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 @ 5:05 AM
Ignite Modification Date: 2025-12-26 @ 4:08 AM
NCT ID: NCT04050618
Description: None
Frequency Threshold: 3
Time Frame: From dispense up to 4 weeks for ocufilcon D and fanfilcon A - Group A, from dispense up to 2 weeks for etafilcon A and fanfilcon A - Group B. A total of 8 weeks
Study: NCT04050618
Study Brief: Evaluation Of One Silicone Hydrogel Contact Lens and Two Hydrogel Lenses in Daily Wear
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Ocufilcon D - Group A Subjects were randomized to wear ocufilcon D control lens for four weeks. Ocufilcon D - hydrogel contact lens 0 None 0 58 2 58 View
Fanfilcon A - Group A Subjects were randomized to wear fanfilcon A test lens for four weeks. Fanfilcon A - SiHy contact lens 0 None 0 57 0 57 View
Etafilcon A - Group B Subjects were randomized to wear etafilcon A control lens for two weeks. Etafilcon A - hydrogel contact lens 0 None 0 56 0 56 View
Fanfilcon A - Group B Subjects were randomized to wear fanfilcon A test lens for two weeks. Fanfilcon A - SiHy contact lens 0 None 0 56 0 56 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
headache SYSTEMATIC_ASSESSMENT General disorders None View