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 @ 5:05 PM
Ignite Modification Date: 2025-12-25 @ 2:44 PM
NCT ID: NCT02588950
Description: None
Frequency Threshold: 5
Time Frame: Up to 72 weeks
Study: NCT02588950
Study Brief: A Study of U-500 Insulin (LY041001) in Participants With Type 2 Diabetes
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
100-U Bolus U-500R SC Participants received 100-U of human regular U-500 insulin (U-500R) by subcutaneous (SC) injection. 0 None 0 11 4 11 View
100-U Bolus U-500R CSII Participants received 4.25 U/hour U-500R basal infusion for 12 hours prior to and during the 24 hour clamp plus a 100-U of U-500R via continuous SC insulin infusion (CSII). 0 None 0 11 3 11 View
U-500R BID Participants received U-500R twice daily by SC injection for 5 to 10 days. 0 None 0 4 2 4 View
U-500R TID Participants received U-500R thrice daily by SC injection for 5 to 10 days. 0 None 0 6 2 6 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Gastrointestinal disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Infusion site extravasation SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Medical device site swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Peripheral swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Procedural complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.0 View
Increased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Priapism SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 18.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Petechiae SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.0 View
Eye laser surgery SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 18.0 View