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 @ 2:14 AM
Ignite Modification Date: 2025-12-26 @ 12:43 AM
NCT ID: NCT02140060
Description: An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of whether or not the event had a causal relationship with the medication. AEs were obtained through solicited and spontaneous comments from study subjects, and through observations by the study Investigator.
Frequency Threshold: 5
Time Frame: Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 11 weeks). AEs were reported as pre-treatment and treatment-emergent.
Study: NCT02140060
Study Brief: 6-Week Proof-of-Concept Study of Travoprost/Brinzolamide Ophthalmic Suspension 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
TravB/Brinz Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks None None 0 44 11 44 View
TravC/Brinz Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks None None 0 44 15 44 View
TRAV Z Suspension vehicle, 1 drop twice daily in the treated eye(s) morning and night, with travoprost 0.004% ophthalmic solution, 1 drop once daily in the treated eye(s) at night, for 6 weeks None None 1 45 10 45 View
AZOPT Ophthalmic suspension, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night for 6 weeks None None 0 45 9 45 View
TRAV Z + AZOPT Ophthalmic suspension, 1 drop twice daily in the treated eye(s) twice daily morning and night, with travoprost 0.004% ophthalmic solution, 1 drop once daily in the treated eye(s) at night, for 6 weeks None None 0 44 13 44 View
Pre-treatment All subjects who signed an informed consent to participate in the study None None 1 327 1 327 View
TravA/Brinz Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks None None 0 44 7 44 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Angina unstable SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (16.0) View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (16.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Ocular hyperaemia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (16.0) View
Conjunctival hyperaemia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (16.0) View
Eye irritation SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (16.0) View
Eye pain SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (16.0) View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (16.0) View