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 @ 5:19 PM
Ignite Modification Date: 2025-12-25 @ 2:55 PM
NCT ID: NCT02807350
Description: Although no adverse events are anticipated as a result of overminus therapy or non-overminus spectacle wear, any new cases of amblyopia, constant esotropia, or constant exotropia at distance and near will be reported. No surgical procedures are part of the protocol and no treatments are being prescribed that are not part of usual care. Investigators will abide by local IRB reporting requirements.
Frequency Threshold: 1
Time Frame: 18 months
Study: NCT02807350
Study Brief: Trial of Overminus Spectacle Therapy for Intermittent Exotropia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Overminus Treatment spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere Overminus treatment: spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere 0 None 0 196 47 196 View
Non-overminus Treatment spectacles with full cycloplegic refraction without overminus Non-overminus treatment: spectacles with full cycloplegic refraction without overminus 0 None 0 190 15 190 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Development of Esotropia SYSTEMATIC_ASSESSMENT Eye disorders None View
>1 Diopter of Myopic Shift SYSTEMATIC_ASSESSMENT Eye disorders None View
2 or more line decrease in visual acuity SYSTEMATIC_ASSESSMENT Eye disorders None View
Amblyopia treatment prescribed by 12 months SYSTEMATIC_ASSESSMENT Eye disorders None View