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 @ 3:16 PM
Ignite Modification Date: 2025-12-25 @ 1:38 PM
NCT ID: NCT03188692
Description: None
Frequency Threshold: 5
Time Frame: Through study completion, an average of 1 year
Study: NCT03188692
Study Brief: Safety and Efficacy of BK1310 Intramuscular Injection in Healthy Infants
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
BK1310 DPT-IPV-Hib (Combined Vaccine): 0.5mL, intramuscular injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months. 0 None 2 33 33 33 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Bronchiolitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA/J Version 20. View
Exanthema subitum SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA/J Version 20. View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA/J Version 20. View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Crying SYSTEMATIC_ASSESSMENT General disorders MedDRA/J Version 20. View
Injection site erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA/J Version 20. View
Injection site swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA/J Version 20. View
Irritability postvaccinal SYSTEMATIC_ASSESSMENT General disorders MedDRA/J Version 20. View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA/J Version 20. View
Conjunctivitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA/J Version 20. View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA/J Version 20. View
Otitis media SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA/J Version 20. View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA/J Version 20. View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA/J Version 20. View
Viral upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA/J Version 20. View
Arthropod sting SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA/J Version 20. View
Hypersomnia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA/J Version 20. View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA/J Version 20. View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA/J Version 20. View
Upper respiratory tract inflammation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA/J Version 20. View
Asteatosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA/J Version 20. View
Dermatitis diaper SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA/J Version 20. View
Eczema infantile SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA/J Version 20. View
Injection site induration SYSTEMATIC_ASSESSMENT General disorders MedDRA/J Version 20. View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA/J Version 20. View
Hand-foot-and-mouth disease SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA/J Version 20. View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA/J Version 20. View
Dermatitis contact SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA/J Version 20. View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA/J Version 20. View