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 @ 2:15 AM
Ignite Modification Date: 2025-12-26 @ 12:44 AM
NCT ID: NCT00399360
Description: safety visits occurred at 1, 3, 6, and 9 months during which time ALT, creatinine, lactate level and CBC were checked
Frequency Threshold: 0
Time Frame: 12 months
Study: NCT00399360
Study Brief: Lifestyle Modification and Metformin Use in the Treatment of HIV
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
No Lifestyle Modification and Placebo Participants did not participate in lifestyle modification and took a placebo capsule 500mg twice daily x 3 months, which was increased to 850mg twice daily at the 3 month visit for the duration of the study. None None 0 11 0 11 View
Lifestyle Modification and Placebo Participants participated in lifestyle modification sessions 3 times a week for the duration of the study and took a placebo capsule 500mg twice daily for 3 months which was increased to 850mg twice daily at the 3 month visit for the duration of the study. None None 0 11 2 11 View
No Lifestyle Modification and Metformin Participants did not participate in lifestyle modification and took metformin 500mg twice daily for 3 months, this was increased to 850mg twice daily at the 3 month visit for the duration of the study. None None 0 13 3 13 View
Lifestyle Modification and Metformin Participants participated in lifestyle modification sessions 3 times a week for the duration of the study and took metformin 500mg twice daily for 3 months which was increased to 850mg twice daily at the 3 month visit for the duration of the study. None None 0 15 5 15 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (10.0) View
Muscle strain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (10.0) View
elevated creatinine SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (10.0) View