Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2026-02-02 @ 6:43 AM
Study NCT ID:
NCT02689258
Status:
COMPLETED
Last Update Posted:
2023-10-04
First Post:
2016-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of the Efficacy and Safety of HTX-011 for Postoperative Analgesia Following Abdominoplasty Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'cquaratino-baker@herontx.com', 'phone': '1-800-767-0524', 'title': 'Clinical Operations', 'organization': 'Heron Therapeutics, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '28 Days.', 'description': 'Study HTX-011-202 included multiple study parts, various study drugs, formulations, and administration techniques. It was pre-specified in the SAP to pool different doses of the same study drug within study parts for Participant Flow, Baseline Characteristics, and AEs. We pooled different doses of the same study drug within study parts for Participant Flow, Baseline Characteristics, and AEs. However for Outcome Measures, different doses of study drugs were presented separately.', 'eventGroups': [{'id': 'EG000', 'title': 'Part A, Cohort A: HTX-011A', 'description': 'HTX- 011A (bupivacaine/meloxicam), 200 mg/6 mg via injection.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 19, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Parts A and B, Cohort B: Saline Placebo', 'description': 'Saline placebo via injection.', 'otherNumAtRisk': 63, 'deathsNumAtRisk': 63, 'otherNumAffected': 50, 'seriousNumAtRisk': 63, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Part A, Cohorts C Through F: HTX-011B', 'description': 'Cohort C: HTX- 011B (bupivacaine/meloxicam), 200 mg/6 mg via injection; Cohort D: HTX- 011B (bupivacaine/meloxicam), 400 mg/12 mg via injection; Cohort E: HTX- 011B (bupivacaine/meloxicam), 400 mg/12 mg via combination; Cohort F: HTX- 011B (bupivacaine/meloxicam), 600 mg/18 mg via injection.', 'otherNumAtRisk': 48, 'deathsNumAtRisk': 48, 'otherNumAffected': 42, 'seriousNumAtRisk': 48, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Part B, Cohort A: HTX-002', 'description': 'HTX-002, 400 mg via combination.', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 13, 'seriousNumAtRisk': 17, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Part C, Cohort A Through C: HTX-011B', 'description': 'Cohort A: HTX-011B (bupivacaine/meloxicam), 400 mg/12 mg via instillation; Cohort B: HTX-011B (bupivacaine/meloxicam), 400 mg/12 mg via combination; Cohort C: HTX-011B (bupivacaine/meloxicam), 300 mg/9 mg via combination.', 'otherNumAtRisk': 77, 'deathsNumAtRisk': 77, 'otherNumAffected': 67, 'seriousNumAtRisk': 77, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG005', 'title': 'Part C, Cohort D: Bupivacaine HCI', 'description': 'Bupivacaine HCl 100 mg via injection.', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 15, 'seriousNumAtRisk': 17, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG006', 'title': 'Part C, Cohort E: Saline Placebo', 'description': 'Saline placebo via injection.', 'otherNumAtRisk': 32, 'deathsNumAtRisk': 32, 'otherNumAffected': 27, 'seriousNumAtRisk': 32, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Incision site infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 77, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1.'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1.'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 77, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1.'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 77, 'numAffected': 16}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 11}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1.'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 77, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1.'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 77, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1.'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 77, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1.'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1.'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 77, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1.'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 77, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1.'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 77, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1.'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 77, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1.'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1.'