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 @ 9:20 PM
Ignite Modification Date: 2025-12-25 @ 7:07 PM
NCT ID: NCT01174004
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, 15, 29, 43 and Day 71 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: NCT01174004
Study Brief: A Study of the Safety and Efficacy of Pimavanserin 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 4 94 31 94 View
Pimavanserin 40 mg Pimavanserin tartrate (ACP-103), 40 mg, tablet, once daily by mouth, 6 weeks None None 11 104 41 104 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Cardio-respiratory arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Hemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Multi-organ failure SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.1 View
Parkinson's disease SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Transient ischemic attack SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Psychotic disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.1 View
Hallucination SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.1 View
Mental status changes SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.1 View
Sleep disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.1 View
Decubitus ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Edema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Confusional state SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Hallucination SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.1 View