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 @ 2:39 AM
Ignite Modification Date: 2025-12-26 @ 1:17 AM
NCT ID: NCT01421134
Description: None
Frequency Threshold: 2
Time Frame: 6 Weeks
Study: NCT01421134
Study Brief: Major Depressive Disorder (MDD) With Mixed Features - Flexible Dose
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 20, 40 or 60 mg Lurasidone: 20, 40, 60 mg, flexible dose, once daily PM 6 weeks None None 1 109 31 109 View
Placebo Placebo Placebo: Placebo None None 0 100 29 100 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Depression Suicidal SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Somnoelence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Akathisia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.0 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.0 View
Haemarturia SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 14.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 14.0 View