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 @ 11:30 PM
Ignite Modification Date: 2025-12-25 @ 9:18 PM
NCT ID: NCT00449956
Description: None
Frequency Threshold: 2
Time Frame: None
Study: NCT00449956
Study Brief: MK0507A Clinical Study in Patients With Glaucoma and Ocular Hypertension (0507A-149)(COMPLETED)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
MK0507A (Dorzolamide 1.0% / Timolol 0.5% Combination) MK0507A (Dorzolamide 1.0% / Timolol 0.5% combination), one drop per dose twice daily to the study eye. None None 2 None 36 None View
Timolol 0.5% Timolol 0.5%, one drop per dose twice daily to the study eye. None None 1 None 12 None View
Concomitant (Dorzolamide 1.0% / Timolol 0.5%) Concomitant (Dorzolamide 1.0%, one drop per dose three times daily to the study eye / Timolol 0.5%, one drop per dose twice daily to the study eye). None None 0 None 40 None View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Arteriosclerosis obliterans NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.1 View
Forearm fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.1 View
Cerebral infarction NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Conjunctival hyperaemia NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 10.1 View
Corneal epithelium defect NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 10.1 View
Punctate keratitis NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 10.1 View
Instillation site irritation NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.1 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.1 View
Osteoarthritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.1 View
Lumbar spinal stenosis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.1 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.1 View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.1 View
Glucose urine present NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.1 View
Blood urine present NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.1 View