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 @ 1:08 AM
Ignite Modification Date: 2025-12-25 @ 11:19 PM
NCT ID: NCT01248793
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT01248793
Study Brief: Study of the Safety and Efficacy of Golimumab in Chinese Patients With Ankylosing Spondylitis
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 -> Golimumab 50 mg Placebo SC injections every 4 weeks from Week 0 to Week 12 and early escape to receive Golimumab 50 mg SC injection every 4 weeks from Week 16 to Week 20; or Placebo SC injections every 4 weeks from Week 0 to Week 20 and crossed over to receive Golimumab 50 mg SC injections every 4 weeks from Week 24 to Week 48 None None 2 103 37 103 View
Golimumab 50 mg Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 48 None None 4 108 33 108 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Uveitis NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA Version 14.1 View
Enteritis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 14.1 View
Tuberculous Pleurisy NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 14.1 View
Tibia Fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 14.1 View
Ovarian Epithelial Cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA Version 14.1 View
Epistaxis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 14.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Upper Respiratory Tract Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 14.1 View
Alanine Aminotransferase Increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 14.1 View
Liver Function Test Abnormal NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 14.1 View
Transaminases Increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 14.1 View