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: 2025-12-25 @ 3:48 AM
Ignite Modification Date: 2025-12-26 @ 2:36 AM
NCT ID: NCT01090102
Description: None
Frequency Threshold: 1
Time Frame: 24 weeks
Study: NCT01090102
Study Brief: Mesalamine to Reduce T Cell Activation in HIV Infection
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Mesalamine Mesalamine (5-aminosalicylic acid, Apriso): Four mesalamine capsules once daily (1.5 gram/day) PO(by mouth). None None 1 31 2 31 View
Placebo Placebo: Four placebo capsules once daily (1.5g/d) PO (by mouth). None None 1 29 0 29 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Death NON_SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Liver Cirrhosis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Drug relapse NON_SYSTEMATIC_ASSESSMENT General disorders None View