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 @ 12:14 AM
Ignite Modification Date: 2025-12-25 @ 10:16 PM
NCT ID: NCT01683058
Description: A SAE was any untoward medical occurrence that results in death or was life-threatening or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or any new problem, experienced by a participant when enrolled in a trial, whether or not it was considered drug related by the study physician.
Frequency Threshold: 5
Time Frame: AEs were recorded from the time the ICF was signed until follow-up for safety 14 (±2) days after the last trial visit.
Study: NCT01683058
Study Brief: Open-label, Extension Study of Aripiprazole Intramuscular Depot (OPC-14597, Lu AF41155) in Patients With Schizophrenia
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 IM Depot 400/300 mg All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks. None None 5 74 40 74 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Abortion spontaneous NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA 16.0 View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 16.0 View
Schizophrenia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 16.0 View
Suicidal ideation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 16.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Weight decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 16.0 View
Weight increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 16.0 View
Hyperlipidaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 16.0 View
Akathisia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16.0 View