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 @ 11:30 PM
Ignite Modification Date: 2025-12-25 @ 9:17 PM
NCT ID: NCT00239356
Description: Participants were to continue to receive study drug until: treatment intolerance, voluntary withdrawal, death, lost to follow up, no longer receiving benefit, the study drug was otherwise available through marketed means, the development of the study drug was terminated by the sponsor, or until 01 November 2012, whichever came first.
Frequency Threshold: 5
Time Frame: AEs were collected up to the participant's last visit. SAEs that occurred within 4 weeks after study discontinuation were included.
Study: NCT00239356
Study Brief: Aripiprazole for Schizophrenia Outpatients Completing BMS Clinical Trials
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Bipolar I Disorder 5 - 30 mg QD Aripiprazole for Bipolar I Disorder participants: Tablets, Oral, 5 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country. None None 0 20 10 20 View
Schizophrenia 10 - 30 mg QD Aripiprazole for schizophrenic participants: Tablets, Oral, 10 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country. None None 13 97 22 97 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Accidental overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.1 View
Intestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.1 View
Schizophrenia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.1 View
Treatment noncompliance SYSTEMATIC_ASSESSMENT Social circumstances MedDRA 15.1 View
Alcoholism SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.1 View
Gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.1 View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.1 View
Inadequate housing SYSTEMATIC_ASSESSMENT Social circumstances MedDRA 15.1 View
Psychosocial support SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 15.1 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.1 View
Overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.1 View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.1 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View