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 @ 9:16 PM
Ignite Modification Date: 2025-12-25 @ 7:04 PM
NCT ID: NCT01254604
Description: None
Frequency Threshold: 5
Time Frame: Up to 14 days after Week 4 visit
Study: NCT01254604
Study Brief: Preservative-Free Tafluprost (MK-2452) for the Treatment of Open-Angle Glaucoma or Ocular Hypertension (MK-2452-002)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Tafluprost One drop of preservative-free vehicle (contains no active drug) per eye in the morning, and one drop of preservative-free tafluprost (0.0015%) per eye in the evening for four weeks. None None 0 93 19 93 View
Timolol One drop of preservative-free timolol maleate (0.05%) per eye twice daily (morning and evening) for four weeks. None None 1 94 15 94 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
subdural hematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Conjunctivitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 14.0 View
Eye irritation SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 14.0 View
Eye pruritus SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 14.0 View
Ocular hyperaemia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 14.0 View