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 @ 10:48 PM
Ignite Modification Date: 2025-12-25 @ 8:17 PM
NCT ID: NCT04517669
Description: Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. SAF included all participants who received at least one dose (including partial dose) of study medication independently of inclusion/exclusion criteria.
Frequency Threshold: 2
Time Frame: From Baseline (enrollment) until Month 12
Study: NCT04517669
Study Brief: Effectiveness of Treatment With Tofacitinib in Patients With Psoriatic Arthritis in Routine Clinical Practice
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
All Participants All participants with a diagnosis of PsA who received tofacitinib up to 12 months of follow-up were included in this retrospective observational study. 0 None 7 113 50 113 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pyelonephritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA27.0 View
Subcutaneous abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA27.0 View
Meningioma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA27.0 View
Plasma cell leukaemia NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA27.0 View
Acute myocardial infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA27.0 View
Intestinal obstruction NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA27.0 View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA27.0 View
Deep vein thrombosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA27.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Drug ineffective NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA27.0 View
COVID-19 NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA27.0 View
Influenza NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA27.0 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA27.0 View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA27.0 View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA27.0 View
Abdominal pain upper NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA27.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA27.0 View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA27.0 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA27.0 View
Psoriasis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA27.0 View