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 @ 12:36 AM
Ignite Modification Date: 2025-12-25 @ 10:44 PM
NCT ID: NCT03496467
Description: Subjects were asked: "Have you had any problems since your last visit?"
Frequency Threshold: 0
Time Frame: The Nepafenac PPDS or Placebo PPDS was inserted 1-2 days prior to surgery. Subjects were followed for 14 days (+/-2 days) post op
Study: NCT03496467
Study Brief: Safety/Efficacy of Nepafenac Punctal Plug Delivery System Compared to Placebo to Control Ocular Pain/Inflammation After Cataract
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Nepafenac PPDS N-PPDS (Nepafenac Punctal Plug Deliver System) is an L-shaped, silicone punctal plug with a drug eluting core that contains nepafenac (active) Nepafenac PPDS: A punctal plug delivery system (PPDS) is being developed as a device that can deliver a sustained release of a drug to a specific eye. The PPDS is made up of a medical grade silicone punctal plug which holds an insert (core) that contains nepafenac, a nonsteroidal anti-inflammatory drug. 0 None 0 38 10 38 View
Placebo PPDS p-PPDS (placebo Punctal Plug Delivery System) is an L-shaped, silicone punctal plug with a drug insert that contains no active ingredient (placebo). Placebo PPDS: A punctal plug delivery system (PPDS) is being developed as a device that can deliver a sustained release of a drug to a specific eye. The PPDS is made up of a medical grade silicone punctal plug which holds an insert (core) that does not contain nepafenac. 0 None 0 18 3 18 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
posterior capsule rupture SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 10.0 View
Cavity, 3rd molar SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Pain/irritation/inflammation SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 10.0 View
iritis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 10.0 View
elevated IOP SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 10.0 View