Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 8:02 PM
Ignite Modification Date: 2025-12-25 @ 5:35 PM
NCT ID: NCT01749904
Description: Safety Population (analyzed as treated). Of 420 subjects randomized, 418 instilled \>/=1 dose and were included in the Safety Population; 1 subject randomized to BOL-303259-X received timolol and was therefore analyzed as part of the timolol group in the efficacy phase of the study. All subjects were converted to BOL-303259-X during the safety extension phase and AEs reported during that phase are presented below as a third arm
Frequency Threshold: 3
Time Frame: 1 year
Study: NCT01749904
Study Brief: Comparing Safety and Efficacy of BOL-303259-X With Timolol Maleate in Subjects 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
BOL-303259-X BOL-303259-X ophthalmic solution QD (PM) and vehicle QD (AM) administered for 3 months into the study eye during the efficacy phase. None None 3 283 11 283 View
Timolol Timolol maleate ophthalmic solution, 0.5%, administered BID for 3 months into study eye during the efficacy phase. None None 2 135 3 135 View
BOL-303259-X Safety Extension Phase Following completion of the efficacy phase, all subjects were converted to BOL-303259-X ophthalmic solution QD (PM) and vehicle QD (AM) for an additional 9 months from Visit 6 through Visit 9 (1 year) during the open label safety extension phase None None 8 385 5 385 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
torn rotator cuff SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v13.0 View
Chest pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v13.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v13.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v13.0 View
Spider bite SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v13.0 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v13.0 View
Ankle fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v13.0 View
Recurrence of breast cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA v13.0 View
Allergic angioedema due to Motrin SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA v13.0 View
Leg disco-ordination SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v13.0 View
Aphasia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v13.0 View
Food allergy SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA v13.0 View
Hydronephrosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA v13.0 View
Right upper lobe lung cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA v13.0 View
Fracture of right femoral neck SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v13.0 View
Dislocation of intraocular lens SYSTEMATIC_ASSESSMENT General disorders MedDRA v13.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Eye irritation SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (13.0) View