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 @ 4:07 PM
Ignite Modification Date: 2025-12-25 @ 2:08 PM
NCT ID: NCT05360966
Description: All participants were monitored for serious and other ocular and nonocular AEs. All-Cause Mortality was not monitored for the ocular arms. However, the nonocular AE arms were not considered at Risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at Risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs.
Frequency Threshold: 5
Time Frame: An adverse event was (AE) defined as any untoward medical occurrence associated with the administration of the drug in humans, whether or not considered drug related. AE's were collected from time of consent until study exit, approximately 15 weeks. The safety population includes all randomized subjects who have received at least one dose of the investigational product. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Study: NCT05360966
Study Brief: Study Evaluating the Safety and Efficacy of AR-15512 (COMET-3)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Pretreatment AEs reported in this group occurred prior to treatment with the study drug and include the 2-week vehicle run-in. 0 None 0 466 5 466 View
0.003% AR-15512 Ocular AEs reported in this group occurred during the 0.003% AR-15512 ophthalmic solution treatment period. 0 None 0 232 118 232 View
0.003% AR-15512 Nonocular AEs reported in this group occurred during the 0.003% AR-15512 ophthalmic solution treatment period. 0 None 3 232 0 232 View
AR-15512 Vehicle Ocular AEs reported in this group occurred during the AR-15512 vehicle ophthalmic solution treatment period. 0 None 0 234 7 234 View
AR-15512 Vehicle Nonocular AEs reported in this group occurred during the AR-15512 vehicle ophthalmic solution treatment period. 0 None 6 234 0 234 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (25.0) View
Angina unstable SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (25.0) View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (25.0) View
Ankle fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (25.0) View
Prostate cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (25.0) View
Squamous cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (25.0) View
Metabolic encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (25.0) View
Suicidal ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (25.0) View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (25.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Instillation site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA (25.0) View