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 @ 2:17 AM
Ignite Modification Date: 2025-12-26 @ 12:47 AM
NCT ID: NCT00958360
Description: This is a low risk non-interventional study. Adverse events were pre-specified in the case report forms and assessed at the 4-month follow-up interview by self-reporting by participants or notification by a family member.
Frequency Threshold: 0
Time Frame: Adverse event data was collected from inception of the study to 4-month follow-up.
Study: NCT00958360
Study Brief: Low Vision Intervention Trial II (LOVIT II)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Interdisciplinary Low Vision Rehabilitation Group Interdisciplinary Low Vision Rehabilitation: Low vision examination, prescription and dispensing of low vision devices, low vision therapy and homework. Interdisciplinary Low Vision Service: Services are provided by optometrist(s) and low vision therapist(s), and include low vision therapy to improve use of remaining vision and low vision devices, and structured homework to practice use of low vision devices that are prescribed and dispensed. None None 27 163 10 163 View
Basic Low Vision Care Group Basic Low Vision Care: Low vision examination, prescription and dispensing of low vision devices without low vision therapy or assigned homework. Basic Low Vision Service: Service is provided by the optometrist alone and includes demonstration of low vision device use and maintenance of prescribed low vision devices, without low vision therapy or homework and with less contact time. None None 29 160 1 160 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Non-study related Death NON_SYSTEMATIC_ASSESSMENT General disorders None View
Non-study related Prolonged Hospitalization NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Non-study related Prolonged Hospitalization NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Non-study related Prolonged Hospitalization NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Non-study related Prolonged Hospitalization NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Non-study related Prolonged Hospitalization NON_SYSTEMATIC_ASSESSMENT General disorders None View
Non-study related Prolonged Hospitalization NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Non-study related Prolonged Hospitalization NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Non-study related Prolonged Hospitalization NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Non-study related Prolonged Hospitalization NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Non-study related Prolonged Hospitalization NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
other health reason NON_SYSTEMATIC_ASSESSMENT General disorders None View
eye hemorrhage NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
CME NON_SYSTEMATIC_ASSESSMENT Eye disorders None View