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 @ 2:41 PM
Ignite Modification Date: 2025-12-25 @ 1:12 PM
NCT ID: NCT02986659
Description: None
Frequency Threshold: 0
Time Frame: Baseline through week 24
Study: NCT02986659
Study Brief: Genomic Outcomes of Metformin
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Metformin Metformin dosing at 425, 850 and 1700 mg with GLUCOPHAGE® (metformin hydrochloride) Tablets. Treatment with metformin will be initiated at a dose of 425 mg (half pill) taken orally once a day at night for 7 days. After the week, the participant will be called to assess tolerance and will be asked to increase dose to one pill at night at a dose of 850 mg for one week. At the end of the second week, participants will be called again and if they tolerated the second dose, they will be asked to take two 850 mg pills, one in the morning and one at night, for a total dose of 1700 mg which is within the range of the usual effective dose of 1500 to 2000 mg/day for the remainder of the 3 months. 0 None 0 30 9 30 View
Placebo Placebo will be given for 3 months. 0 None 0 30 1 30 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Gastrointestinal--Nausea/Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Itching NON_SYSTEMATIC_ASSESSMENT General disorders None View
Palpitation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Ataxia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View