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1.'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1.'}, {'term': 'Throat irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1.'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 37}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 22}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 77, 'numAffected': 46}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 12}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1.'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 77, 'numAffected': 24}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 7}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1.'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 77, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1.'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1.'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 77, 'numAffected': 12}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1.'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 77, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1.'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 77, 'numAffected': 9}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1.'}, {'term': 'Pruritus generalised', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 77, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1.'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 77, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1.'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 77, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1.'}, {'term': 'Skin irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1.'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 77, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1.'}, {'term': 'Flank pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1.'}, {'term': 'Groin pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1.'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1.'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1.'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 77, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1.'}, {'term': 'Polyuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1.'}, {'term': 'Labia enlarged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1.'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1.'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 77, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1.'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 77, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1.'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1.'}, {'term': 'Hepatic enzyme increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1.'}, {'term': 'Liver function test increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1.'}, {'term': 'Wound dehiscence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 77, 'numAffected': 10}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1.'}, {'term': 'Incision site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 77, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1.'}, {'term': 'Incision site hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1.'}, {'term': 'Incision site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1.'}, {'term': 'Seroma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 77, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1.'}, {'term': 'Wound complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 77, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1.'}, {'term': 'Wound secretion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 77, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1.'}, {'term': 'Restlessness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1.'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 77, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1.'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1.'}, {'term': 'Muscle tightness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1.'}, {'term': 'Peripheral swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1.'}, {'term': 'Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1.'}, {'term': 'Postoperative wound complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 77, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1.'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1.'}, {'term': 'Incision site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1.'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1.'