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 @ 2:39 AM
Ignite Modification Date: 2025-12-26 @ 1:16 AM
NCT ID: NCT02585934
Description: None
Frequency Threshold: 2
Time Frame: Screening through post treatment (up to 33 weeks)
Study: NCT02585934
Study Brief: Study Evaluating Intepirdine (RVT-101) in Subjects With Mild to Moderate Alzheimer's Disease on Donepezil: MINDSET Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
RVT-101 Treatment RVT-101 adjunct to 5 mg or 10 mg donepezil RVT-101: once daily, oral, 35 mg tablets for up to 27 weeks 3 None 40 656 191 656 View
Screening Period Participants screened (0-4 weeks) prior to entering to the first dose of single-blind study medication (ie, prior to the Run-In period) 1 None 12 2173 0 2173 View
RVT-101 Post-Treatment Subjects reported adverse events after completing the treatment period. The Post-Treatment period - defined as up to 30 days post-last-dose 0 None 3 656 0 656 View
Placebo Post-Treatment Subjects reported adverse events after completing the treatment period. The Post-Treatment period - defined as up to 30 days post-last-dose 1 None 3 651 0 651 View
Placebo Treatment Placebo adjunct to 5 mg or 10 mg donepezil Placebo: once daily, oral, pill manufactured to match RVT-101 35 mg tablet for up to 27 weeks 2 None 44 651 166 651 View
Run-In Period Placebo adjunct to 5 mg or 10 mg donepezil Placebo: once daily, oral, pill manufactured to match RVT-101 35 mg tablet (for 3 weeks) 1 None 14 1470 0 1470 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardio-respiratory arrest SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Mitral valve prolapse SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pericardial effusion SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Right ventricular failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Sinus node dysfunction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Delirium SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Mental status changes SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Mood altered SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Psychotic disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Somatic symptom disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Cerebrovascular Accident SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Transient ischaemic attack SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Ischaemic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dementia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hypoxic-ischaemic encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Lethargy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Status epilepticus SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Basal cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Acoustic neuroma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Breast cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Hepatocellular carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Lung neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Malignant melanoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Meningioma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Ovarian cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Prostate cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Squamous cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Uterine leiomyoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atrial Fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Angina unstable SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atrioventricular block SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Hip fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Patella fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Pelvic fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Stoma obstruction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Subdural haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Upper limb fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Wrist fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Duodenal vascular ectasia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pancreatitis acute SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Proctitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Small intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Upper gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Aggression SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Pneumonia aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Chest pain SYSTEMATIC_ASSESSMENT General disorders None View
Hypothermia SYSTEMATIC_ASSESSMENT General disorders None View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders None View
Inner ear disorder SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Vertigo positonal SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Bile duct stone SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Poor peripheral circulation SYSTEMATIC_ASSESSMENT Vascular disorders None View
Haemoglobin decreased SYSTEMATIC_ASSESSMENT Investigations None View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Benign prostatic hyperplasia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Humerus fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Volvulus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
lower respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Squamous cell carcinoma of skin SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Infected bite SYSTEMATIC_ASSESSMENT Infections and infestations None View
Foot fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Pubis fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Pneumothorax spontaneous SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Asthenia SYSTEMATIC_ASSESSMENT General disorders None View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hydrocephalus SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Gait disturbance SYSTEMATIC_ASSESSMENT General disorders None View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
invasive ductal breast carcinoma SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Bronchitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View