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 @ 2:45 PM
Ignite Modification Date: 2025-12-25 @ 1:14 PM
NCT ID: NCT03968159
Description: None
Frequency Threshold: 5
Time Frame: Adverse Events (AEs) were to be documented through 30 days after the last planned dose in the study which was to be administered at Week 6.
Study: NCT03968159
Study Brief: Adjunctive Pimavanserin in Subjects With Major Depressive Disorder and Inadequate Response to Antidepressant Treatment
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 Pimavanserin 34 mg administered orally as a single dose once daily 0 None 2 148 54 148 View
Placebo Placebo tablets administered orally as a single dose once daily 0 None 2 150 43 150 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Atrial fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (23.0) View
Lower gastrointestinal haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (23.0) View
Multiple sclerosis NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (23.0) View
Gastritis haemorrhagic NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (23.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (23.0) View
Dry mouth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (23.0) View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (23.0) View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (23.0) View