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: 2025-12-24 @ 4:34 PM
Ignite Modification Date: 2025-12-25 @ 2:26 PM
NCT ID: NCT00908466
Description: None
Frequency Threshold: 0
Time Frame: 6 Months
Study: NCT00908466
Study Brief: Sirolimus as Therapeutic Approach to Uveitis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Subconjunctival Injection Will receive subconjunctival injections of sirolimus 1320 µg in the study eye on Days 0, 60, and 120. Sirolimus (rapamycin): Will receive subconjunctival injections of sirolimus 1320 µg in the study eye on Days 0, 60, and 120. None None 0 15 6 15 View
Intravitreal Injection Will receive intravitreal injections of sirolimus 352 µg in study eye on Days 0, 60, and 120. Sirolimus (rapamycin): Will receive intravitreal injections of sirolimus (rapamycin) 352 µg in study eye on Days 0, 60, and 120. None None 1 15 0 15 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Serious Ocular Adverse Event NON_SYSTEMATIC_ASSESSMENT Eye disorders Adverse Events View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Inflammation at the injection site NON_SYSTEMATIC_ASSESSMENT Eye disorders Adverse Events View