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 @ 3:22 PM
Ignite Modification Date: 2025-12-25 @ 1:41 PM
NCT ID: NCT00790192
Description: None
Frequency Threshold: 5
Time Frame: 14 days post study therapy
Study: NCT00790192
Study Brief: Lurasidone HCL - A 6-week Phase 3 Study of Patients With Acute 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
Lurasidone 80 mg Lurasidone 80 mg tablets taken orally once a day None None 1 125 71 125 View
Lurasidone 160 mg Lurasidone 160 mg (4 tablets) taken orally once a day None None 4 121 76 121 View
Quetiapine XR 600mg Quetiapine XR 600 mg (4 tablets) orally taken once a day None None 1 119 70 119 View
Placebo Matching placebo to either lurasidone or quetiapine XR. The total for this group is 73 and the adverse events only add up to 69 because the total is based on all treatment emergent adverse events not limited to \>= 5%. None None 4 121 69 121 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Left Ventricular Dysfunction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Non-cardiac Chest Pain SYSTEMATIC_ASSESSMENT General disorders None View
Hand Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Agression SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Suicidal Behavior SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Suicidal Ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Labile Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Abdominal Hernia Obstructive SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hepatitis Viral SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pyschotic Disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Schizophrenia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Physical Assault SYSTEMATIC_ASSESSMENT Social circumstances None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dry Mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Weight Increase SYSTEMATIC_ASSESSMENT Investigations None View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Akathisia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Parkinsonism SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View