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 @ 1:44 AM
Ignite Modification Date: 2025-12-26 @ 12:01 AM
NCT ID: NCT02804594
Description: None
Frequency Threshold: 0
Time Frame: Adverse events are collected over 4 weeks
Study: NCT02804594
Study Brief: A Study of Oxidative Pathways in MS Fatigue
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
N-acetyl Cysteine 1250 mg of N-acetyl cysteine three times daily N-acetyl cysteine: 1250 mg of N- acetyl cysteine taken three times daily 0 None 0 10 6 10 View
Placebo placebo three times daily Placebo: placebo taken three times daily 0 None 0 5 4 5 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE V. 4.0 View
abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE V. 4.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE V. 4.0 View
BACK PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE V. 4.0 View
Salivary gland infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE V. 4.0 View
Respiratory-Other, Common cold SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE V. 4.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE V. 4.0 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE V. 4.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE V. 4.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE V. 4.0 View
Gait disturbance SYSTEMATIC_ASSESSMENT General disorders CTCAE V. 4.0 View
Generalized muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE V. 4.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE V. 4.0 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE V. 4.0 View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE V. 4.0 View
Injury-Other, injury to back SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE V. 4.0 View
Injury-Other, Injury to face secondary to a fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE V. 4.0 View