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: 2025-12-26 @ 10:56 AM
Ignite Modification Date: 2025-12-26 @ 10:56 AM
NCT ID: NCT05027308
Description: Safety Analysis Set included all participants who received at least 1 dose of study teduglutide.
Frequency Threshold: 0
Time Frame: From first dose of study drug until follow-up visit (4 weeks after EOT/ET [up to 47.3-51.3 weeks])
Study: NCT05027308
Study Brief: A Study of Teduglutide in Japanese Children With Short Bowel Syndrome Aged 4 Months or Older
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Teduglutide Participants received teduglutide 0.05 milligram per kilogram \[mg/kg\] (0.025 mg/kg for participants with moderate or greater renal impairment) subcutaneous \[SC\] injection once daily in a 28-week treatment cycle consisting of a 24-week treatment period followed by a 4-week no treatment follow-up period for a maximum of 3 cycles. 0 None 3 3 3 3 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26 View
Catheter site pruritus SYSTEMATIC_ASSESSMENT General disorders MedDRA 26 View
Device breakage SYSTEMATIC_ASSESSMENT Product Issues MedDRA 26 View
Device related infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26 View
Vascular device occlusion SYSTEMATIC_ASSESSMENT General disorders MedDRA 26 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Respiratory syncytial virus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26 View
Skin candida SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26 View
Upper respiratory tract inflammation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 26 View
Blood iron increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 26 View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26 View
Catheter site rash SYSTEMATIC_ASSESSMENT General disorders MedDRA 26 View
Enterocolitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26 View
Lactic acidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 26 View
Liver disorder SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 26 View
Oliguria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 26 View
Parainfluenzae virus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26 View