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 @ 5:56 PM
Ignite Modification Date: 2025-12-25 @ 3:19 PM
NCT ID: NCT01227668
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT01227668
Study Brief: Phase IV Long-term Maintenance Study of Aripiprazole in the Treatment of Irritability Associated 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
Aripiprazole, 2-15 mg (Phase 2) Phase 2: Participants continued aripiprazole at the dose prescribed at the end of Phase 1, once daily for 16 weeks. The dose (within the range of 2-15 mg/day) could have been adjusted based on efficacy and tolerability. None None 0 39 11 39 View
Aripiprazole, 2-15 mg (Phase 1) Phase 1: Participants received an initial dose of aripiprazole 2 mg daily, titered up to 5, 10, or 15 mg once daily to optimize clinical benefit, for a maximum of 26 weeks. None None 1 155 112 155 View
Placebo (Phase 2 Only) Phase 2 only: Participants received placebo for 16 weeks. None None 0 43 5 43 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Aggression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Movement disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Increased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.0 View
Lethargy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Aggression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders 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