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 @ 3:16 PM
Ignite Modification Date: 2025-12-25 @ 1:37 PM
NCT ID: NCT04549792
Description: None
Frequency Threshold: 0
Time Frame: 100 weeks
Study: NCT04549792
Study Brief: An Open-Label and Long-Term Extension Study to Evaluate the Efficacy and Safety of Ustekinumab in the Treatment of Patients With Ichthyoses
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Open Label Ustekinumab: Each subject will receive ustekinumab at Baseline (Day 0) and Months 1, 3, 5, 7, 9, and 11. During the LTE, subjects will receive injections every 8 weeks for one year: Month 13, Month 15, Month 17, Month 19, Month 21, and Month 23. Subjects will come back in for a follow-up visit at Month 25 for an end of study visit (no drug administration). 0 None 2 13 10 13 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hospitalization secondary to sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache NON_SYSTEMATIC_ASSESSMENT General disorders None View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Broken wrist NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Dry eyes NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Pustular psoriasis like eruption NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Heat exhaustion NON_SYSTEMATIC_ASSESSMENT General disorders None View
Increased pain associated with ichthyosis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Onychomycosis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Tooth extraction NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Strep Throat Infection NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin pustules NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Viral gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Viral upper respiratory infection NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Amenorrhea NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
COVID-19 Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Miliaria NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Viral exanthem NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Skin Infection NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View