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 @ 7:19 PM
Ignite Modification Date: 2025-12-25 @ 4:57 PM
NCT ID: NCT03073603
Description: All SAEs are reported in the table of Serious Adverse Events. Other adverse events exceeding a frequency threshold of 5% are reported. Additionally, AEs were classified as being unrelated to treatment, unlikely to be related to treatment, possibly (\> 50% likelihood) related to treatment, probably related to treatment, or definitely related to treatment. Any AEs deemed probably or definitely related to treatment are reported, even if they did not exceed the 5% threshold.
Frequency Threshold: 0
Time Frame: Baseline to end of study (24 months)
Study: NCT03073603
Study Brief: Discontinuation of Disease Modifying Therapies (DMTs) in Multiple Sclerosis (MS)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Drug Continuation Arm Participants who remain on their current Disease Modifying Therapies (DMTs) without any changes. DMTs include \~14 formulations/doses of drugs approved in the US by the FDA that alter the natural history of the disease. Standard of Care: Participants who remain on their current Disease Modifying Therapies (DMTs) without any changes. DMTs include \~14 formulations/doses of drugs approved in the US by the FDA that alter the natural history of the disease. 1 None 1 128 66 128 View
Drug Discontinuation Arm Participants who will discontinue their Disease Modifying Therapies (DMTs). No other changes to their treatment occur. DMTs include \~14 formulations/doses of drugs approved in the US by the FDA that alter the natural history of the disease. Discontinuation of disease modifying therapy: Participants who will discontinue their current MS drug. No other changes to their treatment occur. 2 None 1 131 70 131 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
MS relapse NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
MS relapse NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
New MS MRI lesion NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Leptomeningeal enhancement NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Abnormal white blood cell count NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Abnormal glucose level NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
COVID-19 infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Fall NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Influenza NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Musculoskeletal pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Leg edema NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Elevated PSA NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Injection reaction NON_SYSTEMATIC_ASSESSMENT General disorders None View
Osteoarthritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Upper respiratory infection NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View