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 @ 3:34 PM
Ignite Modification Date: 2025-12-25 @ 1:47 PM
NCT ID: NCT02710292
Description: AEs were 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 (test article). AE's were obtained as volunteered and elicited comments from the subjects and as observations by the Investigator.
Frequency Threshold: 5
Time Frame: Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 26 days). AEs are reported as pretreatment and treatment-emergent.
Study: NCT02710292
Study Brief: Clinical Evaluation of DAILIES TOTAL 1® Performance in a Japanese Population
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
TruEye All subjects exposed to narafilcon A contact lenses None None 0 98 23 98 View
Pretreatment All subjects who consented to participate in the study prior to initiation of study treatment None None 0 104 0 104 View
Dailies Total1 All subjects exposed to delefilcon A contact lenses None None 0 96 7 96 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dry Eye SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (14.0) View
Punctate keratitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (14.0) View