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 @ 3:04 AM
Ignite Modification Date: 2025-12-26 @ 1:43 AM
NCT ID: NCT03011333
Description: Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
Frequency Threshold: 5
Time Frame: 28 Days.
Study: NCT03011333
Study Brief: Phase 2B Upper Extremity Nerve Block Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Group 1: HTX-011 HTX-011 (bupivacaine/meloxicam), 60 mg/1.8 mg via nerve block 0 None 0 12 11 12 View
Group 2: HTX-011 HTX-011(bupivacaine/meloxicam), 120 mg/3.6 mg via nerve block 0 None 0 27 21 27 View
Group 3: HTX-011 HTX-011(bupivacaine/meloxicam), 240 mg/7.2 mg via nerve block 0 None 1 25 23 25 View
Group 4: HTX-011 HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg via nerve block 0 None 0 47 43 47 View
Group 5: HTX-011 HTX-011 (bupivacaine/meloxicam), 400 mg/ 12 mg via instillation 0 None 1 50 47 50 View
Group 6: Bupivacaine HCl Bupivacaine HCl without epinephrine, 50 mg via nerve block 0 None 2 41 33 41 View
Group 7: Saline Placebo Saline placebo via nerve block 0 None 0 41 35 41 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Abortion spontaneous SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA View
Breast haematoma SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 19.1 View
Device breakage SYSTEMATIC_ASSESSMENT Product Issues MedDRA 19.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.1 View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.1 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19.1 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Paraesthesia oral 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
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1 View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.1 View
Muscle twitching 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
Medical device site reaction SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.1 View
Catheter site inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.1 View