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 @ 7:18 PM
Ignite Modification Date: 2025-12-25 @ 4:57 PM
NCT ID: NCT05478603
Description: SAEs and nonserious AEs were recorded on the Case Report Form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24h of awareness. Total number at risk below refers to the number of participants evaluable for SAEs/AEs. Unless otherwise noted, all treatment-emergent, all-causality events are reported.
Frequency Threshold: 5
Time Frame: Day 1 to Day 36
Study: NCT05478603
Study Brief: A Study to Understand How the Study Medicine (PF-07081532) is Processed in People With Liver Dysfunction
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Without Hepatic Impairment This arm included participants without hepatic impairment who received PF-07081532 20mg on Day 1. 0 None 0 6 1 6 View
Mild Hepatic Impairment This arm included participants with mild hepatic impairment who received PF-07081532 20mg on Day 1. 0 None 0 6 0 6 View
Moderate Hepatic Impairment This arm included participants with moderate hepatic impairment who received PF-07081532 20mg on Day 1. 0 None 0 6 0 6 View
Severe Hepatic Impairment This arm included participants with severe hepatic impairment who received PF-07081532 20mg on Day 1. 0 None 0 6 1 6 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v25.1 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v25.1 View
Hypoglycaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v25.1 View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v25.1 View