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 @ 6:31 PM
Ignite Modification Date: 2025-12-25 @ 4:01 PM
NCT ID: NCT01358357
Description: During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
Frequency Threshold: 3
Time Frame: For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
Study: NCT01358357
Study Brief: Bipolar Maintenance Study of Lurasidone Adjunctive to Lithium or Divalproex
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 20-80 mg Flexible Dose Lurasidone: Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter None None 13 246 81 246 View
Placebo Placebo: 20-80 mg flexible dose None None 11 250 81 250 View
All Subjects During the open-label stabilization phase, subjects received flexible does of lurasidone 20-80 mg daily None None 41 962 474 962 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Artiral fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders 15.0 View
Adominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Medra 15.0 View
Chest discomfort NON_SYSTEMATIC_ASSESSMENT General disorders Medra 15.0 View
Cholelithiasis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders Medra 15.0 View
Cholecytitis acute NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders Medra 15.0 View
Cholecystitis chronic NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders Medra 15.0 View
Appendicitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations Medra 15.0 View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations Medra 15.0 View
Postoperative Wound Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations Medra 15.0 View
Ankle Fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications Medra 15.0 View
Clavicle Fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications Medra 15.0 View
Facial Bones Fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications Medra 15.0 View
Lower Limb Fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications Medra 15.0 View
Toxicity to Various Agents NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications Medra 15.0 View
Alanine Aminotransferase Increased NON_SYSTEMATIC_ASSESSMENT Investigations Medra 15.0 View
Aspartate Aminotransferase Increased NON_SYSTEMATIC_ASSESSMENT Investigations Medra 15.0 View
Hypokalaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders Medra 15.0 View
Type 2 Diabetes Mellitus NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders Medra 15.0 View
Back Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders Medra 15.0 View
Chondromalacia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders Medra 15.0 View
Patellofemoral Pain Syndrome NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders Medra 15.0 View
Benign Ovarian Tumour NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) Medra 15.0 View
Brain Neoplasm NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) Medra 15.0 View
Ovarian Cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) Medra 15.0 View
Convulsion NON_SYSTEMATIC_ASSESSMENT Nervous system disorders Medra 15.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders Medra 15.0 View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders Medra 15.0 View
Mania NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders Medra 15.0 View
Agitation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders Medra 15.0 View
Suicidal Ideation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders Medra 15.0 View
Bipolar 1 Disorder NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders Medra 15.0 View
Bipolar Disorder NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders Medra 15.0 View
Intentional Self Injury NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders Medra 15.0 View
Suicide Attempt NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders Medra 15.0 View
Depressive Symptom NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders Medra 15.0 View
Acute Psychosis NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders Medra 15.0 View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders Medra 15.0 View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders Medra 15.0 View
Panic Attack NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders Medra 15.0 View
Somatoform Disorder NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders Medra 15.0 View
Nephrolithiasis NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders 15.0 View
Ovarian Cyst NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders Medra 15.0 View
Uterine Prolapse NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders Medra 15.0 View
Asthma NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Medra 15.0 View
Hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders Medra 15.0 View
Joint Swelling NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders Medra 15.0 View
Cerebral edema NON_SYSTEMATIC_ASSESSMENT Nervous system disorders Medra 15.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 15.0 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Medra 15.0 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Medra 15.0 View
Fatigue NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Medra 15.0 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations Medra 15.0 View
Upper Respiratory Tract Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations Medra 15.0 View
Weight Increased NON_SYSTEMATIC_ASSESSMENT Investigations Medra 15.0 View
Increased Appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders Medra 15.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders Medra 15.0 View
Tremor NON_SYSTEMATIC_ASSESSMENT Nervous system disorders Medra 15.0 View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders Medra 15.0 View
Sedation NON_SYSTEMATIC_ASSESSMENT Nervous system disorders Medra 15.0 View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders Medra 15.0 View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders Medra 15.0 View
Akathisia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders Medra 15.0 View