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 @ 6:43 PM
Ignite Modification Date: 2025-12-25 @ 4:14 PM
NCT ID: NCT00508157
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00508157
Study Brief: A Phase 4 Study to Assess the Effects of Aripiprazole Versus Other Atypical Antipsychotics in the Treatment of Schizophrenic Patients With Metabolic Syndrome
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 Aripiprazole 5 mg, 10 mg, and 15 mg tablets: 5 mg once daily (QD) orally during the first week; 10 mg QD orally during the second week. Dosing was adjusted in 5 mg increments every 7 days within a range of 10 to 30 mg daily. Participants were treated for 16 weeks. None None 0 25 9 25 View
Control Group Olanzapine 5 mg and 10 mg, risperidone 1 mg and 4 mg, and quetiapine 100 mg and 200 mg oral tablets. Participants entered the study at the same dose as prior to randomization. Dose adjustments during the study were allowed within the dose range specified in the respective Summaries of Product Characteristics (SmPCs), according the investigator's judgment. Participants were treated for 16 weeks. None None 0 26 2 26 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Blood cholesterol increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.1 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.1 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View