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 @ 2:15 AM
Ignite Modification Date: 2025-12-26 @ 12:44 AM
NCT ID: NCT04496960
Description: None
Frequency Threshold: 0
Time Frame: Up to day 196
Study: NCT04496960
Study Brief: Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Primary Sjogren's Syndrome
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Drug: Tofacitinib Sjogren's Disease (SjD) patients with mild to moderate disease activity receive tofacitinib 5 mg orally twice daily for 168 days. 0 None 1 8 6 8 View
Placebo Sjogren's Disease (SjD) patients with mild to moderate disease activity receive placebo orally twice daily for 168 days. 0 None 1 3 2 3 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Allergy to arthropod sting SYSTEMATIC_ASSESSMENT Immune system disorders None View
Otitis media SYSTEMATIC_ASSESSMENT Infections and infestations None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Salivary gland calculus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Herpes simplex reactivation SYSTEMATIC_ASSESSMENT Infections and infestations None View
BK virus infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Conjunctivitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Oral candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Vaginal infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Barotrauma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Reflux laryngitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Spinal fusion surgery SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View