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: 2025-12-26 @ 4:00 PM
Ignite Modification Date: 2025-12-26 @ 4:00 PM
NCT ID: NCT00191906
Description: None
Frequency Threshold: 1
Time Frame: None
Study: NCT00191906
Study Brief: Comparison of Atomoxetine and Placebo in Children With Attention-Deficit/Hyperactivity Disorder (ADHD) and/or Reading Disorder (RD)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
As Randomized Placebo (Crossover) Patients in either Crossover Period receiving Placebo None None 0 76 28 76 View
As Randomized Atomoxetine (Crossover) Patients in either Crossover Period receiving Atomoxetine None None 0 74 35 74 View
Open Label Atomoxetine Patients in the Open Label extension receiving Atomoxetine None None 0 25 24 25 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Ear pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 11.0 View
Eyelid oedema SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 11.0 View
Mydriasis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 11.0 View
Visual disturbance SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 11.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Tooth disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Feeling abnormal SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Peripheral coldness SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Gastroenteritis viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Tonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Joint sprain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Upper limb fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Wound SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.0 View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Disturbance in attention SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Poor quality sleep SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Apathy SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.0 View
Eating disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.0 View
Emotional disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.0 View
Fear SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.0 View
Initial insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.0 View
Negativism SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.0 View
Nightmare SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Rhinalgia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Rash erythematous SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Skin discolouration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Swelling face SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Job dissatisfaction SYSTEMATIC_ASSESSMENT Social circumstances MedDRA 11.0 View
Pallor SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.0 View
Raynaud's phenomenon SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.0 View