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 @ 7:21 PM
Ignite Modification Date: 2025-12-25 @ 5:00 PM
NCT ID: NCT01786603
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT01786603
Study Brief: Rasagiline in Subjects With Amyotrophic Lateral Sclerosis (ALS)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Rasagiline Rasagiline 1mg administered orally as a 2mg single dose once daily for 12 months. Rasagiline: Rasagiline 2mg once a day for 12 months. 5 None 0 60 28 60 View
Placebo Inactive ingredient equal to 1mg rasagiline 2mg administered as a single dose once daily for 12 months. Placebo: Placebo (looks like study drug but has no active ingredients) once a day for 12 months. 1 None 0 20 15 20 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Cardiac SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Ear and Labyrinth SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Eye SYSTEMATIC_ASSESSMENT Eye disorders None View
Gastrointestinal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
General Disorders SYSTEMATIC_ASSESSMENT General disorders None View
Infections SYSTEMATIC_ASSESSMENT Infections and infestations None View
Injury, Poisoning, Procedural Complications SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Laboratory Abnormality SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Metabolism and Nutrition SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Musculoskeletal SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Nervous System SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Psychiatric SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Renal and Urinary SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Respiratory SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Surgical/Medical SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Vascular SYSTEMATIC_ASSESSMENT Vascular disorders None View
Skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View