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 @ 9:24 PM
Ignite Modification Date: 2025-12-25 @ 7:10 PM
NCT ID: NCT02035332
Description: None
Frequency Threshold: 0
Time Frame: 1 year
Study: NCT02035332
Study Brief: A Two-Phase Clinical Study of the Minerva AURORA Ablation System
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Aurora Treatment Arm Endometrial Ablation Aurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System None None 1 21 13 21 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Surgery for Heart Valve Replacement SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anesthesia Related SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Bleeding SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Pelvic Cramping (non-specific) SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Back pain-occasional in middle-back SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
pregnancy- empty sac SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Chest Pain SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Weakness SYSTEMATIC_ASSESSMENT General disorders None View