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 @ 1:10 AM
Ignite Modification Date: 2025-12-25 @ 11:21 PM
NCT ID: NCT04895293
Description: All adverse events and serious adverse events were continually assessed throughout the study. The investigator assessed safety throughout the study to determine appropriateness of continuing dosing and enrollment.
Frequency Threshold: 4
Time Frame: 3 months
Study: NCT04895293
Study Brief: RBM-007 in Treatment naïve Exudative Age-related Macular Degeneration
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
RBM-007 Injectable Solution - 2.0 mg Single intravitreal injection in study eye RBM-007 Injectable Solution: Sterile solution 0 None 0 5 4 5 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Positive COVID test NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Subretinal hemorrhage NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Myocardial infarction (mild) NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Diarrhea (severe) NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View