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: 2025-12-25 @ 12:56 AM
Ignite Modification Date: 2025-12-25 @ 11:10 PM
NCT ID: NCT05677867
Description: Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Frequency Threshold: 5
Time Frame: From the first dose up to 28 to 35 days after administration of the final dose of study intervention (maximum of 51 days)
Study: NCT05677867
Study Brief: A Study to Compare Two Different Forms of PF-07081532 in Adults Who Are Overweight or Obese
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Formulation A Formulation A was administrated as PF-07081532 20 mg immediate release tablet + 60 mg immediate release tablet. Participants in Sequence 1 received Formulation A in Period 1, Participants in Sequence 2 received Formulation A in Period 2. 0 None 0 20 9 20 View
Formulation B Formulation B was administrated as PF-07081532 80 mg immediate release tablet. Participants in Sequence 1 received Formulation B in Period 2, Participants in Sequence 2 received Formulation B in Period 1. 0 None 0 20 8 20 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dyspepsia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 25.1 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 25.1 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 25.1 View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 25.1 View
Dysgeusia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 25.1 View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 25.1 View