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 @ 3:05 AM
Ignite Modification Date: 2025-12-26 @ 1:44 AM
NCT ID: NCT02669433
Description: None
Frequency Threshold: 5
Time Frame: Screening through post treatment (up to 33 weeks)
Study: NCT02669433
Study Brief: Study Evaluating Intepirdine (RVT-101) in Subjects With Dementia With Lewy Bodies: The HEADWAY-DLB 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 70 mg RVT-101 70 mg once daily RVT-101 70 mg: once daily, oral, 35-mg tablets 2 None 13 88 59 88 View
Placebo Placebo Placebo: once daily, oral, matching tablets 1 None 11 91 66 91 View
RVT-101 35 mg RVT-101 35 mg once daily RVT-101 35 mg: once daily, oral, 35-mg tablets 1 None 11 89 69 89 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Deep vein Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19.1 View
Concussion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.1 View
Facial bones fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.1 View
Femur fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.1 View
Spinal compression fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.1 View
Atrial Flutter SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.1 View
Trifascicular block SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.1 View
Squamous cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.1 View
Basal cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.1 View
Prostatic adenoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.1 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.1 View
Ischaemic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Dementia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Haemorrhagic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Metabolic encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Transient ischaemic attack SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Subdural haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.1 View
Delirium SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.1 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.1 View
Hallucination, visual SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.1 View
Mental status change SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.1 View
Neuropsychiatric syndrome SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.1 View
Rectal Haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Diverticulum intestinal haemorrhagic SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Enteritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Volvulus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Cholecystitiis acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 19.1 View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 19.1 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.1 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.1 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Escherichia urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Lower respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Pyelonephritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Urosepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Hip fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.1 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Orthostatic hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19.1 View
Nasopharygitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Hallucination, visual SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.1 View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.1 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.1 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19.1 View