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 @ 2:44 PM
Ignite Modification Date: 2025-12-25 @ 1:14 PM
NCT ID: NCT01564459
Description: All participants who received at least 1 dose of study drug. One participant who was randomly assigned to placebo for double-blind treatment period actually received MK-6096 10 mg. AEs are reported by treatment received and not by randomly assigned treatment arm.
Frequency Threshold: 5
Time Frame: up to 42 days (up to 14 days for run-in; up to 28 days for active treatment period)
Study: NCT01564459
Study Brief: Study to Evaluate MK-6096 in the Treatment of Painful Diabetic Neuropathy (PDN) in Adults (MK-6096-021)
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 Period Participants who received placebo during double-blind treatment period None None 1 82 0 82 View
MK-6096 10 Mg-Double Blind Period Participants who received MK-6096 during double blind treatment period None None 0 88 0 88 View
MK-6096 10 mg - Run-in Period Participants who received MK-6096 10 mg during run-in period None None 3 182 0 182 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Upper gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 16.0 View
Sepsis syndrome SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 16.0 View
Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 16.0 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 16.0 View
Renal failure acute SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA version 16.0 View
Pneumonia aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 16.0 View
Blood pressure inadequately controlled SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA version 16.0 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA version 16.0 View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA version 16.0 View
Cardio-respiratory arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA version 16.0 View
Other Events(If Any):