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 @ 11:16 PM
Ignite Modification Date: 2025-12-25 @ 8:53 PM
NCT ID: NCT02688556
Description: None
Frequency Threshold: 1
Time Frame: 12 weeks
Study: NCT02688556
Study Brief: Phase 3 Study of OTX-101 in the Treatment of Keratoconjunctivitis Sicca
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
OTX-101 0.09% 0.09% cyclosporine nanomicellar ophthalmic solution. A total of 744 subjects were included in the Safety population, with 372 subjects in the OTX-101 0.09% group and 372 subjects in the Vehicle group. The only difference between the ITT and the Safety populations is that Subject 14-003 was analyzed in the Safety population according to the treatment received, which was OTX-101 0.09% 1 None 6 372 130 372 View
Vehicle vehicle of OTX-101 A total of 744 subjects were included in the Safety population, with 372 subjects in the OTX-101 0.09% group and 372 subjects in the Vehicle group. The only difference between the ITT and the Safety populations is that Subject 14-003 was analyzed in the Safety population according to the treatment received, which was OTX-101 0.09% 0 None 2 372 66 372 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Death SYSTEMATIC_ASSESSMENT General disorders None View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Lung neoplasm malignant SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Subdural haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Spinal column stenosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Perforated ulcer SYSTEMATIC_ASSESSMENT General disorders None View
Spinal osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Conjunctival hyperaemia SYSTEMATIC_ASSESSMENT Eye disorders None View
Blepharitis SYSTEMATIC_ASSESSMENT Eye disorders None View
Eye irritation SYSTEMATIC_ASSESSMENT Eye disorders None View
Eye pruritus SYSTEMATIC_ASSESSMENT Eye disorders None View
Instillation site pain SYSTEMATIC_ASSESSMENT General disorders None View
Instillation site lacrimation SYSTEMATIC_ASSESSMENT General disorders None View
Instillation site reaction SYSTEMATIC_ASSESSMENT Eye disorders None View
Sinusitis SYSTEMATIC_ASSESSMENT Eye disorders None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Eye disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Foreign body sensation in eyes SYSTEMATIC_ASSESSMENT Eye disorders None View
Conjunctival haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders None View
Posterior capsule opacification SYSTEMATIC_ASSESSMENT Eye disorders None View
Punctate keratitis SYSTEMATIC_ASSESSMENT Eye disorders None View