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 @ 3:52 PM
Ignite Modification Date: 2025-12-25 @ 1:58 PM
NCT ID: NCT00769392
Description: None
Frequency Threshold: 5
Time Frame: Adverse Event frequency was monitored from the time of participant consent to the end of the study at 6 months.
Study: NCT00769392
Study Brief: Pilot Study: A Randomized Trial Of Anesthetic Agents For Intravitreal Injection
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
All Participants Participants will be randomized to receive a unique sequence of one of the 4 anesthetic agents per month, prior to a standard of care monthly intravitreal injection (1 injection per month for a total of 4 months). At the end of study participation, each patient will have received each of the 4 anesthetic agents once prior to one of the 4 intravitreal injections (ex. Randomization to sequence: Proparcacaine used prior to Injection 1; Tetracaine used prior to Injection 2; Lidocaine sponge used prior to Injection 3; Lidocaine suconjunctival injection used prior to Injection 4). 0 None 0 24 13 24 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Subconjunctival Hemorrage with Lidocaine subconjunctival injection NON_SYSTEMATIC_ASSESSMENT Eye disorders None View