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 @ 4:16 AM
Ignite Modification Date: 2025-12-26 @ 3:16 AM
NCT ID: NCT01028820
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT01028820
Study Brief: FMRI Brain Activation of Aripiprazole Treatment in Autism Spectrum Disorders
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Open-Label, Flexible-Dose Aripiprazole This is a single group assignment pharmacodynamics study in which all study participants are given an open-label, flexible dose of aripiprazole for up to 8 weeks. Aripiprazole : 8 weeks, starting dosage 5mg titrating up 5mg every week as needed to maximum dosage of 25mg daily None None 0 13 13 13 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anxiety SYSTEMATIC_ASSESSMENT Social circumstances None View
Body Pain SYSTEMATIC_ASSESSMENT General disorders None View
Depressed Mood SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Drowsiness SYSTEMATIC_ASSESSMENT General disorders None View
Dry Mouth SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Increased Appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Increased Sleep SYSTEMATIC_ASSESSMENT General disorders None View
Nausea SYSTEMATIC_ASSESSMENT General disorders None View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Restlessness SYSTEMATIC_ASSESSMENT General disorders None View
Tinnitus SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Tremors SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Urination SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Weight Gain SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View