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 @ 4:30 AM
Ignite Modification Date: 2025-12-26 @ 3:33 AM
NCT ID: NCT00549718
Description: None
Frequency Threshold: 5
Time Frame: 14 days post study therapy
Study: NCT00549718
Study Brief: Lurasidone HCl: A 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 40mg Lurasidone 40 mg tablets taken once a day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 3 subjects were randomized but never received a dose of study drug. None None 2 124 96 124 View
Lurasidone 80mg lurasidone 40m mg tablets taken once/day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 4 subjects were randomized but never received a dose of study drug. None None 3 121 90 121 View
Lurasidone 120mg Lurasidone 40 mg tablets taken once/day None None 6 124 106 124 View
Placebo Matching placebo to Lurasidone 40 mg taken once/day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 4 subjects were randomized but never received a dose of study drug. None None 5 127 85 127 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cholecystitis None Hepatobiliary disorders MedDRA (10.0) View
Staphylococcal Infection None Infections and infestations MedDRA (10.0) View
Blood Lactate Dehydrogenase Increased None Investigations MedDRA (10.0) View
Psychotic Disorders None Psychiatric disorders MedDRA (10.0) View
Schizophrenia None Psychiatric disorders MedDRA (10.0) View
Complex Partial Seizures None Nervous system disorders MedDRA (10.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Back Pain None Musculoskeletal and connective tissue disorders MedDRA (10.0) View
Akathisia None Nervous system disorders MedDRA (10.0) View
Dystonia None Nervous system disorders MedDRA (10.0) View
Headache None Nervous system disorders MedDRA (10.0) View
Parkinsonism None Nervous system disorders MedDRA (10.0) View
Sedation None Nervous system disorders MedDRA (10.0) View
Somnolence None Nervous system disorders MedDRA (10.0) View
Agitation None Psychiatric disorders MedDRA (10.0) View
Weight Increase None Investigations MedDRA (10.0) View
Insomnia None Psychiatric disorders MedDRA (10.0) View
Dyspepsia None Gastrointestinal disorders MedDRA (10.0) View
Nausea None Gastrointestinal disorders MedDRA (10.0) View
Vomiting None Gastrointestinal disorders MedDRA (10.0) View