Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2026-02-28 @ 3:31 AM
Study NCT ID:
NCT02243202
Status:
COMPLETED
Last Update Posted:
2016-10-06
First Post:
2014-09-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effects of Co-administration of Canagliflozin 300 mg and Phentermine 15 mg With Placebo in the Treatment of Non-Diabetic Overweight and Obese Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068896', 'term': 'Canagliflozin'}, {'id': 'D010645', 'term': 'Phentermine'}], 'ancestors': [{'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005960', 'term': 'Glucosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D000662', 'term': 'Amphetamines'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialDisclosure@its.jnj.com', 'title': 'Clinical Leader', 'organization': 'Janssen Research & Development, LLC'}, 'certainAgreement': {'otherDetails': 'If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 33 weeks', 'description': 'Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Participants received placebo tablets orally for 26 weeks.', 'otherNumAtRisk': 82, 'otherNumAffected': 41, 'seriousNumAtRisk': 82, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Phentermine 15 mg', 'description': 'Participants received phentermine 15 mg over-encapsulated tablets orally for 26 weeks.', 'otherNumAtRisk': 85, 'otherNumAffected': 37, 'seriousNumAtRisk': 85, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Canagliflozin 300 mg', 'description': 'Participants received canagliflozin 300 mg over-encapsulated tablets orally for 26 weeks.', 'otherNumAtRisk': 84, 'otherNumAffected': 42, 'seriousNumAtRisk': 84, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Canagliflozin 300 mg/Phentermine 15 mg', 'description': 'Participants received co-administration of canagliflozin 300 mg and phentermine 15 mg orally for 26 weeks.', 'otherNumAtRisk': 83, 'otherNumAffected': 42, 'seriousNumAtRisk': 83, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Abdominal Distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 84, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Dry Mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 84, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 84, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Rectal Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 84, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 84, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 84, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Acute Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 84, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 84, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 84, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 84, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 84, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Pharyngitis Streptococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 84, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 84, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Tooth Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 84, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 84, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Viral Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 84, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Vulvovaginal Candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 84, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Vulvovaginal Mycotic Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 84, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Muscle Strain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 84, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Blood Creatine Phosphokinase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 84, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Decreased Appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Polydipsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 84, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 84, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Pain in Extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 84, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 84, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 84, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Tension Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 84, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Sleep Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 84, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Sinus Congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 84, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 84, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}], 'seriousEvents': [{'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Change From Baseline in Body Weight at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo tablets orally for 26 weeks.'