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 @ 10:50 PM
Ignite Modification Date: 2025-12-25 @ 8:20 PM
NCT ID: NCT02046369
Description: number of participants at risk is equal to the number of patients in the safety population (172 in placebo and 175 in lurasidone)
Frequency Threshold: 5
Time Frame: Through study completion. Treatment emergent adverse event (TEAE) is defined as an AE with a start date on or after the date of first does through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete the double blind study but do not enter the extension study or early discontinue during the double blind study), or through the last study day of the double blind period for subjects continuing into the extension study
Study: NCT02046369
Study Brief: Lurasidone Pediatric Bipolar Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Luradisone Luradisone 20- 80 mg administered once daily Lurasidone: Lurasidone flexibly dosed 20-80 mg once daily None None 2 175 112 175 View
Placebo Placebo administered once daily Placebo: Placebo Comparator once daily None None 4 172 75 172 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Bipolar I disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (16.0) View
depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (16.0) View
psychotic disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (16.0) View
humerus fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (16.0) View
abortion spontaneous SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA (16.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (16.0) View
nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (16.0) View
vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (16.0) View
insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (16.0) View
nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (16.0) View
weight increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (16.0) View
headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (16.0) View
somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (16.0) View