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 @ 11:28 PM
Ignite Modification Date: 2025-12-25 @ 9:15 PM
NCT ID: NCT02097056
Description: Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment. Summary and analysis of adverse events were analyzed using TEAEs.
Frequency Threshold: 0
Time Frame: AEs were collected from Day 1 through Week 24 of study.
Study: NCT02097056
Study Brief: Safety and Efficacy of Donepezil HCl 23 mg in Patients With Moderate to Severe Alzheimer's Disease
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Donepezil Hydrochloride Donepezil hydrochloride (HCl) at 23 mg was administered once daily, just before bed, for 24 weeks. None None 12 170 109 170 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Femur fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.0 View
Rib fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.0 View
Ankle fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.0 View
Cervical vertebral fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.0 View
Ligament injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.0 View
Lumbar vertebral fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Gait disturbance SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Sleep disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.0 View
Compulsions SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.0 View
Compulsive hoarding SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.0 View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.0 View
Delusion SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.0 View
Depressed mood SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.0 View
Disinhibition SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Gait disturbance SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Productive cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Lethargy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.0 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Gastrointestinal disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Faecal incontinence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Dental caries SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Sedation SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Dreamy state SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Drooling SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Dysarthria SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Facial spasm SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Hypersomnia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.0 View
Aggression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.0 View
Behavioural and psychiatric symptoms of dementia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.0 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.0 View
Irritability SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.0 View
Nightmare SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.0 View
Restlessness SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.0 View
Hyperlipidaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.0 View
Hypophagia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.0 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.0 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.0 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.0 View
Electrocardiogram QT prolonged SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Blood glucose increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Glucose urine present SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Blood cholesterol increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Blood creatine phosphokinase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Blood triglycerides increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Electrocardiogram ST segment elevation SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Electrocardiogram T wave abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Ankle fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.0 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.0 View
Urinary incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.0 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.0 View
Enuresis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.0 View
Incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.0 View
Nocturia SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.0 View
Pollakiuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Periodontitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.0 View
Cold sweat SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Hiccups SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Nasal discomfort SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Rhinitis allergic SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Atrioventricular block second degree SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.0 View
Pallor SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.0 View
Eye pain SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 18.0 View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 18.0 View