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 @ 10:23 PM
Ignite Modification Date: 2025-12-25 @ 7:55 PM
NCT ID: NCT01688635
Description: Study-specific clinical outcomes due to progressive disease were not considered to be serious adverse events (SAEs) unless it was deemed related to study drug by the investigator.
Frequency Threshold: 4
Time Frame: Randomization to study completion
Study: NCT01688635
Study Brief: A Study to Compare LY2963016 and US-approved Lantus® After Single Dose Administration to Healthy Participants
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
LY2963016 Single 0.5 units per kilogram (U/kg) dose of LY2963016 administered subcutaneously twice during the study. There was at least a 7-day washout between the treatment periods. None None 0 89 42 89 View
US-approved Lantus Single 0.5 U/kg dose of US-approved Lantus administered subcutaneously twice during the study. There was at least a 7-day washout between the treatment periods. None None 0 90 42 90 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Catheter site haematoma SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Catheter site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Catheter site swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Infusion site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Infusion site swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Procedural site reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View