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 @ 1:23 AM
Ignite Modification Date: 2025-12-25 @ 11:33 PM
NCT ID: NCT04706793
Description: Safety set population included all randomized participants who received at least 1 dose of study intervention.
Frequency Threshold: 5
Time Frame: All-cause mortality, non-serious treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected during the 40-week continuous treatment period, followed by a 4-week follow-up period up to Week 44 of C5041013 (APD334-308).
Study: NCT04706793
Study Brief: Oral Etrasimod Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis in Adult Japanese Participants (ELEVATE UC 40 JAPAN)
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 Comparator: Placebo Participants received etrasimod matching placebo 1 tablet by mouth, once daily up to 40 weeks in APD334-308 0 None 1 14 8 14 View
Experimental: Etrasimod 2 mg Participants received etrasimod 2 mg tablet by mouth, once daily up to 40 weeks in APD334-308 0 None 1 28 16 28 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
COVID-19 NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Colitis ulcerative NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Colitis ulcerative NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Stomatitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders None View
Malaise NON_SYSTEMATIC_ASSESSMENT General disorders None View
Vaccination site pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Infected dermal cyst NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Tonsillitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cervicobrachial syndrome NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cataract NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Contusion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Glucose urine present NON_SYSTEMATIC_ASSESSMENT Investigations None View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Oropharyngeal discomfort NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View