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 @ 3:30 AM
Ignite Modification Date: 2025-12-26 @ 2:12 AM
NCT ID: NCT02477605
Description: An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.
Frequency Threshold: 5
Time Frame: Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months).
Study: NCT02477605
Study Brief: Clinical Comparison of 27+® and 23-gauge ULTRAVIT® 7500 Cpm Vitrectomy Outcomes
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
27-Gauge Treated Eye Ocular events, treated (study) eye 0 None 15 66 18 66 View
27-Gauge Fellow Eye Ocular events, untreated (fellow) eye 0 None 0 66 0 66 View
27-Gauge Systemic Non-ocular adverse events 0 None 0 66 0 66 View
23-Gauge Treated Eye Ocular events, treated (study) eye 0 None 16 69 14 69 View
23-Gauge Fellow Eye Ocular events, untreated (fellow) eye 0 None 0 69 0 69 View
23-Gauge Systemic Non-ocular adverse events 0 None 1 69 0 69 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hypotony of eye SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (18.0) View
Retinal detachment SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (18.0) View
Visual acuity reduced SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (18.0) View
Cerebral haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (18.0) View
Eye operation SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA (18.0) View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (18.0) View
Macular fibrosis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (18.0) View
Macular hole SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (18.0) View
Retinal tear SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (18.0) View
Retinopathy proliferative SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (18.0) View
Vitreous haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (18.0) View
Intraocular pressure decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA (18.0) View
Craniotomy SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA (18.0) View
Eye laser surgery SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA (18.0) View
Retinal laser coagulation SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA (18.0) View
Retinal operation SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA (18.0) View
Vitrectomy SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA (18.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Conjunctival haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (18.0) View
Conjunctival oedema SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (18.0) View
Punctate keratitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (18.0) View
Intraocular pressure increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (18.0) View