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 @ 2:45 AM
Ignite Modification Date: 2025-12-26 @ 1:25 AM
NCT ID: NCT05338333
Description: AE's were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AE's is reported in units of eyes according to actual study lens exposure. All other populations are reported in units of subjects.
Frequency Threshold: 5
Time Frame: Adverse events (AE's) were collected from time of consent to study exit, approximately 60 days.
Study: NCT05338333
Study Brief: Clinical Performance Evaluation of Two Frequent Replacement Silicone Hydrogel Multifocal 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
Pretreatment Events reported in this group occurred prior to exposure to the study contact lenses 0 None 0 101 0 101 View
LID210464 Ocular Events reported in this group occurred while exposed to the lehfilcon A contact lenses 0 None 0 202 0 202 View
LID210464 Non-Ocular Events reported in this group occurred while exposed to the lehfilcon A contact lenses 0 None 0 101 0 101 View
AOHG MF Ocular Events reported in this group occurred while exposed to the lotrafilcon B contact lenses 0 None 0 200 0 200 View
AOHG MF Non-Ocular Events reported in this group occurred while exposed to the lotrafilcon B contact lenses 0 None 1 100 0 100 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Blood potassium decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 25.0 View
Other Events(If Any):