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 @ 1:48 PM
Ignite Modification Date: 2025-12-25 @ 12:41 PM
NCT ID: NCT03555695
Description: None
Frequency Threshold: 0
Time Frame: 10 weeks
Study: NCT03555695
Study Brief: Kick Out Parkinson's Disease- Karate Intervention
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Karate Class Participants Eligible subjects will engage in twice-weekly karate classes for 10 weeks, specifically designed for individuals with early to middle stage PD. Subjects will complete in-person pre- and post-intervention focus groups, and a 6 month post-intervention follow up phone call. Pre-Intervention Focus Group: Study logistics will be reviewed, informed consent process will occur, the subject will complete a brief, individual pre-intervention assessment focused on overall mobility, gait, balance, mood, neurological status, and quality of life. Subjects will be prompted to share their thoughts on exercise, balance, and mindfulness practices in general and in PD specifically, and any expectations they have regarding karate for PD. Karate Classes: Specifically designed for individuals with early to middle stage PD, focused on incorporating limb movements in multiple directions, increasing body awareness, shifting body weight and rotation, muscle relaxation, improving reaction time, using complex repetitive actions to improve coordination, footwork training and centered weight shifts to help with fall prevention, and striking shields for self-defense and stress relief. Post-Intervention Focus Group: Pre-intervention assessments will be readministered, along with global impression of change. Subjects will be asked their thoughts on how the intervention impacted overall wellbeing, balance, and mindfulness; whether the intervention met their expectations; and to provide feedback. 0 None 1 19 1 19 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Appendicitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Exacerbation of pre-existing sciatica SYSTEMATIC_ASSESSMENT Nervous system disorders None View