Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 5:32 PM
Ignite Modification Date: 2025-12-25 @ 3:05 PM
NCT ID: NCT01912768
Description: AEs were collected for the duration of the study (Dec 2013-May 2014). AEs were obtained as solicited and volunteered comments from subjects and as observations by the Investigator as outlined in the protocol. One subject was randomized but never received investigational product and was excluded from the safety dataset.
Frequency Threshold: 5
Time Frame: An Adverse Event (AE) was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, whether or not related to the investigational medical device. AEs are reported as pre-treatment and treatment-emergent.
Study: NCT01912768
Study Brief: Safety and Efficacy Evaluation of a New Contact Lens Disinfecting Solution in Soft Contact Lens Wearers
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Pre-treatment All subjects who consented to participate in the study prior to exposure to investigational product None None 0 362 0 362 View
FID 120947A All subjects who were exposed to FID 120947A None None 1 238 0 238 View
Renu Fresh All subjects who were exposed to renu fresh None None 0 113 0 113 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
ankle fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (16.0) View
Other Events(If Any):