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 @ 9:06 PM
Ignite Modification Date: 2025-12-25 @ 6:57 PM
NCT ID: NCT01668004
Description: All safety analyses were performed on the All Treated Set, defined as all patients who received at least one dose of golimumab in the study. Only safety data during the GLM period was collected.
Frequency Threshold: 5
Time Frame: Up to one year
Study: NCT01668004
Study Brief: The Incidence of Extra-Articular Manifestations in Participants With Ankylosing Spondylitis Treated With Golimumab (MK-8259-012)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
GLM 50 mg GLM given subcutaneously at a dose of 50 mg once monthly for up to 12 months None None 7 101 21 101 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Acute Coronary Syndrome SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA version 16.1 View
Cardiac Failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA version 16.1 View
Colitis Ulcerative SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 16.1 View
Large Intestinal Ulcer Haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 16.1 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 16.1 View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 16.1 View
Bursitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version 16.1 View
Prostate Cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version 16.1 View
Fistula Repair SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA version 16.1 View
Hypovolaemic shock SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA version 16.1 View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 16.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 16.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 16.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 16.1 View