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 @ 9:50 PM
Ignite Modification Date: 2025-12-25 @ 7:27 PM
NCT ID: NCT02446132
Description: Safety population included all subjects who received the study treatment.
Frequency Threshold: 5
Time Frame: From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Study: NCT02446132
Study Brief: Long Term, Extension Study of the Safety and Efficacy of AVP-786 for the Treatment of Agitation in Patients With Dementia of the 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
AVP-786 18 mg Participants who received AVP-786-18 (d6-DM 18 mg/Q 4.9 mg) capsules in the previous studies 15-AVP-786-301 (NCT02442765), 15-AVP-786-302 (NCT02442778), or 17-AVP-786-305 (NCT03393520) continued to receive AVP-786-18 (d6-DM 18 mg/Q 4.9 mg), capsules, twice a day for 52 weeks in the current study. 4 None 22 166 54 166 View
AVP-786 28 mg Participants who received AVP-786-28 (d6-DM 28 mg/Q 4.9 mg) capsules in the previous studies 15-AVP-786-301 (NCT02442765), 15-AVP-786-302 (NCT02442778), or 17-AVP-786-305 (NCT03393520) continued to receive AVP-786-28 (d6-DM 28 mg/Q 4.9 mg), capsules, twice a day for 52 weeks in the current study. 22 None 75 516 150 516 View
AVP-786 42.63 mg Participants who received placebo in the previous studies 15-AVP-786-301 (NCT02442765), 15-AVP-786-302 (NCT02442778), or 17-AVP-786-305 (NCT03393520) and those who had delayed enrolment, started AVP-786-28/4.9 (d6-DM 28 mg/Q 4.9 mg) in the current study and were eventually titrated to receive AVP-786-42.63/4.9 (d6-DM 42.63 mg/Q 4.9 mg) capsules, twice a day for 52 weeks. 16 None 70 509 149 509 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA27.0 View
Leukocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA27.0 View
Normocytic anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA27.0 View
Thrombocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA27.0 View
Cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA27.0 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA27.0 View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA27.0 View
Cardio-respiratory arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA27.0 View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA27.0 View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA27.0 View
Coronary artery disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA27.0 View
Sinus bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA27.0 View
Acute coronary syndrome SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA27.0 View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA27.0 View
Atrioventricular block complete SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA27.0 View
Atrioventricular block first degree SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA27.0 View
Bundle branch block left SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA27.0 View
Bundle branch block right SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA27.0 View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA27.0 View
Cardiac failure acute SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA27.0 View
Cardiopulmonary failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA27.0 View
Ischaemic cardiomyopathy SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA27.0 View
Left ventricular failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA27.0 View
Pulmonary valve stenosis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA27.0 View
Keratitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA27.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA27.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA27.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA27.0 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA27.0 View
Gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA27.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA27.0 View
Small intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA27.0 View
Diverticular perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA27.0 View
Faecaloma SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA27.0 View
Gastric ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA27.0 View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA27.0 View
Inguinal hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA27.0 View
Melaena SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA27.0 View
Pancreatitis acute SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA27.0 View
Volvulus of small bowel SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA27.0 View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA27.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA27.0 View
Disease progression SYSTEMATIC_ASSESSMENT General disorders MedDRA27.0 View
Inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA27.0 View
Multiple organ dysfunction syndrome SYSTEMATIC_ASSESSMENT General disorders MedDRA27.0 View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA27.0 View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA27.0 View
Cholecystitis acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA27.0 View
Cholelithiasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA27.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA27.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA27.0 View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA27.0 View
Cystitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA27.0 View
Pneumonia aspiration SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA27.0 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA27.0 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA27.0 View
Abdominal abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA27.0 View
Bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA27.0 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA27.0 View
COVID-19 pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA27.0 View
Colonic abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA27.0 View
Diarrhoea infectious SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA27.0 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA27.0 View
Gastroenteritis viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA27.0 View
Lower respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA27.0 View
Lower respiratory tract infection viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA27.0 View
Necrotising fasciitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA27.0 View
Pneumonia viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA27.0 View
Psoas abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA27.0 View
Pyuria SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA27.0 View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA27.0 View
Urosepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA27.0 View
Viral upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA27.0 View
Wound infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA27.0 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA27.0 View
Femur fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA27.0 View
Hip fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA27.0 View
Cervical vertebral fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA27.0 View
Femoral neck fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA27.0 View
Humerus fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA27.0 View
