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 @ 3:06 PM
Ignite Modification Date: 2025-12-25 @ 1:27 PM
NCT ID: NCT03154359
Description: None
Frequency Threshold: 2.5
Time Frame: Adverse event data was collected over the full 18 weeks of participation in the study.
Study: NCT03154359
Study Brief: Atomoxetine PBPK-PD Clinical 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
Atomoxetine HCl (Strattera) Study participants will receive atomoxetine at a dose expected to result in steady-state maximum concentration (Cmax,ss) values of 400 ng/mL. Dose will be calculated using a model based on CYP2D6 predicted phenotype, height, weight, body habitus, and gender. Study clinicians may titrate up the dose to reach Cmax,ss values of 600 ng/mL or 800 ng/mL according to participant response. 0 None 0 42 37 42 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea/Vomiting/Upset Stomach NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Decreased Appetite NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Cold/Flu NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Fever NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Ear Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sore Throat NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Irritability NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Mood Disturbance NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Self-Injurious Behavior NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Foot injury NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View