Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 12:02 AM
Ignite Modification Date: 2025-12-25 @ 10:00 PM
NCT ID: NCT01922258
Description: Only participants who received at least 1 dose of investigational medical product were analyzed for safety (Brexpiprazole N=132).
Frequency Threshold: 5
Time Frame: Through the trial: From screening to Week 12 and 30 (+2) days follow-up period.
Study: NCT01922258
Study Brief: Safety and Tolerability Study of Flexible Dosing of Brexpiprazole in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Brexpiprazole (Flexible Dose Range 0.5 to 2 mg/Day) Titrate up from 0.25 mg/day brexpiprazole to 1 mg/day brexpiprazole. After achieving 1 mg/day target, dose may be increased or decreased based on efficacy and tolerability. Allowable flexible doses will be 0.5 mg/day, 1 mg/day, or 2 mg/day. 0 None 7 132 24 132 View
Placebo (Flexible Dose Range 0.5 to 2 mg/Day) Titrate up from 0.25 mg/day placebo to 1 mg/day placebo. After achieving 1 mg/day target, dose may be increased or decreased based on efficacy and tolerability. Allowable flexible doses will be 0.5 mg/day, 1 mg/day, or 2 mg/day. 1 None 6 137 29 137 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Gastrointestinal haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 19.0 View
Non-Cardiac Chest Pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDra 19.0 View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 19.0 View
Femur Fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDra 19.0 View
Hip Fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDra 19.0 View
Subdural haematoma NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDra 19.0 View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDra 19.0 View
Failure to thrive NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDra 19.0 View
Loss of consciousness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 19.0 View
Presyncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 19.0 View
Seizure NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 19.0 View
Syncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 19.0 View
Dyspnoea Exertional NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 19.0 View
Hypertensive crisis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDra 19.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 19.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 19.0 View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 19.0 View