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 @ 4:54 AM
Ignite Modification Date: 2025-12-26 @ 3:54 AM
NCT ID: NCT05002218
Description: None
Frequency Threshold: 5
Time Frame: AE data was collected during in-person assessments at baseline, 6 months, 9 months, and 12 months
Study: NCT05002218
Study Brief: Training in Ataxia - Individuals With Degenerative Cerebellar Diseases
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Aerobic Training Participants will be given a stationary exercise bike for home use. They will be instructed to use the exercise bike five times a week for thirty-minute sessions. The exercise intensity prescription will be based on the subject's VO2max determined on pre-test day. The exercise program will start at 60% of intensity per session, and then will be increased by steps of 5% intensity every 2 sessions until participants reach 30 minutes of training at 80% intensity. Participants will be contacted weekly by e-mail or phone to answer any questions about the exercise protocol and will be instructed to log each training session. Subjects will record duration of exercise, perceived exertion, average heart rate, maximum heart rate, and distance. 0 None 2 31 8 31 View
Balance Training A physical therapist will tailor a home balance training program for each participant based on pre- training capabilities. Subjects will be asked to perform exercises five times a week for thirty-minute sessions. Both dynamic and static exercises will be performed in sitting and standing positions. Exercises will start with stabilizing in a challenging static position and progress to dynamic arm and leg movements in the same or modified position. Participants will be contacted weekly by e-mail or phone to answer any questions about the exercise protocol and will be required to log their exercise effort in terms of frequency and level of balance challenge. 0 None 1 31 10 31 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Car Accident, hospitalized NON_SYSTEMATIC_ASSESSMENT Social circumstances None View
Infection, hospitalized NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Muscle Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Falls NON_SYSTEMATIC_ASSESSMENT General disorders None View
Infection, not hospitalized NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View