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 @ 11:11 PM
Ignite Modification Date: 2025-12-25 @ 8:44 PM
NCT ID: NCT01697969
Description: At each visit, after the subject had the opportunity to spontaneously mention any problems, the investigator inquired about AEs by asking the standard questions, "Have you had any health problems since your last study visit? Have there been any changes in the medicines you take since your last study visit?"
Frequency Threshold: 5
Time Frame: Adverse events were collected for the duration of the study (October 11, 2012 to July 25, 2013). This analysis group includes all participants exposed to the test product.
Study: NCT01697969
Study Brief: Confocal Analysis of Corneal Structures of Symptomatic Allergic Conjunctivitis Patients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Overall Study Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop once daily in both eyes for 14 days None None 0 13 1 13 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Arthropod infestation SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View