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 @ 11:02 PM
Ignite Modification Date: 2025-12-25 @ 8:32 PM
NCT ID: NCT04764669
Description: None
Frequency Threshold: 0
Time Frame: From first dose of study drug up to Week 16
Study: NCT04764669
Study Brief: A Study of E2027 in Participants With Dementia With Lewy Bodies (DLB) or Parkinson's Disease Dementia (PDD) With or Without Amyloid Copathology
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
DLB With Amyloid Copathology Participants with DLB (with amyloid copathology) received E2027 50 mg capsules, orally, once daily up to 12 weeks. 0 None 0 11 4 11 View
PDD Without Amyloid Copathology Participants with PDD (without amyloid copathology) received E2027 50 mg capsules, orally, once daily up to 12 weeks. 0 None 0 10 3 10 View
DLB Without Amyloid Copathology Participants with DLB (without amyloid copathology) received E2027 50 mg capsules, orally, once daily up to 12 weeks. 1 None 1 10 5 10 View
PDD With Amyloid Copathology Participants with PDD (with amyloid copathology) received E2027 50 mg capsules, orally, once daily up to 12 weeks. 0 None 0 3 2 3 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 24.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 24.1 View
Supraventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 24.1 View
Abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 24.1 View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 24.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 24.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 24.1 View
Temperature intolerance SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 24.1 View
Ear infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 24.1 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 24.1 View
Skin laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 24.1 View
Vaccination complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 24.1 View
Blood creatine phosphokinase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 24.1 View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA Version 24.1 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA Version 24.1 View
Akathisia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 24.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 24.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 24.1 View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 24.1 View
Aggression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA Version 24.1 View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA Version 24.1 View
Delusion SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA Version 24.1 View
Hallucination SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA Version 24.1 View
Mental status changes SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA Version 24.1 View
Restlessness SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA Version 24.1 View
Orthostatic hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA Version 24.1 View