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1.'}], 'seriousEvents': [{'term': 'Wound dehiscence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 77, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1.'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Summed Pain Intensity Scores Collected Over 24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A, Cohort A: HTX-011A', 'description': 'HTX- 011A (bupivacaine/meloxicam), 200 mg/6 mg via injection.'}, {'id': 'OG001', 'title': 'Parts A and B, Cohort B: Saline Placebo', 'description': 'Saline placebo via injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '92.60', 'spread': '47.531', 'groupId': 'OG000'}, {'value': '96.16', 'spread': '43.775', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours', 'description': 'The SPI is derived by summing the pain intensity score weighted by the scheduled time duration. SPI0-24 will be calculated by summing the Pain intensity (PI) score at the relevant time points weighted by the scheduled time duration since the prior PI assessment as follows: SPI0-24= PI1+PI2+2\\*PI4+2\\*PI6+2\\*PI8+2\\*PI10+2\\*PI12+2\\*PI14+4\\*PI18+6\\*PI24. Min = 0 (if PI=0 at every time) and Max = 240 (if PI=10 at every time).', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population.'}, {'type': 'PRIMARY', 'title': 'Summed Pain Intensity Scores Collected Over 24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A, Cohort C: HTX-011B', 'description': 'HTX- 011B (bupivacaine/meloxicam), 200 mg/6 mg via injection.'}, {'id': 'OG001', 'title': 'Part A, Cohort D: HTX-011B', 'description': 'HTX- 011B (bupivacaine/meloxicam), 400 mg/12 mg via injection.'}, {'id': 'OG002', 'title': 'Part A, Cohort E: HTX-011B', 'description': 'HTX- 011B (bupivacaine/meloxicam), 400 mg/12 mg via combination.'}, {'id': 'OG003', 'title': 'Part A, Cohort F: HTX-011B', 'description': 'HTX- 011B (bupivacaine/meloxicam), 600 mg/18 mg via injection.'}, {'id': 'OG004', 'title': 'Part B, Cohort A: HTX-002', 'description': 'HTX-002, 400 mg via combination.'}], 'classes': [{'categories': [{'measurements': [{'value': '79.53', 'spread': '40.458', 'groupId': 'OG000'}, {'value': '74.64', 'spread': '46.893', 'groupId': 'OG001'}, {'value': '66.38', 'spread': '53.214', 'groupId': 'OG002'}, {'value': '89.46', 'spread': '45.402', 'groupId': 'OG003'}, {'value': '83.85', 'spread': '37.326', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 Hours', 'description': 'The SPI is derived by summing the pain intensity score weighted by the scheduled time duration. SPI0-24 will be calculated by summing the Pain intensity (PI) score at the relevant time points weighted by the scheduled time duration since the prior PI assessment as follows: SPI0-24= PI1+PI2+2\\*PI4+2\\*PI6+2\\*PI8+2\\*PI10+2\\*PI12+2\\*PI14+4\\*PI18+6\\*PI24. Min = 0 (if PI=0 at every time) and Max = 240 (if PI=10 at every time).', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population.'}, {'type': 'PRIMARY', 'title': 'Summed Pain Intensity Scores Collected Over 24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '32', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part C, Cohort A: HTX-011B', 'description': 'HTX-011B (bupivacaine/meloxicam), 400 mg/12 mg via instillation.'}, {'id': 'OG001', 'title': 'Part C, Cohort B: HTX-011B', 'description': 'HTX-011B (bupivacaine/meloxicam), 400 mg/12 mg via combination.'}, {'id': 'OG002', 'title': 'Part C, Cohort C: HTX-011B', 'description': 'HTX-011B (bupivacaine/meloxicam), 300 mg/9 mg via combination.'}, {'id': 'OG003', 'title': 'Part C, Cohort D: Bupivacaine HCI', 'description': 'Bupivacaine HCl 100 mg via injection.'}, {'id': 'OG004', 'title': 'Part C, Cohort E: Saline Placebo', 'description': 'Saline placebo via injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '113.72', 'spread': '49.109', 'groupId': 'OG000'}, {'value': '83.23', 'spread': '43.966', 'groupId': 'OG001'}, {'value': '104.65', 'spread': '44.140', 'groupId': 'OG002'}, {'value': '110.22', 'spread': '41.980', 'groupId': 'OG003'}, {'value': '121.93', 'spread': '52.530', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 Hours', 'description': 'The SPI is derived by summing the pain intensity score weighted by the scheduled time duration. SPI0-24 will be calculated by summing the Pain intensity (PI) score at the relevant time points weighted by the scheduled time duration since the prior PI assessment as follows: SPI0-24= PI1+PI2+2\\*PI4+2\\*PI6+2\\*PI8+2\\*PI10+2\\*PI12+2\\*PI14+4\\*PI18+6\\*PI24. Min = 0 (if PI=0 at every time) and Max = 240 (if PI=10 at every time).', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Part A, Cohort A: HTX-011A', 'description': 'HTX- 011A (bupivacaine/meloxicam), 200 mg/6 mg via injection.'