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 @ 10:09 PM
Ignite Modification Date: 2025-12-25 @ 7:44 PM
NCT ID: NCT02260635
Description: All randomized participants who received at least 1 dose of study drug.
Frequency Threshold: 0
Time Frame: None
Study: NCT02260635
Study Brief: A Study of Evacetrapib (LY2484595) in Japanese Participants With Primary Hypercholesterolemia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Evacetrapib Double Blind Treatment Period 130mg evacetrapib given PO once a day for 12 weeks. None None 0 27 5 27 View
Placebo Double Blind Treatment Period Placebo given PO once a day for 12 weeks None None 0 26 7 26 View
Evacetrapib Open Label Extension Participants begin open label extension (130 mg evacetrapib given PO once a day for 40 weeks) after week 12. None None 0 26 6 26 View
Placebo/Evacetrapib Open Label Extension Participants begin open label extension (130 mg evacetrapib given PO once a day for 40 weeks) after week 12. None None 0 25 4 25 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Seasonal allergy SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 18.1 View
Acute sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Tonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Blood pressure increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Influenza b virus test positive SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Diabetes mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.1 View
Musculoskeletal stiffness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Occipital neuralgia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Dermatitis contact SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Wisdom teeth removal SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 18.1 View
Conjunctivitis allergic SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 18.1 View