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 @ 3:00 AM
Ignite Modification Date: 2025-12-26 @ 1:40 AM
NCT ID: NCT03896633
Description: One Brinzolamide participant did not receive treatment and is not included in the participant counts for safety. Two Brinzolamide participants received at least one dose of Azopt in error, and therefore the Azopt group has 2 additional participants for safety.
Frequency Threshold: 5
Time Frame: 6 weeks
Study: NCT03896633
Study Brief: Therapeutic Equivalence Study of Generic Brinzolamide vs Azopt
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Brinzolamide 1% Ophthalmic Suspension ophthalmic suspension brinzolamide 1% ophthalmic suspension: brinzolamide 1% ophthalmic suspension 0 None 0 320 15 320 View
Azopt 1% Ophthalmic Suspension Ophthalmic suspension Azopt 1%: Azopt 1%, RLD 0 None 2 318 22 318 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Abdominal pain upper NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Asthma NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dysgeusia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View