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 @ 4:12 AM
Ignite Modification Date: 2025-12-26 @ 3:10 AM
NCT ID: NCT05525520
Description: For participants who received placebo up to Week 6 and then switched to EP547, adverse events are presented by the treatment they were on at onset of the event.
Frequency Threshold: 5
Time Frame: 12 weeks
Study: NCT05525520
Study Brief: Study to Evaluate EP547 in Subjects With Cholestatic Pruritus Due to Primary Biliary Cholangitis or Primary Sclerosing Cholangitis
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 Participants were randomized to receive oral placebo 100 milligrams (mg) once daily (QD) for 6 weeks in the Double-Blind (DB) Treatment Period. 0 None 0 30 7 30 View
EP547 Participants were randomized to receive oral EP547 100 mg QD for 6 weeks in the DB Treatment Period and for 6 weeks in the Open-Label Extension Period. Participants who were randomized to receive oral placebo 100 mg QD for 6 weeks during the DB Treatment Period received EP547 100 mg QD for 6 weeks in the Open-Label Extension Period. 0 None 1 60 24 60 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 26.0 View
Gun shot wound SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 26.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26.0 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 26.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 26.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.0 View