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 @ 4:52 PM
Ignite Modification Date: 2025-12-25 @ 2:35 PM
NCT ID: NCT01010750
Description: Safety Set includes all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
Frequency Threshold: 5
Time Frame: None
Study: NCT01010750
Study Brief: Lisdexamfetamine Dimesylate (LDX) Pilot Cognition Study to Evaluate the Utility of a Standardized Battery of Tests in Adults With Attention-Deficit Hyperactivity Disorder (ADHD)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
LDX 50 mg None None None 0 18 12 18 View
MAS-IR 20 mg None None None 0 17 9 17 View
Placebo None None None 0 17 8 17 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dizziness None Nervous system disorders None View
Headache None Nervous system disorders None View
Paraesthesia None Nervous system disorders None View
Bruxism None Psychiatric disorders None View
Insomnia None Psychiatric disorders None View
Nervousness None Psychiatric disorders None View
Obsessive-Compulsive Disorder None Psychiatric disorders None View
Sedation None Nervous system disorders None View
Dysuria None Renal and urinary disorders None View
Micturition Disorder None Renal and urinary disorders None View
Dyspnoea None Respiratory, thoracic and mediastinal disorders None View
Palpitations None Cardiac disorders None View
Abdominal pain None Gastrointestinal disorders None View
Diarrhea None Gastrointestinal disorders None View
Dry Mouth None Gastrointestinal disorders None View
Nausea None Gastrointestinal disorders None View
Chest Pain None General disorders None View
Fatigue None General disorders None View
Feeling Jittery None General disorders None View
Irritability None General disorders None View
Heart Rate Increased None Investigations None View
Decreased Appetite None Metabolism and nutrition disorders None View
Sensation of Heaviness None Musculoskeletal and connective tissue disorders None View