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 @ 9:56 PM
Ignite Modification Date: 2025-12-25 @ 7:34 PM
NCT ID: NCT03155932
Description: A TEAE was defined as any adverse events (AE) that were reported following study treatment administration and up to 2 weeks after the last treatment intake. An SAE was any untoward medical occurrence that at any dose resulted in the following outcomes: death, was life-threatening, required/prolonged hospitalization, disability/incapacity, congenital anomaly/birth defect, and important medical events.
Frequency Threshold: 0
Time Frame: Up to Week 26
Study: NCT03155932
Study Brief: Safety, Tolerability, and Efficacy of Etrasimod (APD334) in Participants With Primary Biliary 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
APD334 Participants received APD334 1 mg tablet once daily (qd) by mouth for 12 weeks. The dose for APD334 was escalated to 2 mg at Week 12 to Week 24, based on the participant's safety and pharmacokinetic (PK) data. 0 None 0 2 2 2 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Skin rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDra 20.0 View
Common cold - Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 20.0 View
Lower abdominal cramps SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 20.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 20.0 View
Worsening right hip pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDra 20.0 View
Elevated gamma-glutamyl transferase-worsening SYSTEMATIC_ASSESSMENT Investigations MedDra 20.0 View
Loose stools SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 20.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDra 20.0 View
Elevated alkaline phosphatase-worsening SYSTEMATIC_ASSESSMENT Investigations MedDra 20.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDra 20.0 View
Cognitive defects SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 20.0 View
Olecranon bursitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDra 20.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDra 20.0 View