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: 2025-12-25 @ 4:33 AM
Ignite Modification Date: 2025-12-26 @ 3:35 AM
NCT ID: NCT03368118
Description: None
Frequency Threshold: 5
Time Frame: Adverse event were collected from first day of dosing (baseline) up to last safety visit (up to 49 months : 48 months on treatment and one month safety follow-up)
Study: NCT03368118
Study Brief: Study Evaluating the Long-term Safety and Efficacy of ABX464 in Active Ulcerative Colitis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
ABX464 Treatment Arm All subjects received ABX464 at 50 mg o.d for an overall period of 48 months. ABX464: All subjects received ABX464 given at 50 mg o.d for an overall period of 48 months. 0 None 3 22 20 22 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.1 View
enteropathic spondylitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.1 View
benign ovarian tumor SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 23.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.1 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.1 View
colitis ulcerative SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.1 View
diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.1 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.1 View
nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.1 View
vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.1 View
arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.1 View
headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.1 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.1 View
oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.1 View
nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.1 View