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 @ 9:32 PM
Ignite Modification Date: 2025-12-25 @ 7:17 PM
NCT ID: NCT03733132
Description: None
Frequency Threshold: 0
Time Frame: 9 months
Study: NCT03733132
Study Brief: Metformin Effect on Brain Function in Insulin Resistant Elderly People
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Participants in the placebo group received Placebo Oral Tablets identical to the metformin tablets for 10 months. Placebo Oral Tablet: Placebo treatment of identical tablets to metformin group 0 None 1 20 9 20 View
Metformin Participants in Metformin group received an escalating dose of Metformin hydrochloride tablets up to a dose of 2500mg for 10 months. Metformin Hydrochloride: Metformin treatment of 2500mg for 10 months in the Metformin group 0 None 0 20 12 20 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
COVID-19 infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Infections and infestations: Other SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pain SYSTEMATIC_ASSESSMENT General disorders None View
Gastroesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Social circumstances SYSTEMATIC_ASSESSMENT Social circumstances None View
Eye disorders SYSTEMATIC_ASSESSMENT Eye disorders None View
COVID-19 Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Nausea SYSTEMATIC_ASSESSMENT General disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Headache SYSTEMATIC_ASSESSMENT General disorders None View
Stroke SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Weight loss SYSTEMATIC_ASSESSMENT General disorders None View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hepatobiliary disorders SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View