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 @ 5:58 PM
Ignite Modification Date: 2025-12-24 @ 5:58 PM
NCT ID: NCT04559568
Description: All enrolled participants, irrespective of the completion of all protocol requirements.
Frequency Threshold: 5
Time Frame: Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
Study: NCT04559568
Study Brief: A Study of LY3522348 in 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
Part A: Placebo A single dose of Placebo administered orally on Day 1. 0 None 0 10 1 10 View
Part A: 5 mg LY3522348 A single dose of 5 mg LY3522348 administered orally on Day 1. 0 None 0 6 2 6 View
Part A: 15 mg LY3522348 A single dose of 15 mg LY3522348 administered orally on Day 1. 0 None 0 6 1 6 View
Part A: 50 mg LY3522348 A single dose of 50 mg LY3522348 administered orally on Day 1. 0 None 0 6 1 6 View
Part A: 150 mg LY3522348 A single dose of 150 mg LY3522348 administered orally on Day 1. 0 None 0 6 3 6 View
Part A: 380 mg LY3522348 A single dose of 380 mg LY3522348 administered orally on Day 1. 0 None 0 6 1 6 View
Part B: Placebo Placebo administered orally once daily on Days 1-14. 0 None 0 4 0 4 View
Part B: Placebo + Midazolam Placebo administered orally once daily on Days 1-15 and a single dose of 200 μg Midazolam administered orally on Days -1 and 15. 0 None 0 2 0 2 View
Part B: 50 mg LY3522348 50 mg LY3522348 administered orally once daily on Days 1-14. 0 None 0 6 0 6 View
Part B: 120 mg LY3522348 120 mg LY3522348 administered orally once daily on Days 1-14. 0 None 0 6 3 6 View
Part B: 290 mg LY3522348 + Midazolam 290 mg LY3522348 administered orally once daily on Days 1-15 and a single dose of 200 μg Midazolam administered orally on Days -1 and 15. 0 None 0 7 1 7 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 23.0 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Rectal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Medical device site dermatitis SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Asymptomatic COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 23.0 View
Rhinitis allergic SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View