}, {'id': 'FG001', 'title': 'Parts A and B, Cohort B: Saline Placebo', 'description': 'Saline placebo via injection.'}, {'id': 'FG002', 'title': 'Part A, Cohort C: HTX-011B', 'description': 'HTX- 011B (bupivacaine/meloxicam), 200 mg/6 mg via injection.'}, {'id': 'FG003', 'title': 'Part A, Cohort D: HTX-011B', 'description': 'HTX- 011B (bupivacaine/meloxicam), 400 mg/12 mg via injection.'}, {'id': 'FG004', 'title': 'Part A, Cohort E: HTX-011B', 'description': 'HTX- 011B (bupivacaine/meloxicam), 400 mg/12 mg via combination.'}, {'id': 'FG005', 'title': 'Part A, Cohort F: HTX-011B', 'description': 'HTX- 011B (bupivacaine/meloxicam), 600 mg/18 mg via injection.'}, {'id': 'FG006', 'title': 'Part B, Cohort A: HTX-002', 'description': 'HTX-002, 400 mg via combination.'}, {'id': 'FG007', 'title': 'Part C, Cohort A: HTX-011B', 'description': 'HTX-011B (bupivacaine/meloxicam), 400 mg/12 mg via instillation.'}, {'id': 'FG008', 'title': 'Part C, Cohort B: HTX-011B', 'description': 'HTX-011B (bupivacaine/meloxicam), 400 mg/12 mg via combination.'}, {'id': 'FG009', 'title': 'Part C, Cohort C: HTX-011B', 'description': 'HTX-011B (bupivacaine/meloxicam), 300 mg/9 mg via combination.'}, {'id': 'FG010', 'title': 'Part C, Cohort D: Bupivacaine HCI', 'description': 'Bupivacaine HCl 100 mg via injection.'}, {'id': 'FG011', 'title': 'Part C, Cohort E: Saline Placebo', 'description': 'Saline placebo via injection.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '63'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '11'}, {'groupId': 'FG004', 'numSubjects': '17'}, {'groupId': 'FG005', 'numSubjects': '10'}, {'groupId': 'FG006', 'numSubjects': '17'}, {'groupId': 'FG007', 'numSubjects': '17'}, {'groupId': 'FG008', 'numSubjects': '27'}, {'groupId': 'FG009', 'numSubjects': '35'}, {'groupId': 'FG010', 'numSubjects': '17'}, {'groupId': 'FG011', 'numSubjects': '32'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '59'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '11'}, {'groupId': 'FG004', 'numSubjects': '16'}, {'groupId': 'FG005', 'numSubjects': '10'}, {'groupId': 'FG006', 'numSubjects': '17'}, {'groupId': 'FG007', 'numSubjects': '17'}, {'groupId': 'FG008', 'numSubjects': '25'}, {'groupId': 'FG009', 'numSubjects': '35'}, {'groupId': 'FG010', 'numSubjects': '17'}, {'groupId': 'FG011', 'numSubjects': '31'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '2'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Subject Non-Compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'type': 'Subject Refusal to Continue', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': '1 Subject underwent complete abdominoplasty and was unintentionally randomized to receive HTX-002 (intended for mini-abdominoplasty procedure only). This subject is included in the Safety, ITT, and mITT Populations.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '77', 'groupId': 'BG004'}, {'value': '17', 'groupId': 'BG005'}, {'value': '32', 'groupId': 'BG006'}, {'value': '274', 'groupId': 'BG007'}]}], 'groups': [{'id': 'BG000', 'title': 'Part A, Cohort A: HTX-011A', 'description': 'HTX- 011A (bupivacaine/meloxicam), 200 mg/6 mg via injection.'}, {'id': 'BG001', 'title': 'Parts A and B, Cohort B: Saline Placebo', 'description': 'Saline placebo via injection.'}, {'id': 'BG002', 'title': 'Part A, Cohorts C Through F: HTX-011B', 'description': 'Cohort C: HTX- 011B (bupivacaine/meloxicam), 200 mg/6 mg via injection; Cohort D: HTX- 011B (bupivacaine/meloxicam), 400 mg/12 mg via injection; Cohort E: HTX- 011B (bupivacaine/meloxicam), 400 mg/12 mg via combination; Cohort F: HTX- 011B (bupivacaine/meloxicam), 600 mg/18 mg via injection.'}, {'id': 'BG003', 'title': 'Part B, Cohort A: HTX-002', 'description': 'HTX-002, 400 mg via combination.'}, {'id': 'BG004', 'title': 'Part C, Cohort A Through C: HTX-011B', 'description': 'Cohort A: HTX-011B (bupivacaine/meloxicam), 400 mg/12 mg via instillation; Cohort B: HTX-011B (bupivacaine/meloxicam), 400 mg/12 mg via combination; Cohort C: HTX-011B (bupivacaine/meloxicam), 300 mg/9 mg via combination.'}, {'id': 'BG005', 'title': 'Part C, Cohort D: Bupivacaine HCI', 'description': 'Bupivacaine HCl 100 mg via injection.'}, {'id': 'BG006', 'title': 'Part C, Cohort E: Saline Placebo', 'description': 'Saline placebo via injection.'