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 @ 2:22 AM
Ignite Modification Date: 2025-12-26 @ 12:54 AM
NCT ID: NCT05063734
Description: All Adverse Events were collected from the time the subject provided consent to participate in the study until the end of the study (last study visit) for the subject.
Frequency Threshold: 5
Time Frame: Up to End of Study (up to Month 6 for Part A and up to Month 8 for Part B)
Study: NCT05063734
Study Brief: A Study to Evaluate THR-687 Treatment for Diabetic Macular Oedema.
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Part A, THR-687 1.2mg THR-687: 3 intravitreal injections of THR-687, 1 month apart 0 None 0 7 4 7 View
Part A, THR-687 2.0mg THR-687: 3 intravitreal injections of THR-687, 1 month apart 0 None 0 9 6 9 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Cataract Subcapsular SYSTEMATIC_ASSESSMENT Eye disorders None View
Diabetic Retinal Oedema SYSTEMATIC_ASSESSMENT Eye disorders None View
Optic Disc Haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders None View
Posterior Capsule Opacification SYSTEMATIC_ASSESSMENT Eye disorders None View
Gastroenteritis Viral SYSTEMATIC_ASSESSMENT Infections and infestations None View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Retinal Thickening SYSTEMATIC_ASSESSMENT Eye disorders None View
Visual Acuity Reduced SYSTEMATIC_ASSESSMENT Eye disorders None View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations None View
Intraocular Pressure Increased SYSTEMATIC_ASSESSMENT Investigations None View
Diabetes Mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Cerebrovascular Accident SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Genital Disorder SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View