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 @ 4:32 AM
Ignite Modification Date: 2025-12-26 @ 3:34 AM
NCT ID: NCT02660918
Description: Postoperative Infection
Frequency Threshold: 2
Time Frame: From recovery through post operative Day 1
Study: NCT02660918
Study Brief: Decreasing Postoperative Pain Following Endometrial Ablation
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Control Women undergoing endometrial ablation that meet the eligibility criteria will receive an equal volume standardized paracervical injection of Normal Saline at the completion of the procedure. Normal Saline: Equal volume injection of normal saline with the same paracervical technique 0 None 0 41 1 41 View
Treatment Women undergoing endometrial ablation that meet the eligibility criterial will receive a standardized paracervical injection of Bupivacaine 20 mL 0.25% at the completion of the procedure. Bupivacaine: Paracervical injection of 20 mL 0.25% Bupivacaine at the completion of the procedure 0 None 0 41 2 41 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Potsoperative Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View