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 @ 9:07 PM
Ignite Modification Date: 2025-12-25 @ 6:58 PM
NCT ID: NCT04507204
Description: Since participants may have received multiple dose levels during the study and a participant may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s), the adverse events are presented for all dose levels combined.
Frequency Threshold: 5
Time Frame: All adverse events were reported starting from the time informed consent for study participation up to 6 months.
Study: NCT04507204
Study Brief: Real-World Evidence of Duration of Effect of Adhansia XR (Extended-Release) for Treatment of 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
Adhansia XR Methylphenidate extended-release capsules taken once daily. 0 None 3 133 28 133 View
Concerta Concerta tablets taken orally once daily in the morning and swallowed whole with the aid of liquids, with or without food. 1 None 4 134 27 134 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Delusion NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.1 View
Hallucination, auditory NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.1 View
Suicidal ideation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.1 View
Death NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Decreased appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.1 View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.1 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Dry Mouth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View