}, {'id': 'BG007', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40.3', 'spread': '10.11', 'groupId': 'BG000'}, {'value': '43.3', 'spread': '10.56', 'groupId': 'BG001'}, {'value': '41.0', 'spread': '9.66', 'groupId': 'BG002'}, {'value': '47.3', 'spread': '9.77', 'groupId': 'BG003'}, {'value': '39.9', 'spread': '9.44', 'groupId': 'BG004'}, {'value': '40.6', 'spread': '6.38', 'groupId': 'BG005'}, {'value': '43.2', 'spread': '8.53', 'groupId': 'BG006'}, {'value': '41.8', 'spread': '9.67', 'groupId': 'BG007'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '77', 'groupId': 'BG004'}, {'value': '17', 'groupId': 'BG005'}, {'value': '32', 'groupId': 'BG006'}, {'value': '272', 'groupId': 'BG007'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '11', 'groupId': 'BG007'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}]}, {'title': 'Black or African American', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '9', 'groupId': 'BG006'}, {'value': '64', 'groupId': 'BG007'}]}, {'title': 'White', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '57', 'groupId': 'BG004'}, {'value': '13', 'groupId': 'BG005'}, {'value': '23', 'groupId': 'BG006'}, {'value': '194', 'groupId': 'BG007'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '77', 'groupId': 'BG004'}, {'value': '17', 'groupId': 'BG005'}, {'value': '32', 'groupId': 'BG006'}, {'value': '274', 'groupId': 'BG007'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Study HTX-011-203 included multiple study parts, various study drugs, formulations, and administration techniques. It was pre-specified in the SAP to pool different doses of the same study drug within study parts for Participant Flow, Baseline Characteristics, and AEs. We pooled different doses of the same study drug within study parts for Participant Flow, Baseline Characteristics, and AEs. However for Outcome Measures, different doses of study drugs were presented separately.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-02-06', 'size': 1050150, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-06-14T11:05', 'hasProtocol': True}, {'date': '2017-08-23', 'size': 992357, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-06-14T11:08', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 277}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'dispFirstSubmitDate': '2018-06-08', 'completionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-13', 'studyFirstSubmitDate': '2016-02-16', 'dispFirstSubmitQcDate': '2018-06-08', 'resultsFirstSubmitDate': '2021-06-11', 'studyFirstSubmitQcDate': '2016-02-22', 'dispFirstPostDateStruct': {'date': '2018-06-12', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2023-10-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-09-13', 'studyFirstPostDateStruct': {'date': '2016-02-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-10-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Summed Pain Intensity Scores Collected Over 24 Hours', 'timeFrame': '24 hours', 'description': 'The SPI is derived by summing the pain intensity score weighted by the scheduled time duration. SPI0-24 will be calculated by summing the Pain intensity (PI) score at the relevant time points weighted by the scheduled time duration since the prior PI assessment as follows: SPI0-24= PI1+PI2+2\\*PI4+2\\*PI6+2\\*PI8+2\\*PI10+2\\*PI12+2\\*PI14+4\\*PI18+6\\*PI24. Min = 0 (if PI=0 at every time) and Max = 240 (if PI=10 at every time).'}]}, 'conditionsModule': {'conditions': ['Postoperative Pain']}, 'descriptionModule': {'briefSummary': 'A Phase 2, Randomized, Controlled Evaluation of the Efficacy and Safety of HTX-011 or HTX-002 for Post-Operative Analgesia Following Abdominoplasty Surgery', 'detailedDescription': 'This study includes multiple formulations for formulation selection of the fixed-combination product and for the factorial design assessment of the contribution of the bupivacaine component. HTX-011A is the second formulation studied (HTX-011-49). HTX-011B is the final formulation studied (HTX-011-56), which was also included in subsequent Phase 2b and Phase 3 studies. For the factorial design assessment, HTX-002, a bupivacaine-only formulation in the same HTX-011 proprietary polymer was evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nSubjects must meet all of the following criteria to be considered eligible to participate in the study:\n\n1. Be scheduled to undergo abdominoplasty surgery that is amenable to treatment with a long acting local anesthetic as per the anesthesia protocol\n2. Be American Society of Anesthesiology (ASA) physical Class I or II\n3. Subjects 18 years of age or older\n4. Have clinical laboratory values that are within normal limits (WNL); subjects with AST/ALT \\< 3 x ULN, and/or creatinine \\< 2 x ULN are acceptable.