Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-25 @ 12:04 AM
Ignite Modification Date: 2025-12-25 @ 10:02 PM
NCT ID: NCT02689258
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.
Frequency Threshold: 5
Time Frame: 28 Days.
Study: NCT02689258
Study Brief: Evaluation of the Efficacy and Safety of HTX-011 for Postoperative Analgesia Following Abdominoplasty Surgery
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Part A, Cohorts C Through F: HTX-011B 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. 0 None 0 48 42 48 View
Part B, Cohort A: HTX-002 HTX-002, 400 mg via combination. 0 None 0 17 13 17 View
Part C, Cohort A Through C: HTX-011B 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. 0 None 1 77 67 77 View
Part C, Cohort D: Bupivacaine HCI Bupivacaine HCl 100 mg via injection. 0 None 1 17 15 17 View
Part C, Cohort E: Saline Placebo Saline placebo via injection. 0 None 0 32 27 32 View
Part A, Cohort A: HTX-011A HTX- 011A (bupivacaine/meloxicam), 200 mg/6 mg via injection. 0 None 0 20 19 20 View
Parts A and B, Cohort B: Saline Placebo Saline placebo via injection. 0 None 0 63 50 63 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Wound dehiscence SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.1. View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19.1. View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.1. View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.1. View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.1. View
Throat irritation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.1. View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1. View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1. View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1. View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1. View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1. View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1. View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1. View
Pruritus generalised SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1. View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1. View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1. View
Skin irritation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1. View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.1. View
Flank pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.1. View
Groin pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.1. View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.1. View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.1. View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 19.1. View
Polyuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 19.1. View
Labia enlarged SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 19.1. View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.1. View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.1. View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.1. View
Gamma-glutamyltransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1. View
Hepatic enzyme increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1. View
Liver function test increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1. View
Wound dehiscence SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.1. View
Incision site erythema SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.1. View
Incision site hypoaesthesia SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.1. View
Incision site swelling SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.1. View
Seroma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.1. View
Wound complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.1. View
Wound secretion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.1. View
Restlessness SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.1. View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.1. View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1. View
Muscle tightness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.1. View
Peripheral swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.1. View
Swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.1. View
Postoperative wound complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.1. View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.1. View
Incision site pruritus SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.1. View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.1. View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.1. View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.1. View
Incision site infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1. View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.1. View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.1. View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1. View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1. View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1. View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1. View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1. View
Tinnitus SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 19.1. View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.1. View