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 @ 6:28 PM
Ignite Modification Date: 2025-12-25 @ 3:58 PM
NCT ID: NCT03468868
Description: During coaching sessions, the exercise coaches queried participants about any adverse events they experienced since the previous session. The site PI, study project manager, and study PI were notified of all AEs as they were reported.
Frequency Threshold: 1
Time Frame: Adverse events were collected from the time of consent through the end of the 16 week intervention phase.
Study: NCT03468868
Study Brief: Comparative Effectiveness Study Telerehab Versus Conventional
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Facility-based Rehabilitation Participants will conduct the exercise program for people with MS in a facility, for example a gym, or rehabilitation center. They will receive coaching on site at the facility. Exercise program for people with MS: The intervention consists of 30 minutes of resistance training and 30 minutes of cardio three times per week for 16 weeks. 0 None 8 198 80 198 View
Telerehabilitation Participants will conduct the exercise program for people with MS at home and receive coaching via phone or Skype sessions. Exercise program for people with MS: The intervention consists of 30 minutes of resistance training and 30 minutes of cardio three times per week for 16 weeks. 0 None 2 181 88 181 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Coronavirus infections SYSTEMATIC_ASSESSMENT Infections and infestations None View
Elective hip arthroplasty SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Fall resulting in fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Herniated disc SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Increase in multiple sclerosis (MS) symptoms SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Septic shock of unknown etiology SYSTEMATIC_ASSESSMENT Infections and infestations None View
Viral infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Influenza Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Medication side effects SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Migraine SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Motor Vehicle Accident (MVA) with Sequelae SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Multiple Sclerosis (MS) Flare SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Multiple Sclerosis (MS) Relapse SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Neurological Symptoms SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Other Musculoskeletal Conditions SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Symptoms post-COVID vaccine SYSTEMATIC_ASSESSMENT Immune system disorders None View
Upper respiratory infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Vertigo SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Weakness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Coronavirus infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Dental conditions SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Fall with injury SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Fall without injury SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Gastroenteritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
General illness SYSTEMATIC_ASSESSMENT General disorders None View
Heat intolerance SYSTEMATIC_ASSESSMENT Nervous system disorders None View