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: 2025-12-24 @ 9:36 PM
Ignite Modification Date: 2025-12-25 @ 7:19 PM
NCT ID: NCT00576732
Description: None
Frequency Threshold: 5
Time Frame: Double-blind period: 6 weeks. Open-label period: 6 months.
Study: NCT00576732
Study Brief: A Study of the Effectiveness and Safety of Two Doses of Risperidone in the Treatment of Children and Adolescents With Autistic Disorder
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Double-blind Period. Oral solution for 6 weeks. None None 1 35 20 35 View
Risperidone Low Dose Double-blind Period. Risperidone oral solution 0.125 mg (if \<45 kg) or 0.175 mg (if \>=45 kg) for 6 weeks. None None 0 30 12 30 View
Risperidone High Dose Double-blind Period. Risperidone oral solution 1.25 mg (if \<45 kg) or 1.75 mg (if \>=45 kg) for 6 weeks. None None 0 31 27 31 View
Open-label Risperidone Subjects who continued into open-label risperidone period. Risperidone oral solution 0.125 mg (if \<45 kg) or 0.175 mg (if \>=45 kg) for 3 days, 0.25 mg tablet on Day 4, flexible dose in 0.25 mg or 0.5 mg increments every 2 weeks, as clinically indicated, to a maximum dose of 1.25 mg (if \<45 kg) or 1.75 mg (if \>=45 kg). None None 1 79 39 79 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Aggression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12.1 View
Hydrocele NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 12.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Abdominal discomfort NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Abdominal pain upper NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Aggression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12.1 View
Agitation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12.1 View
Akathisia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12.1 View
Ear infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Enuresis NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12.1 View
Epistaxis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.1 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
Hypersomnia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
Increased appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.1 View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12.1 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Psychomotor hyperactivity NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.1 View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12.1 View
Sedation NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
Thirst NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.1 View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Weight increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.1 View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.1 View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.1 View