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 @ 1:06 PM
Ignite Modification Date: 2025-12-25 @ 12:21 PM
NCT ID: NCT03669861
Description: A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or causes prolongation of existing hospitalization; results in persistent or significant disability/incapacity/congenital anomaly. All Serious Adverse Events (SAEs) that occur following the subject's written consent to participate in the study through 30 days of discontinuation of dosing must be reported.
Frequency Threshold: 4
Time Frame: Adverse Event monitoring (from time of study drug administration) to end of study (visit 10 (week 36) or safety follow up visit, if needed). Ten subjects were enrolled in the study between December 2018 and August 2019. Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug a nd that does not necessarily have a causal relationship with this treatment.
Study: NCT03669861
Study Brief: Safety and Efficacy of Abatacept in IgG4-Related Disease
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Abatacept To assess the effect of weekly subcutaneous (SC) administration of abatacept on complete remission of IgG4-RD Abatacept: Subjects will receive weekly subcutaneous doses of abatacept (125mg) for 24 doses (24 weeks) 0 None 1 10 3 10 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Myocardial Infarction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
episcleritis SYSTEMATIC_ASSESSMENT Eye disorders None View
abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View