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 @ 5:06 AM
Ignite Modification Date: 2025-12-26 @ 4:09 AM
NCT ID: NCT01743027
Description: An adverse event was defined as any untoward medical occurrence in a patient who was administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. Reports of AEs were obtained as solicited comments from the study patients and as observations by the study Investigator.
Frequency Threshold: 5
Time Frame: Adverse events (AEs) were collected for the duration of the study (6 months). This analysis population includes all participants who were exposed to investigational product for 1-2 instillation(s).
Study: NCT01743027
Study Brief: Efficacy and Safety of an Ophthalmic Solution in Patients With Allergic Conjunctivitis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Vehicle AL-4943A ophthalmic solution vehicle, 1 drop per eye Day 0, followed by 1 drop per eye Day 14 None None 0 49 0 49 View
AL-4943A AL-4943A ophthalmic solution, 1 drop per eye Day 0, followed by 1 drop per eye Day 14 None None 0 98 0 98 View
PATADAY Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14 None None 0 99 0 99 View
PATANOL Olopatadine hydrochloride ophthalmic solution, 0.1%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14 None None 0 99 0 99 View
Serious Events(If Any):
Other Events(If Any):