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 @ 11:13 PM
Ignite Modification Date: 2025-12-25 @ 8:48 PM
NCT ID: NCT02132169
Description: Throughout the visits, staff collected all Adverse Events reported, elicited or observed.
Frequency Threshold: 1
Time Frame: Adverse events were collected for the duration of the study. All subjects who received study medication were evaluable for the safety analysis.
Study: NCT02132169
Study Brief: A Multi-Center Study Evaluating the Safety of AC-170 0.24%
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
AC-170 0.24% 1 drop in each eye 2 times daily for up to 6 weeks AC-170 0.24% None None 1 341 65 341 View
AC-170 0% 1 drop in each eye 2 times daily for up to 6 weeks AC-170 0% None None 1 171 39 171 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Herpes zoster SYSTEMATIC_ASSESSMENT Infections and infestations None View
Anaphylactic shock SYSTEMATIC_ASSESSMENT Immune system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Conjunctival Hyperaemia SYSTEMATIC_ASSESSMENT Eye disorders None View
Ocular Hyperaemia SYSTEMATIC_ASSESSMENT Eye disorders None View
Vision Blurred SYSTEMATIC_ASSESSMENT Eye disorders None View
Dry eye SYSTEMATIC_ASSESSMENT Eye disorders None View
Visual acuity reduced SYSTEMATIC_ASSESSMENT Eye disorders None View
Eye discharge SYSTEMATIC_ASSESSMENT Eye disorders None View
Instillation Site Pain SYSTEMATIC_ASSESSMENT General disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View