Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 4:38 PM
Ignite Modification Date: 2025-12-25 @ 2:28 PM
NCT ID: NCT06052566
Description: All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received treatment.
Frequency Threshold: 0
Time Frame: Up to 35 days
Study: NCT06052566
Study Brief: A Study of Efinopegdutide in Participants With Hepatic Impairment (MK-6024-014)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Efinopegdutide in Participants With Moderate Hepatic Impairment Participants with moderate hepatic impairment received a single 7 mg dose of efinopegdutide 14 mg/ml by subcutaneous (SC) injection. 0 None 1 8 2 8 View
Efinopegdutide in Participants With Severe Hepatic Impairment Participants with severe hepatic impairment received a single 7 mg dose of efinopegdutide 14 mg/ml by SC injection. 0 None 0 8 4 8 View
Efinopegdutide in Healthy-Matched Control Group Healthy matched participants received a single 7 mg dose of efinopegdutide 14 mg/ml by SC injection. 0 None 0 6 4 6 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Multiple injuries SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 27.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Hyperbilirubinaemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 27.1 View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Hepatic encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View