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 @ 9:48 PM
Ignite Modification Date: 2025-12-25 @ 7:27 PM
NCT ID: NCT03392532
Description: An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the protocol. This analysis population includes all subjects/eyes exposed to any study lenses evaluated.
Frequency Threshold: 0
Time Frame: Dispense through study completion, approximately 2 hours
Study: NCT03392532
Study Brief: Comparison of Two Silicone Hydrogel Toric Contact Lenses
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
AOHG Toric All subjects exposed to lotrafilcon B toric contact lenses with HYDRAGLYDE® in Period 1 or Period 2, as randomized 0 None 0 36 0 36 View
AO Toric All subjects exposed to lotrafilcon B toric contact lenses in Period 1 or Period 2, as randomized 0 None 0 36 0 36 View
Serious Events(If Any):
Other Events(If Any):