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 @ 4:31 PM
Ignite Modification Date: 2025-12-25 @ 2:23 PM
NCT ID: NCT02521766
Description: Safety Analysis Population: All eyes with attempted study lens (HMIOL) implantation (successful or aborted after contact with the eye).
Frequency Threshold: 5
Time Frame: Adverse events (AEs) were collected from time of consent until study: Cohort 1: Up to 15 months, including a Day -90 to Day -1 preoperative period and a 12 month post-operative follow-up period. Cohort 2: Up to 18 months, including a Day -90 to Day -1 preoperative period, an optic exchange at Month 3 postoperative, and a 12 month post-exchange follow-up period. "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Study: NCT02521766
Study Brief: A Clinical Investigation of the ClarVista HARMONI™ Modular Intraocular Lens Implant Following Cataract Surgery
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Cohort 1 (Ocular) HMIOL implantation with no optic exchange Events reported in this group occurred in the study eye from time of consent to study exit (up to 15 months) 0 None 2 51 2 51 View
Cohort 2 Pre-exchange (Ocular) HMIOL implantation pre-optic exchange Events reported in this group occurred in the study eye from time of consent to time of optic exchange (up to 6 months) 0 None 2 65 1 65 View
Cohort 2 Post-exchange (Ocular) HMIOL implantation post-optic exchange Events reported in this group occurred in the study eye from time of optic exchange to time of study exit (up to 12 months) 0 None 0 65 6 65 View
Fellow Eye (Ocular) IOL per standard of care Events reported in this group occurred in the fellow eye from time of consent to study exit (up to 15 months if study eye was enrolled in Cohort 1, up to 18 months if study eye was enrolled in Cohort 2) 0 None 2 114 5 114 View
Systemic (Non-ocular) Events reported in this group occurred from time of consent to study exit (up to 15 months if subject was enrolled in Cohort 1, up to 18 months if subject was enrolled in Cohort 2) 0 None 4 114 0 114 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Neovascular age-related macular degeneration SYSTEMATIC_ASSESSMENT Eye disorders None View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Endophthalmitis SYSTEMATIC_ASSESSMENT Eye disorders None View
Posterior Capsule Rupture SYSTEMATIC_ASSESSMENT Eye disorders None View
Breast cancer stage II SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Parkinsonism SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Eye operation SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Intraocular lens implant SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Surgery SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dry eye SYSTEMATIC_ASSESSMENT Eye disorders None View