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 @ 2:19 AM
Ignite Modification Date: 2025-12-26 @ 12:50 AM
NCT ID: NCT03320434
Description: Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.
Frequency Threshold: 0
Time Frame: Adverse events were collected through study completion, an average of 9 weeks. All subjects who received study medication were evaluable for the safety analysis.
Study: NCT03320434
Study Brief: Study Evaluating the Efficacy and Safety of PRT-2761 for the Treatment of Acute and Chronic Allergic Conjunctivitis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
PRT-2761 0.5% PRT-2761 0.5%: Six drops in each eye over a 17 day period. 0 None 0 32 4 32 View
PRT-2761 1% PRT-2761 1%: Six drops in each eye over a 17 day period. 0 None 0 29 9 29 View
Patanol Patanol: Six drops in each eye over a 17 day period. 0 None 0 30 1 30 View
PRT-2761 0% PRT-2761 0%: Six drops in each eye over a 17 day period. 0 None 0 29 7 29 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Conjunctival Pigmentation SYSTEMATIC_ASSESSMENT Eye disorders None View
Corneal Opacity SYSTEMATIC_ASSESSMENT Eye disorders None View
Dry Eye SYSTEMATIC_ASSESSMENT Eye disorders None View
Eye Discharge SYSTEMATIC_ASSESSMENT Eye disorders None View
Eyelid Oedema SYSTEMATIC_ASSESSMENT Eye disorders None View
Meibomian Gland Dysfunction SYSTEMATIC_ASSESSMENT Eye disorders None View
Punctate Keratitis SYSTEMATIC_ASSESSMENT Eye disorders None View
Retinal Haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders None View
Visual Acuity Reduced SYSTEMATIC_ASSESSMENT Eye disorders None View
Conjunctival Haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders None View
Skin Discolouration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Abdominal Discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Irritable Bowel Syndrome SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Carpal Tunnel Syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders None View