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 @ 4:07 PM
Ignite Modification Date: 2025-12-25 @ 2:08 PM
NCT ID: NCT01909466
Description: A SAE was an untoward medical occurrence resulted in death or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or a new problem experienced by a participant when enrolled in a trial whether or not it was considered drug related by study physician.
Frequency Threshold: 5
Time Frame: Adverse events were reported from the signing of the ICF until follow-up for up to 28 days after the last dose of study medication.
Study: NCT01909466
Study Brief: Safety and Tolerability Study of Aripiprazole IM Depot in Adult Subjects 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 mg - Total Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days. None None 4 138 112 138 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Atrial fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 16.0 View
Psychotic disorder NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 16.0 View
Schizophrenia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 16.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.0 View
Dyspepsia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.0 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.0 View
Toothache NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.0 View
Injection site pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.0 View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Weight increased NON_SYSTEMATIC_ASSESSMENT Investigations 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
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 16.0 View
Restlessness NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 16.0 View