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 @ 2:00 AM
Ignite Modification Date: 2025-12-26 @ 12:23 AM
NCT ID: NCT03853694
Description: None
Frequency Threshold: 5
Time Frame: Adverse events and serious adverse events (SAEs) were recorded from the time the ICF was signed through Day 14.
Study: NCT03853694
Study Brief: Efficacy and Safety of EXPAREL Versus Standard of Care (SoC) in Subjects Undergoing Elective Cesarean Section
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 (Standard of Care Group) 150 mcg Duramorph® + postoperative multi-modal pain regimen. No EXPAREL TAP infiltration 150 mcg Duramorph + multi-modal pain regimen: Intrathecal injection of 150 mcg Duramorph + multi-modal pain regimen. 0 None 2 53 43 53 View
Group 2 (Duramorph + EXPAREL TAP) 50 mcg Duramorph + EXPAREL TAP infiltration + postoperative multi-modal pain regimen. 50 mcg Duramorph+ EXPAREL + multi-modal pain regimen: Intrathecal injection of 50 mcg Duramorph + EXPAREL administered via TAP infiltration + multi-modal pain regimen. 0 None 2 48 41 48 View
Group 3 (EXPAREL TAP) EXPAREL TAP infiltration + postoperative multi-modal pain regimen. No Duramorph. Exparel TAP + multi-modal pain regimen: EXPAREL administered via TAP infiltration + multi-modal pain regimen. 0 None 2 52 30 52 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Postpartum hemorrhage NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.1 View
Abdominal wall hematoma NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.1 View
Dyspnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Incision Site Pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.1 View
Pre-eclampsia NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA 21.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.1 View
Abdominal distention SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Incision site pruritus SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.1 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.1 View
Pruritus generalised SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.1 View