}, {'id': 'OG001', 'title': 'Phentermine 15 mg', 'description': 'Participants received phentermine 15 mg over-encapsulated tablets orally for 26 weeks.'}, {'id': 'OG002', 'title': 'Canagliflozin 300 mg', 'description': 'Participants received canagliflozin 300 mg over-encapsulated tablets orally for 26 weeks.'}, {'id': 'OG003', 'title': 'Canagliflozin 300 mg/Phentermine 15 mg', 'description': 'Participants received co-administration of canagliflozin 300 mg and phentermine 15 mg orally for 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.6', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '-4.1', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '-1.9', 'spread': '0.6', 'groupId': 'OG002'}, {'value': '-7.5', 'spread': '0.6', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Square Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.5', 'ciLowerLimit': '-5.3', 'ciUpperLimit': 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'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 26', 'description': 'The percent change from baseline in body weight at Week 26 was analysed.', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The modified intent-to-treat (mITT) analysis set included all randomized participants who received at least 1 dose of double-blind study agent. N=number of participants analysed is the total participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Weight Loss More Than Equal to (>=) 5 Percent at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo tablets orally for 26 weeks.'}, {'id': 'OG001', 'title': 'Phentermine 15 mg', 'description': 'Participants received phentermine 15 mg over-encapsulated tablets orally for 26 weeks.'}, {'id': 'OG002', 'title': 'Canagliflozin 300 mg', 'description': 'Participants received canagliflozin 300 mg over-encapsulated tablets orally for 26 weeks.'}, {'id': 'OG003', 'title': 'Canagliflozin 300 mg/Phentermine 15 mg', 'description': 'Participants received co-administration of canagliflozin 300 mg and phentermine 15 mg orally for 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.5', 'groupId': 'OG000'}, {'value': '41.7', 'groupId': 'OG001'}, {'value': '17.9', 'groupId': 'OG002'}, {'value': '66.7', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.15', 'ciLowerLimit': '1.70', 'ciUpperLimit': '10.14', 'statisticalMethod': 'Generalized linear Mixed Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.825', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.12', 'ciLowerLimit': '0.41', 'ciUpperLimit': '3.06', 'statisticalMethod': 'Generalized linear Mixed Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.20', 'ciLowerLimit': '4.15', 'ciUpperLimit': '25.05', 'statisticalMethod': 'Generalized linear Mixed Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 26', 'description': 'Percentage of participants with weight loss \\>= 5 percent were analysed at week 26.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The mITT analysis set included all randomized participants who received at least 1 dose of double-blind study agent. N=number of participants analysed is the total participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Systolic Blood Pressure at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo tablets orally for 26 weeks.'}, {'id': 'OG001', 'title': 'Phentermine 15 mg', 'description': 'Participants received phentermine 15 mg over-encapsulated tablets orally for 26 weeks.'}, {'id': 'OG002', 'title': 'Canagliflozin 300 mg', 'description': 'Participants received canagliflozin 300 mg over-encapsulated tablets orally for 26 weeks.'}, {'id': 'OG003', 'title': 'Canagliflozin 300 mg/Phentermine 15 mg', 'description': 'Participants received co-administration of canagliflozin 300 mg and phentermine 15 mg orally for 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.7', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '-1.4', 'spread': '1.2', 'groupId': 'OG001'}, {'value': '-3.1', 'spread': '1.3', 'groupId': 'OG002'}, {'value': '-6.9', 'spread': '1.2', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.456', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Square Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.3', 'ciLowerLimit': '-2.1', 'ciUpperLimit': '4.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.8', 'statisticalMethod': 'Mixed Model for Repeated Measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.827', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Square Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-3.9', 'ciUpperLimit': '3.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.8', 'statisticalMethod': 'Mixed Model for Repeated Measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.015', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Least Square Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.2', 'ciLowerLimit': '-7.7', 'ciUpperLimit': '-0.