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: 2025-12-24 @ 6:48 PM
Ignite Modification Date: 2025-12-25 @ 4:20 PM
NCT ID: NCT01649557
Description: The safety dataset comprised of those participants who received at least one dose of open-label brexpiprazole.
Frequency Threshold: 5
Time Frame: AEs were recorded from Screening (ICF was signed) to Follow-up 30 (± 2) days, up to 52 weeks.
Study: NCT01649557
Study Brief: Multicenter, Open-label, Safety and Tolerability 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
Prior Brexpiprazole The participants were grouped based on the medications that they received prior to the trial. The participants in prior brexpiprazole group included the participants who received brexpiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated. None None 4 178 31 178 View
Prior Placebo The participants were grouped based on the medications that they received prior to the trial. The participants in prior placebo group included the participants who received placebo prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated. None None 6 41 10 41 View
Prior Aripiprazole The participants were grouped based on the medications that they received prior to the trial. The participants in prior aripiprazole group included the participants who received aripiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated. None None 1 23 4 23 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA V11.1 View
Influenza NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA V11.1 View
Convulsion NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA V11.1 View
Psychotic disorder NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA V11.1 View
Schizophrenia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA V11.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA V11.1 View
Tremor NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA V11.1 View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA V11.1 View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA V11.1 View
Extrapyramidal disorder NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA V11.1 View