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 @ 2:41 AM
Ignite Modification Date: 2025-12-26 @ 1:20 AM
NCT ID: NCT02194933
Description: An adverse event (AE) was any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug-related. Suspected adverse reaction (AR) - any AE caused by drug; in drug safety reporting, "reasonable possibility" meant to suggest a causal relationship between the drug and the AE. A serious AE (SAE) included any event that resulted in death, life-threatening, inability, hospitalization, congenital anomaly and requirement of medical/surgical intervention
Frequency Threshold: 5
Time Frame: Trial visits (Days 0 to 42)
Study: NCT02194933
Study Brief: Monotherapy Brexpiprazole (OPC-34712) Trial in the Treatment of Adults With Schizophrenia With Impulsivity
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 2 mg Brexpiprazole 2 mg/day, once daily dose, tablet, orally Brexpiprazole: Brexpiprazole 2 mg/day, once daily dose, tablet, orally, for 6 weeks - Brexpiprazole 4 mg/day, once daily dose, tablet, orally, for 6 weeks 0 None 0 19 13 19 View
Brexpiprazole 4 mg Brexpiprazole 4 mg/day, once daily dose, tablet, orally Brexpiprazole: Brexpiprazole 2 mg/day, once daily dose, tablet, orally, for 6 weeks - Brexpiprazole 4 mg/day, once daily dose, tablet, orally, for 6 weeks 0 None 0 19 14 19 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dyspepsia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Preferred Ter View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Preferred Ter View
Blood creatine phosphokinase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA Preferred Ter View
Weight increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA Preferred Ter View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA Preferred Ter View
Akathisia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Preferred Ter View
Extrapyramidal disorder NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Preferred Ter View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Preferred Ter View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Preferred Ter View
Agitation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA Preferred Ter View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA Preferred Ter View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA Preferred Ter View
Irritability NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA Preferred Ter View
Restlessness NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA Preferred Ter View
Nasal congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Preferred Ter View
Oropharyngeal pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Preferred Ter View
Acne NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA Preferred Ter View
Hyperkeratosis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA Preferred Ter View
Abdominal pain upper NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Preferred Ter View