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 @ 3:51 PM
Ignite Modification Date: 2025-12-25 @ 1:57 PM
NCT ID: NCT03020992
Description: None
Frequency Threshold: 5
Time Frame: Treatment emergent adverse events were collected from Baseline to the Safety Follow-up Visit (up to Week 104)
Study: NCT03020992
Study Brief: A Study to Assess the Effects of Certolizumab Pegol on the Reduction of Anterior Uveitis (AU) Flares in Axial Spondyloarthritis Subjects With a Documented History of AU
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Certolizumab Pegol (SS) Participants received a loading dose of Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) administered at Baseline, Week 2, and Week 4 followed by CZP 200 mg sc Q2W (starting at Week 6 until Week 94). 0 None 11 89 51 89 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Breast cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA19.0 View
Haemangioma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA19.0 View
Prostate cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA19.0 View
Pregnancy NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA19.0 View
Vestibular disorder NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA19.0 View
Uveitis NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA19.0 View
Anal polyp NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA19.0 View
Incarcerated hernia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA19.0 View
Cholelithiasis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA19.0 View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA19.0 View
Sarcoidosis NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA19.0 View
Pneumonia haemophilus NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA19.0 View
Tenosynovitis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA19.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Influenza NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA19.0 View
Rhinitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA19.0 View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA19.0 View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA19.0 View
Oropharyngeal pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA19.0 View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA19.0 View
Uveitis NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA19.0 View
Iridocyclitis NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA19.0 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA19.0 View