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 @ 9:18 PM
Ignite Modification Date: 2025-12-25 @ 7:06 PM
NCT ID: NCT05282004
Description: Any signs or symptoms were collected throughout the study for 31 days
Frequency Threshold: 0
Time Frame: Adverse events were collected throughout the study for 31 days
Study: NCT05282004
Study Brief: Study of the Safety of Use of Intravitreal SOK583A1 Provided in a Vial Kit
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
SOK583A1 40 mg/mL SOK583A1 was provided in a vial kit, with 40 mg/mL of aflibercept solution for IVT injection (2 mg/0.05 mL) 0 None 2 36 17 36 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cystitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 24.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version 24.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Conjunctival haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 24.1 View
Vitreous floaters SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 24.1 View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 24.1 View
Intraocular pressure increased SYSTEMATIC_ASSESSMENT Investigations MedDRA version 24.1 View