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 @ 4:26 AM
Ignite Modification Date: 2025-12-26 @ 3:30 AM
NCT ID: NCT05227820
Description: None
Frequency Threshold: 0
Time Frame: Adverse event data were collected during the treatment period (day 1-90), and the follow up period (day 91-115)
Study: NCT05227820
Study Brief: Insulin-Sensitizing Anti-Inflammatory Small Molecule for Investigative Treatment of Dementia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Experimental Arm: NE3107 All participants will take 20mg BID (12 hours apart) of NE3107 for 3 months. NE3107: Participants will take 20mg twice daily (BID) approximately 12 hours apart. The dose will be stable the duration of the study intervention (3 months) 0 None 0 23 8 23 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dry Mouth SYSTEMATIC_ASSESSMENT General disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Elevated Lipase SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Dizziness SYSTEMATIC_ASSESSMENT General disorders None View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
COVID-19 Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Knee Injury SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View