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 @ 11:31 PM
Ignite Modification Date: 2025-12-25 @ 9:19 PM
NCT ID: NCT03325556
Description: None
Frequency Threshold: 5
Time Frame: Adverse Events (AEs) were to be documented through 30 days after the last dose in the study.
Study: NCT03325556
Study Brief: Relapse Prevention Study of Pimavanserin in Dementia-related Psychosis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Pimavanserin Open-Label Period Pimavanserin 34 mg once daily, with the possibility to adjust to pimavanserin 20 mg once daily between Weeks 1 and 4 based on tolerability. After Week 4, the dose of study drug remained fixed at either 34 or 20 mg once daily 1 None 20 392 24 392 View
Pimavanserin Double-Blind Period Pimavanserin 34 mg once daily or pimavanserin 20 mg once daily (the dose at which patients completed the Open-Label Period) for 26 weeks or until relapse 1 None 5 105 16 105 View
Placebo Double-Blind Period Placebo once daily for 26 weeks or until relapse 0 None 4 112 9 112 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cardiac failure congestive NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 22.0 View
Myocardial infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 22.0 View
Abdominal pain lower NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Abdominal pain upper NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Haematemesis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Intestinal obstruction NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Oedema peripheral NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.0 View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.0 View
Abscess jaw NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.0 View
Diverticulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.0 View
Erysipelas NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.0 View
Fall NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22.0 View
Bone fissure NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22.0 View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 22.0 View
Malnutrition NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 22.0 View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22.0 View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.0 View
Sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.0 View
Septic encephalopathy NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.0 View
Decreased appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 22.0 View
Prostate cancer metastatic NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 22.0 View
Metabolic encephalopathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.0 View
Transient ischaemic attack NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.0 View
Agression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 22.0 View
Dementia Alzheimer's type NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.0 View
Agitation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 22.0 View
Mental status changes NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 22.0 View
Neuropsychiatric symptoms NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 22.0 View
Psychotic disorder NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 22.0 View
Acute kidney injury NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 22.0 View
Syncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.0 View