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 @ 11:20 PM
Ignite Modification Date: 2025-12-25 @ 9:03 PM
NCT ID: NCT04203056
Description: Note: Dosages are not assigned levels of the intervention and dosage levels may be changed at any time throughout the 12-month intervention based on clinical need and clinician judgement. Starting dosages do not indicate separate treatment conditions. Therefore, Adverse events are not separated according to starting dosage. In any case, there were no serious adverse events to report for patients in the AL-LAI arm of the study.
Frequency Threshold: 5
Time Frame: Adverse event data were collected from the time of enrollment (signing the informed consent form) until completing the 12 month protocol or withdrawing early.
Study: NCT04203056
Study Brief: Aripiprazole Lauroxil for Preventing Psychotic Relapse After an Initial Schizophrenia Episode
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
AL-LAI: Long-Acting Injectable Antipsychotic Patients successfully completing the Stabilization period will be randomized to one of the two medications groups: For patients assigned to the AL-LAI (aripiprazole lauroxil- long-acting injections), initiation of AL-LAI will begin with a one-day initiation regimen (using AL-NCD IM (aripiprazole lauroxil NanoCrystal Dispersion)). Subsequent dosing of AL-LAI will be flexible based on clinician judgment. Treatment with AL-LAI can be initiated at a dose of 441mg or 661mg (administered monthly), 882mg (administered monthly or every 6 weeks), or 1064mg (administered every 2 months). Aripiprazole Lauroxil: 12 month longitudinal aripirprazole lauroxil treatment and assessment follow-through AL-NCD: Aripiprazole Lauroxil 675 MG/2.4 ML Intramuscular Suspension, Extended Release 0 None 0 6 0 6 View
ARI-ORAL: Aripiprazole Oral Antipsychotic Patients successfully completing the Stabilization period will be randomized to one of the two medications groups: Patients assigned to the oral medication condition will continue with ARI-ORAL. ARI-ORAL dosage will be flexible and dosage will be at the discretion of the treating psychiatrist. Patients discontinuing ARI-ORAL study drug after Randomization to oral antipsychotic medication, can remain in active treatment and follow-up within the study, and may be prescribed any of a number of first-line oral antipsychotics. ARI-ORAL: oral aripiprazole 0 None 1 9 0 9 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Arrest NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Other Events(If Any):