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 @ 3:21 AM
Ignite Modification Date: 2025-12-26 @ 1:59 AM
NCT ID: NCT02517905
Description: An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. The safety analysis set included all subjects who received study drug, based on the treatment received.
Frequency Threshold: 2
Time Frame: From screening to postsurgical day 29
Study: NCT02517905
Study Brief: Evaluation of EXPAREL for Prolonged Postsurgical Analgesia in Subjects Undergoing Third Molar Extraction
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
EXPAREL 133 mg 10 mL EXPAREL (bupivacaine liposome injectable suspension) injected into the maxilla (4 mL; 2 mL per side) and mandible (6 mL; 3 mL per side) at the end of surgery and ≥20 min after lidocaine administration Bupivacaine liposome: Local administration 0 None 0 105 105 105 View
Placebo 10 mL normal saline injected into the maxilla (4 mL; 2 mL per side) and mandible (6 mL; 3 mL per side) at the end of surgery and ≥20 min after lidocaine administration Placebo: Local administration 0 None 0 57 57 57 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hypoesthesia oral SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 18.0 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 18.0 View
Muscle contractions involuntary SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 18.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 18.0 View
Paresthesia oral SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 18.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 18.0 View
Alveolar osteitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 18.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 18.0 View
Post procedural swelling SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 18.0 View
Muscle twitching SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version 18.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 18.0 View
Wound infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 18.0 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 18.0 View
Hot flush SYSTEMATIC_ASSESSMENT General disorders MedDRA version 18.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 18.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 18.0 View
Post procedural edema SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 18.0 View
Dermatitis contact SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA version 18.0 View
Blurred Vision SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 18.0 View