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: 2025-12-26 @ 10:37 AM
Ignite Modification Date: 2025-12-26 @ 10:37 AM
NCT ID: NCT01435928
Description: None
Frequency Threshold: 3
Time Frame: For the open label phase - all subjects SAEs and AEs were reported over 24 weeks. For the double blind phase, lurasidone and placebo, SAEs and AEs were reported over 28 weeks. The study was stopped once the anticipated number of relapses were reached.
Study: NCT01435928
Study Brief: PEARL Schizophrenia Maintenance
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
All Subjects During the Open Label Phase subjects will receive Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating None None 59 676 373 676 View
Lurasidone During double blind phase subjects received Lurasidone flexibly dosed 40 or 80 mg once daily None None 6 144 46 144 View
Placebo During double blind phase subjects received matching placebo. None None 11 141 47 141 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.0 View
Artial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.0 View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Drug ineffective SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Sudden cardiac death SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Therapeutic response delayed SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Cholelithiasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 15.0 View
Intentional overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
Overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
Facial bones fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
Radius fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
Toxicity to various agents SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
Road traffic accident SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.0 View
Hyponytremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.0 View
Pin in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Akathasia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Transient ischemic attach SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Schizophrenia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.0 View
Psychotic disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.0 View
Suicidal ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.0 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.0 View
Acute psychosis SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.0 View
Aggression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.0 View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.0 View
Hallucination, auditory SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.0 View
Homicidal ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.0 View
Hostility SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.0 View
Psychiatric decompensation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.0 View
Substance induced psychotic disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.0 View
Suicide attempt SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.0 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.0 View
Acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Schizophrenia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.0 View
Psychotic disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Weight increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Akathisia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Dystonia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Sedation SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.0 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.0 View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.0 View