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 @ 11:39 PM
Ignite Modification Date: 2025-12-25 @ 9:30 PM
NCT ID: NCT03652051
Description: AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
Frequency Threshold: 5
Time Frame: 3 months
Study: NCT03652051
Study Brief: A Multicenter Study Evaluating AZR-MD-001 in Patients With Meibomian Gland Dysfunction and Evaporative Dry Eye Disease (DED)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Stage 1: AZR-MD-001 Low Dose AZR-MD-001 Low Dose was dosed twice weekly. AZR-MD-001 Low Dose: AZR-MD-001 is an ophthalmic ointment 0 None 0 9 2 9 View
Stage 1: AZR-MD-001 Mid Dose AZR-MD-001 Mid Dose was dosed twice weekly. AZR-MD-001 Mid Dose: AZR-MD-001 is an ophthalmic ointment 0 None 0 27 13 27 View
Stage 1: AZR-MD-001 High Dose AZR-MD-001 High Dose was dosed twice weekly. AZR-MD-001 High Dose: AZR-MD-001 is an ophthalmic ointment 0 None 2 24 14 24 View
Stage 1: AZR-MD-001 Vehicle AZR-MD-001 Vehicle was dosed twice weekly. AZR-MD-001 Vehicle: AZR-MD-001 is a vehicle ophthalmic ointment 0 None 0 16 4 16 View
Stage 2: AZR-MD-001 Vehicle AZR-MD-001 Vehicle was dosed twice weekly. AZR-MD-001 Vehicle: AZR-MD-001 is a vehicle ophthalmic ointment 0 None 2 80 8 80 View
Stage 2: AZR-MD-001 Mid Dose AZR-MD-001 Mid Dose was dosed twice weekly. AZR-MD-001 Mid Dose: AZR-MD-001 is an ophthalmic ointment 0 None 1 82 54 82 View
Stage 2: AZR-MD-001 High Dose AZR-MD-001 High Dose was dosed twice weekly. AZR-MD-001 High Dose: AZR-MD-001 is an ophthalmic ointment 0 None 1 83 60 83 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 25.0 View
Pericarditis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA version 25.0 View
Thyroid mass SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA version 25.0 View
Post procedural haemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 25.0 View
n intervertebral disc protrusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version 25.0 View
ocular toxicity SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 25.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Eye irritation SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 25.0 View
Photophobia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 25.0 View
Application site pain SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 25.0 View
Lacrimation increased SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 25.0 View
Punctate keratitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 25.0 View
Vital dye staining cornea present SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 25.0 View
Eye pain SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 25.0 View
Application site reaction SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 25.0 View
Foreign body sensation SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 25.0 View
Administration site reaction SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 25.0 View
Eye inflammation SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 25.0 View
Application site irritation SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 25.0 View