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 @ 4:23 AM
Ignite Modification Date: 2025-12-26 @ 3:26 AM
NCT ID: NCT01297920
Description: An adverse event was any untoward medical occurrence in a subject exposed to study drug. The AE did not necessarily have to have had a causal relationship with the study drug. Reports of AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the Investigator as outlined in the study protocol.
Frequency Threshold: 5
Time Frame: Adverse events were collected for the duration of the study. The safety population includes all subjects who were exposed to study drug.
Study: NCT01297920
Study Brief: Three Month Efficacy/Safety Study With a 3-Month Safety Extension of Brinzolamide 1%/Brimonidine 0.2% vs. Brinzolamide 1% or Brimonidine 0.2%
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Brinzolamide Brinzolamide ophthalmic suspension, 1%, 1 drop instilled in each eye 3 times a day for 3 months None None 7 234 35 234 View
Brimonidine Brimonidine tartrate ophthalmic solution, 0.2%, 1 drop instilled in each eye 3 times a day for 3 months None None 7 235 27 235 View
Brinz/Brim Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each eye 3 times a day for 3 months None None 7 221 53 221 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Abdominal abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Anaphylactic reaction SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 13.0 View
Aortic aneurysm repair SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 13.0 View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Nephrectomy SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 13.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Prostatectomy SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 13.0 View
Retinal detachment SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.0 View
Retinal tear SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.0 View
Amnesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Delirium SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.0 View
Endometrial hyperplasia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 13.0 View
Intervertebral disc operation SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 13.0 View
Pancreatic 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
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.0 View
Knee arthroplasty SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 13.0 View
Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.0 View
Otitis media chronic SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Prostatitis SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 13.0 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.0 View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 13.0 View
Benign prostatic hyperplasia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 13.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Conjunctivitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.0 View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.0 View
Eye allergy SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.0 View
Eye irritation SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.0 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View