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 @ 11:37 PM
Ignite Modification Date: 2025-12-25 @ 9:27 PM
NCT ID: NCT01469156
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT01469156
Study Brief: Safety Study of 2.0mg Lucentis to Treat Polypoidal Choroidal Vasculopathy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Control Group: Ranibizumab 0.5mg standard-dose ranibizumab in 3 monthly loading doses, followed by 9 months of criteria-based, as-needed retreatment None None 0 5 2 5 View
Ranibizumab 1.0mg or 2.0mg high-dose ranibizumab in 3 monthly loading doses, followed by 9 months of criteria-based, as-needed retreatment None None 0 15 9 15 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Affected vision SYSTEMATIC_ASSESSMENT Eye disorders None View
Intravitreal injection side effects SYSTEMATIC_ASSESSMENT Eye disorders None View
Increased cataract SYSTEMATIC_ASSESSMENT Eye disorders None View
Superior hemorrhage SYSTEMATIC_ASSESSMENT Eye disorders None View
Increased Choroidal neovascularization SYSTEMATIC_ASSESSMENT Eye disorders None View
Corneal Abrasion SYSTEMATIC_ASSESSMENT Eye disorders None View
Trace epiretinal membrane SYSTEMATIC_ASSESSMENT Eye disorders None View
Progression of edema SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Elevated Blood pressure SYSTEMATIC_ASSESSMENT Cardiac disorders None View