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 @ 4:42 AM
Ignite Modification Date: 2025-12-26 @ 3:44 AM
NCT ID: NCT01256918
Description: None
Frequency Threshold: 0
Time Frame: any occurrence of corneal epithelial damage due to A scan biometry during preoperative assessment was noted during the period from day of examination to 24hrs. thereafter for each participant during the entire period of recruitment.
Study: NCT01256918
Study Brief: Study of Phacodepth Required for Safe and Effective Chop During Phacoemulsification for 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
Patients Undergoing Phacoemulsification Patients (\> 40 years of age) with grade 3.0 to 6.9( according to LOCS-III) of senile cataract were included in this study.200 consecutive patients were enrolled and achievement of milestone noted while attempting vertical chop during phacoemulsification using a calibrated phacotip. None None 0 200 0 200 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
posterior capsular rupture NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Other Events(If Any):