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.7', 'statisticalMethod': 'Mixed Model for Repeated Measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 26', 'description': 'Change from baseline in systolic blood pressure was analysed at week 26.', 'unitOfMeasure': 'mmHg (millimeters of mercury)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The mITT analysis set included all randomized participants who received at least 1 dose of double-blind study agent. N=number of participants analysed is the total participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Absolute Change From Baseline in Body Weight at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo tablets orally for 26 weeks.'}, {'id': 'OG001', 'title': 'Phentermine 15 mg', 'description': 'Participants received phentermine 15 mg over-encapsulated tablets orally for 26 weeks.'}, {'id': 'OG002', 'title': 'Canagliflozin 300 mg', 'description': 'Participants received canagliflozin 300 mg over-encapsulated tablets orally for 26 weeks.'}, {'id': 'OG003', 'title': 'Canagliflozin 300 mg/Phentermine 15 mg', 'description': 'Participants received co-administration of canagliflozin 300 mg and phentermine 15 mg orally for 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.6', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '-4.1', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '-1.9', 'spread': '0.7', 'groupId': 'OG002'}, {'value': '-7.3', 'spread': '0.6', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Square Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.5', 'ciLowerLimit': '-5.3', 'ciUpperLimit': '-1.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.9', 'statisticalMethod': 'Mixed Model for Repeated Measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.153', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Square Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.3', 'ciLowerLimit': '-3.1', 'ciUpperLimit': '0.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.9', 'statisticalMethod': 'Mixed Model for Repeated Measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Least Square Mean Difference', 'ciPctValue': '95', 'paramValue': '-6.7', 'ciLowerLimit': '-8.5', 'ciUpperLimit': '-4.9', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.9', 'statisticalMethod': 'Mixed Model for Repeated Measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 26', 'description': 'Absolute change from baseline in body weight was analysed at week 26.', 'unitOfMeasure': 'Kilogram (Kg)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The mITT analysis set included all randomized participants who received at least 1 dose of double-blind study agent. N=number of participants analysed is the total participants who were evaluable for this outcome measure.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in Diastolic Blood Pressure (DBP) at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo tablets orally for 26 weeks.'}, {'id': 'OG001', 'title': 'Phentermine 15 mg', 'description': 'Participants received phentermine 15 mg over-encapsulated tablets orally for 26 weeks.'}, {'id': 'OG002', 'title': 'Canagliflozin 300 mg', 'description': 'Participants received canagliflozin 300 mg over-encapsulated tablets orally for 26 weeks.'}, {'id': 'OG003', 'title': 'Canagliflozin 300 mg/Phentermine 15 mg', 'description': 'Participants received co-administration of canagliflozin 300 mg and phentermine 15 mg orally for 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.9', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '-1.5', 'spread': '0.9', 'groupId': 'OG002'}, {'value': '-2.5', 'spread': '0.8', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 26', 'description': 'Change from baseline in diastolic blood pressure (DBP) at week 26.', 'unitOfMeasure': 'mmHg (millimeters of mercury)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The mITT analysis set included all randomized participants who received at least 1 dose of double-blind study agent. N=number of participants analysed is the total participants who were evaluable for this outcome measure.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in Pulse Rate at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo tablets orally for 26 weeks.'}, {'id': 'OG001', 'title': 'Phentermine 15 mg', 'description': 'Participants received phentermine 15 mg over-encapsulated tablets orally for 26 weeks.'}, {'id': 'OG002', 'title': 'Canagliflozin 300 mg', 'description': 'Participants received canagliflozin 300 mg over-encapsulated tablets orally for 26 weeks.'