Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 2:00 AM
Ignite Modification Date: 2025-12-26 @ 12:23 AM
NCT ID: NCT04417894
Description: Participants included adults and adolescents (≥12 years) and were randomized at 1:1 to Dupilumab and placebo. For each group, adults and adolescents with body weight ≥60kg who had 300mg Q2W is similar to adolescents with body weight \< 60kg who had 200mg Q2W. The 300mg Q2W and 200mg Q2W were similar dosing for participants with different weight and age, rather than different dosing for the same population. Thus, they were combined to compare Dupilumab with placebo.
Frequency Threshold: 5
Time Frame: From first dose to Week 28
Study: NCT04417894
Study Brief: A Study to Evaluate the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Moderate-to-Severe Atopic Hand and Foot Dermatitis (Liberty-AD-HAFT)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Matching Placebo Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1 0 None 1 66 34 66 View
Dupilumab Q2W Administered SC Q2W, following a loading dose on Day 1 0 None 3 67 33 67 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Metastases to lung SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (25.1) View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (25.1) View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (25.1) View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (25.1) View
Post procedural infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (25.1) View
Adenocarcinoma of colon SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (25.1) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (25.1) View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (25.1) View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (25.1) View
Dermatitis atopic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (25.1) View
Blood creatine phosphokinase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (25.1) View