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 @ 2:41 PM
Ignite Modification Date: 2025-12-25 @ 1:12 PM
NCT ID: NCT00716859
Description: The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Frequency Threshold: 2
Time Frame: None
Study: NCT00716859
Study Brief: A Phase 3 Prospective, Randomized, Double-Masked, 12-Week, Parallel Group Study In Pediatric Subjects With Glaucoma.
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Timolol Timolol maleate ophthalmic solution; 1 drop of timolol 0.5% (or optionally 0.25% for participants younger than 3 years old) at approximately 8 AM and again at approximately 8 PM . None None 7 69 20 69 View
Latanoprost Latanoprost ophthalmic solution and vehicle; 1 drop of vehicle daily at approximately 8 AM and 1 drop (latanoprost 0.005%) daily at approximately 8 PM. None None 2 68 12 68 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Glaucoma, both eyes SYSTEMATIC_ASSESSMENT Eye disorders MedDRA v12.1 View
Eye haemorrhage, study eye SYSTEMATIC_ASSESSMENT Eye disorders MedDRA v12.1 View
Lens dislocation, study eye SYSTEMATIC_ASSESSMENT Eye disorders MedDRA v12.1 View
Corneal perforation, fellow eye SYSTEMATIC_ASSESSMENT Eye disorders MedDRA v12.1 View
Acute tonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v12.1 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v12.1 View
Angle closure glaucoma, both eyes SYSTEMATIC_ASSESSMENT Eye disorders MedDRA v12.1 View
Bronchopneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v12.1 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v12.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v12.1 View
Pneumonia viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v12.1 View
Epilepsy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v12.1 View
Trabeculectomy, both eyes SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA v12.1 View
Developmental glaucoma, both eyes SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA v12.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Conjunctival disorder, both eyes SYSTEMATIC_ASSESSMENT Eye disorders MedDRA v12.1 View
Conjunctival hyperaemia, both eyes SYSTEMATIC_ASSESSMENT Eye disorders MedDRA v12.1 View
Conjunctival hyperaemia, study eye SYSTEMATIC_ASSESSMENT Eye disorders MedDRA v12.1 View
Visual acuity reduced, study eye SYSTEMATIC_ASSESSMENT Eye disorders MedDRA v12.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA v12.1 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v12.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v12.1 View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v12.1 View
Viral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v12.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v12.1 View