}, {'id': 'OG003', 'title': 'Canagliflozin 300 mg/Phentermine 15 mg', 'description': 'Participants received co-administration of canagliflozin 300 mg and phentermine 15 mg orally for 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.7', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '4.1', 'spread': '1.0', 'groupId': 'OG001'}, {'value': '0.7', 'spread': '1.0', 'groupId': 'OG002'}, {'value': '3.5', 'spread': '0.9', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 26', 'description': 'Change from baseline in pulse rate at week 26', 'unitOfMeasure': 'Beats Per Minute (Beats/Min)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The modified intent-to-treat (mITT) analysis set included all randomized participants who received at least 1 dose of double-blind study agent. N=number of participants analysed is the total participants who were evaluable for this outcome measure.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With Weight Loss More Than Equal to (>=) 10 Percent at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}, {'value': '83', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo tablets orally for 26 weeks.'}, {'id': 'OG001', 'title': 'Phentermine 15 mg', 'description': 'Participants received phentermine 15 mg over-encapsulated tablets orally for 26 weeks.'}, {'id': 'OG002', 'title': 'Canagliflozin 300 mg', 'description': 'Participants received canagliflozin 300 mg over-encapsulated tablets orally for 26 weeks.'}, {'id': 'OG003', 'title': 'Canagliflozin 300 mg/Phentermine 15 mg', 'description': 'Participants received co-administration 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'description': 'Participants received canagliflozin 300 mg over-encapsulated tablets orally for 26 weeks.'}, {'id': 'FG003', 'title': 'Canagliflozin 300 mg/Phentermine 15 mg', 'description': 'Participants received co-administration of canagliflozin 300 mg and phentermine 15 mg orally for 26 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '82'}, {'groupId': 'FG001', 'numSubjects': '85'}, {'groupId': 'FG002', 'numSubjects': '84'}, {'groupId': 'FG003', 'numSubjects': '84'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '82'}, {'groupId': 'FG001', 'numSubjects': '85'}, {'groupId': 'FG002', 'numSubjects': '84'}, {'groupId': 'FG003', 'numSubjects': '83'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '57'}, {'groupId': 'FG001', 'numSubjects': '60'}, {'groupId': 'FG002', 'numSubjects': '53'}, {'groupId': 'FG003', 'numSubjects': '61'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '31'}, {'groupId': 'FG003', 'numSubjects': '23'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '14'}, {'groupId': 'FG003', 'numSubjects': '11'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Randomized but not received treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'Between screening and randomisation, eligible subjects were included in a 4-week single-blind run-in period in which all subjects were placed on a hypocaloric diet.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'BG000'}, {'value': '85', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}, {'value': '83', 'groupId': 'BG003'}, {'value': '334', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Participants received placebo tablets orally for 26 weeks.'}, {'id': 'BG001', 'title': 'Phentermine 15 mg', 'description': 'Participants received phentermine 15 mg over-encapsulated tablets orally for 26 weeks.'}, {'id': 'BG002', 'title': 'Canagliflozin 300 mg', 'description': 'Participants received canagliflozin 300 mg over-encapsulated tablets orally for 26 weeks.'}, {'id': 'BG003', 'title': 'Canagliflozin 300 mg/Phentermine 15 mg', 'description': 'Participants received co-administration of canagliflozin 300 mg and phentermine 15 mg orally for 26 weeks.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44.8', 'spread': '11.09', 'groupId': 'BG000'}, {'value': '46.4', 'spread': '11.14', 'groupId': 'BG001'}, {'value': '45.2', 'spread': '11.02', 'groupId': 'BG002'}, {'value': '46.3', 'spread': '12.45', 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'BG003'}, {'value': '334', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Baseline Weight', 'classes': [{'categories': [{'measurements': [{'value': '104.3', 'spread': '18.16', 'groupId': 'BG000'}, {'value': '102.8', 'spread': '17.89', 'groupId': 'BG001'}, {'value': '103.3', 'spread': '19.14', 'groupId': 'BG002'}, {'value': '101.1', 'spread': '18.07', 'groupId': 'BG003'}, {'value': '102.9', 'spread': '18.28', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Kilogram [kg]', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '38', 'spread': '5.2', 'groupId': 'BG000'}, {'value': '37', 'spread': '5.4', 'groupId': 'BG001'}, {'value': '37.3', 'spread': '4.68', 'groupId': 'BG002'}, {'value': '36.8', 'spread': '5.36', 'groupId': 'BG003'}, {'value': '37.3', 'spread': '5.16', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilogram per meter square [kg/m²]', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline Systolic Blood Pressure', 'classes': [{'categories': [{'measurements': [{'value': '122.5', 'spread': '13.86', 'groupId': 'BG000'}, {'value': '123.0', 'spread': '11.83', 'groupId': 'BG001'}, {'value': '124.5', 