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 @ 10:58 PM
Ignite Modification Date: 2025-12-25 @ 8:27 PM
NCT ID: NCT02969369
Description: An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Untoward medical occurrences that occur after first administration of study drug are considered AEs. Results presented are for DB + OL periods combined (all study AEs). AE counts are displayed according to the actual treatment the subject was on at the time of the event.
Frequency Threshold: 5
Time Frame: All adverse events (AEs) during the 6-week DB and 12-week OL periods by actual treatment group.
Study: NCT02969369
Study Brief: A Study to Evaluate the Efficacy, Safety and Tolerability of SEP-363856 in Subjects 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 (QD) 0 None 0 14 12 14 View
SEP-363856 SEP-363856 (25, 50, or 75 mg/day flexible dosing QD) 0 None 2 32 22 32 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hip fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Mental disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.0 View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.0 View
Abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Corneal abrasion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Balance disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Lethargy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Aggression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.0 View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.0 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.0 View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.0 View
Delusion SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.0 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.0 View
Disorientation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.0 View
Hallucination SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.0 View
Hallucination, auditory SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19.0 View
Orthostatic hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19.0 View