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 @ 1:33 PM
Ignite Modification Date: 2025-12-25 @ 12:33 PM
NCT ID: NCT03651895
Description: Adverse events were reviewed at every study visit.
Frequency Threshold: 0
Time Frame: 1 year
Study: NCT03651895
Study Brief: Metformin to Reduce Airway Glucose in COPD 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
Treatment Group Metformin 500mg/1g bd Metformin: The Drug was administered 500 mg twice daily for one week and increased to 1g twice daily for the reminder of the 3 months. 0 None 0 14 7 14 View
Placebo Group Placebo Placebo: The Drug was administered 500 mg twice daily for one week and increased to 1g twice daily for the reminder of the 3 months. 0 None 1 14 7 14 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Exacerbation of COPD with hospitalisation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal cramps SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Lower respiratory tract infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Procedural related adverse event SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View