Adverse Events Module

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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 @ 10:21 PM
Ignite Modification Date: 2025-12-25 @ 7:54 PM
NCT ID: NCT01241435
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT01241435
Study Brief: A Study of LY2216684 in Participants With Impaired Hepatic Function
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Normal Hepatic Function LY2216684: A single dose of 18 milligrams (mg) administered orally in participants with normal hepatic function None None 0 12 6 12 View
Mild Hepatic Impairment LY2216684: A single dose of 18 milligrams (mg) administered orally in participants with mild hepatic impairment (Child-Pugh A) None None 0 8 3 8 View
Moderate Hepatic Impairment LY2216684: A single dose of 18 milligrams (mg) administered orally in participants with moderate hepatic impairment (Child-Pugh B) None None 0 8 6 8 View
Severe Hepatic Impairment LY2216684: A single dose of 18 milligrams (mg) administered orally in participants with severe hepatic impairment (Child-Pugh C) None None 0 8 5 8 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.0 View
Tinnitus SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 13.0 View
Blepharitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.0 View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.0 View
Abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Feeling abnormal SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Hallucination SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.0 View
Micturition urgency SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.0 View
Pollakiuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.0 View
Urinary hesitation SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.0 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.0 View