Pelvic fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA27.0 View
Skin laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA27.0 View
Ankle fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA27.0 View
Clavicle fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA27.0 View
Concussion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA27.0 View
Craniocerebral injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA27.0 View
Head injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA27.0 View
Incisional hernia SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA27.0 View
Intentional medical device removal by patient SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA27.0 View
Ligament rupture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA27.0 View
Lumbar vertebral fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA27.0 View
Rib fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA27.0 View
Spinal fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA27.0 View
Subdural haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA27.0 View
Tracheostomy malfunction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA27.0 View
Ulna fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA27.0 View
Wound dehiscence SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA27.0 View
Blood glucose increased SYSTEMATIC_ASSESSMENT Investigations MedDRA27.0 View
Blood osmolarity increased SYSTEMATIC_ASSESSMENT Investigations MedDRA27.0 View
Electrocardiogram QT prolonged SYSTEMATIC_ASSESSMENT Investigations MedDRA27.0 View
QRS axis abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA27.0 View
Troponin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA27.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA27.0 View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA27.0 View
Fluid retention SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA27.0 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA27.0 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA27.0 View
Lactic acidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA27.0 View
Musculoskeletal stiffness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA27.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA27.0 View
Myositis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA27.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA27.0 View
Spinal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA27.0 View
Myelodysplastic syndrome SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA27.0 View
Breast cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA27.0 View
Follicular thyroid cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA27.0 View
Invasive ductal breast carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA27.0 View
Lung cancer metastatic SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA27.0 View
Metastases to liver SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA27.0 View
Renal cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA27.0 View
Transitional cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA27.0 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA27.0 View
Dementia Alzheimer's type SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA27.0 View
Transient ischaemic attack SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA27.0 View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA27.0 View
Metabolic encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA27.0 View
Unresponsive to stimuli SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA27.0 View
Balance disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA27.0 View
Basal ganglia haematoma SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA27.0 View
Brain hypoxia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA27.0 View
Cerebral haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA27.0 View
Dementia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA27.0 View
Depressed level of consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA27.0 View
Dysstasia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA27.0 View
Generalised tonic-clonic seizure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA27.0 View
Guillain-Barre syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA27.0 View
Ischaemic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA27.0 View
Neurodegenerative disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA27.0 View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA27.0 View
Subarachnoid haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA27.0 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA27.0 View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA27.0 View
Mental status changes SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA27.0 View
Aggression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA27.0 View
Delirium SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA27.0 View
Suicidal ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA27.0 View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA27.0 View
Disturbance in social behaviour SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA27.0 View
Dysphemia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA27.0 View
Psychotic disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA27.0 View
Suicide attempt SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA27.0 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA27.0 View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA27.0 View
Azotaemia SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA27.0 View
Neurogenic bladder SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA27.0 View
Urinary tract obstruction SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA27.0 View
Prostatitis SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA27.0 View
Acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA27.0 View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA27.0 View
Acute respiratory distress syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA27.0 View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA27.0 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA27.0 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA27.0 View
Pneumonitis aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA27.0 View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA27.0 View
Pulmonary oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA27.0 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA27.0 View
Dermatitis contact SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA27.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA27.0 View
Orthostatic hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA27.0 View
Femoral artery aneurysm SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA27.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA27.0 View
Peripheral artery aneurysm SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA27.0 View
Peripheral artery occlusion SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA27.0 View
Peripheral embolism SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA27.0 View
Peripheral ischaemia SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA27.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.0 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.0 View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 27.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View