Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 12:36 AM
Ignite Modification Date: 2025-12-25 @ 10:44 PM
NCT ID: NCT00658567
Description: From the time the informed consent was signed, adverse events were recorded in the subject's source documents and entered into the appropriate eCRF pages at the Screening visit, at visits on Study Days 1, 8, 15, 29, 42 and Day 70 or 4 weeks after the last dose for subjects who do not continue into the open-label, extension protocol.
Frequency Threshold: 5.00
Time Frame: 6 weeks
Study: NCT00658567
Study Brief: A Study of Safety and Efficacy of Pimavanserin (ACP-103) in Patients With Parkinson's Disease 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
Placebo Placebo tablet, once daily by mouth, 6 weeks None None 2 39 12 39 View
Pimavanserin 10 mg Pimavanserin tartrate (ACP-103) 10 mg, tablet, once daily by mouth, 6 weeks None None 3 41 4 41 View
Pimavanserin 20 mg Pimavanserin tartrate (ACP-103) 20 mg, tablet, once daily by mouth, 6 weeks None None 1 41 8 41 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (11.1) View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (11.1) View
Hip fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (11.1) View
Parkinson's disease SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (11.1) View
Delusion SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (11.1) View
Delusional disorder, persecutory type SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (11.1) View
Delirium SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (11.1) View
Mental status changes SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (11.1) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (11.1) View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (11.1) View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (11.1) View
Orthostatic hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (11.1) View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (11.1) View
Hallucination SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (11.1) View