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 @ 10:52 PM
Ignite Modification Date: 2025-12-25 @ 8:21 PM
NCT ID: NCT01159769
Description: This reporting group includes all subjects who used the study medication at least once (intent to treat). Subjects were queried about any symptoms that would suggest an adverse event with, "Have you had any health problems since your last study visit?" and "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: 7 June 2010 to 7 August 2010.
Study: NCT01159769
Study Brief: Patient Perceptions and Quality of Life Associated With the Use of Olapatadine 0.2% for the Treatment of 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
Olopatadine 0.2% 1 drop self-administered in each eye once daily in the morning for 7 days None None 2 215 0 215 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Stomach pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (10.0) View
Colorectal cancer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (10.0) View
Other Events(If Any):