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 @ 12:21 PM
Ignite Modification Date: 2025-12-25 @ 12:03 PM
NCT ID: NCT02176161
Description: Adverse events were monitored on a monthly basis
Frequency Threshold: 0
Time Frame: 9 months
Study: NCT02176161
Study Brief: Metformin Prostate Cancer Adjuvant Trial
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Surgery - High Risk, Undetectable Prostate-specific Antigen (PSA) Metformin Hydrochloride Extended Release 750mg twice per day for 9 months. 0 None 0 18 5 18 View
Radiation - Rising PSA Metformin Hydrochloride Extended Release 750mg twice per day for 9 months. 0 None 0 15 0 15 View
Surgery - Rising PSA Metformin Hydrochloride Extended Release 750mg twice per day for 9 months. 0 None 0 26 1 26 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Tick Bite SYSTEMATIC_ASSESSMENT Infections and infestations None View
Left basal ganglia hemorrhage SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
right inguinal hernia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View