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 @ 2:12 PM
Ignite Modification Date: 2025-12-25 @ 12:51 PM
NCT ID: NCT01029795
Description: None
Frequency Threshold: 4
Time Frame: None
Study: NCT01029795
Study Brief: A Study of LY2599506 (Oral Agent Medication: Glucokinase Activator 1) in Type 2 Diabetes Mellitus
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
LY2599506 Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day. None None 1 16 5 16 View
Glyburide Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day. None None 0 22 5 22 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hepatitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 13.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab 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
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Infectious mononucleosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Lower respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View