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: 2025-12-25 @ 2:10 AM
Ignite Modification Date: 2025-12-26 @ 12:37 AM
NCT ID: NCT04222660
Description: The only possible adverse event would have been eye discomfort due to the Muro 128 solution. However, after this procedure the subjects eyes were flushed with warm saline. The total time each participant took to complete the study was 2 hours. For this reason all-cause mortality was not monitored.
Frequency Threshold: 0
Time Frame: The procedure for each subject lasted a total of no more than 2 hours. None of the procedures were invasive and had very low risks. The subject was monitored during the procedures.
Study: NCT04222660
Study Brief: Corneal Nerves Function and Structure
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Type 2 Diabetes With Neuropathy Subjects with type 2 diabetes will be enrolled and determination if they have neuropathy will be determined from their clinical record and evaluation. Blackmores Omega Daily (4 1g capsules per day): Subjects enrolled in phase two of the study will be instructed to take 4 capsules per day (2 in the morning and 2 in the evening). Each capsule contains 1000 mg of triglyceride; 35% eicosapentaenoic acid and 25% docosahexaenoic acid. 0 None 0 28 0 28 View
Normal Subjects, Aged Match With no Symptoms of Diabetes Healthy, aged matched control subjects will be enrolled and determination if they have neuropathy will be determined from their clinical record and evaluation. Blackmores Omega Daily (4 1g capsules per day): Subjects enrolled in phase two of the study will be instructed to take 4 capsules per day (2 in the morning and 2 in the evening). Each capsule contains 1000 mg of triglyceride; 35% eicosapentaenoic acid and 25% docosahexaenoic acid. 0 None 0 16 0 28 View
Serious Events(If Any):
Other Events(If Any):