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 @ 7:09 PM
Ignite Modification Date: 2025-12-25 @ 4:42 PM
NCT ID: NCT03026257
Description: Adverse events (AEs) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all subjects/eyes exposed to study lens and/or study LCS evaluated in this study as a regimen (Safety Analysis Set). "At risk" population for ocular AEs is reported in units of eyes, as treated.
Frequency Threshold: 5
Time Frame: Lens insertion (Day 1) through study completion, an average of 30 days
Study: NCT03026257
Study Brief: Clinical Assessment of a HYDRAGLYDE® Regimen
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/OFPM Ocular Eyes exposed to AOHG contact lenses and OFPM for lens care 0 None 0 130 0 130 View
AOHG/OFPM Nonocular Subjects exposed to AOHG contact lenses and OFPM for lens care 0 None 0 65 0 65 View
Habitual SiHy/MPS Ocular Eyes exposed to habitual SiHy contact lenses and habitual MPS for lens care 0 None 0 258 0 258 View
Habitual SiHy/MPS Nonocular Subjects exposed to habitual SiHy contact lenses and habitual MPS for lens care 0 None 0 129 0 129 View
AOHG/CCP Ocular Eyes exposed to AOHG contact lenses and CCP for lens care 0 None 0 116 0 116 View
AOHG/CCP Nonocular Subjects exposed to AOHG contact lenses and CCP for lens care 0 None 0 58 0 58 View
Serious Events(If Any):
Other Events(If Any):