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 @ 1:11 AM
Ignite Modification Date: 2025-12-25 @ 11:22 PM
NCT ID: NCT02734693
Description: None
Frequency Threshold: 5
Time Frame: 3 weeks
Study: NCT02734693
Study Brief: A Study to Evaluate the Efficacy and Safety of Dasotraline in Children 6 to 12 Years of Age With Attention-Deficit Hyperactivity Disorder (ADHD) in a Simulated Classroom Setting.
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Placebo capsule 0 None 1 56 14 56 View
Dasotraline 6mg Dasotraline capsule 6mg/day 0 None 0 20 14 20 View
Dasotraline 4mg Dasotraline capsule 4mg/day 0 None 0 56 24 56 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hand fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Postural orthostatic tachycardia syndrome SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.0 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Oral herpes SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.0 View
Musle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Dizziness postural SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Affect lability SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.0 View
Delusion SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.0 View
Emotional poverty SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.0 View
Hallucination tactile SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.0 View
Hallucination visual SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.0 View
Initial insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.0 View
Irritability SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.0 View
Nightmare SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.0 View
Tic SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.0 View