'spread': '13.01', 'groupId': 'BG002'}, {'value': '124.8', 'spread': '12.83', 'groupId': 'BG003'}, {'value': '123.7', 'spread': '12.87', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'millimeters of mercury [mmHg]', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline Diastolic Blood Pressure', 'classes': [{'categories': [{'measurements': [{'value': '78.8', 'spread': '8.43', 'groupId': 'BG000'}, {'value': '78.1', 'spread': '9.00', 'groupId': 'BG001'}, {'value': '80.2', 'spread': '7.88', 'groupId': 'BG002'}, {'value': '79.4', 'spread': '8.21', 'groupId': 'BG003'}, {'value': '79.1', 'spread': '8.39', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'millimeters of mercury [mmHg]', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline Pulse Rate', 'classes': [{'categories': [{'measurements': [{'value': '73.5', 'spread': '8.72', 'groupId': 'BG000'}, {'value': '70.7', 'spread': '10.09', 'groupId': 'BG001'}, {'value': '71.5', 'spread': '9.40', 'groupId': 'BG002'}, {'value': '72.4', 'spread': '9.66', 'groupId': 'BG003'}, {'value': '72.0', 'spread': '9.50', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': '(BEATS/MIN)', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'The modified intent-to-treat (mITT) analysis set included all randomized participants who received at least 1 dose of double-blind study agent.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 335}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-10', 'studyFirstSubmitDate': '2014-09-16', 'resultsFirstSubmitDate': '2016-06-16', 'studyFirstSubmitQcDate': '2014-09-16', 'lastUpdatePostDateStruct': {'date': '2016-10-06', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-08-10', 'studyFirstPostDateStruct': {'date': '2014-09-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-10-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change From Baseline in Diastolic Blood Pressure (DBP) at Week 26', 'timeFrame': 'Week 26', 'description': 'Change from baseline in diastolic blood pressure (DBP) at week 26.'}, {'measure': 'Change From Baseline in Pulse Rate at Week 26', 'timeFrame': 'Week 26', 'description': 'Change from baseline in pulse rate at week 26'}, {'measure': 'Percentage of Participants With Weight Loss More Than Equal to (>=) 10 Percent at Week 26', 'timeFrame': 'Week 26', 'description': 'Percentage of participants with weight loss \\>= 10 percent at week 26.'}], 'primaryOutcomes': [{'measure': 'Percent Change From Baseline in Body Weight at Week 26', 'timeFrame': 'Week 26', 'description': 'The percent change from baseline in body weight at Week 26 was analysed.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Weight Loss More Than Equal to (>=) 5 Percent at Week 26', 'timeFrame': 'Week 26', 'description': 'Percentage of participants with weight loss \\>= 5 percent were analysed at week 26.'}, {'measure': 'Change From Baseline in Systolic Blood Pressure at Week 26', 'timeFrame': 'Week 26', 'description': 'Change from baseline in systolic blood pressure was analysed at week 26.'}, {'measure': 'Absolute Change From Baseline in Body Weight at Week 26', 'timeFrame': 'Week 26', 'description': 'Absolute change from baseline in body weight was analysed at week 26.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Obesity', 'Overweight', 'Canagliflozin', 'Phentermine', 'INVOKANA®'], 'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the effects of canagliflozin and phentermine to those of placebo to promote on a change in body weight over a 26 week period.', 'detailedDescription': 'This is a randomized (the study medication is assigned by chance), double-blind (neither physician nor participant knows the identity of the assigned treatment), placebo-controlled (an inactive substance that is compared with a medication to test whether the medication has a real effect), parallel-group, multicenter study of the effects of canagliflozin and phentermine co-administration in non-diabetic overweight or obese participants. The study will be conducted for about 33 weeks, approximately 344 participants will be randomly assigned in a 1:1:1:1 ratio to one of the four treatment groups: co-administration of canagliflozin and phentermine, canagliflozin alone, phentermine alone, or placebo. All participants will be also provided with diet and exercise counseling for weight loss (standardized non-pharmacological therapy).