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 @ 11:15 PM
Ignite Modification Date: 2025-12-25 @ 8:52 PM
NCT ID: NCT03398356
Description: Other- important gastrointestinal side effects which did not allow the prescribed dose to be continued
Frequency Threshold: 0
Time Frame: 15 weeks
Study: NCT03398356
Study Brief: Metformin and Its Impact on the Substances Associated With NO Production in Prediabetes Patients.
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Group A metformin dose 3 x 500 mg Metformin: for group A: 12 weeks metformin treatment in a final dose 3 x 500 mg for group B: 3 weeks metformin treatment in a dose 3 x 500 mg, next: 3 weeks metformin treatment in a final dose 3 x 1000mg, next: 3 weeks metformin treatment in a dose 3 x 500 mg. 0 None 0 15 3 15 View
Group B metformin dose 3 x 1000 mg Metformin: for group A: 12 weeks metformin treatment in a final dose 3 x 500 mg for group B: 3 weeks metformin treatment in a dose 3 x 500 mg, next: 3 weeks metformin treatment in a final dose 3 x 1000mg, next: 3 weeks metformin treatment in a dose 3 x 500 mg. 0 None 0 21 2 21 View
Group C healthy volunteers, no intervention 0 None 0 11 0 11 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
drug intolerance SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View