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 @ 2:56 AM
Ignite Modification Date: 2025-12-26 @ 1:36 AM
NCT ID: NCT01635933
Description: The analysis population includes all participants exposed to the study product. An AE is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings), whether or not related to the investigational medical device.
Frequency Threshold: 5
Time Frame: Adverse Events (AE) were collected for the duration of the study (3 months). AEs were obtained as solicited comments from subjects and as observations by the study Investigator as outlined in the study protocol.
Study: NCT01635933
Study Brief: A Comparison of AIR OPTIX® COLORS Versus FRESHLOOK® COLORBLENDS
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
FRESHLOOK® COLORBLENDS Phemfilcon A contact lens with color worn in daily wear modality for 4 weeks, with a replacement pair dispensed at 14 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day. None None 2 185 0 185 View
AIR OPTIX® COLORS Lotrafilcon B contact lens with color worn in daily wear modality for 4 weeks. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day. None None 1 178 0 178 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Corneal abrasion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (15.0) View
Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (15.0) View
Cholecystitis infective SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (15.0) View
Other Events(If Any):