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 @ 11:49 PM
Ignite Modification Date: 2025-12-25 @ 9:43 PM
NCT ID: NCT02471651
Description: AEs and SAEs were monitored at every visit and recorded.
Frequency Threshold: 0
Time Frame: 12 months.
Study: NCT02471651
Study Brief: Dexamethasone Intravitreal Implant for the Treatment of Persistent Diabetic Macular Edema
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Implant Subjects randomized to dexamethasone intravitreal implant (0.7mg) will receive the initial treatment at Month 3 (visit 4) and Month 6 (visit 7) and are eligible to receive one additional dose at Month 9 (visit 10), Month 10 (visit 11) or Month 11 (visit 12) for persistent or recurrent macular edema documented on SDOCT. If dexamethasone intravitreal implant (0.7mg) is administered at Month 10 (visit 11) or Month 11 (visit 12) an additional safety study visit will be required at one to two months following Month 12 (visit 13). The investigator can withhold treatment with dexamethasone intravitreal implant (0.7mg) beginning at Month 9 if there is complete resolution of diabetic macular edema document on SDOCT. Dexamethasone intravitreal implant (0.7 mg): Subjects with persistent DME who are randomized to this arm may get up to 3 treatments with the implant (0.7 mg dexamethasone). 0 None 1 20 10 20 View
Intravitreal Anti-VEGF Injection Subjects randomized to continue on anti-vegf therapy will receive intravitreal anti-vegf injections at Month 3 (visit 4) Month 4 (visit 5) and Month 5 (visit 6). Beginning at Month 6 (visit 7), subjects who have received 6 intravitreal anti-vegf injections and continue to present with persistent diabetic macular edema defined as less than 10% reduction or any increase in CST compared to baseline values and CST is greater than 300 microns, will receive dexamethasone intravitreal implant (0.7mg) at Month 6 (visit 7) and Month 9 (visit 10). The follow-up period for all subjects will continue through 12 months from the baseline study visit. Intravitreal anti-VEGF injection: This injection may be ranibizumab, bevacizumab, or aflibercept. 0 None 1 20 6 20 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Rhegmatogenous Retinal Detachment SYSTEMATIC_ASSESSMENT Eye disorders None View
Skin graft SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Bronchitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pinched Nerve SYSTEMATIC_ASSESSMENT Nervous system disorders None View
High IOP SYSTEMATIC_ASSESSMENT Eye disorders None View
Eye Pain SYSTEMATIC_ASSESSMENT Eye disorders None View
flu SYSTEMATIC_ASSESSMENT General disorders None View
hypertension SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
subconjunctival irritation SYSTEMATIC_ASSESSMENT Eye disorders None View
vitreous hemorrhage SYSTEMATIC_ASSESSMENT Vascular disorders None View
cold/cough SYSTEMATIC_ASSESSMENT General disorders None View
iron deficiency SYSTEMATIC_ASSESSMENT General disorders None View
Blepharitis SYSTEMATIC_ASSESSMENT Eye disorders None View
viral conjunctivitis SYSTEMATIC_ASSESSMENT Eye disorders None View
eye itchiness SYSTEMATIC_ASSESSMENT Eye disorders None View
Toe infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
general fatigue SYSTEMATIC_ASSESSMENT General disorders None View
stomach virus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
tooth being pulled SYSTEMATIC_ASSESSMENT General disorders None View
headache SYSTEMATIC_ASSESSMENT General disorders None View
leg injury SYSTEMATIC_ASSESSMENT General disorders None View
dry eye SYSTEMATIC_ASSESSMENT Eye disorders None View
tooth ache SYSTEMATIC_ASSESSMENT General disorders None View
active neovascularization SYSTEMATIC_ASSESSMENT Eye disorders None View
Continuing/increased macular edema SYSTEMATIC_ASSESSMENT Vascular disorders None View