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: 2025-12-25 @ 4:02 AM
Ignite Modification Date: 2025-12-26 @ 2:55 AM
NCT ID: NCT04493502
Description: All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Frequency Threshold: 5
Time Frame: Baseline Up to Follow-up Period (46 weeks)
Study: NCT04493502
Study Brief: A Study of LY3041658 in Adults With Hidradenitis Suppurativa
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo_Double-Blind Treatment Period Participants received placebo IV Q2W for 16 weeks. 0 None 2 22 2 22 View
Follow-Up Period Participants did not receive study drug during this period. 0 None 0 39 2 39 View
600 mg LY3041658 _Double-Blind Treatment Period Participants received 600 mg LY3041658 IV Q2W for 16 weeks. 0 None 0 45 10 45 View
600 mg LY3041658_Open-Label Extension Participants received 600 mg IV LY3041658 Q2W from week 16-34 weeks. 0 None 1 49 13 49 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Post procedural infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.1 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.1 View
Aortic stenosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.1 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25.1 View
Balanoposthitis SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 25.1 View
Scrotal operation SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 25.1 View
Covid-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.1 View