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: 2025-12-25 @ 4:41 AM
Ignite Modification Date: 2025-12-26 @ 3:43 AM
NCT ID: NCT00102518
Description: Spontaneously reported at each visit in response to query of "How have you felt since your last assessment?"
Frequency Threshold: 5
Time Frame: Adverse event data were collected as spontaneous reports at all scheduled visit. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.
Study: NCT00102518
Study Brief: Aripiprazole Open-Label, Safety and Tolerability Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
NCT00102063 and NCT00110461 Subjects All subjects had either completed or had withdrawn from the double-blind extension phase of study 31-03-240 and study 31-03-239. None None 20 325 230 325 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Bronchitis acute NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9.1 View
Hepatitis A NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9.1 View
Electrocution NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 9.1 View
Intentional overdose NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 9.1 View
Acute psychosis NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 9.1 View
Aggression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 9.1 View
Bipolar disorder NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 9.1 View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 9.1 View
Hallucination, auditory NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 9.1 View
Homicidal ideation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 9.1 View
Impulsive behavior NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 9.1 View
Psychotic disorder NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 9.1 View
Schizophrenia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 9.1 View
Suicidal ideation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 9.1 View
Intentional self injury NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 9.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9.1 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9.1 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9.1 View
Weight increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 9.1 View
Increased appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 9.1 View
Akathisia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9.1 View
Extrapyramidal disorder NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9.1 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9.1 View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9.1 View
Tremor NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9.1 View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 9.1 View