 'numEvents': 37, 'numAffected': 35}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}], 'seriousEvents': [{'term': 'Abdominal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1593, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1584, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 573, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 697, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1593, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1584, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 573, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 697, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Abortion spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1593, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1584, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 573, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 697, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1593, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1584, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 573, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 283, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 697, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1593, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1584, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 573, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 697, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1593, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1584, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 573, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 697, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1593, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1584, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 573, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 697, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1593, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1584, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 573, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 697, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1593, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1584, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 573, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 697, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Biliary dyskinesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1593, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1584, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 573, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 697, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Bladder cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1593, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1584, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 573, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 697, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Blood pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1593, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1584, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 573, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 697, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1593, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1584, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 573, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 697, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Breast hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1593, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1584, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 573, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 697, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Bronchospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1593, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1584, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 573, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 697, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Carcinoid tumour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1593, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1584, 'numEvents': 0, 'numAffected': 0}, 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'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Urinary incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1593, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1584, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 573, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 697, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Uterine haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1593, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1584, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 573, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 697, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Uterine leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1593, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1584, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 573, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 697, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Uterine malposition', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1593, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1584, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 573, 'numEvents': 0, 'numAffected': 0}, {'groupId': 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[{'categories': [{'measurements': [{'value': '-5.87', 'spread': '0.18', 'groupId': 'OG000'}, {'value': '-2.20', 'spread': '0.18', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportion (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.67', 'ciLowerLimit': '-4.09', 'ciUpperLimit': '-3.25', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '52 weeks', 'description': 'Year 1: The % change in body weight (kg) from baseline to week 52.', 'unitOfMeasure': '% change from baseline: body wt (kg)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT with LOCF'}, {'type': 'SECONDARY', 'title': 'Year 2: Percent Change in Body Weight From Week 52 to Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '553', 'groupId': 'OG000'}, {'value': '267', 'groupId': 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'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'dispFirstSubmitDate': '2012-07-26', 'completionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-19', 'studyFirstSubmitDate': '2006-10-31', 'dispFirstSubmitQcDate': '2012-08-06', 'resultsFirstSubmitDate': '2013-01-04', 'studyFirstSubmitQcDate': '2006-10-31', 'dispFirstPostDateStruct': {'date': '2012-08-14', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2019-10-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-01-04', 'studyFirstPostDateStruct': {'date': '2006-11-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-02-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Year 1: Co-Primary Endpoint- Proportion (%) of Patients Achieving > or = 5% 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change in body weight (kg) from week 52 to week 104.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Obesity', 'Weight loss', 'lorcaserin', 'APD356', 'BLOOM', 'Hypertension', 'Dyslipidemia', 'Sleep apnea', 'glucose tolerance', 'cardiovascular disease', 'Arena'], 'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '27888609', 'type': 'DERIVED', 'citation': 'Weissman NJ, Smith SR, Fain R, Hall N, Shanahan WR. Effects of lorcaserin on pre-existing valvulopathy: A pooled analysis of phase 3 trials. Obesity (Silver Spring). 2017 Jan;25(1):39-44. doi: 10.1002/oby.21695. Epub 2016 Nov 26.'}, {'pmid': '27659698', 'type': 'DERIVED', 'citation': 'Handelsman Y, Fain R, Wang Z, Li X, Fujioka K, Shanahan W. Lorcaserin treatment allows for decreased number needed to treat for weight and glycemic parameters in week 12 responders with >/=5% weight loss. Postgrad Med. 2016 Nov;128(8):740-746. doi: 10.1080/00325481.2016.1240591. Epub 2016 Oct 19.'}, {'pmid': '27206567', 'type': 'DERIVED', 'citation': 'Nguyen CT, Zhou S, Shanahan W, Fain R. Lorcaserin in Obese and Overweight Patients Taking Prohibited Serotonergic Agents: A Retrospective Analysis. Clin Ther. 2016 Jun;38(6):1498-1509. doi: 10.1016/j.clinthera.2016.04.004. Epub 2016 May 17.'}, {'pmid': '27116910', 'type': 'DERIVED', 'citation': 'Nesto R, Fain R, Li Y, Shanahan W. Evaluation of lorcaserin on progression of prediabetes to type 2 diabetes and reversion to euglycemia. Postgrad Med. 2016 May;128(4):364-70. doi: 10.1080/00325481.2016.1178590.'}, {'pmid': '23661689', 'type': 'DERIVED', 'citation': 'Weissman NJ, Sanchez M, Koch GG, Smith SR, Shanahan WR, Anderson CM. Echocardiographic assessment of cardiac valvular regurgitation with lorcaserin from analysis of 3 phase 3 clinical trials. Circ Cardiovasc Imaging. 2013 Jul;6(4):560-7. doi: 10.1161/CIRCIMAGING.112.000128. Epub 2013 May 9.'}, {'pmid': '20647200', 'type': 'DERIVED', 'citation': 'Smith SR, Weissman NJ, Anderson CM, Sanchez M, Chuang E, Stubbe S, Bays H, Shanahan WR; Behavioral Modification and Lorcaserin for Overweight and Obesity Management (BLOOM) Study Group. Multicenter, placebo-controlled trial of lorcaserin for weight management. N Engl J Med. 2010 Jul 15;363(3):245-56. doi: 10.1056/NEJMoa0909809.'}], 'seeAlsoLinks': [{'url': 'http://www.arenapharm.com', 'label': 'Arena Pharmaceuticals, Inc. 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