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 @ 11:33 PM
Ignite Modification Date: 2025-12-25 @ 9:21 PM
NCT ID: NCT02767856
Description: Reverse amblyopia: defined as two or more logMAR lines worse in the fellow non-amblyopic eye at the primary visit; significant changes in ocular alignment: defined as deviation changes of ≥10Δ; any injury associated with IO-therapy glasses or the microsensor.
Frequency Threshold: 0
Time Frame: From enrollment until the primary outcome visit and the follow-up visits. For the Intense Group, the primary outcome visit is at 4 weeks, and they also follow up at 12 weeks; for the Standard group, the primary outcome visit is at 12 weeks, if improved, they follow up at 24 weeks.
Study: NCT02767856
Study Brief: Regimens of Intermittent Occlusion Therapy for Amblyopia in Children
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Intense 12-hour IO-therapy Group Participants wear 12-hour daily IO-therapy glasses for 4 weeks IO-therapy Glasses 0 None 0 7 0 7 View
Standard 4-hour IO-therapy Group Participants wear 4-hour daily IO-therapy glasses for 12 weeks IO-therapy Glasses 0 None 0 12 0 12 View
Serious Events(If Any):
Other Events(If Any):