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 @ 2:10 AM
Ignite Modification Date: 2025-12-26 @ 12:37 AM
NCT ID: NCT01438060
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT01438060
Study Brief: Aripiprazole in the Treatment of Patients With Psychosis Associated With Dementia of Alzheimer's Type
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
3 Ext - Aripiprazole None None None 84 161 101 161 View
1 Double Blind Aripiprazole None None None 16 105 31 105 View
2 Double Blind Placebo None None None 8 102 27 102 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
ACUTE RESPIRATORY DISTRESS SYNDROME SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.1 View
MUSCULOSKELETAL STIFFNESS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.1 View
FALL SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.1 View
LEUKOPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12.1 View
PERIPHERAL ISCHAEMIA SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.1 View
DEHYDRATION SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.1 View
HUMERUS FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.1 View
ISCHAEMIC STROKE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
LETHARGY SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
PNEUMONIA ASPIRATION SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.1 View
PULMONARY OEDEMA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.1 View
DIABETES MELLITUS SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.1 View
FEMORAL NECK FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.1 View
MALNUTRITION SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.1 View
DEMENTIA SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
THROMBOSIS SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.1 View
SEPTIC SHOCK SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
VASCULAR DEMENTIA SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
BLOOD GLUCOSE INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.1 View
BRONCHOPNEUMONIA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
CARDIAC FAILURE SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.1 View
CARDIO-RESPIRATORY ARREST SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.1 View
CEREBROVASCULAR ACCIDENT SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
CHOLECYSTITIS SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 12.1 View
DELIRIUM SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12.1 View
HAND FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.1 View
PSYCHOTIC DISORDER SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12.1 View
SALIVARY GLAND NEOPLASM SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.1 View
SCIATICA SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
SOCIAL PROBLEM SYSTEMATIC_ASSESSMENT Social circumstances MedDRA 12.1 View
SUDDEN CARDIAC DEATH SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.1 View
SYNCOPE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
AGGRESSION SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12.1 View
CATARACT SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 12.1 View
RESPIRATORY ARREST SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.1 View
VARICOSE VEIN SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.1 View
VOMITING SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
ABDOMINAL PAIN SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
ANAEMIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12.1 View
BRADYCARDIA SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.1 View
BRONCHITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
CHEST PAIN SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.1 View
CHILLS SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.1 View
HIP FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.1 View
LOSS OF CONSCIOUSNESS SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
LUNG INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
MENDELSON'S SYNDROME SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.1 View
MYOCARDIAL ISCHAEMIA SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.1 View
PANCREATIC CARCINOMA METASTATIC SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.1 View
PELVIC FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.1 View
RESPIRATORY DISTRESS SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.1 View
SUDDEN DEATH SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.1 View
TRANSIENT ISCHAEMIC ATTACK SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
ACQUIRED DIAPHRAGMATIC EVENTRATION SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.1 View
CARDIOVASCULAR INSUFFICIENCY SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.1 View
DEATH SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.1 View
DIABETIC COMA SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
ECZEMA VESICULAR SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12.1 View
ESCHERICHIA SEPSIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
FEMUR FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.1 View
HAEMOPTYSIS SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.1 View
LUNG DISORDER SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.1 View
MUSCLE RIGIDITY SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.1 View
OSTEOARTHRITIS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.1 View
SALIVARY HYPERSECRETION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
SEPSIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
URINARY RETENTION SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12.1 View
URINARY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
BRONCHOPNEUMOPATHY SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.1 View
CIRCULATORY COLLAPSE SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.1 View
DYSPNOEA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.1 View
PROSTATE CANCER SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.1 View
PYELONEPHRITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
DEMENTIA ALZHEIMER'S TYPE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
EPILEPSY SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
ERYSIPELAS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
FAECALOMA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
HEPATITIS ACUTE SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 12.1 View
INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
INTESTINAL OBSTRUCTION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
JAW FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.1 View
PSYCHOSOCIAL SUPPORT SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 12.1 View
PULMONARY EMBOLISM SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.1 View
ACUTE PULMONARY OEDEMA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.1 View
ASTHENIA SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.1 View
CARDIAC ARREST SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.1 View
CARDIAC FAILURE ACUTE SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.1 View
CARDIOPULMONARY FAILURE SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.1 View
MALAISE SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.1 View
PNEUMONIA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
PYREXIA SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.1 View
RENAL FAILURE SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12.1 View
ATRIAL FLUTTER SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.1 View
CONFUSIONAL STATE SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12.1 View
DIARRHOEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
EMBOLISM SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.1 View
HAEMATEMESIS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
MYOCARDIAL INFARCTION SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
URINARY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
APATHY SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12.1 View
VOMITING SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
CONSTIPATION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
OSTEOARTHRITIS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.1 View
SOMNOLENCE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
FALL SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.1 View
INSOMNIA SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12.1 View
ANXIETY SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12.1 View
OEDEMA PERIPHERAL SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.1 View
DIARRHOEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
EXTRAPYRAMIDAL DISORDER SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
BRONCHITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View