Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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: 2025-12-26 @ 10:16 PM
Ignite Modification Date: 2025-12-26 @ 10:16 PM
NCT ID: NCT04055012
Description: None
Frequency Threshold: 5
Time Frame: up to 15 months
Study: NCT04055012
Study Brief: Effects of Metformin on Low Back Pain
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
High Dose Metformin High Dose Metformin Group (n=100). Subjects will receive metformin and will be instructed to take 2 tabs per day (1,000mg) for the first week then increase to 3 tabs per day (1,500mg) for the remaining 6 months. Metformin: 500mg tabs of Metformin Extended Release 0 None 0 8 6 8 View
Low Dose Metformin Low Dose Metformin Group (n=100). Subjects will receive metformin and will be instructed to take 1 tab per day (1 metformin tab (500mg) for 6 months. Metformin: 500mg tabs of Metformin Extended Release 0 None 0 8 6 8 View
High Dose Placebo High Dose Placebo Group (n=50). Subjects will receive placebo and will be instructed to take 2 tabs per day for the first week then increase to 3 tabs per day for the remaining 6 months. Placebo: Placebo Tabs 0 None 0 2 2 2 View
Low Dose Placebo Low Dose Placebo Group (n=50). Subjects will receive placebo and will be instructed to take 1 placebo tab for 6 months. Placebo: Placebo Tabs 0 None 0 3 1 3 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abnormal Lab Value - Low Vitamin B12 NON_SYSTEMATIC_ASSESSMENT General disorders None View
Abnormal Lab Value - Elevated ESR NON_SYSTEMATIC_ASSESSMENT General disorders None View
Abnormal Lab Value - Low Alkaline Phosphatase NON_SYSTEMATIC_ASSESSMENT General disorders None View
Abnormal Lab Value - Hypoglycemia NON_SYSTEMATIC_ASSESSMENT General disorders None View
Abnormal Lab Value - Elevated CBC NON_SYSTEMATIC_ASSESSMENT General disorders None View
Abnormal Lab Value - Hypercalcemia NON_SYSTEMATIC_ASSESSMENT General disorders None View
Abnormal Lab Value - Elevated Potassium NON_SYSTEMATIC_ASSESSMENT General disorders None View
Low Iron NON_SYSTEMATIC_ASSESSMENT General disorders None View
Gastrointestinal Discomfort NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Acid Reflux NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gas NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal Cramping NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Upper Respiratory Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View