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: 2025-12-24 @ 3:56 PM
Ignite Modification Date: 2025-12-25 @ 2:00 PM
NCT ID: NCT02173392
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT02173392
Study Brief: A Bioequivalence Study Comparing a Single 1.5mL Dose of Brodalumab vs. Two Doses (1.0mL + 0.5mL) of Brodalumab
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
(Treatment B Days 1-28 + Treatment A Days 29-56) 210 mg SC Brodalumab (2 Pre-filled Syringes \[1.0mL + 0.5mL, Treatment B Days 1-28\])" first, then "Brodalumab (Single 1.5mL Pre-filled Syringe, treatment A Days 29-56) Brodalumab: Brodalumab is a large molecule for the treatment of inflammatory diseases None None 0 131 39 131 View
(Treatment A Day 1-28 + Treatment B Day 29-56) 210 mg SC Brodalumab (Single 1.5mL, Pre-filled Syringe, treatment A Days 1-28)" first, then followed by "Brodalumab (2 Pre-filled Syringes \[1.0mL + 0.5mL, treatment A Days 29-56) Brodalumab: Brodalumab is a large molecule for the treatment of inflammatory diseases None None 0 141 41 141 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Oropharyngeal Candidiasis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Injection Site Reaction NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hypersensitivity NON_SYSTEMATIC_ASSESSMENT General disorders None View
Infections NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Injection Site haemorrhage NON_SYSTEMATIC_ASSESSMENT General disorders None View
Upper Respiratory Tract Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Muscle Strain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View