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 @ 7:48 PM
Ignite Modification Date: 2025-12-25 @ 5:25 PM
NCT ID: NCT05359003
Description: Adverse Events include worsening of seizure frequency, falls, and injuries. These will be recorded by the participant in their study diary, which will be returned electronically daily. All other adverse events will be collected at each study visit (visits 2-4) by asking "have you had any health problems since your last visit?"
Frequency Threshold: 0
Time Frame: 7 months (Day 0 - Week 28)
Study: NCT05359003
Study Brief: Steps for Epilepsy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Arm 2: Control Participants randomized to the wait-list attention control group will continue to undergo standard care for 12 weeks. 0 None 1 6 4 6 View
Arm 1: Exercise Intervention Participants in this arm will undergo a 12-week physical activity program aimed to achieve the equivalent of 8,000 steps per day (56,000 weekly steps). 12-week physical activity program: Program aimed to achieve the equivalent of 8,000 steps per day (56,000 weekly steps). Includes weekly meetings with a trained health coach. 0 None 4 15 11 15 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Fall with injury that required medical attention SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Dizziness that resulted in ER visit SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Weakness that resulted in ER visit SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Planned admission for electrode implant placement SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Seizure with minor injury (not during exercise) SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dizziness and vomiting SYSTEMATIC_ASSESSMENT General disorders None View
Bumped into furniture SYSTEMATIC_ASSESSMENT General disorders None View
Seizure frequency increased SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Depression episode SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Headache or migraine SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Joint pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Kidney stone SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Lipoma SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Lupus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Minor fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Strep throat SYSTEMATIC_ASSESSMENT General disorders None View
Seizure within 30 min of physical activity SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Routine surgery to replace battery medical device SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Seizure frequency increased SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Skin irritation at site of activity monitor SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View