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 @ 10:08 PM
Ignite Modification Date: 2025-12-25 @ 7:44 PM
NCT ID: NCT02167035
Description: Site utilized a systematic assessment of adverse events on this trial. Adverse events (AEs) were assessed at each study visit outlined on the protocol. Subjects were instructed to contact site to report any AEs between study visits. Unscheduled visits were conducted to assess these reported AEs between study visits.
Frequency Threshold: 0
Time Frame: Adverse events were assessed from the time patients signed consent to their study exit, which was approximately 90 days for each patient.
Study: NCT02167035
Study Brief: Comparison of Combigan Two Times Daily (BID) Versus Simbrinza Three Times Daily (TID)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Combigan BID Combigan 0.2%/0.5% one drop BID Combigan BID 0 None 0 21 3 21 View
Simbrinza TID Simbrinza 1/0.2% one drop TID Simbrinza TID 0 None 0 22 3 22 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Ocular Adverse Events SYSTEMATIC_ASSESSMENT Eye disorders None View
Non-ocular Adverse Events SYSTEMATIC_ASSESSMENT General disorders None View