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: 2025-12-25 @ 12:06 AM
Ignite Modification Date: 2025-12-25 @ 10:05 PM
NCT ID: NCT01612858
Description: None
Frequency Threshold: 0
Time Frame: Adverse event data were collected for three months.
Study: NCT01612858
Study Brief: Metabolic Abnormalities in HIV-infected Persons
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: Metformin at a dose of one 500mg tablet twice a day with meals for one week, after which the dose will increase to 500 mg three times a day with meals for the remaining 11 weeks of the study. None None 7 16 4 16 View
Pioglitazone Pioglitazone: Pioglitazone at a dose of one 30 mg tablet once per day for the 12 weeks of the study. None None 0 4 1 4 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Colitis None Gastrointestinal disorders None View
Elevated serum creatinine None Renal and urinary disorders None View
Elevated lactic acid None Metabolism and nutrition disorders None View
Right upper quadrant abdominal pain None Gastrointestinal disorders None View
Head trauma accompanied by syncope None Nervous system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Bloating None Gastrointestinal disorders None View
diarrhea None Gastrointestinal disorders None View
vomiting None Gastrointestinal disorders None View
nausea None Gastrointestinal disorders None View
Baker's cyst None Musculoskeletal and connective tissue disorders None View
tooth pain None Infections and infestations None View