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: 2025-12-26 @ 10:32 AM
Ignite Modification Date: 2025-12-26 @ 10:32 AM
NCT ID: NCT03184428
Description: No interventions were performed in the Department of Ophthalmology (only a questionnaire for information sampling was required), thus adverse events were not monitored (including Serious Adverse Events, All-Cause-Mortality, Other Adverse Events). An investigation would have been necessary only in case of low patient's response.
Frequency Threshold: 0
Time Frame: n/a All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed because no interventions were performed in the Department of Ophthalmology (only a questionnaire for information sampling was required).
Study: NCT03184428
Study Brief: Posterior Capsule Opacification Following Cataract Surgery With Implantation of the MICS IOL L313
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Implantation of IOL L313 Patients who have undergone a cataract surgery with implantation of the monofocal MICS IOL L313 more than 3 Years ago will be asked about the Treatment for Postoperative observation and survey. 0 None 0 0 0 0 View
Serious Events(If Any):
Other Events(If Any):