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 @ 12:32 AM
Ignite Modification Date: 2025-12-25 @ 10:39 PM
NCT ID: NCT03088267
Description: None
Frequency Threshold: 5
Time Frame: The duration of the study (5 weeks from screening to final follow-up assessment)
Study: NCT03088267
Study Brief: Dyanavel® XR Extended-Release Oral Suspension in the Treatment of Children With ADHD: A Laboratory School Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Crossover Phase: AMPH EROS These AEs occurred during the crossover phase of the study. 0 None 0 18 0 18 View
Crossover Phase: Placebo These AEs occurred during the crossover phase of the study. 0 None 0 18 0 18 View
AMPH EROS: Open Label Phase All AEs reported are from the open-label dose optimization phase with AMPH EROS. The open-label dose optimization phase preceded the crossover portion of the study. 0 None 0 18 6 18 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Respiratory tract viral infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Abdominal pain, upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Motion sickness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Affect lability SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Constricted affect SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Visioned blurred SYSTEMATIC_ASSESSMENT Eye disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View