\n5. Have a body mass index ≤ 30 kg/m2\n6. Female subjects are eligible only if all of the following apply:\n\n * Not pregnant (female subject of child bearing potential must have a negative serum pregnancy tests at screening and negative urine pregnancy test before surgery)\n * Not lactating\n * Not planning to become pregnant during the study\n * Be surgically sterile; or at least two years post-menopausal; or have a monogamous partner who is surgically sterile; or is practicing double-barrier contraception; or practicing abstinence (must agree to use double-barrier contraception in the event of sexual activity); or using an insertable, injectable, transdermal, or combination oral contraceptive approved by the FDA for greater than 2 months prior to screening visits and commits to the use of an acceptable form of birth control for the duration of the study\n7. Male subjects must be surgically sterile (biologically or surgically) or commit to the use of a reliable method of birth control for the duration of the study\n8. Does NOT have, as determined by the investigator or the study's medical monitor, a history or clinical manifestations of significant renal, hepatic, cardiovascular, metabolic, neurologic, psychiatric, or other condition that would preclude participation in the study\n9. Must be able to understand study procedures and be willing to comply and give informed consent for the conduct of all study procedures, using an IRB approved consent\n\nExclusion Criteria:\n\nSubjects who meet any of the following criteria will be excluded from participating in the study:\n\n1. Have a contraindication or be allergic to any medication to be used during the trial period\n2. Have another painful physical condition that, in the opinion of the investigator, may confound the assessments of post-operative pain\n3. Have a history of migraine or frequent headaches, seizures, or are currently taking anticonvulsants\n4. Currently taking analgesics for a chronically painful condition, or has taken long acting opioids within 3 days of surgery, or taken any opioids within 24 hours of surgery\n5. Previous abdominal surgery, as determined by the investigator, that would preclude participation in the study\n6. Subjects that require liposuction as part of the abdominoplasty procedure in Part A of the protocol\n7. Subjects that are to have ancillary procedures performed during the abdominoplasty surgery that are unrelated to the abdominal area (breast reduction, breast augmentation, etc.)\n8. Subjects unable to discontinue medications that have not been at a stable dose for at least 14 days prior to the scheduled abdominoplasty procedure and before dosing with investigational product\n9. Subjects taking the following medications; anticonvulsants, sedatives (including benzodiazepines) corticosteroids (by any means of administration), nonsteroidal anti-inflammatory drugs (NSAIDS) within 24 hours of study drug dosing, morphine, monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants (TCAs), neuroleptics, or serotonin-norepinephrine reuptake inhibitors (SNRIs). Gabapentin and pregabalin are not permitted\n10. Have a known or suspected history of alcohol or drug abuse\n11. Have positive results on the alcohol breath test indicative of alcohol abuse or urine drug screen indicative of illicit drug use (unless results can be explained by a current prescription or acceptable over-the-counter medication at screening as determined by the investigator). The urine drug screen prior to surgery must be negative\n12. Have evidence of a clinically significant 12-lead ECG abnormality according to the judgment of the investigator\n13. Have received any investigational product within 30 days before start of study\n14. Have previously received HTX-011 in clinical trials\n15. Experiences a clinically significant event during surgery prior to the administration of the investigational product (e.g., excessive bleeding, hemodynamic instability) that would render the subject medically unstable, complicate their post-surgical course, or significantly increase the risk of study drug administration as per the judgment of the investigator. This will result in the subject being reported as randomized, not treated.