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 @ 5:49 PM
Ignite Modification Date: 2025-12-25 @ 3:15 PM
NCT ID: NCT01518868
Description: Adverse events (AEs) were not coded. Therefore, source vocabulary is not applicable. A total of 126 participants (262 eyes) were assessed for AEs. Participants/eyes received both treatment groups in this cross-over study.
Frequency Threshold: 0
Time Frame: 2 weeks
Study: NCT01518868
Study Brief: A Study to Evaluate the Feasibility of a High Add Multi Focal Contact Lens
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Investigational Contact Lens multifocal high add soft contact lens Investigational contact lens: Worn on a daily wear basis by adapted monovision soft contact lens wearers for one week. Investigational contact lens: Worn on a daily wear basis by adapted multifocal soft contact wearers for one week. Investigational contact lens: Worn on a daily wear basis by adapted spherical soft contact lens wearers who may also use spectacles for near vision correction for one week None None 0 126 0 126 View
PureVision Contact Lens Multi-focal contact lens PureVision contact lens: Worn on a daily wear basis by adapted monovision soft contact lens wearers for one week PureVision contact lens: Worn on a daily wear basis by adapted multifocal soft contact wearers for one week. PureVision contact lens: Worn on a daily wear basis by adapted spherical soft contact lens wearers who may also use spectacles for near vision correction for one week None None 0 126 0 126 View
Serious Events(If Any):
Other Events(If Any):