Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 4:16 PM
Ignite Modification Date: 2025-12-25 @ 2:14 PM
NCT ID: NCT00181766
Description: None
Frequency Threshold: 1
Time Frame: None
Study: NCT00181766
Study Brief: Strattera Treatment in Adults With Attention Deficit Hyperactivity Disorder Not Otherwise Specified (ADHD NOS)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Strattera (Atomoxetine) Atomoxetine monotherapy up o 1.2 mg/kg/day or 120 mg/day. None None 0 45 45 45 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dry Mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastrointestinal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Insomnia SYSTEMATIC_ASSESSMENT General disorders None View
Tired/fatigued None General disorders None View
Headache SYSTEMATIC_ASSESSMENT General disorders None View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Warmth/flushing/sweating SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Colds/allergies/infections SYSTEMATIC_ASSESSMENT Immune system disorders None View
Lightheaded/dizzy SYSTEMATIC_ASSESSMENT General disorders None View
Musculoskeletal discomfort SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Tension/jitteriness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Mood change SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Sexual function SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Urinary hesitancy SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Neurologic SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Vision/ocular SYSTEMATIC_ASSESSMENT Eye disorders None View
Feeling cold SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Muscle twitch/tremor SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Impaired concentration SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Tingling sensation SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Vivid dreams SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Bad taste SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Chest discomfort SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Skin changes SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Increased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Paresthesia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Shortness of breath SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Urinary incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View