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 @ 2:07 AM
Ignite Modification Date: 2025-12-26 @ 12:33 AM
NCT ID: NCT01573260
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT01573260
Study Brief: Tango for Treatment of Motor and Non-motor Manifestations in Parkinson's Disease.
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Argentinean Tango A biweekly 3-month tango program Argentinean Tango classes: Tango participants will attend an 1-hour Argentinean Tango classes twice a week during 12 weeks, with experienced professional tango instructors. None None 0 18 4 18 View
A 'Wait-list' Control Group Patient information about exercise in PD. After 12 weeks, these patients will then start the same 12-weeks tango program. Simple pamphlet about the exercise in PD: Controls will follow their usual schedule of pharmacological treatment; will be provided by simple pamphlet about the exercise in PD, and will otherwise to go about their lives as usual. None None 0 15 2 15 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
respiratory infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Falls SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
mild fatigue and muscle cramps SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View