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 @ 1:33 AM
Ignite Modification Date: 2025-12-25 @ 11:46 PM
NCT ID: NCT04064294
Description: Total # at risk for All Cause Mortality: 88 - Includes those withdrawn during the AE collection period. Total # at risk for SAE/AE: 80 - Excludes those withdrawn, did not complete day visit and therefore not at risk of AE during levodopa infusion/day visit.
Frequency Threshold: 5
Time Frame: 3 months - time between the screening visit and completion of the day visit.
Study: NCT04064294
Study Brief: Preventing Levodopa Induced Dyskinesia in Parkinson's Disease With HMG-CoA Reductase Inhibitors
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Statin Before Levodopa Historical use of a statin BEFORE beginning levodopa Intravenous Infusion: Intravenous levodopa given 1.0 to 1.5 mg/kg/hr from 0930 - 1130 on a single visit day. 1 None 1 29 0 29 View
Statin After Levodopa Historical use of a statin AFTER beginning levodopa Intravenous Infusion: Intravenous levodopa given 1.0 to 1.5 mg/kg/hr from 0930 - 1130 on a single visit day. 1 None 1 16 1 16 View
No Statin No historical use of a statin Intravenous Infusion: Intravenous levodopa given 1.0 to 1.5 mg/kg/hr from 0930 - 1130 on a single visit day. 0 None 3 35 1 35 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (Unspecified) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
LightHeadedness SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (Unspecified) View