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 @ 3:02 PM
Ignite Modification Date: 2025-12-25 @ 1:25 PM
NCT ID: NCT00365859
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00365859
Study Brief: Study of Aripiprazole in the Treatment of Serious Behavioral Problems in Children and Adolescents With Autistic Disorder (AD)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
De Novo None None None 3 86 73 86 View
Roll Over Aripiprazole None None None 5 174 136 174 View
Roll Over Placebo None None None 1 70 61 70 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
CHOLECYSTITIS SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 12 View
CHOLELITHIASIS SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 12 View
CONVULSION SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12 View
DYSPHAGIA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
SINUSITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12 View
SKIN INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12 View
OTITIS MEDIA ACUTE SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12 View
PHARYNGOTONSILLITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12 View
ASTHMA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12 View
IMPULSIVE BEHAVIOUR SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12 View
AGGRESSION SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12 View
SUICIDAL IDEATION SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
TIC SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12 View
WEIGHT INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 12 View
ANXIETY SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12 View
INSOMNIA SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12 View
AGITATION SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12 View
AGGRESSION SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12 View
DROOLING SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12 View
HEADACHE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12 View
LETHARGY SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12 View
SEDATION SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12 View
DYSKINESIA SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12 View
SOMNOLENCE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12 View
NAUSEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
VOMITING SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
DIARRHOEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
CONSTIPATION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
SINUSITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12 View
EAR INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12 View
NASOPHARYNGITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12 View
GASTROENTERITIS VIRAL SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12 View
UPPER RESPIRATORY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12 View
ENURESIS SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12 View
DECREASED APPETITE SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12 View
INCREASED APPETITE SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12 View
RASH SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12 View
COUGH SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12 View
EPISTAXIS SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12 View
NASAL CONGESTION SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12 View
RESPIRATORY TRACT CONGESTION SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12 View
FATIGUE SYSTEMATIC_ASSESSMENT General disorders MedDRA 12 View
PYREXIA SYSTEMATIC_ASSESSMENT General disorders MedDRA 12 View
IRRITABILITY SYSTEMATIC_ASSESSMENT General disorders MedDRA 12 View