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 @ 12:53 PM
Ignite Modification Date: 2025-12-25 @ 12:17 PM
NCT ID: NCT00854061
Description: The safety population was comprised of participants who received study treatment and had at least one post-baseline safety assessment. Participants received both treatment groups, one in each eye. The treatment assigned to an eye (right or left) was randomly assigned.g
Frequency Threshold: 5
Time Frame: 35 days
Study: NCT00854061
Study Brief: Study of T-PRED(TM) Compared to Pred Forte(R) II
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
T-Pred None None None 1 162 0 162 View
Pred-Forte None None None 1 162 0 162 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
IOL dislocation NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 2.0 View
Vitritis NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 2.0 View
Other Events(If Any):