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 @ 9:20 PM
Ignite Modification Date: 2025-12-25 @ 7:07 PM
NCT ID: NCT01309204
Description: This reporting group includes all subjects who received study medication, as treated. Reports of AEs were obtained through solicited and spontaneous comments from the study subjects, and through observations by the study Investigator as outlined in the study protocol.
Frequency Threshold: 5
Time Frame: Adverse events (AE) were collected for the duration of the study (1 year, 8 months). An AE was defined as any untoward medical occurrence in a subject that was administered a study medication, regardless of causal relationship with the medication.
Study: NCT01309204
Study Brief: Brinzolamide/Brimonidine Twice a Day (BID) Fixed Combination (FC) vs Brinzolamide BID Plus Brimonidine BID in Patients With Open Angle Glaucoma or Ocular Hypertension
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Brinz+Brim Brimonidine tartrate 0.2% ophthalmic solution, 1 drop instilled in each eye, followed by Brinzolamide 1% ophthalmic suspension, 1 drop instilled in each eye. A 10-minute waiting period separated the instillations. Study drugs were instilled twice a day for 6 months. None None 8 436 0 436 View
Brinz/Brim Vehicle, 1 drop instilled in each eye, followed by Brinzolamide 1%/brimonidine tartrate 0.2% fixed combination ophthalmic suspension, 1 drop instilled in each eye. A 10-minute waiting period separated the instillations. Study drugs were instilled twice a day for 6 months. None None 11 452 0 452 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Corneal erosion SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (13.0) View
Aortic valve incompetence SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (13.0) View
Arthroscopy SYSTEMATIC_ASSESSMENT Investigations MedDRA (13.0) View
Finger amputation SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA (13.0) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (13.0) View
Kidney infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (13.0) View
Mastectomy SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA (13.0) View
Neuropathy peripheral SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (13.0) View
Prostatic specific antigen increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (13.0) View
Renal cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (13.0) View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA (13.0) View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (13.0) View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA (13.0) View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (13.0) View
Pneumonia primary atypical SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (13.0) View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (13.0) View
Sleep apnoea syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (13.0) View
Uterine cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (13.0) View
Venous occlusion SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (13.0) View
Spinal osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (13.0) View
Other Events(If Any):