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 @ 2:55 PM
Ignite Modification Date: 2025-12-25 @ 1:20 PM
NCT ID: NCT00868959
Description: January 22, 2009 - February 19, 2013 - recruitment period
Frequency Threshold: 5
Time Frame: 24 Weeks
Study: NCT00868959
Study Brief: Lurasidone - A 24-week Extension Study of Patients With Bipolar I Depression
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 lurasidone: Lurasidone 20-120 mg/d Flexibly Dosed - 24 weeks None None 24 813 246 813 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.1 View
Disease Progression SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.1 View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.1 View
Hand Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.1 View
Radius Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.1 View
Road Traffic Accident SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.1 View
Lip Neoplasm Malignant Stage Unspecified SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 14.1 View
Completed Suicide SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.1 View
Depression Suicidal SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.1 View
Mania SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.1 View
Suicidal Ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.1 View
Major Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.1 View
Suicide Attempt SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.1 View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 14.1 View
Humerous Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.1 View
Lumbar Spinal Stenosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 14.1 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (14.1) View
Akathisia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (14.1) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (14.1) View
Parkinsonism SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (14.1) View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (14.1) View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (14.1) View