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 @ 4:52 AM
Ignite Modification Date: 2025-12-26 @ 3:53 AM
NCT ID: NCT03022318
Description: Adverse event reporting was based on participant-reported systemic adverse events during each study visit. The goal of evaluating differences in once daily and three times daily dosing was to evaluate potential differences in the tolerance/safety of both arms. This is the only secondary outcome that evaluated total daily dose differences of carbidopa/levodopa.
Frequency Threshold: 1
Time Frame: 1 month
Study: NCT03022318
Study Brief: Carbidopa-levodopa in Neovascular AMD
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Carbidopa/Levodopa Once Daily carbidopa-levodopa 25-100 mg tablets once daily hs for up to 32 days in patients naive to anti-VEGF injections. carbidopa-levodopa 25-100 mg tablets: See arm/group descriptions 0 None 0 10 1 10 View
Carbidopa/Levodopa Three Times Daily carbidopa-levodopa 25-100 mg tablets three times daily for up to 32 days in patients naive to anti-VEGF injections. 0 None 0 7 0 7 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Ear issues SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View