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 @ 11:48 AM
Ignite Modification Date: 2025-12-26 @ 10:20 AM
NCT ID: NCT01575561
Description: None
Frequency Threshold: 2
Time Frame: 12 weeks
Study: NCT01575561
Study Brief: This is an Open-label, Multi-center, Extension Study Designed to Evaluate the Longer Term Safety, Tolerability and Effectiveness of Lurasidone, Flexibly Dosed, Adjunctive to Lithium or Divalproex for the Treatment of Subjects With Bipolar I Disorder Who Have Participated in Study D1050296
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, 60,80 mg flexible dose Lurasidone: Lurasidone 20-80 mg taken orally once daily None None 14 377 51 377 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
anaemia megaloblastic NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.0 View
craniocerebral injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
femur fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
intentional overdose NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
basal cell carcinoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.0 View
depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.0 View
mania NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.0 View
bipolar disorder NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.0 View
emotional distress NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.0 View
panic attack NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.0 View
persecutory delusion NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.0 View
accelerated hyertension NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
akathisia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.0 View