\n16. Subjects with sleep apnea or are on home continuous positive airway pressure (CPAP)\n17. Subjects who are receiving oxygen therapy at the time of screening"}, 'identificationModule': {'nctId': 'NCT02689258', 'briefTitle': 'Evaluation of the Efficacy and Safety of HTX-011 for Postoperative Analgesia Following Abdominoplasty Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': 'Heron Therapeutics'}, 'officialTitle': 'A Phase 2, Randomized, Controlled Evaluation of the Efficacy and Safety of HTX-011 or HTX-002 for Post-Operative Analgesia Following Abdominoplasty Surgery', 'orgStudyIdInfo': {'id': 'HTX-011-C2015-203'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part A, Cohort A: HTX-011A', 'description': 'HTX- 011A (bupivacaine/meloxicam), 200 mg/6 mg via injection', 'interventionNames': ['Drug: HTX-011A']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Parts A and B, Cohort B: Saline Placebo', 'description': 'Saline placebo via injection', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part A, Cohort C: HTX-011B', 'description': 'HTX- 011B (bupivacaine/meloxicam), 200 mg/6 mg via injection', 'interventionNames': ['Drug: HTX-011B']}, {'type': 'EXPERIMENTAL', 'label': 'Part A, Cohort D: HTX-011B', 'description': 'HTX- 011B (bupivacaine/meloxicam), 400 mg/12 mg via injection', 'interventionNames': ['Drug: HTX-011B']}, {'type': 'EXPERIMENTAL', 'label': 'Part A, Cohort E: HTX-011B', 'description': 'HTX- 011B (bupivacaine/meloxicam), 400 mg/12 mg via combination', 'interventionNames': ['Drug: HTX-011B']}, {'type': 'EXPERIMENTAL', 'label': 'Part A, Cohort F: HTX-011B', 'description': 'HTX- 011B (bupivacaine/meloxicam), 600 mg/18 mg via injection', 'interventionNames': ['Drug: HTX-011B']}, {'type': 'EXPERIMENTAL', 'label': 'Part B, Cohort A: HTX-002', 'description': 'HTX-002, 400 mg via combination', 'interventionNames': ['Drug: HTX-002']}, {'type': 'EXPERIMENTAL', 'label': 'Part C, Cohort A: HTX-011B', 'description': 'HTX-011B (bupivacaine/meloxicam), 400 mg/12 mg via instillation', 'interventionNames': ['Drug: HTX-011B']}, {'type': 'EXPERIMENTAL', 'label': 'Part C, Cohort B: HTX-011B', 'description': 'HTX-011B (bupivacaine/meloxicam), 400 mg/12 mg via combination', 'interventionNames': ['Drug: HTX-011B']}, {'type': 'EXPERIMENTAL', 'label': 'Part C, Cohort C: HTX-011B', 'description': 'HTX-011B (bupivacaine/meloxicam), 300 mg/9 mg via combination', 'interventionNames': ['Drug: HTX-011B']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Part C, Cohort D: Bupivacaine HCI', 'description': 'Bupivacaine HCl, 100 mg via injection', 'interventionNames': ['Drug: Bupivicaine HCl']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part C, Cohort E: Saline Placebo', 'description': 'Saline placebo via injection', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'HTX-011B', 'type': 'DRUG', 'description': 'HTX- 011B (bupivacaine/meloxicam) via injection', 'armGroupLabels': ['Part A, Cohort C: HTX-011B', 'Part A, Cohort D: HTX-011B', 'Part A, Cohort E: HTX-011B', 'Part A, Cohort F: HTX-011B', 'Part C, Cohort A: HTX-011B', 'Part C, Cohort B: HTX-011B', 'Part C, Cohort C: HTX-011B']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Saline placebo via injection', 'armGroupLabels': ['Part C, Cohort E: Saline Placebo', 'Parts A and B, Cohort B: Saline Placebo']}, {'name': 'HTX-011A', 'type': 'DRUG', 'description': 'HTX- 011A (bupivacaine/meloxicam) via injection', 'armGroupLabels': ['Part A, Cohort A: HTX-011A']}, {'name': 'HTX-002', 'type': 'DRUG', 'description': 'HTX-002 via combination', 'armGroupLabels': ['Part B, Cohort A: HTX-002']}, {'name': 'Bupivicaine HCl', 'type': 'DRUG', 'description': 'Bupivacaine HCl via injection', 'armGroupLabels': ['Part C, Cohort D: Bupivacaine HCI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85023', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '91105', 'city': 'Pasadena', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.14778, 'lon': -118.14452}}, {'zip': '21122', 'city': 'Pasadena', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 39.119, 'lon': -76.57108}}, {'zip': '77401', 'city': 'Bellaire', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.70579, 'lon': -95.45883}}, {'zip': '77004', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77019', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77027', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '75093', 'city': 'Plano', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 33.01984, 'lon': -96.69889}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heron Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}