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 @ 5:01 PM
Ignite Modification Date: 2025-12-25 @ 2:41 PM
NCT ID: NCT04098250
Description: None
Frequency Threshold: 0
Time Frame: Adverse events were collected from the time of the first dose of investigational product through the end of the safety follow up visit, approximately 12 weeks.
Study: NCT04098250
Study Brief: Multidisciplinary Translational Approach to Investigate Mechanisms Predictors & Prevention of Persistent PTH
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Erenumab 140 mg erenumab Erenumab: a CGRP receptor monoclonal antibody 0 None 0 2 2 2 View
Placebo placebo comparator Placebo: Placebo 0 None 0 4 4 4 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pain at injection site/bruising at injection site NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Abdominal Pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Urinary Tract Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
COVID NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Chest Pain NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Conjunctivitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonia/Bronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Eyelid Twitching NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Facial Numbness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Ear Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Dizziness/Increased Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View