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 @ 3:31 PM
Ignite Modification Date: 2025-12-24 @ 3:31 PM
NCT ID: NCT00862992
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT00862992
Study Brief: Safety, Pharmacokinetics and Efficacy Study of MP-214 in Patients With 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
Cariprazine 3 mg None None None 3 12 9 12 View
Cariprazine 6 mg None None None 1 10 9 10 View
Cariprazine 12.5 mg None None None 2 12 11 12 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Tibia fracture None Injury, poisoning and procedural complications MedDRA 12.0 View
Blood creatine phosphokinase increased None Investigations MedDRA 12.0 View
Neuroleptic malignant syndrome None Nervous system disorders MedDRA 12.0 View
Schizophrenia None Psychiatric disorders MedDRA 12.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pyrexia None General disorders MedDRA 12.0 View
Thirst None General disorders MedDRA 12.0 View
Nasopharyngitis None Infections and infestations MedDRA 12.0 View
Urinary tract infection None Infections and infestations MedDRA 12.0 View
Contusion None Injury, poisoning and procedural complications MedDRA 12.0 View
Hand fracture None Injury, poisoning and procedural complications MedDRA 12.0 View
Nail injury None Injury, poisoning and procedural complications MedDRA 12.0 View
Skin laceration None Injury, poisoning and procedural complications MedDRA 12.0 View
Thermal burn None Injury, poisoning and procedural complications MedDRA 12.0 View
Alanine aminotransferase increased None Investigations MedDRA 12.0 View
Aspartate aminotransferase increased None Investigations MedDRA 12.0 View
Blood bilirubin increased None Investigations MedDRA 12.0 View
Blood creatine phosphokinase increased None Investigations MedDRA 12.0 View
Blood lactate dehydrogenase increased None Investigations MedDRA 12.0 View
Blood potassium increased None Investigations MedDRA 12.0 View
Blood pressure decreased None Investigations MedDRA 12.0 View
Blood pressure increased None Investigations MedDRA 12.0 View
Blood prolactin increased None Investigations MedDRA 12.0 View
Blood triglycerides increased None Investigations MedDRA 12.0 View
Blood uric acid increased None Investigations MedDRA 12.0 View
Blood urine present None Investigations MedDRA 12.0 View
Glucose urine present None Investigations MedDRA 12.0 View
Hepatic enzyme increased None Investigations MedDRA 12.0 View
White blood cell count decreased None Investigations MedDRA 12.0 View
White blood cell count increased None Investigations MedDRA 12.0 View
Polydipsia None Metabolism and nutrition disorders MedDRA 12.0 View
Arthritis None Musculoskeletal and connective tissue disorders MedDRA 12.0 View
Myalgia None Musculoskeletal and connective tissue disorders MedDRA 12.0 View
Akathisia None Nervous system disorders MedDRA 12.0 View
Dysarthria None Nervous system disorders MedDRA 12.0 View
Headache None Nervous system disorders MedDRA 12.0 View
Hyperaesthesia None Nervous system disorders MedDRA 12.0 View
Hypoaesthesia None Nervous system disorders MedDRA 12.0 View
Parkinsonism None Nervous system disorders MedDRA 12.0 View
Sleep paralysis None Nervous system disorders MedDRA 12.0 View
Somnolence None Nervous system disorders MedDRA 12.0 View
Tremor None Nervous system disorders MedDRA 12.0 View
Insomnia None Psychiatric disorders MedDRA 12.0 View
Restlessness None Psychiatric disorders MedDRA 12.0 View
Dysuria None Renal and urinary disorders MedDRA 12.0 View
Pollakiuria None Renal and urinary disorders MedDRA 12.0 View
Urinary retention None Renal and urinary disorders MedDRA 12.0 View
Epistaxis None Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
Productive cough None Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
Upper respiratory tract inflammation None Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
Dermatitis contact None Skin and subcutaneous tissue disorders MedDRA 12.0 View
Eczema None Skin and subcutaneous tissue disorders MedDRA 12.0 View
Hyperkeratosis None Skin and subcutaneous tissue disorders MedDRA 12.0 View
Poor personal hygiene None Social circumstances MedDRA 12.0 View
Orthostatic hypotension None Vascular disorders MedDRA 12.0 View
Hyperthyroidism None Endocrine disorders MedDRA 12.0 View
Nausea None Gastrointestinal disorders MedDRA 12.0 View
Salivary hypersecretion None Gastrointestinal disorders MedDRA 12.0 View
Stomatitis None Gastrointestinal disorders MedDRA 12.0 View
Toothache None Gastrointestinal disorders MedDRA 12.0 View
Feeling abnormal None General disorders MedDRA 12.0 View
Malaise None General disorders MedDRA 12.0 View
Sinus bradycardia None Cardiac disorders MedDRA 12.0 View
Vertigo None Ear and labyrinth disorders MedDRA 12.0 View
Conjunctivitis None Eye disorders MedDRA 12.0 View
Dry eye None Eye disorders MedDRA 12.0 View
Abdominal distension None Gastrointestinal disorders MedDRA 12.0 View
Abdominal pain upper None Gastrointestinal disorders MedDRA 12.0 View
Cheilitis None Gastrointestinal disorders MedDRA 12.0 View
Constipation None Gastrointestinal disorders MedDRA 12.0 View
Diarrhoea None Gastrointestinal disorders MedDRA 12.0 View
Enterocolitis None Gastrointestinal disorders MedDRA 12.0 View
Gastritis None Gastrointestinal disorders MedDRA 12.0 View
Inguinal hernia None Gastrointestinal disorders MedDRA 12.0 View
Lip dry None Gastrointestinal disorders MedDRA 12.0 View