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 @ 10:41 PM
Ignite Modification Date: 2025-12-25 @ 8:12 PM
NCT ID: NCT03949335
Description: Adverse events (AEs) were planned to be reported for each eye separately and AEs not related to eyes were counted and represented in both the eyes. The total number of participants affected by SAE is total number of unique eyes. If an eye has multiple SAEs, the number of affected participant is one (1) but list multiple number of SAEs. Only other (not including serious) adverse events that exceed the frequency threshold of 5% are reported.
Frequency Threshold: 5
Time Frame: 6 months
Study: NCT03949335
Study Brief: Clinical Investigation of the Safety and Effectiveness of an Investigational Model of the TECNIS® Intraocular 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
ZFR00V First Eye Study Lens 0 None 6 135 10 135 View
ZCB00 First Eye Control Lens 0 None 2 137 0 137 View
ZFR00V Second Eye Study Lens 0 None 8 135 0 135 View
ZCB00 Second Eye Control Lens 0 None 3 137 0 137 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cystoid Macular Edema NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Undesirable Optical Phenomena NON_SYSTEMATIC_ASSESSMENT Product Issues None View
Retinal Detachment/tear NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Macular Hole NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Herpes Simplex Virus Keratitis NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Toxic Anterior Segment Syndrome NON_SYSTEMATIC_ASSESSMENT Product Issues None View
Corneal Ulcers NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Hypopyon NON_SYSTEMATIC_ASSESSMENT Product Issues None View
Retained lens material resulting in secondary surgical intervention NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Hospitalization NON_SYSTEMATIC_ASSESSMENT General disorders None View
Fractured right fibula and dislocated ankle requiring surgery NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Hospitalization NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Abdominal Hernia requiring surgical repair NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hospitalization NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Undesirable Optical Phenomena NON_SYSTEMATIC_ASSESSMENT Product Issues None View