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: 2025-12-24 @ 3:05 PM
Ignite Modification Date: 2025-12-25 @ 1:27 PM
NCT ID: NCT03176459
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.
Frequency Threshold: 5
Time Frame: Screening through postsurgical Day 14
Study: NCT03176459
Study Brief: Evaluate the Safety and Efficacy of EXPAREL When Administered Via Infiltration Into the TAP vs. Bupivacaine Alone in Subjects Undergoing Elective C-Sections
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Active Bupivacaine TAP Infiltration Receive 20 mL 0.25% bupivacaine expanded in volume with 40 mL normal saline for a total volume of 60 mL Bupivacaine: Bupivacaine Hydrochloride is indicated for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. 0 None 3 89 50 89 View
EXPAREL+Bupivacaine TAP Infiltration Receive a single 20-mL dose of EXPAREL 266 mg expanded in volume with 20 mL normal saline plus 20 mL 0.25% bupivacaine for a total volume of 60 mL. Exparel + Bupivacaine: EXPAREL is a local analgesic that utilizes bupivacaine in combination with the proven product delivery platform, DepoFoam®. 0 None 3 97 63 97 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cardiomyopathy SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v. 21.1 View
Abdominal wall hematoma SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v. 21.1 View
Panic attack SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA v. 21.1 View
Retained placenta or membranes SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA v. 21.1 View
Gestational hypertension SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA v. 21.1 View
Postpartum hemorrhage SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA v. 21.1 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA v. 21.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v. 21.1 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v. 21.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v. 21.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v. 21.1 View
pruritis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v. 21.1 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v. 21.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v. 21.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v. 21.1 View