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Must have BMI \\>=30 kg/m2 and \\<50 kg/m2 at screening or BMI \\>=27 kg/m2 and \\<50 kg/m2 at screening in the presence of a comorbidity of hypertension and/or dyslipidemia\n* Must have stable weight, ie, change of \\< =5% in the 3 months before screening\n* Must agree to utilize a highly effective method of birth control\n\nExclusion Criteria:\n\n* An established diagnosis of diabetes mellitus\n* Has a history of obesity with a known secondary cause (eg, Cushing's disease/syndrome)\n* Has a history of hereditary glucose-galactose malabsorption or primary renal glycosuria\n* Myocardial infarction, unstable angina, revascularization procedure, or cerebrovascular accident within 12 weeks before screening\n* Has an Glycated hemoglobin (HBA1c) greater than or equal (\\>=) to 65 percent\n* An average of 3 seated blood pressure (BP) readings of systolic BP \\>= 160 mm Hg and/or Diastolic BP \\>= 100 millimeters of mercury at screening"}, 'identificationModule': {'nctId': 'NCT02243202', 'briefTitle': 'Effects of Co-administration of Canagliflozin 300 mg and Phentermine 15 mg With Placebo in the Treatment of Non-Diabetic Overweight and Obese Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Janssen Research & Development, LLC'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Investigate the Safety and Efficacy of the Co-administration of Canagliflozin 300 mg and Phentermine 15 mg Compared With Placebo for the Treatment of Non-diabetic Overweight and Obese Subjects', 'orgStudyIdInfo': {'id': 'CR103086'}, 'secondaryIdInfos': [{'id': '28431754OBE2002', 'type': 'OTHER', 'domain': 'Janssen Research & Development, LLC'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Canagliflozin + Phentermine', 'description': '300 mg capsule of Canagliflozin along with 15 mg capsule of Phentermine, taken once daily, orally for 26 weeks.', 'interventionNames': ['Drug: Canagliflozin', 'Drug: Phentermine']}, {'type': 'EXPERIMENTAL', 'label': 'Canagliflozin + Placebo (Phentermine)', 'description': '300 mg capsule of Canagliflozin along with matching placebo to Phentermine, taken once daily, orally for 26 weeks.', 'interventionNames': ['Drug: Canagliflozin', 'Drug: Matching Placebo to Phentermine']}, {'type': 'EXPERIMENTAL', 'label': 'Phentermine + Placebo (Canagliflozin)', 'description': '15 mg capsule of Phentermine along with matching placebo to Canagliflozin, taken once daily, orally for 26 weeks.', 'interventionNames': ['Drug: Phentermine', 'Drug: Matching Placebo to Canagliflozin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Matching placebo to Canagliflozin and Phentermine, taken once daily, orally for 26 weeks.', 'interventionNames': ['Drug: Matching Placebo to Canagliflozin', 'Drug: Matching Placebo to Phentermine']}], 'interventions': [{'name': 'Canagliflozin', 'type': 'DRUG', 'otherNames': ['INVOKANA'], 'description': '300 mg capsule, taken once daily, orally for 26 weeks.', 'armGroupLabels': ['Canagliflozin + Phentermine', 'Canagliflozin + Placebo (Phentermine)']}, {'name': 'Phentermine', 'type': 'DRUG', 'description': '15 mg capsule, taken once daily, orally for 26 weeks.', 'armGroupLabels': ['Canagliflozin + Phentermine', 'Phentermine + Placebo (Canagliflozin)']}, {'name': 'Matching Placebo to Canagliflozin', 'type': 'DRUG', 'description': 'Placebo capsules look like canagliflozin but do not contain any active drug, taken once daily, orally for 26 weeks.', 'armGroupLabels': ['Phentermine + Placebo (Canagliflozin)', 'Placebo']}, {'name': 'Matching Placebo to Phentermine', 'type': 'DRUG', 'description': 'Placebo capsules look like phentermine but do not contain any active drug, taken once daily, orally for 26 weeks.', 'armGroupLabels': ['Canagliflozin + Placebo (Phentermine)', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'city': 'Walnut Creek', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 37.90631, 'lon': -122.06496}}, {'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'city': 'Meridian', 'state': 'Idaho', 'country': 'United States', 'geoPoint': {'lat': 43.61211, 'lon': -116.39151}}, {'city': 'Evansville', 'state': 'Indiana', 'country': 'United States', 'geoPoint': {'lat': 37.97476, 'lon': -87.55585}}, {'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'city': 'Milford', 'state': 'Massachusetts', 'country': 'United States', 'geoPoint': {'lat': 42.13982, 'lon': -71.51617}}, {'city': 'Manlius', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 43.00201, 'lon': -75.97686}}, {'city': 'Warwick', 'state': 'Rhode Island', 'country': 'United States', 'geoPoint': {'lat': 41.7001, 'lon': -71.41617}}, {'city': 'Mt. Pleasant', 'state': 'South Carolina', 'country': 'United States', 'geoPoint': {'lat': 32.79407, 'lon': -79.86259}}, {'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'city': 'Odessa', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 31.84568, 'lon': -102.36764}}, {'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'city': 'Wauwatosa', 'state': 'Wisconsin', 'country': 'United States', 'geoPoint': {'lat': 43.04946, 'lon': -88.00759}}], 'overallOfficials': [{'name': 'Janssen Research & Development, LLC Clinical Trial', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Janssen Research & Development, LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Janssen Research & Development, LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}